Avandia heart problems are preventing maker from seeking approval to treat Alzheimers
GlaxoSmithKline, Plc. has indicated that their attempts to obtain approval for their diabetes drug, Avandia, to be used to treat Alzheimer’s disease have been delayed. Concerns about Avandia heart attacks have caused many potential participants in their Alzheimer’s studies to drop out. The drug maker was hoping to gain approval to market the drug for treatment of Alzheimer’s disease, which would help them replace some of the lost sales suffered recently by the former blockbuster and off-set some of the costs they will incur as a result of Avandia lawsuits which are being pursued by thousands of diabetics who suffered heart attacks, strokes, congestive heart failure or death while taking the drug.
>>INFORMATION: Avandia heart problems
Avandia is currently only approved for treatment of type 2 diabetes. The drug is advertised to help diabetics regulate blood sugar levels, and Glaxo hopes that Avandia may effectively treat Alzheimer’s disease by regulating blood sugar levels in the brain. A 2005 Avandia study indicated that the drug may improve memory in some patients, but it is necessary for the manufacturer to provide data from clinical trials establishing that the treatment is safe and effective for that purpose to gain FDA approval for marketing.
Alzheimer’s disease is a serious condition which impacts the memory and ability to think clearly. The progressive condition primarily impacts older people and slowly destroys brain cells. According to the World Health Organization, approximately 18 million people worldwide have Alzheimer’s disease, and that number is expected to nearly double over the next 20 years. However, many believe that the Avandia heart attack risk outweighs the potential benefits the drug may provide.
AVANDIA PROBLEMS
Until this year, Avandia was one of the best selling medications for GlaxoSmithKline Plc, generating about $3.3 billion in annual sales. However, sales have fallen by more than $1 billion since a study was published in May 2007 in the New England Journal of Medicine. The study highlighted problems with Avandia which may increase the risk for heart attacks and congestive heart failure.
Although the FDA considered requiring an Avandia recall as a result of the heart attack risk, they have instead elected to place a “black box” warning on the drug, which is the strongest warning which can be put on a prescription medication.
Financial analysts had hoped that Avandia was going to be able to obtain FDA approval for Alzheimer’s treatment next year. However, Glaxo has had difficulty enrolling volunteers in the clinical studies due to the Avandia heart attack risks. Many doctors who previously prescribed Avandia to their patients for treatment of type 2 diabetes have switched to different medications, and likewise many are recommending that their patients not enroll in the study due to concerns about the increased risk of heart attacks and congestive heart failure.
Even if the FDA does eventually approve the drug for treatment of Alzheimers, financial analysts have indicated that Glaxo will need to overcome the Avandia heart attack concerns which many patients and doctors will have. According to an article from Bloomberg, financial analyst Irina Stratan of WestLB AG in London, suggested that the manufacturer may choose to give the drug another name when marketing it for treatment of Alzheimer’s disease. However, such a move would seemingly be an effort to hide or reduce awareness of the Avandia heart risks.
AVANDIA HEART ATTACK LAWSUITS
The Avandia lawyers at Saiontz & Kirk, P.A. represent individuals who took Avandia for type 2 diabetes and subsequently suffered a heart attack, stroke, congestive heart failure or death. Glaxo failed to adequately warn about the potential Avandia heart side effects, which have caused thousands to suffer serious and potentially fatal injuries. If you, a friend or family member have experienced problems, request a free lawsuit evaluation.
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