The consumer watchdog group that nearly four decades ago first warned the Food and Drug Administration (FDA) that the painkiller Darvocet should be banned from the market because it was killing people, has taken aim at a diet pill. Public Citizen has petitioned the FDA to take a closer look at side effects caused by orlistate, the weight loss drug sold over-the-counter under the brand name Alli and by prescription in higher doses under the name Xenical.
The group says it pored through the FDA’s public database of serious side effects to drugs and identified 47 cases of acute pancreatitis and 73 cases of kidney stones among patients who took the drugs. The drugs also carry warnings on their safety labels about the risk for liver damage.
Both Alli and Xenical have unpleasant side effects, such as oily, loose stools. As a precaution, product packaging advises users to start the program when they have a few days off work, or to bring an extra pair of pants to the office.
With an average weight loss of just 3 percent, Public Citizen says orilstat offers to few benefits that don’t come close to outweighing the risk of organ damage.
Public Citizen petitioned the FDA twice over the past 40 years to pull the painkiller Darvocet from the market because of serious health problems including accidental overdose. Both times the FDA opted to keep the drug on the market, saying its benefits outweighed the risks.
Darvocet contains the active ingredient propoxyphene. It is also known by the brand name Darvon. Late last year the FDA reviewed a new study that showed drugs containing propoxyphene put users at risk for fatal heart rhythm abnormalities. That data was enough to sway the federal agency to pull the drug, a move that Public Citizen supported but said came decades too late.