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News Articles >> Avandia Dumped From Two Major Formularies
Avandia Dumped From Two Major Formularies
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| December 10, 2007. By Gordon Gibb |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Eagan, MN: A further sign that a diabetes drug linked to heart attack and heart failure is in trouble, was the news yesterday that two major drug benefit plans in the US have pulled Avandia from their formularies. Scores of physicians have recalled their patients from Avandia in recent months, and sales have been plummeting.
Prime Therapeutics, which represents about 12.5 million people, said it had removed Avandia (rosiglitazone) "after careful examination of clinical literature regarding the safety and efficacy" of Avandia. The now well-documented publication of the meta- analysis that appeared in the New England Journal of Medicine (NEJM) earlier this year sparked Prime's own analysis of its roster, which identified at least 25 per cent as having a history of coronary heart disease or heart failure. In view of recently expanded health warnings and black box warnings, not to mention a whopping 58 percent drop in Avandia utilization, Prime made the move to drop it completely.
Another BPM, HealthTrans, will remove Avandia from its formulary at the beginning of next year.
Avandia has been in the headlines for several months since news broke that the popular drug for the treatment of Type 2 diabetes was found to increase the risk of heart attack by 43 percent. A new black box warning linking Avandia to heart failure was recently augmented by a second label update, warning against the potential for Avandia heart attack, a much more serious condition. Unlike heart failure, which can be tracked and managed, a heart attack can occur without warning.
Diabetes experts have articulated concern about Avandia, and the link to Avandia and heart attack, since 1999, but regulators sat on their hands until the meta-analysis was published in the NEJM earlier in the year. Even with two black box warnings on the product, the US Food and Drug Administration (FDA) maintains that Avandia's risk/benefit ration is still favorable.
Once a blockbuster drug, sales of Avandia have plummeted as doctors switch their patients to alternative therapies in droves. Avandia maker GlaxoSmithKline appears to have given up on performance forecasts for Avandia, given how bleak things appear.
Just last week Avandia was tagged as playing a role in the onset of osteoporosis. Long suspected as contributing to brittle bones in women, Avandia has recently been found to actually contribute to bone loss. Before now, Avandia was thought to have some connection to the inability of bone to re-generate.
Meanwhile, Consumer Reports Best Buy Drugs study recently compared a host of different drugs and determined their effectiveness against various criteria, including risk and cost. The publication noted that GlaxoSmithKline, the makers of Avandia, spent $52 million marketing Avandia between 2005 and 2006, and sales of the drug increased by 20 percent. However, the publisher goes on to say that older diabetes drugs cost much less, are equally effective and probably safer. The authors make the point that while newer drugs may have different features, a drug that has been on the market for a long time has a longer profile, and therefore yields more data for analysis of long-term safety and effectiveness.
Consumer Reports Best Buy Drugs says that not only is Avandia expensive, but it has been over-prescribed.
HealthTrans' Pharmacy and Therapeutics Committee, which comprises independent physicians, pharmacists, and nurses, takes the safety and effectiveness of drugs made available to their members very seriously. "(We) have to make some tough decisions about discontinuing drugs that they have determined present significant risks," a HealthTrans spokesperson said.
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