Consumer watchdog group Public Citizen was the first to raise concerns about the safety of propoxyphene, the active ingredient in the brand-name drugs Darvocet and Darvon. The group petitioned the Food and Drug Administration (FDA) twice since the prescription painkiller was introduced more than 50 years ago.
Public Citizen claimed the drug had a sketchy track record for efficacy and that patients were needlessly dying from accidental overdoses while taking the drug. The FDA opted to keep propoxyphene-containing drugs on the market, but did agree to put stronger warnings on the product’s safety label. Still, Public Citizen urged, it was not enough.
Late last year, Public Citizen won the fight to have Darvocet and Darvon banned from the United States market, but only after a new study showed that the pills put users at risk of developing lethal heart rhythm abnormalities.
Now, Public Citizen is petitioning the FDA to take a closer look at the serious side effects caused by another drug, orlistate. The diet drug is sold over-the-counter under the brand name Alli and by prescription in higher doses under the name Xenical. Public Citizen says it has identified 47 case of acute pancreatitis and 73 cases of kidney stones in patients who took the drugs. The data was pulled from the FDA’s public database of adverse reactions to drugs.
The drugs already carry unpleasant side effects such as oily, loose stools, and product packaging advises users to start the program when they have a few days off work, or to bring an extra pair of pants with them to the office. Last year the FDA placed warnings on the packaging of both drugs about the risk for liver damage. Both Alli and Xenical have dramatically dropped in sales over the years.
Public citizen also claims that with an average weight loss of just 3 percent, like propoxyphene, orilstat’s meager benefits hardly outweigh the risks. “Orlistat is a drug used to treat people who are either overweight or obese,” states the petition. “Unfortunately, it has little clinical effectiveness and has the potential to damage a number of organs, including the liver, pancreas, and kidneys.”