FDA Not Convinced Vivus Obesity Pill Is Safe

Despite nationwide actions to reduce and control obesity, the United States remains the country with the highest rates in the world. With 64 percent of adults in the U.S. suffering from obesity, there is an urgent need for a treatment that works faster and longer than conventional solutions. One of these is thought to be the Vivus obesity pill, but so far, the FDA is not convinced the drug is safe.

Although the Food and Drug Administration (FDA) isn’t yet convinced the Vivus obesity pill is safe, producers still have until new week to make their point. If they do, then the FDA might just approve the first new prescription diet pill in over a decade.

Vivus is one of the producers that is trying hard to bring to the market breakthrough drugs, such as Qnexa, the obesity pill. However, so far authorities don’t seem too confident the pill will make it to consumers. In 2010, Qnexa was rejected by the same FDA but Vivus didn’t back down and submitted the drug for review once again.

According to the updated appraisal of Qnexa, the FDA said that the drug looks “somewhat reassuring” but the authority remained concerned over the heart risks it carries. However, the FDA asked its advisers to bring forth any other data that would pertain to the health risks Qnexa might carry.

A short glimpse at the FDA’s website is enough to see why the regulators aren’t fully convinced the drug will have only health benefits. The website presents FDA’s concerns regarding potential heart problems and even birth defects in women on the drug. These are the same concerns that got the authority to dismiss Qnexa two years ago.

ABC News writes that Qnexa is actually a combination of two older drugs: the amphetamine phentermine and topiramate, both approved drugs. If this time the FDA passes the drug, Vivus will be in for a record breaking success.

Analysts told Business Week that the drug may generate $448 million in sales in 2015. Jason Butler, analyst with JMP Securities, declared: “The positive here is the FDA is saying exactly what the data says. This drug has risk, it has side effects. The benefit here is compelling”.

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