Attached is a copy of the Memorandum written by Janet Woodcock, M.D., the current Director for the Center for Drug Evaluation and Research at the FDA, FDA concerning Avandai
(rosiglitazone) in which the FDA finds:
- 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.
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;
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity.
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
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