Two years ago the FDA rejected Contrave, a weight loss medication, because of a lack of long term data for this drug that is, at best, minimally effective for weight loss. But the FDA has now approved this drug. What happened?
The company resubmitted its application in December of 2013 citing encouraging result in the 8900 patient study that is ongoing.
The obesity epidemic was well known, but medications to treat obesity have minimal long-term effectiveness and are costly. There has never been a study showing that taking these drugs lowers the risk of heart attacks or strokes (the major cause of death among obese individuals). The FDA two years ago did request a long term study to look at heart rate and blood pressure since they withdrew Meridia from the market because of its effects.
What are the results: In four clinical trials involving 4500 people those who took Contrave lost 4.2 percent more weight than those who took a sugar pill. Well below the FDA standard of five per cent. The other requirement, losing five percent of their weight was met.
To put this into some perspective: it is minimally more effective as Belviq, which is not recommended by Consumer Reports.
Contrave is a combination of two drugs, and thus will have the side effects of both drugs. One of those drugs is Wellbutrin (Bupropion) which is used for treatment of mood disorders. Serious side effects of this drug include chest pain, rapid and irregular heart beat, rise in blood pressure, confusion, seizures, hallucinating, irrational fears. More common side effects include agitation, dry mouth, constipation, headache, nausea, insomnia, blurred vision, and many others.
The second part of this drug is a medication called naloxone which on withdrawal of the drug has side effects including feeling nervous, body aches, dizziness, diarrhea, runny nose. The naloxone has side effects such as abnormal heart rate and rhythm, trouble breathing, cardiac arrest, fluid in the lungs, and diarrhea.
It should not be used in mothers who are breast feeding.
Obesity is a disease that does not need this drug. The changes in lifestyle for diet and exercise still remain the safest, best, and only long term solution.
Dr. Terry Simpson
Dr. Terry Simpson received his undergraduate and graduate degrees from the University of Chicago where he spent several years in the Kovler Viral Oncology laboratories doing genetic engineering. He found he liked people more than petri dishes, and received his MD. Dr. Simpson, a renowned weight loss surgeon, is a leading advocate of culinary medicine. A frequent contributor to media outlets discussing health related topics and advances in medicine, he is also a proud dad, husband, author, cook, and surgeon “in that order.” For media inquiries, please visit www.terrysimpson.com.