Avandia Side Effects & FDA Restrictions

Avandia (Rosiglitazone), produced by the pharmaceutical giant GlaxoSmithKline, has been used for the treatment of type-2 diabetes since long time but now in numerous countries use of Avandia is banned due to its severe side effects shown by many studies. This drug was a very well-known in last few years; indeed GSK attained annual peak sales of around $2.5bn in 2006 but gradually Avandia lost its popularity after reports of side effects that include Edema, Fluid retention, Liver failure and Liver toxicity, Low blood pressure, Bone fractures, Heart failure, back pain, fatigue, headache, and sinusitis. One of the major factors is heart risk among all the side effects.

In November 2007 in U.S., a “black box” warning was added to Avandia, but lots of critics sustained to argue that the warning was not sturdy enough and called for an Avandia recall to be issued in the United States. FDA had also issued a safety alert in the same year. More complicated changes in the body can be lead by the long time treatment with Avandia so FDA has put restriction on its use now. Hence, the doctors are prohibited to prescribe this drug to any patient that has little fluctuations in the sugar blood level. If a doctor committee assesses that the coefficient gains: risk is in favor of the benefit then the people who have bad regulation of their sugar level can get the drug.

The company which manufactures this medicament is being asked to make new clinical trials with impend team of doctors and scientists to scrutinize the side effects of long treatment with Avandia. Until the new clinical trials end, Avandia fda restrictions will last.

FDA Warns of Avandia Side Effects video from Youtube: