Weight Loss Drug News
An FDA advisory panel announced yesterday that they voted unanimously against the approval of a new weight loss drug, rimonabant (planned to be marketed in the US under the brand name Zimulti). The panel stated that the applicant drug manufacturer, French-based sanofi-aventis, did not show sufficient safety of the drug. Specifically, subjects receiving the drug in clinical trials showed a two-fold incidence of psychiatric side effects, including depression, anxiety and sleep problems, than those who received placebo.
The efficacy of the drug for weight loss was not called into question. Subjects taking the drug in clinical trials lost an average of 14 pounds over a year compared to four pound average losses in those taking placebo. However, most subjects gained the lost weight back after stopping the drug.
FDA is not required to follow the recommendation of the advisory panel; however, they likely will. The final decision is expected to be announced on July 27. Of note, the drug is already available in 14 other countries, marketed under the brand name Accomplia.
In other weight loss drug news, GlaxoSmithKline's Alli (orlistat), an over-the-counter version of the Hoffman-La Roche's prescription-only weight loss product, Xenical, was released yesterday. Demand is expected to be so high for this product that many stores are likely to be sold out of it by today.
Orlistat is a fairly safe weight loss adjunct. It works by blocking fat absorption from the gut. People with malabsorption syndromes or gall bladder problems should not take the drug. Other people who should use extreme caution in taking orlistat include organ transplant recipients and people with a history of eating disorder or kidney stones. Orlistat is minimally absorbed, so most of its side effects are intestinally related. Specifically, the most common side effects are diarrhea, oily anal leakage, increased bowel movements, fecal incontinence, and flatulence. (Stay near a bathroom at all times.) The common side effects can usually be minimized by reducing fatty food intake. Rare hypersensitivity (allergic) reactions have occurred.
The efficacy of the drug for weight loss was not called into question. Subjects taking the drug in clinical trials lost an average of 14 pounds over a year compared to four pound average losses in those taking placebo. However, most subjects gained the lost weight back after stopping the drug.
FDA is not required to follow the recommendation of the advisory panel; however, they likely will. The final decision is expected to be announced on July 27. Of note, the drug is already available in 14 other countries, marketed under the brand name Accomplia.
In other weight loss drug news, GlaxoSmithKline's Alli (orlistat), an over-the-counter version of the Hoffman-La Roche's prescription-only weight loss product, Xenical, was released yesterday. Demand is expected to be so high for this product that many stores are likely to be sold out of it by today.
Orlistat is a fairly safe weight loss adjunct. It works by blocking fat absorption from the gut. People with malabsorption syndromes or gall bladder problems should not take the drug. Other people who should use extreme caution in taking orlistat include organ transplant recipients and people with a history of eating disorder or kidney stones. Orlistat is minimally absorbed, so most of its side effects are intestinally related. Specifically, the most common side effects are diarrhea, oily anal leakage, increased bowel movements, fecal incontinence, and flatulence. (Stay near a bathroom at all times.) The common side effects can usually be minimized by reducing fatty food intake. Rare hypersensitivity (allergic) reactions have occurred.