Drug Recalls and Safety Alerts:
Drug Recalls and Safety Alerts: A selection compiled by Dr. Myatt.
Rosiglitazone (Avandia) Increases MI and CV Death in Meta-Analysis
The U.S. Food and Drug Administration (FDA) is aware of a potential safety
issue related to Avandia (rosiglitazone), a drug approved to treat type 2
diabetes. Safety data from controlled clinical trials have shown that there is
a potentially significant increase in the risk of heart attack and
heart-related deaths in patients taking Avandia.(1,2)
Hormone Replacement Therapy Linked to Ovarian Cancer
April 24, 2007 -- The Million Women Study, a trial in the United Kingdom of
postmenopausal women, has found that those receiving hormone replacement
therapy (HRT) were 20% more likely to develop and die from ovarian cancer than
women who never received therapy.
Pergolide Withdrawn From US Market
With both branded and generic versions being pulled due to potential for
serious heart valve damage, the FDA is urging clinicians to consider
transitioning any Parkinson's disease patients to other dopamine agonists.(7)
Use of Zolpidem Tartrate (Ambien) for ADHD-Related Insomnia in Pediatric
Patients Linked to Hallucinations
On March 28, the FDA approved safety labeling revisions for zolpidem tartrate
tablets (Ambien; Sanofi-Aventis US, Inc) to warn of adverse events associated
with its use in the treatment of insomnia associated with
attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 to 17
years. The drug is linked to risks for dizziness, headaches, and
Desogestrel/Ethinyl Estradiol Tablets (Cyclessa) Linked to Risk for Stroke
in Obese Women
On March 26, the FDA approved safety labeling revisions for desogestrel/ethinyl
estradiol tablets (Cyclessa; Organon USA, Inc) to update information regarding
the risks for cerebrovascular events, breast cancer, and depression in women
taking desogestrel/ethinyl estradiol tablets for contraception. (5)
Excessive Exposure to Benzyl Alcohol in Triamcinolone Hexacetonide
Injectable Suspension (Aristospan) Linked to Pediatric Toxicity
On March 1, the FDA approved safety labeling revisions for triamcinolone
hexacetonide. Benzyl alcohol dosages higher than 99 mg/kg/day in neonates and
low-birth-weight neonates have been linked with "gasping syndrome," gradual
neurologic deterioration, seizures, intracranial hemorrhage, hematologic
abnormalities, skin breakdown, hepatic and renal failure, hypotension,
bradycardia, and cardiovascular collapse.(6)
FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults
Who Take Antidepressant Medications
The U.S. Food and Drug Administration (FDA) today proposed that makers of all
antidepressant medications update the existing black box warning on their
products' labeling to include warnings about increased risks of suicidal
thinking and behavior, known as suicidality, in young adults ages 18 to 24
during initial treatment (generally the first one to two months). (3)
1.) FDA Press Release #P07-88,
May 21, 2007.
2.) Nissen SE and Wolski K. Effect of rosiglitazone on the risk of myocardial
infarction and death from cardiovascular causes. N Engl J Med 2007;DOI.
3.) FDA Press Release #P07-77, May 2, 2007.
4.) FDA Safety Changes: Ambien, Cyclessa, Aristospan. Medscape, May 16, 2007.
7.) FDA Press Release #P07-54, March 29, 2007.
8.) Ovarian cancer and hormone replacement therapy in the Million Women Study.
Lancet. 2007 May 19;369(9574):1703-10.