Avandia Renewed Concerns
FDA Re-opens Avandia Investigation Over Renewed Concerns Of Increased Risk Of Heart Attacks
A new study being reviewed by the FDA has linked 304 deaths in only one quarter of 2009 with the use of Avandia, a prescription drug prescribed for the treatment of Type 2 diabetes. Â If you take Avandia, also known as rosiglitazone, be aware that you are at an increased danger of heart attack and cardiovascular risks.
If you have suffered a heart attack or chest pain, or a loved one has suffered a heart-related death while using Avandia, you may have a legal claim. Contact the Florida lawyers of Gordon & Doner today at 1-800-659-1159 for a free case evaluation. The attorneys at Gordon & Doner have received professional accolades for their work representing clients in West Palm Beach, Martin County, Stuart, Pembroke Pines, Miami and throughout Florida.
Since 2000, consumer groups have voiced concern over the deaths and illnesses that have been associated with the drug. GlaxoSmithKline (GSK), the maker of the drug, has continued to stand behind Avandia, but the FDA has placed a "Black Box" warning on the medicine. A Black Box warning is required when a drug carries a risk of severe injury or death.
The FDA is now reviewing the primary data from the completed Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) study, conducting follow-up audits, and reviewing additional studies to evaluate the cardiovascular safety of Avandia. The FDA previously issued warnings that rosiglitazone is not recommended in patients with symptomatic heart failure, and that Avandia causes or exacerbates congestive heart failure in some patients.
A separate federal investigation into Avandia conducted by the Senate Committee on Finance in January 2010 sharply criticized GlaxoSmithKline, saying the company failed to warn patients' years earlier that Avandia was potentially deadly. GSK denies these claims and has responded to the statement by saying the investigation "mischaracterizes and distorts the efforts that GSK took to continue to monitor the safety and efficacy of its diabetes medication."
While cardiovascular-related issues are the most common reported with Avandia, the use of the drug has also been linked to liver toxicity, increased risk of bone fractures, anemia and vision loss from macular edema, a swelling of the retina caused by fluids accumulating in the eye.
The FDA recommends that patients currently taking Avandia discuss any questions or concerns they have about the use with their healthcare professional and to report any side effects with rosiglitazone to FDA's MedWatch.
At Gordon & Doner, we believe the makers of dangerous drugs such as Avandia should be held accountable when someone is injured or killed by their products. If you or a loved one has been harmed by the use of Avandia, you need to explore your legal options before it is too late. For more information or to schedule a free case evaluation, contact the lawyers of Gordon & Doner today at 1-800-659-1159.
