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Medical Forum / General / General / January 2005

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Statin Adverse Effects FAQ: LIVER OR KIDNEY DAMAGE

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Sharon Hope - 10 Jan 2005 02:10 GMT
Statin Adverse Effects FAQ: STATINS AND LIVER OR KIDNEY DAMAGE

(The Cholesterol-lowering Statin Drug Names: Lipitor, Crestor, Mevacor,
Pravachol, Zocor, Lescol, and Baycol, aka atorvastatin, rosuvastatin,
cerivastatin, fluvastatin, lovastatin, pravastatin, and simvastatin; This
class of drugs is also known as HMG-CoA Reductase Inhibitors, short for
3-Hydroxy-3-Methyl-Glutaryl Coenzyme A Reductase. )

To my physician,

I believe that my symptoms may be due to the adverse effects a_ssociated
with cholesterol-lowering statin drugs.  I need your help to understand the
cause of my symptoms, treatment options, and the prognosis for my recovery.

Please review the references below, published medical studies that show
similar problems a_ssociated with statin drugs.  These are made available
via the National Institutes of Health (NIH,
http://www.ncbi.nlm.nih.gov/Entrez/) library of biomedical journal citations
and other major repositories of medical research.

Also, I am respectfully requesting that you file an adverse effects report
with the FDA (http://www.fda.gov/medwatch/how.htm), and that you please send
a copy of the report to the to the NIH-funded Statin Study, attention: Dr.
Beatrice Golomb, Principal Investigator.
Statin Study website: http://medicine.ucsd.edu/statin/
Statin Study contact info: http://medicine.ucsd.edu/statin/contactinfo.html
UCSD STATIN STUDY E-MAIL ADDRESS: statinstudy@ucsd.edu
MAILING ADDRESS: UCSD Statin Study 9500 Gilman Dr. La Jolla, CA 92093-0995
PHONE NUMBER: (858) 558-4950

In Canada:

Health Canada:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_adverse_report_e.html

PharmaWatch:
http://www.pharmawatch.net/

Thank you

STATINS AND LIVER OR KIDNEY DAMAGE

References (updated as of  January 7, 2005):

Kaplowitz N.

Statin-induced hepatotoxicity.

Gastroenterology. 2004 Oct;127(4):1278; author reply 1278-9. No abstract
available.

PMID: 15481021 [PubMed - indexed for MEDLINE]

Kubota T, Fujisaki K, Itoh Y, Yano T, Sendo T, Oishi R.

Apoptotic injury in cultured human hepatocytes induced by HMG-CoA reductase
inhibitors.

Biochem Pharmacol. 2004 Jun 15;67(12):2175-86.

PMID: 15163549 [PubMed - indexed for MEDLINE]

de Denus S, Spinler SA, Miller K, Peterson AM.

Statins and liver toxicity: a meta-analysis.

Pharmacotherapy. 2004 May;24(5):584-91. Review.

PMID: 15162892 [PubMed - indexed for MEDLINE]

 Lado Lado FL, Rodriguez Moreno C, Cinza Sajurjo S, Duran Parrondo C, Pazo
Nunez M, Lois Pernas A, Masa Vazquez L.

[Statin-induced rhabdomyolysis and renal failure: also with fluvastatine]

An Med Interna. 2004 May;21(5):235-7. Spanish.

PMID: 15176926 [PubMed - indexed for MEDLINE]

Jacobson TA.

Combination lipid-lowering therapy with statins: safety issues in the
postcerivastatin era.

Expert Opin Drug Saf. 2003 May;2(3):269-86. Review.

PMID: 12904106 [PubMed - indexed for MEDLINE]

Braun RN, Halhuber MJ, Hitzenberger G.

[Information regarding adverse drug effects and treatment indications
("package inserts") exemplified by cervistatin (Lipobay)]

Wien Med Wochenschr. 2003;153(3-4):80-2. German.

PMID: 12658968 [PubMed - indexed for MEDLINE]

Lewin JJ 3rd, Nappi JM, Taylor MH.

Rhabdomyolysis with concurrent atorvastatin and diltiazem.

Ann Pharmacother. 2002 Oct;36(10):1546-9.

PMID: 12243603 [PubMed - indexed for MEDLINE]

Bae J, Jarcho JA, Denton MD, Magee CC.

Statin specific toxicity in organ transplant recipients: case report and
review of the literature.

J Nephrol. 2002 May-Jun;15(3):317-9. Review.

PMID: 12113605 [PubMed - indexed for MEDLINE]

Omar MA, Wilson JP, Cox TS.

Rhabdomyolysis and HMG-CoA reductase inhibitors.

Ann Pharmacother. 2001 Sep;35(9):1096-107. Review. Erratum in: Ann
Pharmacother 2001 Oct;35(10):1296.

PMID: 11573861 [PubMed - indexed for MEDLINE]

Oldemeyer JB, Lund RJ, Koch M, Meares AJ, Dunlay R.

Rhabdomyolysis and acute renal failure after changing statin-fibrate
combinations.

Cardiology. 2000;94(2):127-8.

PMID: 11173785 [PubMed - indexed for MEDLINE]

Ozdemir O, Boran M, Gokce V, Uzun Y, Kocak B, Korkmaz S.

A case with severe rhabdomyolysis and renal failure a_ssociated with
cerivastatin-gemfibrozil combination therapy--a case report.

Angiology. 2000 Aug;51(8):695-7.

PMID: 10959522 [PubMed - indexed for MEDLINE]
Zee - 10 Jan 2005 03:05 GMT
For Canadian healthcare consumers.

Canadian Adverse Events reporting:

Health Canada:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_adverse_report_e.html

PharmaWatch:
http://www.pharmawatch.net/

PharmaWatch: Working for Consumer Rights and Safe Medicines

PharmaWatch is a non-profit advocacy group that believes
patients/consumers must play a central role in prescription drug safety
in Canada. All prescription drugs have side effects, and it is up to
patients, in consultation with their physician, to determine if the
benefits outweigh the risks. One of the main ways we are able to learn
about the risks is when patients tell us if and when they have had an
adverse drug reaction (ADR), especially (but not only) ADRs that are
serious or unexpected. Patients who know about a drug's side effects
can make more informed choices about what medicines they will use. But
if no one reports ADRs, it is impossible to know whether the benefits
continue to outweigh the risks.

Canadians rely on safe medicines to help them manage chronic conditions
like asthma or diabetes or to overcome a temporary or long-term
illness. The job of Health Canada is to make sure these drugs are safe
and effective when they make it on to the market. It also is Health
Canada's job to ensure that patient experiences with approved
prescription drugs are monitored. This is called "post-market
surveillance" and it is the early warning system that allows us to know
what the potentially dangerous side effects of prescription drugs might
be.

People who experience adverse reactions to prescription medicine are
often left alone to search for information about the drug they may be
having problems with, as well as the problems themselves. They often
lack the support they need to connect with others who may have similar
experiences. As patients, people are often isolated and made to feel at
fault for adverse reactions.
PharmaWatch believes that consumers and patients have unique
perspectives and experiences. They can provide information and insight
that contributes to the effective and safe use of medicines. Reporting
by patients and consumers can provide an early warning signal to
regulators, manufacturers, physicians, health professionals and other
consumers.

The goal of PharmaWatch is to highlight and validate consumer
experiences and heighten consumer involvement in adverse drug reaction
reporting. In addition to documenting these experiences, we aim to
facilitate networking among individual patients/consumers and advocacy
groups who share our concerns about the lack of adequate post-market
monitoring by the pharmaceutical industry and Health Canada.

PharmaWatch aims to raise public awareness about the role of
consumers/patients in reporting their own adverse drug reactions - or
those experienced by their children, a spouse, a brother or sister, or
a parent. The group plans to teach people how to report an ADR, how to
encourage others to report, and what role ADR reporting has played or
can play to help ensure the medicine we take is right for us.

~~~~~~~~~~~~~~~

> Statin Adverse Effects FAQ: STATINS AND LIVER OR KIDNEY DAMAGE
>
[quoted text clipped - 122 lines]
>
>  Rhabdomyolysis and acute renal failure after changing statin-fibrate

> combinations.
>
[quoted text clipped - 5 lines]
>
>  A case with severe rhabdomyolysis and renal failure a_ssociated with

> cerivastatin-gemfibrozil combination therapy--a case report.
>
> Angiology. 2000 Aug;51(8):695-7.
>
> PMID: 10959522 [PubMed - indexed for MEDLINE]
David Wright - 10 Jan 2005 03:21 GMT
>For Canadian healthcare consumers.
>
>Canadian Adverse Events reporting:
>
>Health Canada:
>http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_adverse_report_e.html

Hey, Zee, are you taking statins?  Maybe they would explain your
amnesia, which I presume is what is causing you to post the same
damn thing over and over and over.

 -- David Wright :: alphabeta at prodigy.net
    These are my opinions only, but they're almost always correct.
      "If I have not seen as far as others, it is because giants
          were standing on my shoulders."  (Hal Abelson, MIT)
Sharon Hope - 10 Jan 2005 03:35 GMT
She is doing it on the valid assumption that not everyone has all adverse
effects.  If they look at only one, the miss the Canadian info.

>>For Canadian healthcare consumers.
>>
[quoted text clipped - 11 lines]
>       "If I have not seen as far as others, it is because giants
>           were standing on my shoulders."  (Hal Abelson, MIT)
David Wright - 10 Jan 2005 04:00 GMT
>She is doing it on the valid assumption that not everyone has all adverse
>effects.  If they look at only one, the miss the Canadian info.

So you're suggesting what?  That Canadian readers are so stupid that
they won't read any of the other articles, and must be led around by
the hand?

 -- David Wright :: alphabeta at prodigy.net
    These are my opinions only, but they're almost always correct.
      "If I have not seen as far as others, it is because giants
          were standing on my shoulders."  (Hal Abelson, MIT)

>>>For Canadian healthcare consumers.
>>>
[quoted text clipped - 6 lines]
>> amnesia, which I presume is what is causing you to post the same
>> damn thing over and over and over.
P.Snot - 10 Jan 2005 15:18 GMT
STOP SCREAMING!  Like everyone else (except, you know who, your
friends), please follow the rules of the internet society.
Just like you don't fart at dinner or don't squeeze boobies in public,
there are rules on usenet too.
 
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