Avandia Recall
The prescription medication Avandia, which is also sold as Avandamet, Avandaryl and generically as rosiglitazone maleate, has been linked to a variety of fatal and near-fatal side effects and cardiovascular events that have prompted consumer advocates and health organizations to recommend an Avandia recall. Despite the international pressure placed on regulatory agencies and the manufacturer, GlaxoSmithKline, Avandia is still available to some patients. Access to this oral medication for type-II diabetics has been restricted as of November 18, 2011.
History of Adverse Reactions
Avandia was released in 1999 as a medication for type-II diabetics to manage their blood sugar without insulin. Within a year of its release, the first Avandia-related heart attack was reported, and many other patients have experienced cardiovascular side effects. Health conditions linked to this medication include heart attacks, congestive heart failure, pulmonary embolisms, deep vein thrombosis (DVT), fatal blood clots and stroke. Other dangerous side effects linked to Avandia include liver disorders, bone fractures in the hands and feet, high blood pressure, pulmonary hypertension, heart disease, diabetes-related vision problems, severe hypoglycemia and dangerously high blood sugar levels.
Interactions with Other Drugs
Patients who take thyroid hormones, steroids, birth control pills, diuretics, asthma medications and anticonvulsants are at a greater risk of developing dangerously low blood sugar while taking Avandia. These dangerous and potentially fatal side effects resulted in two nationwide drug advisories in 2007 and stringent restrictions on access to Avandia that were put in place in November, 2011. However, a complete Avandia recall and withdrawal from the market has not been ordered.
FDA Warning
In 2007, the FDA issued a national warning to healthcare professionals and the general public. The FDA also ordered GlaxoSmithKline to place a black box warning on all Avandia packaging. These patient warnings indicate that a drug has been linked to fatal side effects. The FDA also requires pharmaceutical outlets to provide patients with a medication guide that covers the potential benefits and side effects of Avandia and rosiglitazone.
What Studies Show
Official data shows that Avandia has been linked to more than 100,000 heart attacks since 1999. GlaxoSmithKline has been involved in a large number of lawsuits and has set aside more than $3.4 billion to cover anticipated legal expenses. One study on the safety and efficacy of Avandia, which was conducted by the Cleveland Clinic and published in the New England Journal of Medicine, shows that patients taking Avandia have a 43 percent higher chance of experiencing a heart attack, a 50 percent higher chance of suffering congestive heart failure and a 64 percent higher chance of experiencing cardiac arrest or sudden cardiac death.
Current Restrictions
As of November, 2011, patients who are successfully using rosiglitazone and patients who cannot take other anti-diabetic medications can obtain Avandia only by registering with the Avandia-Rosiglitazone Medicines Access Program, which distributes the medication through a limited number of mail-order pharmacies.
Getting Help
If you or a loved one has been prescribed Avandia, talk to your doctor immediately about the risks and benefits of continuing to take the drug. Never stop your medication without your doctor's approval. Further, if you or they have been injured by the drug and need information regarding your legal rights contact our Patient and Family Advocates to discuss the legalities involved. If circumstances suggest that compensation for the injury is available they will be happy to set you up with an immediate, free consultation with a highly experienced Avandia lawsuit attorney.