After Aventis, FDA weighs Acomplia's side effects

People wanting to curb their urge to eat more may cross their fingers as a new drug intended to do just the same is in line for approval by experts who are going to decide in a meeting on Wednesday whether Food and Drug Administration (FDA) should authorize the sale of the wonder drug, rimonabant by Sanofi-Aventis, in USA.

The agenda of the meeting to be held shall be mainly reviewing data on the drug that has been delayed three times and weigh the intensity of its potential side effects like depression, raising suicidal thoughts and anxiety with its potential benefits of reducing weight, cholesterol and blood sugar. The FDA advisory committee is expected to declare the result by the end of July.

Rimonabant which is already on the shelves in Europe (known as Acomplia), if approved in USA would be sold as the prescription medication Zimulti and as a rival to few other drugs meant to keep dietary fats from being absorbed by the body or develop a feeling of fullness in the brain in order to control the individual’s diet. A lot of new drugs on the same lines are being developed by various companies.

The drug which helps patients to lose weight at the highest dose of 20 milligrams is meant for seriously overweight people with health problems and not for people looking at reducing a few pounds here and there.

Sanofi-Aventis, the maker of the drug claims on the basis of four-company sponsored drug trials that people taking the required dose of the drug managed to lose an average of 14 pounds in three to six months as compared to ones taking placebo who could lose only 3½ pounds.

Julissa Viana, spokeswoman for Sanofi-Aventis also revealed that Zimulti takers were also better off as they experienced improvements in HDL ("good" cholesterol), triglycerides (blood fats) and insulin sensitivity than would be expected from weight loss alone.

“People who stayed on the rimonabant kept the weight off for two years, and those who stopped taking it regained”, Viana says.

The study also showed some side effects attached with taking the drug like 9% people undergoing depression as compared to 5% of those taking placebos. Other side effects included nausea, vomiting, diarrhea, dizziness and insomnia.

Rimonabant belongs to a new class of drugs called CB1 antagonists that acts directly on fat cells and blocks receptors in the brain that regulates appetite. It helps to create a feeling of fullness and as a result helps in controlling the diet, explained Louis Aronne, director of the Comprehensive Weight Control Center at New York-Presbyterian Hospital who was also a part of the research.

“Research indicates that the endocannabinoid system, which functions in the brain, fat cells and other organs involved in weight regulation, is overactive in obese people compared with normal-weight people. An overactive system leads to increased eating and desire for food as well as an increase in fat deposits in liver and fat cells. That creates a vicious cycle leading to greater obesity”, Aronne added.

According to Psychologist Thomas Wadden, an obesity expert at the University Of Pennsylvania School Of Medicine in Philadelphia, the drug is not recommended to people suffering from acute psychiatric illness in Europe due to fear of side effects like depression and anxiety.

Wadden also revealed that the drug had effects similar to another medication called sibutramine (Meridia) used for the same purpose. He quoted data saying that people using the drug lost about 7% of their starting weight as compared to people on placebos loosing only 1.5% to 2% (overall 5%).

Experts like Sidney Wolfe, director of the Public Citizen Health Research Group have expressed their concern over the long term effects of such drugs. There is no evidence till now to support that the drugs will continue working if you stop using them.

FDA is reviewing the decision of the drug release very meticulously as it is already under pressure due to objections raised against GlaxoSmithKline’s Avandia, a diabetes drug, to have increased the risk of heart attacks which was approved by the agency in 1999.

Sanofi-Aventis, one of the five largest Pharmaceutical companies in the world after Pfizer, Bristol-Myers Squibb, Novartis and GlaxoSmithKline, is headquartered in Paris, France. The company engages in the research, development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but they also develop over-the-counter medication.