Statin Adverse Effects FAQ: RHABDOMYOLYSIS AND STATINS
(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
RHABDOMYOLYSIS AND STATINS
References (updated as of January 7, 2005):
FDA adverse event reports on statin-a_ssociated rhabdomyolysis.
Omar MA, Wilson JP.
Ann Pharmacother. 2002 Feb;36(2):288-95. Review.
PMID: 11847951
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1
1847951&dopt=Abstract
Of 871 reports detailing 601 cases in a 29 month time frame, the list of
statin, number of cases, and percentage of the whole follows:
simvastatin, 215 (35.8%);
cerivastatin, 192 (31.9%);
atorvastatin, 73 (12.2%);
pravastatin, 71 (11.8%);
lovastatin, 40 (6.7%);
fluvastatin, 10 (1.7%)
As of August, 2001, there were at least 81rhabdomyolysis deaths a_ssociated
with Non-Baycol statins.
http://www.essentialdrugs.org/edrug/archive/200108/msg00064.php
The Public Citizen petition to the FDA, August 20,2001:
http://www.citizen.org/publications/release.cfm?ID=7051
At that time the count of deaths by statin-induced rhabdomyolysis:
Outcome
Number of Cases
Percent of Total Deaths
Deaths
Atorvastatin
13
18.1%
Cerivastatin
20
27.8%
Fluvastatin
1
1.4%
Lovastatin
5
6.9%
Pravastatin
9
12.5%
Simvastatin
24
33.3%
1: Jones PH, Davidson MH. Reporting rate of rhabdomyolysis with
fenofibrate + statin versus gemfibrozil +any statin.Am J Cardiol. 2005 Jan
1;95(1):120-2. PMID: 15619408 [PubMed - in process] 2: Koller H, Neuhaus O,
Schroeter M, Hartung HP. [Myopathies under therapy with lipid-lowering
agents.]Nervenarzt. 2004 Dec 18; [Epub ahead of print] German. PMID:
15609055 [PubMed - as supplied by publisher] 3: De Angelis G. The
influence of statin characteristics on their safety and tolerability.Int J
Clin Pract. 2004 Oct;58(10):945-55. PMID: 15587774 [PubMed - in process] 4:
Ducobu J, Sternon J. [Ezetimibe (Ezetrol): the statins' partner]Rev Med
Brux. 2004 Oct;25(5):456-61. French. PMID: 15584647 [PubMed - in process]
5: [No authors listed] A warning about one statin at a high dose.Heart
Advis. 2004 Nov;7(11):2. No abstract available. PMID: 15580669 [PubMed -
indexed for MEDLINE] 6: Graham DJ, Staffa JA, Shatin D, Andrade SE, Schech
SD, La Grenade L, GurwitzJH, Chan KA, Goodman MJ, Platt R. Incidence of
hospitalized rhabdomyolysis in patients treated withlipid-lowering
drugs.JAMA. 2004 Dec 1;292(21):2585-90. Epub 2004 Dec 1. PMID: 15572716
[PubMed - indexed for MEDLINE] 7: [No authors listed] Safety of aggressive
statin therapy.Med Lett Drugs Ther. 2004 Nov 22;46(1196):93-5. PMID:
15557874 [PubMed - indexed for MEDLINE] 8: [No authors listed]
Rosuvastatin: new preparation. Opt for statins with evidence of efficacy
onclinical outcome.Prescrire Int. 2004 Aug;13(72):132-4. PMID: 15532136
[PubMed - indexed for MEDLINE] 9: Sniderman AD. Is there value in liver
function test and creatine phosphokinase monitoringwith statin use?Am J
Cardiol. 2004 Nov 4;94(9A):30F-34F. Review. PMID: 15519289 [PubMed - indexed
for MEDLINE] 10: Johnson TE, Zhang X, Bleicher KB, Dysart G, Loughlin AF,
Schaefer WH,Umbenhauer DR. Statins induce apoptosis in rat and human
myotube cultures by inhibitingprotein geranylgeranylation but not
ubiquinone.Toxicol Appl Pharmacol. 2004 Nov 1;200(3):237-50. PMID: 15504460
[PubMed - indexed for MEDLINE] 11: Davidson MH. Rosuvastatin safety:
lessons from the FDA review and post-approvalsurveillance.Expert Opin Drug
Saf. 2004 Nov;3(6):547-57. PMID: 15500414 [PubMed - in process] 12:
Alsheikh-Ali AA, Kuvin JT, Karas RH. Risk of adverse events with
fibrates.Am J Cardiol. 2004 Oct 1;94(7):935-8. PMID: 15464682 [PubMed -
indexed for MEDLINE] 13: Baker SK, Goodwin S, Sur M, Tarnopolsky MA.
Cytoskeletal myotoxicity from simvastatin and colchicine.Muscle Nerve. 2004
Dec;30(6):799-802. PMID: 15389652 [PubMed - in process] 14: Chang JT,
Staffa JA, Parks M, Green L. Rhabdomyolysis with HMG-CoA reductase
inhibitors and gemfibrozil combinationtherapy.Pharmacoepidemiol Drug Saf.
2004 Jul;13(7):417-26. PMID: 15269925 [PubMed - indexed for MEDLINE] 15:
Maggini M, Raschetti R, Traversa G, Bianchi C, Caffari B, Da Cas R, PaneiP.
The cerivastatin withdrawal crisis: a "post-mortem" analysis.Health Policy.
2004 Aug;69(2):151-7. PMID: 15212862 [PubMed - indexed for MEDLINE] 16:
Rundek T, Naini A, Sacco R, Coates K, DiMauro S. Atorvastatin decreases the
coenzyme Q10 level in the blood of patients at riskfor cardiovascular
disease and stroke.Arch Neurol. 2004 Jun;61(6):889-92. PMID: 15210526
[PubMed - indexed for MEDLINE] 17: Jamal SM, Eisenberg MJ, Christopoulos S.
Rhabdomyolysis a_ssociated with hydroxymethylglutaryl-coenzyme A
reductaseinhibitors.Am Heart J. 2004 Jun;147(6):956-65. Review. PMID:
15199341 [PubMed - indexed for MEDLINE] 18: Bellosta S, Paoletti R, Corsini
A. Safety of statins: focus on clinical pharmacokinetics and drug
interactions.Circulation. 2004 Jun 15;109(23 Suppl 1):III50-7. Review. PMID:
15198967 [PubMed - indexed for MEDLINE] 19: Lado Lado FL, Rodriguez Moreno
C, Cinza Sajurjo S, Duran Parrondo C, PazoNunez 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] 20: Takagi S. [Neurological complication
due to the drug and the maneuver for the treatmentand prevention of
cerebrovascular diseases: iatrogenic neurology]Rinsho Shinkeigaku. 2003
Nov;43(11):877-9. Review. Japanese. PMID: 15152491 [PubMed - indexed for
MEDLINE] 21: Roten L, Schoenenberger RA, Krahenbuhl S, Schlienger RG.
Rhabdomyolysis in a_ssociation with simvastatin and amiodarone.Ann
Pharmacother. 2004 Jun;38(6):978-81. Epub 2004 Apr 06. PMID: 15069169
[PubMed - indexed for MEDLINE] 22: Fauchais AL, Iba Ba J, Maurage P, Kyndt
X, Bataille D, Hachulla E, ParentD, Queyrel V, Lambert M, Michon Pasturel U,
Hatron PY, Vanhille P, Devulder B. [Polymyositis induced or a_ssociated
with lipid-lowering drugs: five cases]Rev Med Interne. 2004 Apr;25(4):294-8.
French. PMID: 15050796 [PubMed - indexed for MEDLINE] 23: Moosmann B, Behl
C. Selenoprotein synthesis and side-effects of statins.Lancet. 2004 Mar
13;363(9412):892-4. Review. PMID: 15031036 [PubMed - indexed for MEDLINE]
24: Manhas A, Farmer JA. Hypolipidemic therapy and cholesterol
absorption.Curr Atheroscler Rep. 2004 Mar;6(2):89-93. Review. PMID: 15023291
[PubMed - indexed for MEDLINE] 25: Koumis T, Nathan JP, Rosenberg JM,
Cicero LA. Strategies for the prevention and treatment of statin-induced
myopathy: isthere a role for ubiquinone supplementation?Am J Health Syst
Pharm. 2004 Mar 1;61(5):515-9. Review. No abstract available. PMID: 15018231
[PubMed - indexed for MEDLINE] 26: Dreier JP, Endres M. Statin-a_ssociated
rhabdomyolysis triggered by grapefruit consumption.Neurology. 2004 Feb
24;62(4):670. No abstract available. PMID: 14981197 [PubMed - in process]
27: Schaefer WH, Lawrence JW, Loughlin AF, Stoffregen DA, Mixson LA, Dean
DC,Raab CE, Yu NX, Lankas GR, Frederick CB. Evaluation of ubiquinone
concentration and mitochondrial function relative tocerivastatin-induced
skeletal myopathy in rats.Toxicol Appl Pharmacol. 2004 Jan 1;194(1):10-23.
PMID: 14728975 [PubMed - indexed for MEDLINE] 28: Andreou ER, Ledger S.
Potential drug interaction between simvastatin and danazol
causingrhabdomyolysis.Can J Clin Pharmacol. 2003 Winter;10(4):172-4. PMID:
14712320 [PubMed - indexed for MEDLINE] 29: Ehrhardt M, Lindenmaier H,
Burhenne J, Haefeli WE, Weiss J. Influence of lipid lowering fibrates on
P-glycoprotein activity in vitro.Biochem Pharmacol. 2004 Jan
15;67(2):285-92. PMID: 14698041 [PubMed - indexed for MEDLINE] 30: Jamil S,
Iqbal P. Rhabdomyolysis induced by a single dose of a statin.Heart. 2004
Jan;90(1):e3. PMID: 14676266 [PubMed - indexed for MEDLINE] 31: Zeman M,
Zak A, Vecka M, Romaniv S. [Long-term hypolipidemic treatment of mixed
hyperlipidemia with a combinationof statins and fibrates]Cas Lek Cesk. 2003
Aug;142(8):500-4. Czech. PMID: 14626567 [PubMed - indexed for MEDLINE] 32:
Foody JM, Krumholz HM. Are statins indicated for the primary prevention of
CAD in octogenarians?antagonist viewpoint.Am J Geriatr Cardiol. 2003
Nov-Dec;12(6):357-60. Review. PMID: 14610384 [PubMed - indexed for MEDLINE]
33: Shammas NW, Kapalis MJ, Deckert J, Harris M, Dippel EJ, Labroo A,
McKinneyD. Effectiveness of statin-gemfibrozil combination therapy in
patients with mixedhyperlipidemia: experience of a community lipid clinic
and safety review fromthe literature.Prev Cardiol. 2003 Fall;6(4):189-94.
PMID: 14605512 [PubMed - indexed for MEDLINE] 34: Corsini A. The safety of
HMG-CoA reductase inhibitors in special populations at highcardiovascular
risk.Cardiovasc Drugs Ther. 2003 May;17(3):265-85. Review. PMID: 14574085
[PubMed - indexed for MEDLINE] 35: Klotz U. Pharmacological comparison of
the statins.Arzneimittelforschung. 2003;53(9):605-11. Review. PMID: 14558433
[PubMed - indexed for MEDLINE] 36: Newman CB, Palmer G, Silbershatz H,
Szarek M. Safety of atorvastatin derived from analysis of 44 completed
trials in 9,416patients.Am J Cardiol. 2003 Sep 15;92(6):670-6. PMID:
12972104 [PubMed - indexed for MEDLINE] 37: Kajinami K, Takekoshi N, Saito
Y. Pitavastatin: efficacy and safety profiles of a novel synthetic
HMG-CoAreductase inhibitor.Cardiovasc Drug Rev. 2003 Fall;21(3):199-215.
Review. PMID: 12931254 [PubMed - indexed for MEDLINE] 38: Luh JY, Karnath
BM. Issues in statin-a_ssociated myopathy.JAMA. 2003 Aug 20;290(7):888;
author reply 888-9. No abstract available. PMID: 12928463 [PubMed - indexed
for MEDLINE] 39: [No authors listed] Statins: new data in secondary
prevention and diabetes. Pravastatin andsimvastatin are the best-a_ssessed
statins.Prescrire Int. 2003 Aug;12(66):143-8. PMID: 12908497 [PubMed -
indexed for MEDLINE] 40: Muller T. [Statin-induced Parkinson's-syndrome.
Reader's letter on the article by J.Finsterer in "Der Nervenarzt" (2003)
74:115-122]Nervenarzt. 2003 Aug;74(8):726-7. Epub 2003 May 10. German. No
abstractavailable. PMID: 12904874 [PubMed - indexed for MEDLINE] 41: Chuck
SK, Penzak SR. Risk-benefit of HMG-CoA reductase inhibitors in the
treatment of HIV proteaseinhibitor-related hyperlipidaemia.Expert Opin Drug
Saf. 2002 May;1(1):5-17. Review. PMID: 12904155 [PubMed - indexed for
MEDLINE] 42: Davidson MH. Controversy surrounding the safety of
cerivastatin.Expert Opin Drug Saf. 2002 Sep;1(3):207-12. Review. PMID:
12904136 [PubMed - indexed for MEDLINE] 43: Jacobson TA. Combination
lipid-lowering therapy with statins: safety issues in thepostcerivastatin
era.Expert Opin Drug Saf. 2003 May;2(3):269-86. Review. PMID: 12904106
[PubMed - indexed for MEDLINE] 44: Ito MK. Advances in the understanding
and management of dyslipidemia: usingniacin-based therapies.Am J Health Syst
Pharm. 2003 Jul 1;60(13 Suppl 2):S15-21; quiz S25. PMID: 12901026 [PubMed -
indexed for MEDLINE] 45: Parker RA, Huang Q, Tesfamariam B. Influence of
3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitors onendothelial
nitric oxide synthase and the formation of oxidants in
thevasculature.Atherosclerosis. 2003 Jul;169(1):19-29. PMID: 12860247
[PubMed - indexed for MEDLINE] 46: Andrejak M, Gras V, Ma_ssy ZA, Caron J.
[Adverse effects of statins]Therapie. 2003 Jan-Feb;58(1):77-83. Review.
French. PMID: 12822204 [PubMed - indexed for MEDLINE] 47: Wierzbicki AS,
Mikhailidis DP, Wray R, Schacter M, Cramb R, Simpson WG,Byrne CB.
Statin-fibrate combination: therapy for hyperlipidemia: a review.Curr Med
Res Opin. 2003;19(3):155-68. Review. PMID: 12814127 [PubMed - indexed for
MEDLINE] 48: Schmitz G, Drobnik W. Pharmacogenomics and pharmacogenetics
of cholesterol-lowering therapy.Clin Chem Lab Med. 2003 Apr;41(4):581-9.
Review. PMID: 12747606 [PubMed - indexed for MEDLINE] 49: Bays H, Dujovne
C. Colesevelam HCl: a non-systemic lipid-altering drug.Expert Opin
Pharmacother. 2003 May;4(5):779-90. Review. PMID: 12740000 [PubMed - indexed
for MEDLINE] 50: Paragh G, Balogh Z, Romics L. [Antilipemic therapy and
rhabdomyolysis]Orv Hetil. 2003 Mar 16;144(11):515-20. Review. Hungarian.
PMID: 12731338 [PubMed - indexed for MEDLINE] 51: Gotto AM Jr. Risks and
benefits of continued aggressive statin therapy.Clin Cardiol. 2003 Apr;26(4
Suppl 3):III3-12. Review. PMID: 12708633 [PubMed - indexed for MEDLINE] 52:
Thompson PD, Clarkson P, Karas RH. Statin-a_ssociated myopathy.JAMA. 2003
Apr 2;289(13):1681-90. Review. PMID: 12672737 [PubMed - indexed for MEDLINE]
53: Clark LT. Treating dyslipidemia with statins: the risk-benefit
profile.Am Heart J. 2003 Mar;145(3):387-96. Review. PMID: 12660659 [PubMed -
indexed for MEDLINE] 54: Braun RN, Halhuber MJ, Hitzenberger G.
[Information regarding adverse drug effects and treatment indications
("packageinserts") exemplified by cervistatin (Lipobay)]Wien Med Wochenschr.
2003;153(3-4):80-2. German. PMID: 12658968 [PubMed - indexed for MEDLINE]
55: [No authors listed] How a statin might destroy a drug company.Lancet.
2003 Mar 8;361(9360):793. No abstract available. PMID: 12642039 [PubMed -
indexed for MEDLINE] 56: Gotto AM Jr. Safety and statin therapy:
reconsidering the risks and benefits.Arch Intern Med. 2003 Mar
24;163(6):657-9. No abstract available. PMID: 12639194 [PubMed - indexed for
MEDLINE] 57: Ballantyne CM, Corsini A, Davidson MH, Holdaas H, Jacobson TA,
LeitersdorfE, Marz W, Reckless JP, Stein EA. Risk for myopathy with statin
therapy in high-risk patients.Arch Intern Med. 2003 Mar 10;163(5):553-64.
Review. PMID: 12622602 [PubMed - indexed for MEDLINE] 58: Farmer JA.
Statins and myotoxicity.Curr Atheroscler Rep. 2003 Mar;5(2):96-100. Review.
PMID: 12573193 [PubMed - indexed for MEDLINE] 59: Black C, Jick H.
Etiology and frequency of rhabdomyolysis.Pharmacotherapy. 2002
Dec;22(12):1524-6. PMID: 12495162 [PubMed - indexed for MEDLINE] 60: Bolego
C, Baetta R, Bellosta S, Corsini A, Paoletti R. Safety considerations for
statins.Curr Opin Lipidol. 2002 Dec;13(6):637-44. Review. PMID: 12441888
[PubMed - indexed for MEDLINE] 61: Prasad GV, Wong T, Meliton G, Bhaloo S.
Rhabdomyolysis due to red yeast rice (Monascus purpureus) in a renal
transplantrecipient.Transplantation. 2002 Oct 27;74(8):1200-1. PMID:
12438974 [PubMed - indexed for MEDLINE] 62: Lawrence JM, Reckless JP.
Fluvastatin.Expert Opin Pharmacother. 2002 Nov;3(11):1631-41. Review. PMID:
12437496 [PubMed - indexed for MEDLINE] 63: Mehra MR, Uber PA,
Vivekananthan K, Solis S, Scott RL, Park MH, Milani RV,Lavie CJ.
Comparative beneficial effects of simvastatin and pravastatin on
cardiacallograft rejection and survival.J Am Coll Cardiol. 2002 Nov
6;40(9):1609-14. PMID: 12427413 [PubMed - indexed for MEDLINE] 64: Kind AH,
Zakowski LJ, McBride PE. Rhabdomyolysis from the combination of a statin
and gemfibrozil: an uncommonbut serious adverse reaction.WMJ.
2002;101(7):53-6. PMID: 12426921 [PubMed - indexed for MEDLINE] 65:
Schuff-Werner P, Kohlschein P. [Current therapy of hypercholesterolemia.
How much statin does your patientneed?]MMW Fortschr Med. 2002 Aug
8;144(31-32):24-6. German. PMID: 12422725 [PubMed - indexed for MEDLINE]
66: Hare CB, Vu MP, Grunfeld C, Lampiris HW. Simvastatin-nelfinavir
interaction implicated in rhabdomyolysis and death.Clin Infect Dis. 2002 Nov
15;35(10):e111-2. Epub 2002 Oct 25. PMID: 12410494 [PubMed - indexed for
MEDLINE] 67: Talpur R, Ward S, Apisarnthanarax N, Breuer-Mcham J, Duvic M.
Optimizing bexarotene therapy for cutaneous T-cell lymphoma.J Am Acad
Dermatol. 2002 Nov;47(5):672-84. PMID: 12399758 [PubMed - indexed for
MEDLINE] 68: McLaughlin T, Abbasi F, Lamendola C, Leary E, Reaven GM.
Comparison in patients with type 2 diabetes of fibric acid versus
hepatichydroxymethyl glutaryl-coenzyme a reductase inhibitor treatment of
combineddyslipidemia.Metabolism. 2002 Oct;51(10):1355-9. PMID: 12370858
[PubMed - indexed for MEDLINE] 69: 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] 70:
Sinzinger H, Chehne F, Lupattelli G. Oxidation injury in patients receiving
HMG-CoA reductase inhibitors: occurrencein patients without enzyme elevation
or myopathy.Drug Saf. 2002;25(12):877-83. PMID: 12241128 [PubMed - indexed
for MEDLINE] 71: Aboulafia DM, Johnston R. Simvastatin-induced
rhabdomyolysis in an HIV-infected patient with coronaryartery disease.AIDS
Patient Care STDS. 2000 Jan;14(1):13-8. PMID: 12240878 [PubMed - indexed for
MEDLINE] 72: Evans M, Rees A. The myotoxicity of statins.Curr Opin
Lipidol. 2002 Aug;13(4):415-20. Review. PMID: 12151857 [PubMed - indexed for
MEDLINE] 73: Evans M, Rees A. Effects of HMG-CoA reductase inhibitors on
skeletal muscle: are all statins thesame?Drug Saf. 2002;25(9):649-63.
Review. PMID: 12137559 [PubMed - indexed for MEDLINE] 74: Bae J, Jarcho JA,
Denton MD, Magee CC. Statin specific toxicity in organ transplant
recipients: case report and reviewof the literature.J Nephrol. 2002
May-Jun;15(3):317-9. Review. PMID: 12113605 [PubMed - indexed for MEDLINE]
75: Williams D, Feely J. Pharmacokinetic-pharmacodynamic drug interactions
with HMG-CoA reductaseinhibitors.Clin Pharmacokinet. 2002;41(5):343-70.
Review. PMID: 12036392 [PubMed - indexed for MEDLINE] 76: [No authors
listed] Statin stories.Diabetes Obes Metab. 2002 Mar;4(2):138. No abstract
available. PMID: 11993442 [PubMed - indexed for MEDLINE] 77:
Martinez-Castelao A, Ramos R, Gonzalez MT, Castineiras MJ. [Dyslipidemia
and cardiovascular risk in type 2 diabetes mellitus patients witha_ssociated
diabetic nephropathy]Nefrologia. 2002;22 Suppl 1:51-8. Spanish. PMID:
11987671 [PubMed - indexed for MEDLINE] 78: Maxa JL, Melton LB, Ogu CC,
Sills MN, Limanni A. Rhabdomyolysis after concomitant use of cyclosporine,
simvastatin, gemfibrozil,and itraconazole.Ann Pharmacother. 2002
May;36(5):820-3. PMID: 11978159 [PubMed - indexed for MEDLINE] 79: Foxton
J. Statin safety.Nurs Stand. 2001 Sep 19-25;16(1):20. No abstract
available. PMID: 11977679 [PubMed - indexed for MEDLINE] 80: Ambrosi P,
Gayet JL, Andrejak M. [The best of 2001. Clinical pharmacology]Arch Mal
Coeur Vaiss. 2002 Jan;95 Spec No 1(5 Spec 1):33-8. Review. French. PMID:
11901897 [PubMed - indexed for MEDLINE] 81: Gensini GF, Conti AA, Conti A,
Panti A. [From prevention to cardiovascular rehabilitation: statins and
evidence-basedmedicine]Ital Heart J Suppl. 2002 Jan;3(1):91-4. Review.
Italian. PMID: 11899580 [PubMed - indexed for MEDLINE] 82: Sica DA, Gehr
TW. 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors and
rhabdomyolysis:considerations in the renal failure patient.Curr Opin Nephrol
Hypertens. 2002 Mar;11(2):123-33. Review. PMID: 11856903 [PubMed - indexed
for MEDLINE] 83: Omar MA, Wilson JP. FDA adverse event reports on
statin-a_ssociated rhabdomyolysis.Ann Pharmacother. 2002 Feb;36(2):288-95.
Review. PMID: 11847951 [PubMed - indexed for MEDLINE] 84: Prieto JC.
[Safety profile of statins]Rev Med Chil. 2001 Nov;129(11):1237-40. Spanish.
PMID: 11836874 [PubMed - indexed for MEDLINE] 85: Patel DN, Pagani FD,
Koelling TM, Dyke DB, Baliga RR, Cody RJ, Lake KD,Aaronson KD. Safety and
efficacy of atorvastatin in heart transplant recipients.J Heart Lung
Transplant. 2002 Feb;21(2):204-10. PMID: 11834348 [PubMed - indexed for
MEDLINE] 86: Sica DA, Gehr TW. Rhabdomyolysis and statin therapy:
relevance to the elderly.Am J Geriatr Cardiol. 2002 Jan-Feb;11(1):48-55.
Review. PMID: 11773716 [PubMed - indexed for MEDLINE] 87: Banga JD.
[Myotoxicity and rhabdomyolisis due to statins]Ned Tijdschr Geneeskd. 2001
Dec 8;145(49):2371-6. Review. Dutch. PMID: 11770264 [PubMed - indexed for
MEDLINE] 88: Hamilton-Craig I. Statin-a_ssociated myopathy.Med J Aust.
2001 Nov 5;175(9):486-9. Review. PMID: 11758079 [PubMed - indexed for
MEDLINE] 89: Bernini F, Poli A, Paoletti R. Safety of HMG-CoA reductase
inhibitors: focus on atorvastatin.Cardiovasc Drugs Ther. 2001;15(3):211-8.
Review. PMID: 11713888 [PubMed - indexed for MEDLINE] 90: Chazerain P,
Hayem G, Hamza S, Best C, Ziza JM. Four cases of tendinopathy in patients
on statin therapy.Joint Bone Spine. 2001 Oct;68(5):430-3. PMID: 11707010
[PubMed - indexed for MEDLINE] 91: Holdaas H, Jardine AG, Wheeler DC,
Brekke IB, Conlon PJ, Fellstrom B,Hammad A, Holme I, Isoniemi H, Moore R,
Rowe PA, Sweny P, Talbot DA, Wadstrom J,Ostraat O. Effect of fluvastatin on
acute renal allograft rejection: a randomizedmulticenter trial.Kidney Int.
2001 Nov;60(5):1990-7. PMID: 11703619 [PubMed - indexed for MEDLINE] 92:
Federman DG, Hussain F, Walters AB. Fatal rhabdomyolysis caused by
lipid-lowering therapy.South Med J. 2001 Oct;94(10):1023-6. PMID: 11702815
[PubMed - indexed for MEDLINE] 93: Igel M, Sudhop T, von Bergmann K.
Metabolism and drug interactions of 3-hydroxy-3-methylglutaryl
coenzymeA-reductase inhibitors (statins).Eur J Clin Pharmacol. 2001
Aug;57(5):357-64. Review. PMID: 11599653 [PubMed - indexed for MEDLINE] 94:
Bangratz S. [Complications in heart transplantation: diagnosis and
treatment]Presse Med. 2001 Sep 1;30(24 Pt 2):8-12. Review. French. PMID:
11577591 [PubMed - indexed for MEDLINE] 95: Omar MA, Wilson JP, Cox TS.
Rhabdomyolysis and HMG-CoA reductase inhibitors.Ann Pharmacother. 2001
Sep;35(9):1096-107. Review. Erratum in: Ann Pharmacother2001
Oct;35(10):1296. PMID: 11573861 [PubMed - indexed for MEDLINE] 96: Boger
RH. Drug interactions of the statins and consequences for drug
selection.Int J Clin Pharmacol Ther. 2001 Sep;39(9):369-82. Review. PMID:
11563683 [PubMed - indexed for MEDLINE] 97: Comarow A. Rest easy, statin
users. Benefits dwarf risks for these cholesterol drugs.US News World Rep.
2001 Sep 3;131(8):45. No abstract available. PMID: 11550394 [PubMed -
indexed for MEDLINE] 98: Shek A, Ferrill MJ. Statin-fibrate combination
therapy.Ann Pharmacother. 2001 Jul-Aug;35(7-8):908-17. Review. PMID:
11485144 [PubMed - indexed for MEDLINE] 99: Moghadasian MH, Mancini GB,
Frohlich JJ. Pharmacotherapy of hypercholesterolaemia: statins in clinical
practice.Expert Opin Pharmacother. 2000 May;1(4):683-95. Review. PMID:
11249510 [PubMed - indexed for MEDLINE] 100: Oldemeyer JB, Lund RJ, Koch M,
Meares AJ, Dunlay R. Rhabdomyolysis and acute renal failure after changing
statin-fibratecombinations.Cardiology. 2000;94(2):127-8. PMID: 11173785
[PubMed - indexed for MEDLINE] 101: Guyton JR. Combination drug therapy
for combined hyperlipidemia.Curr Cardiol Rep. 1999 Sep;1(3):244-50. Review.
PMID: 10980849 [PubMed - indexed for MEDLINE] 102: Ozdemir O, Boran M,
Gokce V, Uzun Y, Kocak B, Korkmaz S. A case with severe rhabdomyolysis and
renal failure a_ssociated withcerivastatin-gemfibrozil combination
therapy--a case report.Angiology. 2000 Aug;51(8):695-7. PMID: 10959522
[PubMed - indexed for MEDLINE] 103: Keogh A, Macdonald P, Kaan A, Aboyoun
C, Spratt P, Mundy J. Efficacy and safety of pravastatin vs simvastatin
after cardiactransplantation.J Heart Lung Transplant. 2000 Jun;19(6):529-37.
PMID: 10867332 [PubMed - indexed for MEDLINE] 104: Scheen AJ. [Treatment
of combined hyperlipidemia: fibrate and/or statin?]Rev Med Liege. 1999
Jul;54(7):583-7. French. PMID: 10495679 [PubMed - indexed for MEDLINE] 105:
Guyton JR, Capuzzi DM. Treatment of hyperlipidemia with combined
niacin-statin regimens.Am J Cardiol. 1998 Dec 17;82(12A):82U-84U;
discussion 85-86U. Review. PMID: 9915667 [PubMed - indexed for MEDLINE] 106:
Athyros VG, Papageorgiou AA, Hatzikonstandinou HA, Didangelos TP, CarinaMV,
Kranitsas DF, Kontopoulos AG. Safety and efficacy of long-term
statin-fibrate combinations in patients withrefractory familial combined
hyperlipidemia.Am J Cardiol. 1997 Sep 1;80(5):608-13. PMID: 9294990
[PubMed - indexed for MEDLINE] 107: Laaksonen R, Jokelainen K, Laakso J,
Sahi T, Harkonen M, Tikkanen MJ,Himberg JJ. The effect of simvastatin
treatment on natural antioxidants in low-densitylipoproteins and high-energy
phosphates and ubiquinone in skeletal muscle.Am J Cardiol. 1996 Apr
15;77(10):851-4. PMID: 8623738 [PubMed - indexed for MEDLINE] 108: Shviro
I, Leitersdorf E. The patient at risk: who should we be treating?Br J Clin
Pract Suppl. 1996 Jan;77A:24-7. Review. PMID: 8729587 [PubMed - indexed for
MEDLINE] 109: Peters TK. Safety profile of fluvastatin.Br J Clin Pract
Suppl. 1996 Jan;77A:20-3. Review. PMID: 8729586 [PubMed - indexed for
MEDLINE] 110: Dromer C, Vedrenne C, Billey T, Pages M, Fournie B, Fournie
A. [Rhabdomyolysis due to simvastin. Apropos of a case with review of
theliterature]Rev Rhum Mal Osteoartic. 1992 Apr;59(4):281-3. Review.
French. PMID: 1496277 [PubMed - indexed for MEDLINE]
Zee - 10 Jan 2005 03:04 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: RHABDOMYOLYSIS AND STATINS
>
[quoted text clipped - 45 lines]
> Ann Pharmacother. 2002 Feb;36(2):288-95. Review.
> PMID: 11847951
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1
1847951&dopt=Abstract
> Of 871 reports detailing 601 cases in a 29 month time frame, the list of
> statin, number of cases, and percentage of the whole follows:
[quoted text clipped - 56 lines]
> Schroeter M, Hartung HP. [Myopathies under therapy with lipid-lowering
> agents.]Nervenarzt. 2004 Dec 18; [Epub ahead of print] German. PMID:
> 15609055 [PubMed - as supplied by publisher] 3: De Angelis G. The
> influence of statin characteristics on their safety and tolerability.Int J
[quoted text clipped - 17 lines]
> for MEDLINE] 10: Johnson TE, Zhang X, Bleicher KB, Dysart G, Loughlin AF,
> Schaefer WH,Umbenhauer DR. Statins induce apoptosis in rat and human
> myotube cultures by inhibitingprotein geranylgeranylation but not
> ubiquinone.Toxicol Appl Pharmacol. 2004 Nov 1;200(3):237-50. PMID: 15504460
[quoted text clipped - 4 lines]
> fibrates.Am J Cardiol. 2004 Oct 1;94(7):935-8. PMID: 15464682 [PubMed -
> indexed for MEDLINE] 13: Baker SK, Goodwin S, Sur M, Tarnopolsky MA.
> Cytoskeletal myotoxicity from simvastatin and colchicine.Muscle Nerve. 2004
> Dec;30(6):799-802. PMID: 15389652 [PubMed - in process] 14: Chang JT,
[quoted text clipped - 6 lines]
> Rundek T, Naini A, Sacco R, Coates K, DiMauro S. Atorvastatin decreases the
> coenzyme Q10 level in the blood of patients at riskfor cardiovascular
> disease and stroke.Arch Neurol. 2004 Jun;61(6):889-92. PMID: 15210526
> [PubMed - indexed for MEDLINE] 17: Jamal SM, Eisenberg MJ, Christopoulos S.
> Rhabdomyolysis a_ssociated with hydroxymethylglutaryl-coenzyme A
> reductaseinhibitors.Am Heart J. 2004 Jun;147(6):956-65. Review. PMID:
> 15199341 [PubMed - indexed for MEDLINE] 18: Bellosta S, Paoletti R, Corsini
> A. Safety of statins: focus on clinical pharmacokinetics and drug
[quoted text clipped - 10 lines]
> Rhabdomyolysis in a_ssociation with simvastatin and amiodarone.Ann
> Pharmacother. 2004 Jun;38(6):978-81. Epub 2004 Apr 06. PMID: 15069169
> [PubMed - indexed for MEDLINE] 22: Fauchais AL, Iba Ba J, Maurage P, Kyndt
> X, Bataille D, Hachulla E, ParentD, Queyrel V, Lambert M, Michon Pasturel U,
[quoted text clipped - 14 lines]
> 27: Schaefer WH, Lawrence JW, Loughlin AF, Stoffregen DA, Mixson LA, Dean
> DC,Raab CE, Yu NX, Lankas GR, Frederick CB. Evaluation of ubiquinone
> concentration and mitochondrial function relative tocerivastatin-induced
> skeletal myopathy in rats.Toxicol Appl Pharmacol. 2004 Jan 1;194(1):10-23.
[quoted text clipped - 32 lines]
> author reply 888-9. No abstract available. PMID: 12928463 [PubMed - indexed
> for MEDLINE] 39: [No authors listed] Statins: new data in secondary
> prevention and diabetes. Pravastatin andsimvastatin are the best-a_ssessed
> statins.Prescrire Int. 2003 Aug;12(66):143-8. PMID: 12908497 [PubMed -
[quoted text clipped - 5 lines]
> treatment of HIV proteaseinhibitor-related hyperlipidaemia.Expert Opin Drug
> Saf. 2002 May;1(1):5-17. Review. PMID: 12904155 [PubMed - indexed for
> MEDLINE] 42: Davidson MH. Controversy surrounding the safety of
> cerivastatin.Expert Opin Drug Saf. 2002 Sep;1(3):207-12. Review. PMID:
[quoted text clipped - 8 lines]
> nitric oxide synthase and the formation of oxidants in
> thevasculature.Atherosclerosis. 2003 Jul;169(1):19-29. PMID: 12860247
> [PubMed - indexed for MEDLINE] 46: Andrejak M, Gras V, Ma_ssy ZA, Caron J.
> [Adverse effects of statins]Therapie. 2003 Jan-Feb;58(1):77-83. Review.
[quoted text clipped - 18 lines]
> indexed for MEDLINE] 54: Braun RN, Halhuber MJ, Hitzenberger G.
> [Information regarding adverse drug effects and treatment indications
> ("packageinserts") exemplified by cervistatin (Lipobay)]Wien Med Wochenschr.
> 2003;153(3-4):80-2. German. PMID: 12658968 [PubMed - indexed for MEDLINE]
[quoted text clipped - 7 lines]
> therapy in high-risk patients.Arch Intern Med. 2003 Mar 10;163(5):553-64.
> Review. PMID: 12622602 [PubMed - indexed for MEDLINE] 58: Farmer JA.
> Statins and myotoxicity.Curr Atheroscler Rep. 2003 Mar;5(2):96-100. Review.
> PMID: 12573193 [PubMed - indexed for MEDLINE] 59: Black C, Jick H.
[quoted text clipped - 19 lines]
> 8;144(31-32):24-6. German. PMID: 12422725 [PubMed - indexed for MEDLINE]
> 66: Hare CB, Vu MP, Grunfeld C, Lampiris HW. Simvastatin-nelfinavir
> interaction implicated in rhabdomyolysis and death.Clin Infect Dis. 2002 Nov
> 15;35(10):e111-2. Epub 2002 Oct 25. PMID: 12410494 [PubMed - indexed for
> MEDLINE] 67: Talpur R, Ward S, Apisarnthanarax N, Breuer-Mcham J, Duvic M.
> Optimizing bexarotene therapy for cutaneous T-cell lymphoma.J Am Acad
> Dermatol. 2002 Nov;47(5):672-84. PMID: 12399758 [PubMed - indexed for
> MEDLINE] 68: McLaughlin T, Abbasi F, Lamendola C, Leary E, Reaven GM.
> Comparison in patients with type 2 diabetes of fibric acid versus
[quoted text clipped - 13 lines]
> MEDLINE] 73: Evans M, Rees A. Effects of HMG-CoA reductase inhibitors on
> skeletal muscle: are all statins thesame?Drug Saf. 2002;25(9):649-63.
> Review. PMID: 12137559 [PubMed - indexed for MEDLINE] 74: Bae J, Jarcho JA,
> Denton MD, Magee CC. Statin specific toxicity in organ transplant
[quoted text clipped - 26 lines]
> statin-a_ssociated rhabdomyolysis.Ann Pharmacother. 2002 Feb;36(2):288-95.
> Review. PMID: 11847951 [PubMed - indexed for MEDLINE] 84: Prieto JC.
> [Safety profile of statins]Rev Med Chil. 2001 Nov;129(11):1237-40. Spanish.
> PMID: 11836874 [PubMed - indexed for MEDLINE] 85: Patel DN, Pagani FD,
[quoted text clipped - 8 lines]
> MEDLINE] 88: Hamilton-Craig I. Statin-a_ssociated myopathy.Med J Aust.
> 2001 Nov 5;175(9):486-9. Review. PMID: 11758079 [PubMed - indexed for
> MEDLINE] 89: Bernini F, Poli A, Paoletti R. Safety of HMG-CoA reductase
> inhibitors: focus on atorvastatin.Cardiovasc Drugs Ther. 2001;15(3):211-8.
[quoted text clipped - 9 lines]
> lipid-lowering therapy.South Med J. 2001 Oct;94(10):1023-6. PMID: 11702815
> [PubMed - indexed for MEDLINE] 93: Igel M, Sudhop T, von Bergmann K.
> Metabolism and drug interactions of 3-hydroxy-3-methylglutaryl
> coenzymeA-reductase inhibitors (statins).Eur J Clin Pharmacol. 2001
[quoted text clipped - 10 lines]
> users. Benefits dwarf risks for these cholesterol drugs.US News World Rep.
> 2001 Sep 3;131(8):45. No abstract available. PMID: 11550394 [PubMed -
> indexed for MEDLINE] 98: Shek A, Ferrill MJ. Statin-fibrate combination
> therapy.Ann Pharmacother. 2001 Jul-Aug;35(7-8):908-17. Review. PMID:
[quoted text clipped - 32 lines]
> MEDLINE] 109: Peters TK. Safety profile of fluvastatin.Br J Clin Pract
> Suppl. 1996 Jan;77A:20-3. Review. PMID: 8729586 [PubMed - indexed for
> MEDLINE] 110: Dromer C, Vedrenne C, Billey T, Pages M, Fournie B, Fournie
> A. [Rhabdomyolysis due to simvastin. Apropos of a case with review of
> theliterature]Rev Rhum Mal Osteoartic. 1992 Apr;59(4):281-3. Review.
> French. PMID: 1496277 [PubMed - indexed for MEDLINE]