Avandia Linked to Pulmonary Edema, Visual Problems, and Heart Failure

[VickyRN, MSN, DNP, RN]

Patients taking Avandia and Avandamet (rosiglitazone) have reported blurry vision and swelling of the legs and feet...GlaxoSmithKline has received "very rare" reports of new or worsening diabetic macular edema...This swelling of the portion of the retina most important for sight can cause blurry or distorted vision.

The majority of those patients also reported peripheral edema, or swelling of the legs, ankles and feet... In some cases, stopping treatment or reducing the dose eliminated or improved the condition, it added.

http://www.msnbc.msn.com/id/10725474/

In 2000, Rezulin diabetes drug was recalled after being linked to dozens of fatal liver disease instances. The FDA announced at the time of Rezulin recall that Actos and Avandia were safer alternative in "this important class of diabetes drug," which Rezulin was the first FDA approved drug of the newest class. Public Citizen consumer group criticized the FDA for waiting too long to issue the Rezulin recall and remained skeptical that other drugs, such as Avandia, would not also cause problems.

The Avandia side effects can range from mild to life threatening. Included on Avandia labeling are the warnings that Avandia side effects can be as serious as cardiac events, including failure, and hepatic risks. When Avandia was first approved it was intended to replace the recalled diabetes drug Rezulin as a safe alternative because regulators did not associate as many Avandia side effects to it. Public Citizen consumer group never found that diabetes patients would suffer fewer Avandia side effects but the drug still remains.

Already known to cause fluid accumulation, Avandia is now being discouraged from use amongst anyone with a history of congestive heart failure or chronic renal insufficiency until further Avandia studies have been performed.

http://www.adrugrecall.com/avandia/effects.html

AVANDIA, like other thiazolidinediones, alone or in combination with other antidiabetic agents, can cause fluid retention, which may exacerbate or lead to heart failure. Patients should be observed for signs and symptoms of heart failure. In combination with insulin, thiazolidinediones may also increase the risk of other cardiovascular adverse events. AVANDIA should be discontinued if any deterioration in cardiac status occurs.

http://www.rxlist.com/cgi/generic2/rosigl_wcp.htm#W