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Medical Forum / General / Alternative / May 2006Antidepressant May Raise Suicide Risk SMITHKLINE
The New York Times Printer Friendly Format Sponsored By May 12, 2006 Antidepressant May Raise Suicide Risk By BENEDICT CAREY and GARDINER HARRIS After analyzing data from clinical trials, GlaxoSmithKline has sent letters to doctors warning that its antidepressant drug Paxil appears to increase the risk of suicide attempts in some young adults. The company said it had changed the labeling on the drug to reflect the finding of the study, which analyzed clinical trial data involving some 15,000 people. The study found that reported suicide attempts were rare but significantly more common in adults who took the drug for depression than in those who received placebo pills. The Glaxo researchers reported only one suicide in the trials, a number so small it says nothing about the drug's risk, experts said. In October 2004, the Food and Drug Administration ordered drug companies to place a strong warning on antidepressant labels after studies suggested that some drugs increased suicidal thinking or behavior in children and adolescents. But the Glaxo study - the first by a drug company to find a link between antidepressants and suicidal behavior in adults, experts say - is likely to persuade some skeptics that the risk is real and not confined to minors. The studies of children and adolescents found mainly evidence of suicidal thinking and agitation. There were no completed suicides reported. In a statement issued this week, the F.D.A. said that though it was still evaluating the data, "we are recommending that consumers and prescribers follow current advice to carefully observe adults being treated with antidepressants for worsening of depression and for increased suicidal thinking and behavior." The statement said, "It is essential that patients taking Paxil do not suddenly stop taking their medication." Last year, the agency asked psychiatric drug makers to review all their data on side effects in adults after a prolonged international debate over whether antidepressant drugs increase the risk of suicide in some children. Other companies have not yet reported their findings. "This is the first analysis to show a relationship between suicide attempts and one of the antidepressants" since the F.D.A. required the warning label for children and adolescents, said Kelly Posner, an assistant professor in the department of child psychiatry at Columbia, who has helped the agency interpret bad reactions to antidepressants. Dr. Posner said the Glaxo findings should be treated with caution, because the antidepressant trials done to date were not designed to evaluate suicide risk. "It's not clear that the drug caused the behavior," she said. Glaxo sent out the warnings voluntarily, and its data still show that the drug's benefits outweigh the risks for people with depression, said Mary Anne Rhyne, a company spokeswoman. "We are now advising doctors to monitor all patients to make sure their symptoms don't worsen" in the full course of treatment, Ms. Rhyne said. Previous research has suggested that the risk of suicidal thinking or behavior was highest in the first few weeks of treatment, or when people went off the medication. One large review of antidepressant trials, published last year in BMJ, a British medical journal, found that people taking Paxil and similar drugs like Prozac reported suicide attempts more often. But experts have debated the interpretation and value of these findings. In the Glaxo analysis, the researchers analyzed trials that included 8,958 people who took Paxil and 5,953 who received placebo pills. The study participants ranged in age from 18 to 64 years old and were taking the medication for depression or other disorders, like panic attacks and obsessive compulsive disorder. The analysis found that 11 of 3,455 people who were taking Paxil for depression reported an attempted suicide, compared with 1 in 1,978 taking placebo in the trials. Most were among adults ages 18 to 30, the company said. Over all, the analysis found no increased risk of suicidal behavior in adults over 30. "The new findings are not going to change my practice a lot, but I say, yes, they provide a reason to do even more careful monitoring of people on the medication," said Dr. George Simpson, a professor in psychiatry and behavioral sciences at the Keck School of Medicine at the University of Southern California. Dr. Simpson said the warning underscored the need for more careful tracking of side effects once drugs went on the market. "The current system of postmarketing surveillance is lousy," he said. Home * World * U.S. * N.Y. / Region * Business * Technology * Science * Health * Sports * Opinion * Arts * Style * Travel * Jobs * Real Estate * Autos * Back to Top Copyright 2006 The New York Times Company * Privacy Policy * Search * Corrections * XML * Help * Contact Us * Work for Us * Site Map This research is a testament to the SSRI's ability to treat physiological signs and symptoms of depression. The numbers are very low but do suggest that the SSRI's do give a boost in energy that can provide the lift a suicidal person suffering from extreme depression needs to commit suicide. This is nothing new. TCA's were known for the same thing. Trained psychiatric nurses know that often, the most dangerous time for a severely depressed person is the point where they start to show improvement. The big question here is whether or not this can be considered a "side effect" of the medication. After all, in the scenario where a person commits suicide after being treated with anti-depressants, the person has been getting better, thanks to the medication. Thus the drug is having the desired chemical effect, but the person is using that effect in a maladaptive way.  SignatureTo forget one's purpose is the commonest form of stupidity. Friedrich Nietzsche On 5/12/06 3:57 AM, in article 1147424278.783824.31450@g10g2000cwb.googlegroups.com, "Kathleen" <kathleen.dickson@snet.net> wrote: > The analysis found that 11 of 3,455 people who were taking Paxil for > depression reported an attempted suicide, compared with 1 in 1,978 [quoted text clipped - 3 lines] > Over all, the analysis found no increased risk of suicidal behavior in > adults over 30. True. Classic teaching preaches caution of suicide after starting ANY anti-depressant for the reason you state below. > This research is a testament to the SSRI's ability to treat physiological > signs and symptoms of depression. The numbers are very low but do suggest [quoted text clipped - 19 lines] >> Over all, the analysis found no increased risk of suicidal behavior in >> adults over 30. The assertion is that taking an Antidepressant 'may' RAISE suicide risk; and that the MOST dangerous time for suicide is when a severely depressed person is starting to show improvement after beginning SSRI treatment. Let's take a look at this for a minute and see if I have my assumptions here correct. 1) Untreated, severely depressed people attempt suicide. 2) Untreated, severely depressed people attempt suicide more often than people who have fully adjusted to SSRI treatment. 3) Trained psychiatric nurses know that "often" the MOST dangerous time for a severely depressed person is the point where they start to show improvement? A) Most dangerous? Which is MORE dangerous than what other time? (3.a.1) BEFORE they even start taking medication? (3.a.2) From the subject title above, it is the 'Antidepressant' which is being fingered as the cause of a Raise in a Suicide RISK. I say, BULLSHIT !! 1. Untreated people who are left to linger in deep depression alone are at the highest risk of suicide. 2. People who begin taking antidepressant medication also need counseling at the same time. 3. The 'pill' is not the magic bullet, cure all. 4. It takes time for medication to even begin to work (2 weeks at least). 5. If the patient is not being counseled or monitored, they are will be expecting 'quicker results'. 6. SSRI medication is begun at the lowest possible dosage. 7. SSRI is increased slowly, over time. 8. It could take months to achieve the level required, especially for 'severely depressed patients. 9. Uncounseled patients can easily forget is will take time, become impatient and discouraged. Trying to blame someone's suicide at the very early stages of beginning an SSRI medication is BULLSHIT, just pure and simple. ===================== > This research is a testament to the SSRI's ability to treat physiological > signs and symptoms of depression. The numbers are very low but do suggest [quoted text clipped - 27 lines] > > Over all, the analysis found no increased risk of suicidal behavior in > > adults over 30. > The assertion is that taking an Antidepressant 'may' RAISE suicide risk; > and that the MOST dangerous time for suicide is when a severely depressed [quoted text clipped - 37 lines] > Trying to blame someone's suicide at the very early stages of beginning an > SSRI medication is BULLSHIT, just pure and simple. Do you have something to back that up with? Psychiatric literature disagrees. I'm not going to spend any of my delving into it to find a reference, but they have them to quote. The thinking is that these depressed people are so lethargic they often lack motivation and initiative to make a plan for suicide and follow it through. When treatment kicks in, they still hate their lives, but are now less lethargic and maybe enough to so make a good plan and act on it. Down the road, if they're continuuing to do well, they may have gotten some of their life put back together and have incentive to end their life. > > The assertion is that taking an Antidepressant 'may' RAISE suicide risk; > > and that the MOST dangerous time for suicide is when a severely depressed [quoted text clipped - 47 lines] > do well, they may have gotten some of their life put back together and have > incentive to end their life. ================= Any person who is that 'lethargic' should never be left unsupervised/monitored/counseled/supported. Tossing pills at a person in that condition is like just putting a Band-Aid over a nicked artery and then walking away, hoping they don't bleed to death out of sight of emergency help. In that case the Band-Aid certainly wouldn't have 'raised the risk' of the person bleeding to death. See my point? >> > The assertion is that taking an Antidepressant 'may' RAISE suicide > risk; [quoted text clipped - 64 lines] > ================= > Any person who is that 'lethargic' should never be left "that lethargic"? I didn't give any clinical criteria with that. It is generally believed many depressed who would like to kill themselves are too depressed, or "lethargic" to go about doing so. > unsupervised/monitored/counseled/supported. > [quoted text clipped - 3 lines] > death > out of sight of emergency help. I didn't advocate that treatment, just commented it. > In that case the Band-Aid certainly wouldn't have 'raised the risk' of the > person bleeding to death. > See my point? What I see is the absence of any data to back your statement of "BULLSHIT" up above. > > The assertion is that taking an Antidepressant 'may' RAISE suicide risk; > > and that the MOST dangerous time for suicide is when a severely depressed [quoted text clipped - 47 lines] > do well, they may have gotten some of their life put back together and have > incentive to end their life. Most of the time, anti-depressants will work much better for a true chemical imbalance than it will for a person who just has a f.cked up life. I had major depression for 1 1/2 years before I got help-and I'm damn glad I did. The medicine (Paxil) worked wonders for me. > > > The assertion is that taking an Antidepressant 'may' RAISE suicide > risk; [quoted text clipped - 64 lines] > I had major depression for 1 1/2 years before I got help-and I'm damn glad I > did. The medicine (Paxil) worked wonders for me. You make a wonderful point! > The assertion is that taking an Antidepressant 'may' RAISE suicide risk; > and that the MOST dangerous time for suicide is when a severely depressed > person is starting to show improvement after beginning SSRI treatment. That assertion is TRUE. http://www.businessweek.com/ap/financialnews/D8HIB6EO0.htm?campaign_id=apn_home_ down&chan=db http://www.msnbc.msn.com/id/5989348/ > Let's take a look at this for a minute and see if I have my assumptions > here [quoted text clipped - 69 lines] >> > Over all, the analysis found no increased risk of suicidal behavior in >> > adults over 30. I still say "BULLSHIT". We used to lock people up for their own safety when they got that depressed, but President Reagan turned them loose so years later medication could be blamed for society's lack of comprehensive care. > > The assertion is that taking an Antidepressant 'may' RAISE suicide risk; > > and that the MOST dangerous time for suicide is when a severely depressed > > person is starting to show improvement after beginning SSRI treatment. > > That assertion is TRUE. http://www.businessweek.com/ap/financialnews/D8HIB6EO0.htm?campaign_id=apn_h ome_down&chan=db > http://www.msnbc.msn.com/id/5989348/ > > [quoted text clipped - 71 lines] > >> > Over all, the analysis found no increased risk of suicidal behavior in > >> > adults over 30. > I still say "BULLSHIT". As skeptic pointed out, when the antidepressants begin to kick in, the person's motivation is restored. However, the suicide ideation remains, and, this, coupled with restored motivation can be deadly. This is the most dangerous time. > We used to lock people up for their own safety when they got that depressed, > but President Reagan turned them loose so years later medication could be [quoted text clipped - 91 lines] > in >>>>> adults over 30. <snip> >> I still say "BULLSHIT". >>>> The assertion is that taking an Antidepressant 'may' RAISE suicide >> risk; >>>> and that the MOST dangerous time for suicide is when a severely >> depressed >>>> person is starting to show improvement after beginning SSRI treatment. >>> That assertion is TRUE. Let's look at the facts, and not the ASSumptions nor the screamed *bullshit*! http://www.businessweek.com/ap/financialnews/D8HIB6EO0.htm?campaign_id=apn_h%20o me_down&chan=dbFACT:FDA warns of suicide risks for Paxil. http://www.msnbc.msn.com/id/5989348/FACT:FDA calls for warning on antidepressantshttp://www.mayoclinic.com/health/antidepressants/MH00059FACT: about your child's health.Why do antidepressants need warnings that they are linked to suicidalbehavior in children and adolescents?Federal authorities say that an extensive analysis of clinical trials showsthat antidepressants may increase the risk of suicidal thinking or behaviorin children, particularly in the early months of treatment of depression orother psychiatric illnesses.The Food and Drug Administration (FDA) commissioned researchers to analyze atotal of 24 clinical trials involving more than 4,400 children who weretaking antidepressants for various psychiatric illnesses, includingdepression and anxiety disorders, such as obsessive-compulsive disorder(OCD). According to the FDA, the analysis showed that children takingantidepressants had about a 4 percent chance of developing suicidal thoughtsor behavior, compared to only 2 percent in children taking a placebo. Noneof the children in any of the studies committed suicide.Still, the FDA considers the findings so disturbing that in October 2004 itissued a public health advisory and began requiring manufacturers ofantidepressants to label them with strong warnings about the link to suicidein children.http://vanderbiltowc.wellsource.com/dh/content.asp?ID=1550FACTS:Antidepressant Drugs Associated with Suicidal ThoughtsBy Larry Axmaker, EdD, PhDThe labels on all antidepressant drugs are now required by the U.S. Food andDrug Administration (FDA) to include a boxed warning and expanded warningstatements that alert people to an increased risk of suicidality (suicidalthinking and behavior) in children and adolescents being treated with theseagents.Physicians, their patients, families, and caregivers of patients need toclosely monitor the use of prescription antidepressants in both adults andchildren with depression, especially at the beginning of treatment, or whenthe doses are changed - either an increase or decrease in the dose.The increased warnings were prompted by the results of antidepressantstudies in children. The risk of suicidality for these drugs was identifiedin a combined analysis of short-term (up to four months) placebo-controlledtrials of nine antidepressant drugs, including the selective serotoninreuptake inhibitors (SSRIs) and others, in children and adolescents withmajor depressive disorder (MDD), obsessive compulsive disorder (OCD), orother psychiatric disorders.A total of 24 trials involving more than 4,400 patients were included. Theanalysis showed a greater risk of suicidality during the first few months oftreatment in those receiving antidepressants. The average risk of suchevents on drug was four percent - twice the placebo risk of two percent. Nosuicides occurred in these trials.WarningBased on these data, FDA has determined that the following points areappropriate for inclusion in the boxed warning: a.. Antidepressants increase the risk of suicidal thinking and behavior(suicidality) in children and adolescents with MDD and other psychiatricdisorders. b.. Anyone considering the use of an antidepressant in a child oradolescent for any clinical use must balance the risk of increasedsuicidality with the clinical need. c.. Patients who are started on therapy should be observed closely forclinical worsening, suicidality, or unusual changes in behavior. d.. Families and caregivers should be advised to closely observe thepatient and to communicate with the prescribing physician. e.. A statement regarding whether the particular drug is approved for anypediatric indication(s) and, if so, which one(s).The only one of these drugs that has currently received approval for use inchildren with MDD is fluoxetine (Prozac). Prozac, Zoloft, Luvox, andAnafranil are approved for OCD in pediatric patients. None of the drugs isapproved for other psychiatric indications in children.The drugs receiving a boxed warning, other product labling changes, and aMedication Guide pertaining to pediatric suicidality: Anafranil (clomipramine HCl) Marplan (isocarboxazid) Sinequan (doxepin HCl) Aventyl (nortriptyline HCl) Nardil (phenelzine sulfate) Surmontil (trimipramine) Celexa (citalopram HBr) Norpramin (desipramine HCl) Symbyax (olanzapine/ fluoxetine) Cymbalta (duloxetine HCl) Pamelor (nortriptyline HCl) Tofranil (imipramine HCl) Desyrel (trazodone HCl) Parnate (tranylcypromine sulfate) Tofranil-PM (impiramine pamoate) Effexor (venlafaxine HCl) Paxil (paroxetine HCl) Triavil (Perphenaine/ Amitriptyline) Elavil (amitriptyline HCl) Pexeva (paroxetine mesylate) Vivactil (protriptyline HCl) Lexapro (escitalopram oxalate) Prozac (fluoxetine HCl) Wellbutrin (bupropion HCl) Limbitrol (chlordiazepoxide/ amitriptyline) Remeron (mirtazapine) Zoloft (sertraline HCl) Ludiomil (Maprotiline HCl) Sarafem (fluoxetine HCl) Zyban (bupropion HCl) Luvox (fluvoxamine maleate) Serzone (nefazodone HCl)What to Watch For a.. Pediatric patients being treated with antidepressants for anyindication should be closely observed for clinical worsening, as well asagitation, irritability, suicidality, and unusual changes in behavior,especially during the initial few months of a course of drug therapy, or attimes of dose changes, either increases or decreases. b.. Heathcare providers should carefully evaluate patients in whomdepression persistently worsens, or emergent suicidality is severe, abruptin onset, or was not part of the presenting symptoms, to determine whatintervention, including discontinuing or modifying the current drug therapy,is indicated. This is especially the case at the beginning of therapy ofwhen the dose is changed. c.. Anxiety, agitation, panic attacks, insomnia, irritability, hostility,impulsivity, akathisia (severe restlessness), hypomania, and mania have beenreported in adult and pediatric patients being treated with antidepressantsfor major depressive disorder as well as for other indications. Therapyshould be evaluated, and medications may need to be discontinued, whensymptoms are severe, abrupt in onset, or were not part of the patient'spresenting symptoms. d.. If a decision is made to discontinue treatment, some of thesemedications should be tapered rather than stopped abruptly (see labeling forindividual drug products for details). e.. Because antidepressants are believed to have the potential forinducing manic episodes in patients with bipolar disorder, there is aconcern about using antidepressants alone for these indviduals. Therefore,patients should be adequately screened to determine if they are at risk forbipolar disorder before initiating antidepressant treatment. f.. Healthcare providers should instruct patients, their families, andtheir caregivers to be alert for the emergence of agitation, irritability,and the other symptoms described above, as well as the emergence ofsuicidality and worsening depression, and to report such symptomsimmediately to their healthcare provider.Bottom LineIf you or someone close to you takes prescription antidepressants, it isimperative to be watchful, careful, and report any possible problems orchanges to a doctor.Sources: 1. FDA Public Health Advisory. October 15, 2004. Suicidality in Childrenand Adolescents Being Treated With Antidepressant Medications. Available at:http://www.fda.gov/ cder/drug/ antidepressants/ SSRIPHA200410.htm. AccessedMarch 12, 2006. 2. FDA Talk Paper. March 22, 2004. FDA Issues Public Health Advisory onCautions for Use of Antidepressants in Adults and Children. Available onlineat: http://www.fda.gov/bbs/ topics/ANSWERS/ 2004/ANS01283.html. AccessedMarch 12, 2006.>>>> Let's take a look at this for a minute and see if I have my assumptions>>>> here>>>> correct.>>>>>>>> 1) Untreated, severely depressed people attempt suicide.>>>> 2) Untreated, severely depressed people attempt suicide more oftenthan>>>> people who have fully adjusted to SSRI treatment.>>>> 3) Trained psychiatric nurses know that "often" the MOST dangeroustime>>>> for>>>> a severely depressed person is the point where they start to show>>>> improvement?>>>> A) Most dangerous? Which is MORE dangerous than what other time?>>>> (3.a.1) BEFORE they even start taking medication?>>>> (3.a.2) From the subject title above, it is the>>>> 'Antidepressant'>>>> which is being fingered as the cause of a Raisein>>>> a Suicide RISK.>>>>>>>> I say, BULLSHIT !!>>>> 1. Untreated people who are left to linger in deep depression aloneare>>>> at>>>> the highest risk of suicide.>>>> 2. People who begin taking antidepressant medication also need>> counseling>>>> at the same time.>>>> 3. The 'pill' is not the magic bullet, cure all.>>>> 4. It takes time for medication to even begin to work (2 weeks at>> least).>>>> 5. If the patient is not being counseled or monitored, they are will>> be>>>> expecting 'quicker results'.>>>> 6. SSRI medication is begun at the lowest possible dosage.>>>> 7. SSRI is increased slowly, over time.>>>> 8. It could take months to achieve the level required, especially for>>>> 'severely depressed patients.>>>> 9. Uncounseled patients can easily forget is will take time, become>>>> impatient and discouraged.>>>>>>>> Trying to blame someone's suicide at the very early stages of beginning>> an>>>> SSRI medication is BULLSHIT, just pure and simple.>>>>>>>>>>>>>>>> =====================>>>> "Rick Morris" <wmorris@neb.rr.com> wrote in message>>>> news:C08A1551.F384%wmorris@neb.rr.com...>>>>> This research is a testament to the SSRI's ability to treat>> physiological>>>>> signs and symptoms of depression. The numbers are very low but do>> suggest>>>>> that the SSRI's do give a boost in energy that can provide the lift a>>>>> suicidal person suffering from extreme depression needs to commit>>>>> suicide.>>>>> This is nothing new. TCA's were known for the same thing. Trained>>>>> psychiatric nurses know that often, the most dangerous time for a>>>>> severely>>>>> depressed person is the point where they start to show improvement.>>>>>>>>>> The big question here is whether or not this can be considered a "side>>>>> effect" of the medication. After all, in the scenario where a person>>>> commits>>>>> suicide after being treated with anti-depressants, the person has been>>>>> getting better, thanks to the medication. Thus the drug is having the>>>>> desired chemical effect, but the person is using that effect in a>>>>> maladaptive way.>>>>>>>>>>>>>>> -->>>>> To forget one's purpose is the commonest form of stupidity.>>>>>>>>>> Friedrich Nietzsche>>>>>>>>>>>>>>>>>>>> On 5/12/06 3:57 AM, in article>>>>> 1147424278.783824.31450@g10g2000cwb.googlegroups.com, "Kathleen">>>>> <kathleen.dickson@snet.net> wrote:>>>>>>>>>>> The analysis found that 11 of 3,455 people who were taking Paxil for>>>>>> depression reported an attempted suicide, compared with 1 in 1,978>>>>>> taking placebo in the trials. Most were among adults ages 18 to 30,>> the>>>>>> company said.>>>>>>>>>>>> Over all, the analysis found no increased risk of suicidal behavior>> in>>>>>> adults over 30.>>>>>>>>> Jan Drew barfed: > <snip> Restored: As skeptic pointed out, when the antidepressants begin to kick in, the person's motivation is restored. However, the suicide ideation remains, and, this, coupled with restored motivation can be deadly. This is the most dangerous time. What is YOUR purpose of snipping what I said and leaving my attribution line? If you were feebly attempting to make it look like I was criticizing Coleah in a nasty manner, then you were being dishonest. So, what was your purpose for what you did? >>> I still say "BULLSHIT". > [quoted text clipped - 9 lines] > > http://www.businessweek.com/ap/financialnews/D8HIB6EO0.htm?campaign_id=apn_h%20o me_down&chan=dbFACT:FDA warns of suicide risks for Paxil. http://www.msnbc.msn.com/id/5989348/FACT:FDA calls for warning on antidepressantshttp://www.mayoclinic.com/health/antidepressants/MH00059FACT: about your child's health.Why do antidepressants need warnings that they are linked to suicidalbehavior in children and adolescents?Federal authorities say that an extensive analysis of clinical trials showsthat antidepressants may increase the risk of suicidal thinking or behaviorin children, particularly in the early months of treatment of depression orother psychiatric illnesses.The Food and Drug Administration (FDA) commissioned researchers to analyze atotal of 24 clinical trials involving more than 4,400 children who weretaking antidepressants for various psychiatric illnesses, includingdepression and anxiety disorders, such as obsessive-compulsive disorder(OCD). According to the FDA, the analysis showed that children takingantidepressants had about a 4 percent chance of developing suicidal thoughtsor behavior, compared to only 2 percent in children taking a placebo. Noneof the children in any of the studies committed suicide.Still, the FDA considers the findings so disturbing that in October 2004 itissued a public health advisory and began requiring manufacturers ofantidepressants to label them with strong warnings about the link to suicidein children.http://vanderbiltowc.wellsource.com/dh/content.asp?ID=1550FACTS:Antidepressant Drugs Associated with Suicidal ThoughtsBy Larry Axmaker, EdD, PhDThe labels on all antidepressant drugs are now required by the U.S. Food andDrug Administration (FDA) to include a boxed warning and expanded warningstatements that alert people to an increased risk of suicidality (suicidalthinking and behavior) in children and adolescents being treated with theseagents.Physicians, their patients, families, and caregivers of patients need toclosely monitor the use of prescription antidepressants in both adults andchildren with depression, especially at the beginning of treatment, or whenthe doses are changed - either an increase or decrease in the dose.The increased warnings were prompted by the results of antidepressantstudies in children. The risk of suicidality for these drugs was identifiedin a combined analysis of short-term (up to four months) placebo-controlledtrials of nine antidepressant drugs, including the selective serotoninreuptake inhibitors (SSRIs) and others, in children and adolescents withmajor depressive disorder (MDD), obsessive compulsive disorder (OCD), orother psychiatric disorders.A total of 24 trials involving more than 4,400 patients were included. Theanalysis showed a greater risk of suicidality during the first few months oftreatment in those receiving antidepressants. The average risk of suchevents on drug was four percent - twice the placebo risk of two percent. Nosuicides occurre d in these trials.WarningBased on these data, FDA has determined that the following points areappropriate for inclusion in the boxed warning: a.. Antidepressants increase the risk of suicidal thinking and behavior(suicidality) in children and adolescents with MDD and other psychiatricdisorders. b.. Anyone considering the use of an antidepressant in a child oradolescent for any clinical use must balance the risk of increasedsuicidality with the clinical need. c.. Patients who are started on therapy should be observed closely forclinical worsening, suicidality, or unusual changes in behavior. d.. Families and caregivers should be advised to closely observe thepatient and to communicate with the prescribing physician. e.. A statement regarding whether the particular drug is approved for anypediatric indication(s) and, if so, which one(s).The only one of these drugs that has currently received approval for use inchildren with MDD is fluoxetine (Prozac). Prozac, Zoloft, Luvox , andAnafranil are approved for OCD in pediatric patients. None of the drugs isapproved for other psychiatric indications in children.The drugs receiving a boxed warning, other product labling changes, and aMedication Guide pertaining to pediatric suicidality: Anafranil (clomipramine HCl) Marplan (isocarboxazid) Sinequan (doxepin HCl) Aventyl (nortriptyline HCl) Nardil (phenelzine sulfate) Surmontil (trimipramine) Celexa (citalopram HBr) Norpramin (desipramine HCl) Symbyax (olanzapine/ fluoxetine) Cymbalta (duloxetine HCl) Pamelor (nortriptyline HCl) Tofranil (imipramine HCl) Desyrel (trazodone HCl) Parnate (tranylcypromine sulfate) Tofranil-PM (impiramine pamoate) Effexor (venlafaxine HCl) Paxil (paroxetine HCl) Triavil (Perphenaine/ Amitriptyline) Elavil (amitriptyline HCl) Pexeva (paroxetine mesylate) Vivactil (protriptylin e HCl) Lexapro (escitalopram oxalate) Prozac (fluoxetine HCl) Wellbutrin (bupropion HCl) Limbitrol (chlordiazepoxide/ amitriptyline) Remeron (mirtazapine) Zoloft (sertraline HCl) Ludiomil (Maprotiline HCl) Sarafem (fluoxetine HCl) Zyban (bupropion HCl) Luvox (fluvoxamine maleate) Serzone (nefazodone HCl)What to Watch For a.. Pediatric patients being treated with antidepressants for anyindication should be closely observed for clinical worsening, as well asagitation, irritability, suicidality, and unusual changes in behavior,especially during the initial few months of a course of drug therapy, or attimes of dose changes, either increases or decreases. b.. Heathcare providers should carefully evaluate patients in whomdepression persistently worsens, or emergent suicidality is severe, abruptin onset, or was not part of the presenting symptoms, to determine whatintervention, including discontinuing or modifying the current drug therapy,is indicated. This is especially the case at the beginning of therapy ofwhen the dose is changed. c.. Anxiety, agitation, panic attacks, insomnia, irritability, hostility,impulsivity, akathisia (severe restlessness), hypomania, and mania have beenreported in adult and pediatric patients being treated with antidepressantsfor major depressive disorder as well as for other indications. Therapyshould be evaluated, and medications may need to be discontinued, whensymptoms are severe, abrupt in onset, or were not part of the patient'spresenting symptoms. d.. If a decision is made to discontinue treatment, some of thesemedications should be tapered rather than stopped abruptly (see labeling forindividual drug products for details). e.. Because antidepressants are believed to have the potential forinducing manic episodes in patients with bipolar disorder, there is aconcern about using antidepressants alone for these indviduals. Therefore,pati ents should be adequately screened to determine if they are at risk forbipolar disorder before initiating antidepressant treatment. f.. Healthcare providers should instruct patients, their families, andtheir caregivers to be alert for the emergence of agitation, irritability,and the other symptoms described above, as well as the emergence ofsuicidality and worsening depression, and to report such symptomsimmediately to their healthcare provider.Bottom LineIf you or someone close to you takes prescription antidepressants, it isimperative to be watchful, careful, and report any possible problems orchanges to a doctor.Sources: 1. FDA Public Health Advisory. October 15, 2004. Suicidality in Childrenand Adolescents Being Treated With Antidepressant Medications. Available at:http://www.fda.gov/ cder/drug/ antidepressants/ SSRIPHA200410.htm. AccessedMarch 12, 2006. 2. FDA Talk Paper. March 22, 2004. FDA Issues Public Health Advisory onCautions for Use of Antidepressants in Adults and Children. Available onlineat: http://www.fda.gov/bbs/ topics/ANSWERS/ 2004/ANS01283.html. AccessedMarch 12, 2006.>>>> Let's take a look at this for a minute and see if I have my assumptions>>>> here>>>> correct.>>>>>>>> 1) Untreated, severely depressed people attempt suicide.>>>> 2) Untreated, severely depressed people attempt suicide more oftenthan>>>> people who have fully adjusted to SSRI treatment.>>>> 3) Trained psychiatric nurses know that "often" the MOST dangeroustime>>>> for>>>> a severely depressed person is the point where they start to show>>>> improvement?>>>> A) Most dangerous? Which is MORE dangerous than what other time?>>>> (3.a.1) BEFORE they even start taking medication?>>>> (3.a.2) From the subject title above, it is the>>>> 'Antidepressant'>>>> which is being fingered as the cause of a Raisein>>>> a Suicide RISK.>>>>>>>> I say, BULLSHIT !!>>>> 1. Untreated people who are lef t to linger in deep depression aloneare>>>> at>>>> the highest risk of suicide.>>>> 2. People who begin taking antidepressant medication also need>> counseling>>>> at the same time.>>>> 3. The 'pill' is not the magic bullet, cure all.>>>> 4. It takes time for medication to even begin to work (2 weeks at>> least).>>>> 5. If the patient is not being counseled or monitored, they are will>> be>>>> expecting 'quicker results'.>>>> 6. SSRI medication is begun at the lowest possible dosage.>>>> 7. SSRI is increased slowly, over time.>>>> 8. It could take months to achieve the level required, especially for>>>> 'severely depressed patients.>>>> 9. Uncounseled patients can easily forget is will take time, become>>>> impatient and discouraged.>>>>>>>> Trying to blame someone's suicide at the very early stages of beginning>> an>>>> SSRI medication is BULLSHIT, just pure and simple.>>>>>>>>>>>>>>>> =====================>>>> "Rick Morris" <wmorris@neb.rr.com> wrote in message>>>> news:C08A1551.F384%wmorris@neb.rr.com...>>>>> This research is a testament to the SSRI's ability to treat>> physiological>>>>> signs and symptoms of depression. The numbers are very low but do>> suggest>>>>> that the SSRI's do give a boost in energy that can provide the lift a>>>>> suicidal person suffering from extreme depression needs to commit>>>>> suicide.>>>>> This is nothing new. TCA's were known for the same thing. Trained>>>>> psychiatric nurses know that often, the most dangerous time for a>>>>> severely>>>>> depressed person is the point where they start to show improvement.>>>>>>>>>> The big question here is whether or not this can be considered a "side>>>>> effect" of the medication. After all, in the scenario where a person>>>> commits>>>>> suicide after being treated with anti-depressants, the person has been>>>>> getting better, thanks to the medication. Thus the drug is having the>>>>> desired chemical effect, but the person is using that effect in a>>>>> mal adaptive way.>>>>>>>>>>>>>>> -->>>>> To forget one's purpose is the commonest form of stupidity.>>>>>>>>>> Friedrich Nietzsche>>>>>>>>>>>>>>>>>>>> On 5/12/06 3:57 AM, in article>>>>> 1147424278.783824.31450@g10g2000cwb.googlegroups.com, "Kathleen">>>>> <kathleen.dickson@snet.net> wrote:>>>>>>>>>>> The analysis found that 11 of 3,455 people who were taking Paxil for>>>>>> depression reported an attempted suicide, compared with 1 in 1,978>>>>>> taking placebo in the trials. Most were among adults ages 18 to 30,>> the>>>>>> company said.>>>>>>>>>>>> Over all, the analysis found no increased risk of suicidal behavior>> in>>>>>> adults over 30.>>>>>>>>> If the study included SSRI AND "other drugs' PLUS the study covered a broad range of diagnosis' .... and then they came up with a 4% suicide attempt statistic with SSRI (for people diagnosed w/SEVERE DEPRESSION).....would it even be logical to compare 4% to lower suicide attempt rates for people on 'other drugs' who were diagnosed w/ie: obsessive compulsive disorder? Based on the fact that a person with OCD would not tend to have any suicidal tendency to begin with! Of course the suicide attempt rate would be expected to be lower. And I still say BULLSHIT that anyone THAT severely depressed would just be tossed a bottle of pills and not monitored/counseled/supervised. If there is any 'warning' placed on any SSRI, you can bet it was to stave off wacko lawsuits from people who blame it all on medication.....particularly for a medication which blocks the absorption of the 'feel good' chemical, which circulates in 'normal' peoples brains. What a lousy drug, huh? I would venture a guess that for the 4%, those people needed a higher dosage and increases sooner than they were getting. Cause we all know that when people start to 'feel good', they want to kill themselves....... [Yes, I have a different 'take' on this. I worked in a hospital and broke rules with a female severely catatonic patient to help her come out of the stupor she was hiding in. Pills alone, like I said, are like a band-aid on a nicked artery. There has to be more.] > <snip> > >> I still say "BULLSHIT". [quoted text clipped - 8 lines] > Let's look at the facts, and not the ASSumptions nor the screamed > *bullshit*! http://www.businessweek.com/ap/financialnews/D8HIB6EO0.htm?campaign_id=apn_h %20ome_down&chan=dbFACT:FDA warns of suicide risks for Paxil. http://www.msnbc.msn.com/id/5989348/FACT:FDA calls for warning on antidepressantshttp://www.mayoclinic.com/health/antidepressants/MH00059FACT: about your child's health.Why do antidepressants need warnings that they are linked to suicidalbehavior in children and adolescents?Federal authorities say that an extensive analysis of clinical trials showsthat antidepressants may increase the risk of suicidal thinking or behaviorin children, particularly in the early months of treatment of depression orother psychiatric illnesses.The Food and Drug Administration (FDA) commissioned researchers to analyze atotal of 24 clinical trials involving more than 4,400 children who weretaking antidepressants for various psychiatric illnesses, includingdepression and anxiety disorders, such as obsessive-compulsive disorder(OCD). According to the FDA, the analysis showed that children takingantidepressants had about a 4 percent chance of developing suicidal thoughtsor behavior, compared to only 2 percent in children taking a placebo. Noneof the children in any of the studies committed suicide.Still, the FDA considers the findings so disturbing that in October 2004 itissued a public health advisory and began requiring manufacturers ofantidepressants to label them with strong warnings about the link to suicidein children.http://vanderbiltowc.wellsource.com/dh/content.asp?ID=1550FACTS:Ant idepressant Drugs Associated with Suicidal ThoughtsBy Larry Axmaker, EdD, PhDThe labels on all antidepressant drugs are now required by the U.S. Food andDrug Administration (FDA) to include a boxed warning and expanded warningstatements that alert people to an increased risk of suicidality (suicidalthinking and behavior) in children and adolescents being treated with theseagents.Physicians, their patients, families, and caregivers of patients need toclosely monitor the use of prescription antidepressants in both adults andchildren with depression, especially at the beginning of treatment, or whenthe doses are changed - either an increase or decrease in the dose.The increased warnings were prompted by the results of antidepressantstudies in children. The risk of suicidality for these drugs was identifiedin a combined analysis of short-term (up to four months) placebo-controlledtrials of nine antidepressant drugs, including the selective serotoninreuptake inhibitors (SSRIs) and others, in children and adolescents withmajor depressive disorder (MDD), obsessive compulsive disorder (OCD), orother psychiatric disorders.A total of 24 trials involving more than 4,400 patients were included. Theanalysis showed a greater risk of suicidality during the first few months oftreatment in those receiving antidepressants. The average risk of suchevents on drug was four percent - twice the placebo risk of two percent. Nosuicides occurred in these trials.WarningBased on these data, FDA has determined that the following points areappropriate for inclusion in the boxed warning: a.. Antidepressants increase the risk of suicidal thinking and behavior(suicidality) in children and adolescents with MDD and other psychiatricdisorders. b.. Anyone considering the use of an antidepressant in a child oradolescent for any clinical use must balance the risk of increasedsuicidality with the clinical need. c.. Patients who are started on therapy should be observed closely forclinical worsening, suicidality, or unusual changes in behavior. d.. Families and caregivers should be advised to closely observe thepatient and to communicate with the prescribing physician. e.. A statement regarding whether the particular drug is approved for anypediatric indication(s) and, if so, which one(s).The only one of these drugs that has currently received approval for use inchildren with MDD is fluoxetine (Prozac). Prozac, Zoloft, Luvox, andAnafranil are approved for OCD in pediatric patients. None of the drugs isapproved for other psychiatric indications in children.The drugs receiving a boxed warning, other product labling changes, and aMedication Guide pertaining to pediatric suicidality: Anafranil (clomipramine HCl) Marplan (isocarboxazid) Sinequan (doxepin HCl) Aventyl (nortriptyline HCl) Nardil (phenelzine sulfate) Surmontil (trimipramine) Celexa (citalopram HBr) Norpramin (desipramine HCl) Symbyax (olanzapine/ fluoxetine) Cymbalta (duloxetine HCl) Pamelor (nortriptyline HCl) Tofranil (imipramine HCl) Desyrel (trazodone HCl) Parnate (tranylcypromine sulfate) Tofranil-PM (impiramine pamoate) Effexor (venlafaxine HCl) Paxil (paroxetine HCl) Triavil (Perphenaine/ Amitriptyline) Elavil (amitriptyline HCl) Pexeva (paroxetine mesylate) Vivactil (protriptyline HCl) Lexapro (escitalopram oxalate) Prozac (fluoxetine HCl) Wellbutrin (bupropion HCl) Limbitrol (chlordiazepoxide/ amitriptyline) Remeron (mirtazapine) Zoloft (sertraline HCl) Ludiomil (Maprotiline HCl) Sarafem (fluoxetine HCl) Zyban (bupropion HCl) Luvox (fluvoxamine maleate) Serzone (nefazodone HCl)What to Watch For a.. Pediatric patients being treated with antidepressants for anyindication should be closely observed for clinical worsening, as well asagitation, irritability, suicidality, and unusual changes in behavior,especially during the initial few months of a course of drug therapy, or attimes of dose changes, either increases or decreases. b.. Heathcare providers should carefully evaluate patients in whomdepression persistently worsens, or emergent suicidality is severe, abruptin onset, or was not part of the presenting symptoms, to determine whatintervention, including discontinuing or modifying the current drug therapy,is indicated. This is especially the case at the beginning of therapy ofwhen the dose is changed. c.. Anxiety, agitation, panic attacks, insomnia, irritability, hostility,impulsivity, akathisia (severe restlessness), hypomania, and mania have beenreported in adult and pediatric patients being treated with antidepressantsfor major depressive disorder as well as for other indications. Therapyshould be evaluated, and medications may need to be discontinued, whensymptoms are severe, abrupt in onset, or were not part of the patient'spresenting symptoms. d.. If a decision is made to discontinue treatment, some of thesemedications should be tapered rather than stopped abruptly (see labeling forindividual drug products for details). e.. Because antidepressants are believed to have the potential forinducing manic episodes in patients with bipolar disorder, there is aconcern about using antidepressants alone for these indviduals. Therefore,patients should be adequately screened to determine if they are at risk forbipolar disorder before initiating antidepressant treatment. f.. Healthcare providers should instruct patients, their families, andtheir caregivers to be alert for the emergence of agitation, irritability,and the other symptoms described above, as well as the emergence ofsuicidality and worsening depression, and to report such symptomsimmediately to their healthcare provider.Bottom LineIf you or someone close to you takes prescription antidepressants, it isimperative to be watchful, careful, and report any possible problems orchanges to a doctor.Sources: 1. FDA Public Health Advisory. October 15, 2004. Suicidality in Childrenand Adolescents Being Treated With Antidepressant Medications. Available at:http://www.fda.gov/ cder/drug/ antidepressants/ SSRIPHA200410.htm. AccessedMarch 12, 2006. 2. FDA Talk Paper. March 22, 2004. FDA Issues Public Health Advisory onCautions for Use of Antidepressants in Adults and Children. Available onlineat: http://www.fda.gov/bbs/ topics/ANSWERS/ 2004/ANS01283.html. AccessedMarch 12, 2006.>>>> Let's take a look at this for a minute and see if I have my assumptions>>>> here>>>> correct.>>>>>>>> 1) Untreated, severely depressed people attempt suicide.>>>> 2) Untreated, severely depressed people attempt suicide more oftenthan>>>> people who have fully adjusted to SSRI treatment.>>>> 3) Trained psychiatric nurses know that "often" the MOST dangeroustime>>>> for>>>> a severely depressed person is the point where they start to show>>>> improvement?>>>> A) Most dangerous? Which is MORE dangerous than what other time?>>>> (3.a.1) BEFORE they even start taking medication?>>>> (3.a.2) From the subject title above, it is the>>>> 'Antidepressant'>>>> which is being fingered as the cause of a Raisein>>>> a Suicide RISK.>>>>>>>> I say, BULLSHIT !!>>>> 1. Untreated people who are left to linger in deep depression aloneare>>>> at>>>> the highest risk of suicide.>>>> 2. People who begin taking antidepressant medication also need>> counseling>>>> at the same time.>>>> 3. The 'pill' is not the magic bullet, cure all.>>>> 4. It takes time for medication to even begin to work (2 weeks at>> least).>>>> 5. If the patient is not being counseled or monitored, they are will>> be>>>> expecting 'quicker results'.>>>> 6. SSRI medication is begun at the lowest possible dosage.>>>> 7. SSRI is increased slowly, over time.>>>> 8. It could take months to achieve the level required, especially for>>>> 'severely depressed patients.>>>> 9. Uncounseled patients can easily forget is will take time, become>>>> impatient and discouraged.>>>>>>>> Trying to blame someone's suicide at the very early stages of beginning>> an>>>> SSRI medication is BULLSHIT, just pure and simple.>>>>>>>>>>>>>>>> =====================>>>> "Rick Morris" <wmorris@neb.rr.com> wrote in message>>>> news:C08A1551.F384%wmorris@neb.rr.com...>>>>> This research is a testament to the SSRI's ability to treat>> physiological>>>>> signs and symptoms of depression. The numbers are very low but do>> suggest>>>>> that the SSRI's do give a boost in energy that can provide the lift a>>>>> suicidal person suffering from extreme depression needs to commit>>>>> suicide.>>>>> This is nothing new. TCA's were known for the same thing. Trained>>>>> psychiatric nurses know that often, the most dangerous time for a>>>>> severely>>>>> depressed person is the point where they start to show improvement.>>>>>>>>>> The big question here is whether or not this can be considered a "side>>>>> effect" of the medication. After all, in the scenario where a person>>>> commits>>>>> suicide after being treated with anti-depressants, the person has been>>>>> getting better, thanks to the medication. Thus the drug is having the>>>>> desired chemical effect, but the person is using that effect in a>>>>> maladaptive way.>>>>>>>>>>>>>>> -->>>>> To forget one's purpose is the commonest form of stupidity.>>>>>>>>>> Friedrich Nietzsche>>>>>>>>>>>>>>>>>>>> On 5/12/06 3:57 AM, in article>>>>> 1147424278.783824.31450@g10g2000cwb.googlegroups.com, "Kathleen">>>>> <kathleen.dickson@snet.net> wrote:>>>>>>>>>>> The analysis found that 11 of 3,455 people who were taking Paxil for>>>>>> depression reported an attempted suicide, compared with 1 in 1,978>>>>>> taking placebo in the trials. Most were among adults ages 18 to 30,>> the>>>>>> company said.>>>>>>>>>>>> Over all, the analysis found no increased risk of suicidal behavior>> in>>>>>> adults over 30.>>>>>>>>> You touched on an important topic. Many of the homeless today would have been found in an institution a few decades ago. >I still say "BULLSHIT". > We used to lock people up for their own safety when they got that [quoted text clipped - 100 lines] > in >> >> > adults over 30. The real assertion is that getting better may, initially, raise the severely depressed person's risk to commit suicide. The medications are just one instrument of getting better. It is really the getting better that leads to the increase in suicide attempts. Some people have an epiphany, give away all their stuff and then kill themselves without ever swallowing an anti-depressant. Now, a real research study would take non-depressed subjects and have them participate in a double blind study to see if antidepressants made non-depressed people want to off themselves. That would be much better information as non-depressed people have lower suicide rates than depressed people. SignatureTo forget one's purpose is the commonest form of stupidity. Friedrich Nietzsche On 5/12/06 1:14 PM, in article Dg49g.4956$fb2.1504@newssvr27.news.prodigy.net, "Jan Drew" <jdrew1374@sbcglobal.net> wrote: >> The assertion is that taking an Antidepressant 'may' RAISE suicide risk; >> and that the MOST dangerous time for suicide is when a severely depressed >> person is starting to show improvement after beginning SSRI treatment. > > That assertion is TRUE. |
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