On September 23, 2010, the U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
According to the New York Times, experts claim that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia was linked to 304 deaths during the third quarter of 2009 alone.
Janet Woodcock, M.D., the current Director for the Center for Drug Evaluation and Research at the FDA, FDA issued her memorandum finding:
- The drug manufacturer had not met the FDA’s guidelines for 95% confidence for the risk ratio (test drug versus comparators) for Major Adverse Cardiovascular Events (MACE).
- Pioglitazone, the only other drug in this same class of drugs as Avandia does not have similar signals as Avandia.
- There is a concern by some experts that Avandia may increase the risk of heart attacks by as much as 80% as compared to other therapies.
As a result, the FDA is restricting access to rosiglitazone (Avandia) until more substantial evidence of its safety becomes available.
Avandia, a drug manufactured by GlaxoSmithKline’s (GSK), has been widely prescribed drug used to treat type 2 diabetes, has been shown to increase users’ risk of heart attack by 43 percent and cardiac-related death by 64 percent, according to the 2007 study published in the New England Journal of Medicine.
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:
- Physical pain and suffering, mental anguish and physical impairment; and
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity; and
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
Montes Law Group, P.C.
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Fax: (214) 522-9428
Facebook @ Montes Law Group, P.C.