What is the problem?
The controversy surrounding Avandia began when The New England Journal of Medicine (NEJM) published a combined analysis of more than 40 studies that evaluated approximately 28,000 Avandia patients.
The results of the studies were shocking … One of the studies showed that Avandia, made by GlaxoSmithKline, doubled the risks of heart failure and raised the risks of heart attack by 42 percent.
The main author of the NEJM article, Dr. Sonal Singh, has also stated, “In addition to its deleterious effects on the heart, Avandia can cause blindness, and it doubles the risks of bone fractures in women.”
U.S. Food & Drug Administration “Black Box Warning”
After Dr. Singh’s article was published, the FDA stated that it had been evaluating the drug’s risks and issued a safety alert advising Avandia patients to consult their doctors.
The New York Times reported, “In the study’s aftermath, the drug agency said that it had been told in 2005 of a similar study conducted by GlaxoSmithKline, the manufacturer of Avandia that came to a similar conclusion. Critics denounced the agency’s delay in alerting patients.”
After a review of postmarketing adverse event reports, the FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs.
The drugs affected by the FDA Black Box Warning are as follows:
- Avandia® (rosiglitazone maleate) Tablets
- Actos® (pioglitazone hydrochloride) Tablets
- Avandaryl® (rosiglitazone maleate and glimepiride) Tablets
- Avandamet® (rosiglitazone maleate and metformin hydrochloride) Tablets
- Duetact® (pioglitazone hydrochloride and glimepride) Tablets
The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments.
Avandia Side Effects
- Congestive Heart Failure
- Heart Attack
- Vision loss
- Macular Edema
- Bone Fractures
Avandia Update 7/2/12: The U.K.’s largest drugmaker announced today that it has reached an agreement with the U.S. Government and a number of states to conclude several massive federal investigations involving Paxil, Avandia and Wellbutrin. In total, GlaxoSmithKline (GSK) will make payments totaling $3 billion, which will reportedly be covered by existing provisions and funded through existing cash resources.
Avandia Update 5/19/11: Avandia will be pulled from pharmacy shelves in November 2011 due to overwhelming evidence of the cardiovascular risks it poses to users. The move comes eight months after the FDA severely restricted the use of rosiglitazone – the active ingredient in Avandia – to diabetes patients for whom other medications do not work.