Why You Won’t Be Getting New Diet Drugs Soon
The Food and Drug Administration (FDA) officially approved two new diet drugs in July 2012 that have some experts ringing the alarm bells. In fact, the FDA acknowledges they have some concerns with both new drugs, which may hamper your ability to actually get your hands on them anytime soon. The two drugs are:
- Belviq: Manufactured by Arena Pharmaceuticals, the FDA has asked the Drug Enforcement Administration (DEA) to control its use, in the same way they control opiate pain medicines. The DEA will probably take several months to decide how exactly to control Belviq. There have been some concerns that the drug may have a negative effect on heart valves, but tests so far have not shown this to be a problem. Belviq is meant for obese patients with a body mass index (BMI) of 30 or higher. The BMI threshold drops to 27 if the patient also has a weight-related condition, such as high cholesterol, diabetes or high blood pressure. The chemical name for Belviq is (1R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine.
- Qsymia: Manufactured by Vivus, Qsymia is the combination of two drugs known as topiramate (an anticonvulsant) and phentermine (appetite suppressant). Studies show it to be an effective treatment for obesity: in one study, the average participant lost 14.7 percent of their body weight. The minor side effects reported include dry mouth, constipation and tingling digits (fingers and toes). Qsymia is also being tested for its efficacy in treating sleep apnea and high blood pressure. The drug will not be monitored by the DEA, but its sale will be restricted to certified pharmacies. In other words, physicians cannot sell it to you directly – the FDA fears the start of another “pill-mill” epidemic. Vivus will keep track of doctors who prescribe the drug and verify which ones receive training. Pregnant women should avoid Qsymia because it causes birth defects. Others who should avoid the drug include patients with overactive thyroids or irregular heartbeats. Doctors are to monitor any suicidal tendencies on the part of Qsymia users, due to the topiramate portion of the Qsymia formula.
Dr. Sid Wolf of Public Citizen is against these new drugs, and thinks they won’t last long before being pulled due to unknown side effects. Because of the restrictions on both pills, dieters will probably continue to use older, more available formulas like ephedra extract (not to be confused with ephedra alkaloid, which is illegal in the U.S.). By the way, you can “roll your own” Qsymia by having your doctor separately prescribe both of its components, a perfectly legal thing to do, although the FDA frowns on it.