|
| For Canadian healthcare consumers.
Canadian Adverse Events reporting:
Health Canada:
http://www.hc-sc.gc.ca/hpfb-dgpsa/t...e_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.
~~~~~~~~~~~~~~~
Sharon Hope wrote:
- Hide quoted text -
- Show quoted text -
> Statin Adverse Effects FAQ: ELDERLY 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: statinst...@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/t...e_report_e.html
> PharmaWatch:
> http://www.pharmawatch.net/
> Thank you
> ELDERLY AND STATINS
> References (updated as of January 7, 2005):
> Lack of a_ssociation between cholesterol and coronary heart disease
> mortality
> and morbidity and all-cause mortality in persons older than 70 years.
> JAMA. 1994 Nov 2;272(17):1335-40.
> Krumholz HM, Seeman TE, Merrill SS, Mendes de Leon CF, Vaccarino V,
> Silverman DI, Tsukahara R, Ostfeld AM, Berkman LF.
> Department of Internal Medicine, Yale university School of Medicine,
New
> Haven, CT 06520-8017.
> "CONCLUSIONS--Our findings do not support the hypothesis that
> hypercholesterolemia or low HDL-C are important risk factors for
all-cause
> mortality, coronary heart disease mortality, or hospitalization for
> myocardial infarction or unstable angina in this cohort of persons
older
> than 70 years."
> Another study showing people over 65 do not benefit from cholesterol
> reduction:
> Long-Term Prognostic Importance of Total Cholesterol in Elderly
Survivors of
> an Acute Myocardial Infarction: The Cooperative Cardiovascular Pilot
> Project.
> Foody JM, Wang Y, Kiefe CI, Ellerbeck EF, Gold J, Radford MJ,
Krumholz HM.
> Section of Cardiovascular Medicine, Department of Medicine, and
Section of
> Chronic Disease Epidemiology, Department of Epidemiology and Public
Health,
> Yale School of Medicine, New Haven, Connecticut; Qualidigm,
Middletown,
> Connecticut; Yale-New Haven Hospital Center for Outcomes Research and
> Evaluation, New Haven, Connecticut; Center for Outcome and
Effectiveness
> Research and Education, university ofAlabama at Birmingham and
Birmingham
> Veterans Affairs Medical Center, Birmingham, Alabama; Department of
> Preventive Medicine, university of Kansas School of Medicine, Kansas
City,
> Kansas; and Metastar, Madison, Wisconsin.
> J Am Geriatr Soc. 2003 Jul;51(7):930-936. PMID: 12834512
> "PARTICIPANTS: Four thousand nine hundred twenty-three Medicare
> beneficiaries from four states aged 65 and older"
> "CONCLUSION: Among elderly survivors of AMI, elevated total serum
> cholesterol measured postinfarction is not a_ssociated with an
increased
> risk
> of all-cause mortality in the 6 years after discharge. Furthermore,
this
> study found no evidence of an increased risk of all-cause mortality
in
> patients with low total cholesterol. Further studies are needed to
determine
> the relationship of postinfarction lipid subfractions and mortality
in older
> patients with coronary artery disease (CAD)."
> Patients with Alzheimer's disease may be particularly susceptible to
adverse
> effects of statins.
> Algotsson A, Winblad B.
> Dement Geriatr Cogn Disord. 2004;17(3):109-16. Epub 2004 Jan 20.
> Department of Clinical Neuroscience, Occupational Therapy and Elderly
Care
> Research, Division of Geriatric Medicine, Karolinska Institute,
Huddinge
> university Hospital, Huddinge, Sweden.
> In epidemiological, cross-sectional studies, treatment with
> 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins)
> prevented to a large extent the development of Alzheimer's disease
(AD), but
> the results of randomized, placebo-controlled studies, focused on
statin
> therapy in patients with ischemic heart disease (IHD), are at
variance.
> Nonetheless, data from epidemiological, longitudinal studies in
humans as
> well as studies on transgenic mouse models and cultured neuronal cell
lines
> indicate that cholesterol may contribute to the pathogenesis of AD.
Statins
> have proven therapeutic and preventive effects in IHD and other
vascular
> diseases in man. They generally are well tolerated, but some adverse
> effects, probably due to antiproliferative and proapoptotic
properties of
> the statins, are matters of concern. AD patients may be
extrasusceptible to
> adverse effects of statins due to preexisting aberrations in signal
> transduction and energy metabolism in the neurons and a perturbed
> cholesterol metabolism in the brain. This problem might be addressed
in
> randomized, double-blind studies with statins in AD. The statins
differ from
> each other in several aspects, and they are not considered to be
> therapeutically interchangeable. It could be fruitful to use both a
placebo
> and two different types of statins, i.e. an essentially hydrophilic
statin
> and a lipophilic statin, in a double-blinded fashion, and to compare
the
> effects on the cognitive decline in AD. Copyright 2004 S. Karger AG,
Basel
> Publication Types:
> =B7 Review
> =B7 Review, Tutorial
> PMID: 14739530 [PubMed - indexed for MEDLINE]
> Lipid-lowering agents and the risk of hip fracture in a Medicaid
population.
> Ray WA, Daugherty JR, Griffin MR.
> Inj Prev. 2002 Dec;8(4):276-9.
> Department of Preventive Medicine, Vanderbilt university School of
Medicine
> and the Geriatric Research, education and Clinical Center, Nashville
VAMC,
> Nashville, Tennessee 37232, USA. wayne....@mcmail.vanderbilt.edu
> "CONTEXT: Three recent nested case-control studies conducted in
automated
> databases suggest that users of 3-hydroxy-3-methylglutaryl coenzyme A
> reductase inhibitors (statins) have a risk of hip and other
..=2E.
read more =BB
Reply
=A9 2004 Google
Sharon Hope wrote:
> Statin Adverse Effects FAQ: LUPUS-LIKE SYMPTOMS AND STATINS, EXERCISE
> INTOLERANCE
>
>
>
>
>
> 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
>
>
>
> Thank you
>
>
>
>
>
>
>
> LUPUS-LIKE SYMPTOMS AND STATINS, EXERCISE INTOLERANCE
>
> References (updated as of January 7, 2005):
>
>
>
> Drug-induced lupus-like syndrome a_ssociated with severe autoimmune
> hepatitis.
>
http://www.ncbi.nlm.nih.gov/entrez/...db=3DPubMed&li=
st_uids=3D12765306&dopt=3DAbstract
> Graziadei IW, Obermoser GE, Sepp NT, Erhart KH, Vogel W.
> Lupus. 2003;12(5):409-12.
> PMID: 12765306 [PubMed - in process]
>
> "Atorvastatin and other members of the statin family are widely used
for the
> treatment of hypercholesterolaemia in order to reduce the risk of
> atherosclerosis and cardiovascular disease. Atorvastatin-induced
adverse
> events are mostly mild and only a few cases of lupus-like syndrome or
severe
> acute hepatitis have been documented. In this case report we describe
a
> patient who developed an atorvastatin-induced severe autoimmune
hepatitis.
> In addition, this patient presented with a concomitant systemic
lupus-like
> syndrome which has been already described for statins but not in
> a_ssociation with severe liver disease. Although the drug was
immediately
> withdrawn the disease persisted and even deteriorated to a fulminant
disease
> with evidence of acute hepatic failure. The patient failed to respond
to
> conventional immunosuppression with corticosteroids and azathioprine.
Only
> the introduction of intense immunosuppressive therapy, as used in
solid
> organ transplantation, led to a complete and sustained recovery of
the
> patient. Interestingly, the patient was HLA DR3- and HLA
DR4-positive, which
> are well-known genetic factors a_ssociated with autoimmune diseases.
This
> case is the first report of a drug-induced lupus-likesyndrome
concomitant
> with a severe autoimmune hepatitis in a genetically predisposed
patient."
>
>
>
> Noel B, Panizzon RG. Lupus-like syndrome a_ssociated with statin
> therapy.Dermatology. 2004;208(3):276-7. PMID: 15118389 [PubMed -
indexed for
> MEDLINE]"Statins are among the most widely prescribed drugs. An
increasing
> number of lupus-like syndrome has recently been reported with these
> lipid-lowering agents. We describe a new case a_ssociated with
simvastatin
> therapy. The presence of anti-dsDNA antibodies in the serum is for
the first
> time reported confirming that statins may also induce a systemic
autoimmune
> reaction. Statin-induced lupus-like syndrome is characterized by the
long
> delay between the beginning of therapy and the skin eruption.
Antinuclear
> antibodies may persist for many months after drug discontinuation.
The
> causal relationship may be therefore difficult to establish, and
probably
> many cases are unrecognized. Early diagnosis may avoid unnecessary
> immunosuppressive therapy. Copyright 2004 S. Karger AG, Basel"
Lantuejoul S,
> Brambilla E, Brambilla C, Devoua_ssoux G. Statin-induced fibrotic
> nonspecific interstitial pneumonia.Eur Respir J. 2002
Mar;19(3):577-80.
> PMID: 11936540 [PubMed - indexed for MEDLINE]"Statins inhibit the
> 3-hydroxy-3-methylglutaryl coenzyme A reductase, reduce the serum
level of
> low-density lipoprotein cholesterol, and are extensively prescribed
to
> prevent cardiovascular mortality and morbidity. Few systemic adverse
> effects, such as pseudopolymyositis, lupus-like syndromes, and
anecdotal
> hypersensitivity pneumonitis, have been reported. A
simvastatin-induced
> diffuse interstitial pneumonia a_ssociated with a nonspecific
interstitial
> pneumonia pattern at histological analysis is repoted here.
Ultrastructural
> analysis showed a diffuse cytoplasmic accumulation of intralysosomial
> lamellar inclusions in type II pneumonocytes, histiocytes and
endothelial
> cells, suggesting a shared pathogenesis with amphiphilic drug-induced
toxic
> lung injury. Because statins are increasingly prescribed,
statin-induced
> interstitial lung disorders may be more frequently observed and early
> recognition will be required." 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]"During
> the last decade, statins have been widely prescribed as
lipid-lowering
> drugs. Their overall safety profile is good. The main musculoskeletal
side
> effects have consisted of muscle pain and weakness, peripheral
neuropathy,
> and a few cases of drug-induced lupus. We report the first four cases
of
> tendinopathy in patients receiving statin therapy. There were three
men and
> one woman. The diagnoses were extensortenosynovitis at the hands
(case 1),
> tenosynovitis of the tibialis anterior tendon (case 2), and Achilles
> tendinopathy (cases 3 and 4). Two patients were on simvastatin and
two on
> atorvastatin. The tendinopathy developed 1 to 2 months after
treatment
> initiation. The outcome was consistently favorable within 1 to 2
months
> after discontinuation of the drug. Similar cases have been reported
to
> French pharmacovigilance centers. This report of four cases of
tendinopathy
> draws attention to a possible and heretofore unrecognized side effect
of a
> drug cla_ss that is becoming increasingly popular. Statins are
effective in
> lowering high cholesterol levels in patients with type IIa or IIb
> hypercholesterolemia. They have been widely used for the last decade,
> particularly in the secondary and primary prevention of major
coronary
> events. Statins act by inhibiting the enzyme
> hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase. Although
most
> patients tolerate statins extremely well, a few experience side
effects
> requiring treatment discontinuation. Reported musculoskeletal side
effects
> include myalgia and a few cases of rhabdomyolysis and polymyositis.
Induced
> lupus and peripheral neuropathy are exceedingly rare."
>
>
>
>
>
> Malignant hyperthermia susceptibility revealed by increased serum
creatine
> kinase concentrations during statin treatment.
> Krivosic-Horber R, Depret T, Wagner JM, Maurage CA.
> Eur J Anaesthesiol. 2004 Jul;21(7):572-4.
> Publication Types: Case Reports, Letter
>
> PMID: 15318472 [PubMed - indexed for MEDLINE] Metabolic intolerance
to
> exercise
> [Article in Spanish]
> Arenas J, Martin MA.
> Neurologia. 2003 Jul-Aug;18(6):291-302.
> Laboratorio de enfermedades mitocondriales y nurometabolicas, Centro
de
> Investigacion Hospital Universitario 12 de Octubre, Madrid, Spain.
> jarenas@h12o.es
> "Exercise intolerance (EI) is a frequent cause of medical attention,
> although it is sometimes difficult to come to a final diagnosis.
However,
> there is a group of patients in whom EI is due to a metabolic
dysfunction.
> McArdle's disease (type V glucogenosis) is due to myophosphorylase
(MPL)
> deficiency. The ischemic exercise test shows a flat lactate curve.
The most
> frequent mutations in the PYGM gene (MPL gene) in Spanish patients
with MPL
> deficiency are R49X and W797R. Carnitine palmitoyltransferase (CPT)
II
> deficiency is invariably a_ssociated to repetitive episodes of
myoglobinuria
> triggered by exercise, cold, fever or fasting. The diagnosis depends
on the
> demonstration of CPT II deficiency in muscle. The most frequent
mutation in
> the CPT2 gene is the S113L. Patients with muscle adenylate deaminase
> deficiency usually show either a mild myopathy or no symptom. The
diagnosis
> is based on the absence of enzyme activity in muscle and the lack of
rise of
> ammonia in the forearm ischemic exercise test. The mutation Q12X in
the
> AMPD1 gene is strongly a_ssociated with the disease. Exercise
intolerance is
> a common complaint in patients with mitochondrial respiratory chain
(MRC)
> deficiencies, although it is often overshadowed by other symptoms and
signs.
> Only recently we have come to appreciate that exercise intolerance
can be
> the sole presentation of defects in the mtDNA, particularly in
complex I,
> complex III, complex IV, or in some tRNAs. In addition, myoglobinuria
can be
> observed in patients under statin treatment, particularly if
a_ssociated
> with fibrates, due to an alteration in the a_ssembly of the complex
IV of
> the MRC."
> Publication Types: Review, Review, Tutorial
>=20
> PMID: 12838448 [PubMed - indexed for MEDLINE]
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