Latest Avandia® News
What is Happening With Avandia®?
Controversy continues to rage over the heart safety of the type 2 diabetes drug Avandia®. Avandia® has been the subject of debate for years. Many doctors and scientists are certain there is a strong link between the medication and the risk of heart attack and stroke.
The FDA on Sept. 23, 2010, announced it was significantly restricting access to Avandia® to patients with type 2 diabetes who cannot control their illness on other medications.
“These new restrictions,” the agency announcement said, “are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia®.”
The new FDA action required GlaxoSmithKline, the drug’s manufacturer, to develop a restricted access program for Avandia®, using a risk evaluation and mitigation strategy. Under this new strategy, new patients could take Avandia® only if they could not control their glucose levels with other medications and could not take Actos® (pioglitazone), the only other drug in the class.
Doctors now need to attest to and document their patients’ eligibility to take Avandia®. Patients need to read statements about the heart safety of the medication and acknowledge that they understand the risks.
Avandia® Banned in the United Kingdom, not U.S.
In October 2010, the United Kingdom suspended the license for Avandia® and took the drug off the market, following a recommendation by the European Medicines Agency. That agency concluded that the benefits of the drug no longer outweighed its risks for heart problems, including heart attacks and heart failure.
Until recently, the FDA found no conclusive evidence to restrict the use of Avandia®. An FDA revision to the black box warning on Avandia® contained information on studies of thousands of patients:
- One large study concluded that Avandia® increased the risk of heart problems such as angina (chest pain) or heart attack
- The results of three other studies were inconclusive in terms of whether Avandia® increased heart problems
Some at the FDA itself and other medical experts have contested the impartiality of the July advisory panel that recommended that Avandia® not be recalled. The FDA officials and others said the panel was filled with members who were sympathetic to the medication.
Dangers of Avandia®
It has been reported that the most dangerous side effects of Avandia® are:
- Heart attack
- Congestive heart failure
- Bone fractures
Contact an Avandia® injury lawyer for more information about the latest news and updates related to Avandia®. We can help you seek compensation if you think you have been harmed by the drug.