Hot Topics: FDA Rejects New Prescription Diet Drug due to Safety Concerns

The Food and Drug Administration (FDA) recently declined approval for a new prescription diet pill that would fight obesity. This drug, named Lorcaserin, was already denied approval by an advisory committee to the FDA back in September. Although this may be seen as a setback for medical treatment for obesity, this is not surprising. Many prescription diet drugs are not approved, or if they are, are often taken off shelves due to health concerns. In 1997, Fen-Phen was removed from the market because it damaged heart valves, and more recently the FDA has pressured the manufacturers of Meridia to remove that drug due to findings that it increased the risk of heart attacks and strokes in certain patients.

According to the press release from the drug’s manufacturer, Arena Phamaceuticals, the FDA rejected the drug because “safety concerns outweighed what the agency called the drug’s “marginal” effectiveness in causing people to shed pounds.” More specifically, large doses of this drug caused tumors in rats during clinical trials. Arena Phamaceuticals believes that the FDA has “misunderstood and misinterpreted” the data of tumors found in rats, indicating that some are malignant and some are non-malignant, also noting that human trials are needed. The FDA is set to give or reject approval for another obesity drug later this month, the drug Qnexa developed by Vivus.

Obesity drugs are a complex issue and have many implications for us as future dietitians. Many of us intend to enter this profession to help people with medical and health conditions, and obesity is currently the nation’s costliest medical issue. Over a third of our population is obese, with another third being overweight. These weight issues lead to medical conditions like hypertension, diabetes, cancers, stroke, and heart disease. For the first time ever, obesity has out-ranked smoking as the costliest medical issue our healthcare system is facing, and this means huge things for our profession, whether we intend to work in a clinical setting or in the prevention arena.

What prescription diet pills offer those who are overweight and obese in our nation is a quick-fix to eliminate a problem that is difficult to maneuver alone. Our society is obsessed with quick and easy solutions to problems, even in everyday life. When it comes to healthcare, quick solutions are always suggested first. A doctor is more likely to prescribe a statin medication to a patient with high cholesterol rather than encouraging him or her to eat more fiber and whole grains, to exercise, and to reduce intake of saturated fats. Taking a pill is easy; changing your way of life isn’t.

As someone who has never had a major medical issue, I can’t say I wouldn’t be quick to take a pill right away either. I might be scared and think there is nothing else I can do to fix this problem, and I trust my doctor, take my pills everyday, and continue my life as normal. But with diet pills, this is a scary road. Many of these pills, as highlighted above, have major health side effects, some even leading to death. And taking a diet pill without proper counseling on nutrition or to combat the psychological issues of overeating is dangerous for our society and, frankly, highly unlikely to work.

For anyone who has struggled with their weight, we know that it is not easy to change habits for a healthier life, but we know that it’s worth it. In my opinion, these diet pills are setting up a precedent that it’s okay to not take control or responsibility for your weight or lifestyle issues. It’s making it too easy for individuals to look for a quick-fix rather than to get to the bottom of the issue. In cases of morbid obesity, I can see how this drug may help – but just as gastric bypass surgeries usually result with the patient re-gaining all their weight back, it’s necessary to include nutrition intervention and counseling so that re-gain doesn’t occur. I really don’t think a medical doctor has the know-how to offer nutrition counseling for a patient taking an obesity pill. I think a dietitan’s expertise is necessary, and that it may also be prudent to involve a psychological professional to discuss issues like triggers to overeating and overall psychological well-being.

I know my opinion of prescription diet drugs may be a little harsh, but I really do not see this solution as doing anything good for a society that is two-thirds obese or overweight, and the issue of safety with these drugs is quite alarming to me. It may help short-term, but our society got this way because of root issues that aren’t going to be addressed with simply popping a pill. Nutrition counseling, education, and a sense of responsibility for your weight and your health is what is needed in this country to fight obesity long-term.