FDA MedWatch:
2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary
Supplements17 October 2005
Cymbalta
Uses: antidepressant and pain reducer
FDA Broadens Liver Warning for Cymbalta
The FDA and
Eli Lilly and Co.
have broadened a warning about possible liver problems with Cymbalta, a
drug used to treat depression and pain associated with diabetic
peripheral neuropathy....
Discussion on Chronic-Illness.org Forum
04 June 2005
Children's Tylenol Recall
Johnson & Johnson recently recalled several forms of their Children's
Tylenol because of package labeling irregularities. To learn more about
the recall, see
this FDA MedWatch information.
08 April 2005
Bextra Pulled from Market at Government Request
Bextra becomes the latest painkiller withdrawn
from the market. At the request of the Food and Drug Administration,
Pfizer Inc. agreed to suspend sales of the painkiller because it
belongs to a class of drugs that has been linked to higher risk of
cardiovascular disease and because of additional risk of a potentially
serious skin reaction.
Additional Information:
Pfizer Pulls Bextra After Government Request
New York Times
March 2005
FDA Adds Black Box Warning to Eczema Drugs Elidel and Protpic
Because of a potential cancer risk, the FDA is now advising that doctors
should prescribe the two eczema drugs
Elidel (pimecromium)
and
Protopic (tacrolimus) to patients only as directed and only after
other eczema treatments have failed.
March 2005
FDA Public Health Advisory on Crestor (rosuvastatin)
Information on
Astra-Zeneca Pharmaceuticals' revised package insert for their
cholesterol-lowering drug
Crestor (rosuvastatin)
-- a statin.
March 2005
2nd Drug After Heart Attacks Can Help Patients, 2 Studies Find
Studies (in which 80% of the participants were male) have shown that
adding Plavix (clopidogrel
bisulfate) to the other anticlotting drugs given to heart attack
patients prevents some second heart attacks.
PDF of The New England Journal of Medicine article about this
study.
March 2005
FDA piles initiatives on the back burner
The Boston Globe reports that current drug safety problems have
changed FDA focus away from longer-term issues awaiting action.
March 2005
Rare Infection Is Confirmed in 2nd Patient on M.S. Drug
The second MS patient using the drug Tysabri has been confirmed to be
suffering from a rare but deadly brain infection. (According to
information on the drug manufacturer's Web site, Biogen Idec and Elan voluntarily
suspended marketing of that drug on February 28, 2005.)
March 2005
Pfizer Stirs Concern With Plans to Sell Heart Drugs Only as Pair
Not everyone is happy about
Pfizer's announced plans to sell its new heart drug torcetrapib in
combination with the company's best-selling cholesterol treatment,
Lipitor.
March 2005
Type 1 Diabetes Cure
This page is a Question-and-Answer format description of the treatment
known as an islet cell transplant that has cured a 61-year-old UK man of
type 1 diabetes. (news
article about Richard Lane's cure).
March 2005
Paxil CR
and Avandamet Seized by FDA
February 2005
Canadian Suspension of the Use of Hyperactivity Drug
Canadian regulators have suspended the use of a commonly prescribed
hyperactivity drug Adderall XR indefinitely because the drug was linked
to 20 deaths, 12 of those children. Adderall XR and its short-acting
cousin, Adderall, are amphetamines known to cause side effects like
sleeping problems, appetite loss, and irritability as well as elevated
blood pressure and heart rate.
The New York Times reports that "[m]ore than 700,000 Americans
take some form of Adderall, which is made by Shire Pharmaceuticals Group
of Britain."
Source
Eczema Creams Linked to Cancer
The FDA is considering warnings for eczema creams sold under brand
names Elidel and Protopic because of cases of cancer have been reported
among adults and children using the creams, and because animal and
laboratory studies suggest the drugs could be to blame, according to a
new Food and Drug Administration analysis.
Source
Paxil versus St. John's Wort
Contradicting a U.S. trial that found that St. John's wort extract
was no more effective for those with moderately severe depression than
was a placebo, a recent German study shows that extract of the herb St.
John's wort was found to be slightly more effective than the widely
prescribed antidepressant Paxil for people with moderate to severe
depression. The extract used in the German study was a dietary
supplement by Nature's Way products sold under the brand name Perika
[
Nature's Way's St. Johns Wort SE purchase information
].
Source
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