 |
 | Home | Contact Us | FAQ | Search & Site Map | Link to Us |
 | Sign In | Join | Other 45 Sites in Network |
Medical Forum / Diseases and Disorders / Sinusitis / March 2007New Ketolide Antibiotic For Sinusitis
As you know, Ketek, the first ketolide antibiotic, has struggled with reports of numerous safety problems and dangerous side effects. The FDA has withdrawn its recommendation of Ketek for sinusitis. Now comes cethromycin, a new ketolide from Advanced Life Sciences, which the manufacturer claims doesn't have Ketek's safety problems. Late-stage clinical trials should be complete by June 30. ALS is seeking approval from the FDA for using cethromycin to treat community-acquired pneumonia, and hopes to get that approval by the 3rd quarter of this year.  SignatureSteven D. Litvintchouk Email: sdlitvin@earthlinkNOSPAM.net Remove the NOSPAM before replying to me. > Now comes cethromycin, a new ketolide from Advanced Life Sciences, which > the manufacturer claims doesn't have Ketek's safety problems. Late-stage > clinical trials should be complete by June 30. Aren't they supposed to at least pretend to wait for the studies to be done before claiming the drug is safer? Susan > x-no-archive: yes > [quoted text clipped - 6 lines] > > Susan But that would ruin the advertising campaign... >> x-no-archive: yes >> [quoted text clipped - 3 lines] >> Aren't they supposed to at least pretend to wait for the studies to be >> done before claiming the drug is safer? From what the early trials have shown, cethromycin does not appear to aggravate myasthenia gravis like Ketek is now known to do. SignatureSteven D. Litvintchouk Email: sdlitvin@earthlinkNOSPAM.net Remove the NOSPAM before replying to me. > From what the early trials have shown, cethromycin does not appear to > aggravate myasthenia gravis like Ketek is now known to do. That's quite a subgroup. Call me old fashioned, but I like to see phase 3 trials completed, their data scrutinized and post marketing safety data before reaching drug safety conclusions. Susan > x-no-archive: yes > [quoted text clipped - 6 lines] > data scrutinized and post marketing safety data before reaching drug > safety conclusions. You sound like my mom. When I was a young kid in elementary school, I struggled with the side effects from numerous medications. My mom used to joke that she always knew when they would take a drug off the market for safety problems--six months after they prescribed it for me. :-) SignatureSteven D. Litvintchouk Email: sdlitvin@earthlinkNOSPAM.net Remove the NOSPAM before replying to me. > You sound like my mom. > When I was a young kid in elementary school, I struggled with the side > effects from numerous medications. My mom used to joke that she always > knew when they would take a drug off the market for safety problems--six > months after they prescribed it for me. :-) At least you lived and weren't disabled by the results. Not so lucky were some of those rx'ed other drugs the FDA allowed to market. Susan The PharmD who worked with the residents where I used to teach always said: "Don't be the first to use a new drug, or the last to abandon a drug that is no longer useful." Not so sure about the second half, as the older drugs can be very useful, but just aren't marketed. But you would not have believed the marketing that preceded Ketek for two years before it's release (as they were doing additional safety trials mandated by the FDA)--they literally hyped their drug as the only thing that stood between antibiotic resistance and the failure of all antibiotics. I went to lectures about it for two years--and then I heard about the visual disturbances, and the myasthenia gravis--and then the liver failure. I've never prescribed it, but we have samples in the sample closet..... Judy > x-no-archive: yes > [quoted text clipped - 8 lines] > > Susan > The PharmD who worked with the residents where I used to teach always > said: "Don't be the first to use a new drug, or the last to abandon a [quoted text clipped - 9 lines] > in the sample closet..... > Judy Judy, I'd believe it. I was on the board of a Lyme disease organization when GSK tried to buy our endorsement (or silence about) of the now abandoned LymeRix vaccine. And have you seen the CDC news release today, hawking the need for Merck's new HPV vaccine for young women? Susan I just read the NEJM this week: higher prevalence of HPV than expected, but lower prevalence of the cancer causing HPV. I've had young patients die of aggresive cervical cancer, so if this would prevent it, I'm all for it. With any vaccine, I want to hang back and watch how the recipients are doing after getting it. I have daughters in the age group that it's projected for, and I've told them to wait a year or so before we make a decision. In one state, the governor is making school attendance contingent on received the vaccine. I do think it's promising, I just want to make sure there aren't any surprises down the line. I do think that new ketolides could be promising: just like a couple of quinolones weren't safe, and the remaining ones on the market have side effects, but are our only choice for some gram negatives. Maybe this new one will be effective and safe... My medical students tell me that there are exposes that drug companies recruited college cheerleaders for drug reps. Now, with some of the drug companies having financial troubles, they're laying off drug reps and going to emarketing--you get detailed over the internet. After two years of hearing how ketek was going to save the world, I was glad when it was released, but I just couldn't prescribe a drug that could cause you to have "fixed accommodation" where you couldn't focus your eyes. Reportedly a problem for women, within the first day or so of use--in tiny print it said to tell your patients not to drive while on this drug... Judy > x-no-archive: yes > [quoted text clipped - 20 lines] > > Susan > x-no-archive: yes > [quoted text clipped - 6 lines] > > Susan Well, you know we (the general public) are the experiment. Bat ihana@mail.com wrote... > Well, you know we (the general public) are the experiment. Well, at some point a new drug has to be released because no amount of testing will ever completely rule out all risks of side-effects or weird interactions, even death. I always thought that the FDA should have a special probationary or experimental classification for new drugs. The insert would just say "This drug is an experimental class -- take it at your own risk. It has been shown to be effective in treating X but there may be unknown and dangerous side-effects and interactions. Good luck, let us know how it works out." Implicitly, this is the system we have now so why not make it explicit and put an end to the overly-cautious and overly-expensive approval process. This process gives people a false sense of security, only marginally adds to the safety of new drugs and makes it very expensive to develop new drugs. (The true cost is the drugs that we never see). How many drugs end up like Ketek that are pulled or limited in scope after years of clinical trials did not reveal the true risks and problems? We just end up delaying the release of drugs that can really help people who are suffering. Regards, David > ihana@mail.com wrote... >> Well, you know we (the general public) are the experiment. [quoted text clipped - 9 lines] > be unknown and dangerous side-effects and interactions. > Good luck, let us know how it works out." That's impossible in practice because you never know how much time to give a drug to prove itself. How many years did it take before they figured out that ordinary aspirin should not be given to children with fever (Reye's syndrome)? When I was a kid, all us kids took aspirin for the aches and fevers of cold and flu. Ever heard of "St. Joseph's Aspirin for Children"? How many years did it take before they realized that good old Tylenol (acetaminophen) should not be taken with alcohol? How many years did it take before they realized that grapefruit juice interacted unfavorably with many drugs? SignatureSteven D. Litvintchouk Email: sdlitvin@earthlinkNOSPAM.net Remove the NOSPAM before replying to me. Speaking of grapefruit juice, pomegranate juice has the same interaction profile unfortunately: my patient read it in prevention, and I found information that she's right. Too bad, it seems so beneficial in other ways. Judy > > i...@mail.com wrote... > >> Well, you know we (the general public) are the experiment. [quoted text clipped - 28 lines] > Email: sdlit...@earthlinkNOSPAM.net > Remove the NOSPAM before replying to me. On 3/1/07 6:38 PM, in article E6MFh.8135$Jl.3230@newsread3.news.pas.earthlink.net, "Steven L." <sdlitvin@earthlinkNOSPAM.net> wrote: >> ihana@mail.com wrote... >>> Well, you know we (the general public) are the experiment. [quoted text clipped - 23 lines] > How many years did it take before they realized that grapefruit juice > interacted unfavorably with many drugs? Worse than that, for 40 + years every medical student performed a trachotomy on dogs for lab work. Yet hundreds of children died from croup until someone in the early 1900 decided to do a tracheotomy on people! Worse than that, for over 100 years every doctor owned and used a microscope. It wasn't until 1950's that someone thought to use a microscope in the Operating room! I couldn't get my hospital to buy one and had to buy my own. This is why innovation should be encouraged rather than hindered. Steven L. wrote... >> Well, at some point a new drug has to be released >> because no amount of testing will ever completely [quoted text clipped - 22 lines] > How many years did it take before they realized that > grapefruit juice interacted unfavorably with many drugs? You are making my point. We discovered these problems after the drugs were released and after years of use by a wide cross-section of people. That is the *actual* testing system and not the FDA approval process. The post that I was replying to (by ihana@mail.com) was making the same point, only in a cynical way. I say run some clinical trials to rule out serious problems and prove that the drugs are effective against the intended target and lets get them out there where they can do some good and we can learn about side-effects or weird interactions. Regards, David |
Reply to this Message |
 Sign In
 Join
 My Latest Posts My Monitored Threads My Blog My Photo Gallery My Profile My Homepage Start New Thread Enable EMail Alerts Rate this Thread
|
©2008 Advenet LLC Privacy Policy - Terms of Use
This website includes both content owned or controlled by Advenet as well as content owned or controlled by third parties.