One of the newer drugs on the market, Qnexa, is currently undergoing investigation with the FDA about safety concerns and side effects. Released by the Vivius Inc., this drug combines two already FDA approved drugs for appetite-suppressent, phetermine, and seizure-regulation, topiramate. If both of these drugs were considered safe by FDA standards, why won’t they approve Qnexa?
Clinical trials released by Vivius claim some serious fatal side effects from the ladder half of the drug, topiramate; The topiramate label lists: eye problems, decreased sweating and increased body temperature, acidic body fluids, suicidal thoughts and behaviors, and fetal toxicity.
These may not have been major issues in the clinical trials, but troubling safety issues persist. In the FDA’s analysis of Qnexa safety, there were some ominous comments:
- There was indeed evidence of increased heart rate and acidic body fluids in people taking Qnexa.
- The FDA states that “only a long-term” study can tell whether Qnexa increases the risk of heart disease in obese people already at high heart risk. One question before the panel is whether Vivus must conduct such a study.
- A disturbing number of women in the clinical trials got pregnant, even though they had agreed to be on birth control and had regular pregnancy checks. One of the ingredients in Qnexa is linked to birth defects, although none were seen in the clinical trial. Since 36% of U.S. women are obese, the FDA worries that a lot of pregnant women will be exposed to Qnexa.
Does Qnexa Benefit Outweigh Qnexa Risk?
While the argument over Qnexa approval isn’t about efficacy, not everyone taking the drug loses a significant amount of weight:
- On average, people taking the dose of Qnexa proposed for approval lost 6.6% of their body weight. For approval, the FDA requires that a drug result in average loss of at least 5% of body weight.
- In one study, 62% of obese and overweight people taking Qnexa lost at least 5% of their body weight — about three times as many as in the placebo group. The FDA standard is that 35% of people must lose 5% of body weight.
- In a follow-up study, people continuing to take Qnexa for a second year regained some of the weight they lost the first year. They did not regain as much weight as people taking a placebo. (For further reading check out http://www.webmd.com/diet/news/20120217/panel-to-ponder-fate-of-qnexa-weight-loss-pill)
Surprisingly enough, celebs have not used this drug yet; or at least nothing has been publicized. The only FDA approved weight-loss drug Xenical is a prescription-level lipid-inhibitor that I blogged about a little earlier in the month, it is also known as Alli. The rejection rate of weight-loss drugs is impossibly hard to overcome, the FDA sets high standards of such in prevention of safety risk. That being said, the majority of diet fads and weight-loss claims come with a high safety risk; the majority of weight-loss supplements and glamourized diets come with fatal side effects.