Health Canada has announced new restrictions and a consent form for the diabetes medication rosiglitazone, sold under the brand name Avandia, because of an increased risk of heart-related illness. The national drug regulator said Thursday that it changed the restrictions after reviewing recent data and in conjunction with manufacturer GlaxoSmithKline Inc.
The drug may increase the risk of serious heart problems, including heart failure, angina (chest pain), heart attack or fluid retention (with or without rapid weight gain). It should not be used by patients who have or have had heart problems, the agency said in a release Thursday. Taking an approach similar to that implemented by the FDA in America, Health Canada says the medication should be used only in patients with Type 2 diabetes when all other diabetes medicines taken orally have not lowered blood sugar enough, or are not appropriate.
The agency said that patients should not stop taking the medication until they have seen their physician to discuss their diabetes treatment, including other options and the benefits and risks of taking rosiglitazone.
Before starting or renewing a prescription for Avandia, doctors must now advise patients to read the consumer information for the drug and to read and sign a consent form indicating they understand the heart-related risks of the medication and they have discussed other treatment options.
The restrictions affect Avandia (rosiglitazone), Avandamet (contains both rosiglitazone and metformin) and Avandaryl (contains both rosiglitazone and glimepiride).
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. Settlements of these claims are expected to 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;
Medical expenses associated with efforts to remedy the injuries as a result of the original surgery;
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.
Attorneys: Rachel Montes
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Toll Free (877) 529-8899
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA