zee

For Canadian healthcare consumers.

Canadian Adverse Events reporting:

Health Canada:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tp..._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.

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

MEDLINE]

interactions

2002;41(5):343-70.

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of

zee

For Canadian healthcare consumers.

Canadian Adverse Events reporting:

Health Canada:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tp..._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.

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


http://www.ncbi.nlm.nih.gov/entrez/q...stractERECTILE
DYSFUNCTION AND STATIN THERAPY: INTERACTION WITH CARDIOVASCULARRISK
FACTORS AND DRUG THERAPIESH. Solomon1, J. Man1, Y.P. Samarasinghe2,
M.D. Feher2, A.S. Wierzbicki3, G.Jackson11Department of Cardiology, St.
Thomas' Hospital, 2Beta Cell Diabetes Centre,Chelsea & Westminster
Hospital, 3Department of Chemical Pathology, St.Thomas' Hospital,
London UKErectile dysfunction has been a_ssociated with atherosclerotic
risk factorsand drugs used in their treatment. This study investigated
the relationshipof erectile function with cardiovascular risk factors
and specific drugtherapies. International Index of Erectile Function
(IIEF) scores measuredin 100 men attending cardiovascular risk clinics.
Cardiovascular riskfactors and drug therapies were a_ssessed prior to
initation and after 6months of statin therapy. Before statin therapy no
correlation was observedbetween IIEF score and any individual
cardiovascular risk factor thoughbetter scores were observed in
patients on warfarin or angiotensin-IIreceptor blocker therapy (r=0.42;
p <0.001). After 6 months of statintherapy, significant correlations
were observed between lower IIEF scores(r=0.62; P<0.001) and age,
smoking, diabetes and usage of warfarin orangiotensin-2 type 1 receptor
blocker (ARB) therapy. Differences in dose,relative efficacy or
relative lipophilicity of statin prescribed showed nocorrelation with
change in IIEF score. This study suggests impotencefollowing statin
therapy is likelier in patients with more severeendothelial dysfunction
due to established cardiovascular risk factorsincluding age, and
smoking and diabetes. This is complicated by adverseinteractions
between statin therapy and concomitant treatment with warfarinor
angiotensin-II type I receptor
blockers.http://www.kenes.com/73eas/program/a...ts/126.docDrug
Information Center: Information on Statin Drugs"On March 7, 2002,
Colorado HealthSite interviewed Beatrice A. Golomb, MD,PhD, principal
investigator of a study on Statin Drugs by the NationalInstitutes of
Health. Dr. Golomb noted that the most common problemsreported about
statin drugs pertain to muscle pain or weakness, fatigue,memory and
cognitive problems, sleep problems, and neuropathy.
Erectiledysfunction, problems with temperature regulation (feeling hot
or cold, orhaving sweats) are among the other problems reported.
"http://www.coloradohealthsite.org/pharmacology/statins.html"Question:
What are the common complaints of patients who take statins?Dr. Golomb:
The most common problems we hear reported pertain to muscle painor
weakness, fatigue, memory and cognitive problems, sleep problems,
andneuropathy. Erectile dysfunction, problems with temperature
regulation(feeling hot or cold, or having sweats), are among the other
problemsreported.
"http://www.coloradohealthsite.org/topics/interviews/golomb.htmlBBC
News: Wednesday, 15 March, 2000, 19:02 GMTHeart drug impotence
warning"Statins prevent heart attacks by reducing the levels of
dangerouscholesterol in the bloodstream. However, a small number of men
prescribed the life-saving drug havecomplained that they are unable to
achieve an erection.""Dr John Harvey, from the Wrexham Maelor Hospital
in Wales, identified 220men who appeared to have lost their "virility"
after starting to takestatins.
"http://news.bbc.co.uk/1/hi/health/678811.stmBailey DG, Dresser GK.
Interactions between grapefruit juice andcardiovascular drugs.Am J
Cardiovasc Drugs. 2004;4(5):281-97. Review. PMID:15449971 [PubMed -
indexed for MEDLINE] Blumentals WA, Brown RR,Gomez-Caminero A.
Antihypertensive treatment and erectile dysfunction in acohort of type
IIdiabetes patients.Int J Impot Res. 2003 Oct;15(5):314-7.PMID:
14562130 [PubMed - indexed for MEDLINE]