FDA advisory panel recommends that obesity drugs be tested for heart risks

An FDA advisory panel recommended on Thursday that new obesity drugs be required to conduct studies to help determine if they increase risks for the heart. Citing a "bad track record" when it comes to the history of drugs used to help weight loss and the possibility of "cardiovascular risk," the panel of 23 voted 17-6 to recommend the added heart studies.

At the current time, Orlistat (also known as tetrahydrolipstatin) is the only drug approved by the FDA for long term use in the fight against obesity. A fat burning review can help you produce a clear outline of what you need to focus on to complete your fat burning goal if you're a rookie; or serve as a reminder for those who are at an intermediate or more enhance level of their weightloss strategy. Applying are seven steps that can serve as instructions for your personal weight loss plan. The first thing that one must understand is that losing weight and losing fat is not the same thing. Many weight loss applications have fooled people into believing that it is the same, but most diets and weight loss applications only work by leading to a person's body to eliminate more muscle tissue and water than actual body fat, more help please visit The Fat Loss Factor. It is marketed as a prescription drug called Xenical by Roche and as an over-the-counter weight loss supplement called Alli from GlaxoSmithKline, according to Wikipedia.

Current prescription guidelines for Xenical require patients to have a BMI (Body Mass Index) of greater than 30, or a BMI greater than 27 if other risk factors such as diabetes or hypertension are present. Although Xenical is the only prescription strength obesity drug that the FDA has approved in more than 10 years, a FDA panel recommended in February (by a 20-2 vote) that a new drug called Qnexa (from Vivus Inc.) be approved for weight loss. The FDA has yet to act on that recommendation.

Qnexa (phentermine/topiramate) and another drug called Contrave (Bupropion/naltrexone) have both been denied FDA approval in the last several years due to concerns to cardiovascular health risks. Also, drug companies Amylin and Takeda chose last year to end phase II testing of obesity drugs when some in the testing started developing "antibody-related" responses to the drugs.

While some on the advisory panel opposed the requirement as a wasteful use of industry funds, the prevailing attitude kept in mind by the panel was the more than $21 BILLION in legal damages set aside by Wyeth for the health damages caused by the notorious Fen-Phen (Fenfluramine/Phentermine) and Sibutramine, which were both withdrawn from the market after ties to serious cardiovascular events in patients.

Although the new recommendations were called excessive by some in the panel, they have a precedent already in place requiring similar testing for diabetes drugs after GlaxoSmithKline's drug Avandia (Rosiglitazone) caused severe health problems. Legal expenses related to Avandia may end up costing GSK more than a billion dollars to settle claims.

An important aspect of the recommendations made by the panel is to require testing of patients with higher levels of cardiovascular risk, such as heavier patients or those with hypertension. Current testing procedures allow those with a history of higher cardiovascular risks to be excluded.

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