› $150,000,000 verdict in personal injury case
GlaxoSmithKline (GSK) has agreed to pay more than $250 million to resolve about 5,500 claims that its type 2 diabetes drug Avandia (rosiglitazone) caused heart attacks and strokes in patients who used the drug. The payout will help GSK avoid the first trial over claims the pharmaceutical giant allowed the drug to be marketed despite reports that the drug was potentially deadly.
The Food and Drug Administration (FDA) voted today not to remove the Type 2 diabetes drug Avandia from the market, despite studies that indicate the medication puts users at an elevated risk for cardiovascular events, such as heart attack and stroke. But the agency did put tight restrictions on prescriptions of the drug. Meanwhile, European drug regulators announced today they will suspend the drug’s sales throughout Europe.
After two days of deliberation, a Food and Drug Administration (FDA) advisory panel voted Wednesday to keep the diabetes drug Avandia on the market despite studies that suggest the medication puts people at greater risk of heart attacks and strokes. The decision was hardly decisive. Among five possible recommendations, the option to withdraw Avandia from the market received the most votes, however a majority voted to keep it on the market in some form. Thus the drug will still be available.
While an expert panel in the U.S. reviews evidence to decide whether to pull the popular diabetes drug Avandia off the market due to an increased risk of cardiovascular events, BusinessWeek reports that the drug’s maker, GlaxoSmithKline (GSK), has agreed to pay about $460 million to settle lawsuits alleging the company hid evidence that Avandia increased the risk of heart attacks and strokes. GSK faces more than 13,000 lawsuits and has agreed to settle about 10,000 of them. Avandia was to face its first trial in federal court in October. BusinessWeek reports that the FDA review helped prompt the company’s decision to settle the suits.
The fate of the diabetes drug Avandia will likely be decided soon by an expert panel that has spent the past two days reviewing evidence that linked the drug to serious cardiovascular events and whether its developer and manufacturer, GlaxoSmithKline (GSK), influenced the results of a study asserting the safety of Avandia.
It’s a long time coming. This week the Food and Drug Administration (FDA) announced it is reviewing the primary data from a large, long-term clinical study, known as RECORD, on possible cardiovascular risks associated with the diabetes drug Avandia (rosiglitazone). The agency said it is also reviewing on an ongoing basis a number of other published observational studies on the cardiovascular safety of the drug. The FDA’s announcement comes on the heels of news that two U.S. senators are asking why the GlaxoSmithKline (GSK) drug is still on the market when an FDA oversight board in 2008 urged the agency to pull the drug because it was causing 500 additional heart attacks a month. That request by the oversight board was based on the findings from the RECORD study.
Two U.S. senators are asking the Food and Drug Administration (FDA) why the diabetes drug Avandia is still on the market after an agency oversight board in 2008 urged the agency to remove the GlaxoSmithKline (GSK) drug from the market because it was causing 500 additional heart attacks a month. Senators Max Baucus and Charles Crassley said the major drug company even knew about the dangers of Avandia but initiated a cover up to keep the drug available to consumers.
Consumer watchdog group Public Citizen released a petition on Thursday calling for an immediate ban on GlaxoSmithKline’s diabetes drug Avandia. In a petition addressed to Commissioner Dr. Von Eschenbach of the U.S. Food and Drug Administration, Public Citizen urged the ban based on trial data revealing the drug’s “multiple, serious risks.”
A UK newspaper reported yesterday that drug giant GlaxoSmithKline (GSK) – the second largest pharmaceutical company in the world – will cut 150 or more scientists and support staff positions.
Researchers believe that the diabetes drug Avandia may cause bone loss and long-term use may speed up osteoporosis. The thinning of the bones is dangerous and could lead to fatal fractures. The study published in the December 2nd issue of Nature Medicine suggests that usage of rosiglitazone in the treatment of type II diabetes may cause osteoporosis.
