Tuesday, July 24, 2012

Weight-loss drug Qsymia: our take

Bonnie and Steve: Welcome to the next weight-loss strategy: combine an amphetamine with an anticonvulsant! Even more exciting is that “these prescription medications would be taken for the rest of a person’s life," according to the FDA. Don't you feel like going to your doctor's office to get a prescription for Qsymia?

After not approving a weight-loss drug for 13 years, the FDA approved two in consecutive weeks. At least each of the new drugs -- Belviq and Qsymia -- is being restricted. The FDA was so worried about Belviq, that it has asked for the Drug Enforcement Administration to control its use, like it does opiate painkillers. Qsymia won’t have these restrictions. But the FDA and drugmaker Vivus have worked out a plan to try to ensure that doctors don’t start running diet pill-mills. Vivus will track which doctors are prescribing the drug, and which ones undergo training.

Up to 10 percent weight loss sounds great, until you look closely. That weight loss occurred when used by selected volunteer patients in carefully designed, closely monitored clinical trials who made dramatic changes to their diet and exercised regularly as well. That will not happen in the real world.

The funny thing is that a version is already on the market. Any licensed doctor can prescribe phentermine together with certain versions of topiramate, the epilepsy drug.
Here is our take in February when it was formerly named Qnexa (changed the name to Qsymia because of bad press?): http://www.youtube.com/watch?v=I1d9riHd7Ho.

Side effects covered in our blog piece February 2012:

A panel of medical experts voted to endorse the controversial obesity drug Qnexa, clearing the way for the Food and Drug Administration to approve a new prescription obesity medication for the first time since 1999. The FDA will issue a final ruling later this year, but the agency typically follows the recommendations of its advisory committees. In 2010, the same advisory committee decided that the drug's risks of heart problems and birth defects outweighed its benefits. Qnexa, a combination of the anticonvulsant drug topiramate and the appetite suppressant phentermine, led to an average loss of 10% of total body weight in the first year of use. However, the trials also found that that the drug caused a slight increase in heart rate, which can boost the odds of a heart attack or stroke. In addition, researchers detected an increased risk of birth defects - typically cleft lip - in women who became pregnant while taking the drug. According to the clinical trial data and previous studies, the risk of having a baby with a cleft lip is two to five times greater in women who took Qnexa.  In our opinion, we do not recommend touching this med until at least 3 or 4 years of post-market research on its side effects has been performed. Besides, does the economic cost and potential for adverse effects in exchange for a ten percent reduction of body weight seem like a good trade-off?

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