In a split decision vote 20 to 12, an FDA panel has decided to leave diabetes drug Avandia on the market despite recent studies suggesting that Avandia can increase heart risks such as heart attack or heart disease.
GlaxoSmithKline the manufacturer of Avandia says it expects to take a $2.6 billion hit in the second quarter to settle lawsuits for Avandia as well Paxil. Paxil has also has a checker history with safety as an antidepressant linked to birth defects as well as manufacturing problems at a pharmaceutical plant in Puerto Rico.
Oddly enough to the drug maker this huge loss is actually good news. Many stock analysts expected the company could have been exposed to as much as $6 billion in potential damages or losses if the FDA took Avandia off the market, according to the Wall Street Journal. It’s not all roses for GSK as it’s widely believed many of the people taking Avandia will move to a less risky diabetes drug such as Actos.
Not all doctors will immediately move their patients off Avandia. A small coalition of diabetes doctors is actually recommended that Avandia patients remain on the drug until they can find other treatment options. That’s despite the fact that studies have suggested an increased risk of heart attacks, strokes and death in some users.
“Why give a drug with restrictions when a similar drug which has studies that did not show the bad outcomes of Avandia could be used instead,” said Dr. Jacob Warman, chief of endocrinology at The Brooklyn Hospital Center in New York City. “I don’t see anybody willing to take Avandia when they could take Actos.”
In a joint statement released Wednesday after the vote, the Endocrine Society, the American Diabetes Association and the American Association of Clinical Endocrinologists urged patients not to change any drug regimens without first talking to their doctor.
“Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider,” Dr. Robert A. Vigersky, immediate past president of The Endocrine Society, said in the statement. “Stopping diabetes medications can cause significant harm and result in higher levels of blood glucose that may cause severe short-term health problems and could increase the risk of diabetes-related complications in the long term.”
The statement added that “reports regarding the cardiovascular safety of rosiglitazone [Avandia] have not been definitive,” while also pointing out that other drug options are available.