Pointing to new data about side effects, a consumer watchdog group is calling upon federal regulators to ban the sale of over-the-counter and prescription weight-loss drugs.
Public Citizen filed a petition with the Food and Drug Administration, asking the agency to prohibit the sale of GlaxoSmithKline’s Alli and Roche’s Xenical, because of worries about kidney stones and pancreatic damage.
After examining the FDA’s public log of adverse drug reactions, the group says that it has found 47 cases of acute pancreatitis and 73 cases of kidney stones among patients using the medicines.
Over-the-counter Alli and prescription-only Xenical both use the same active drug, known as orlistat, though the concentration in Xenical, which is the only weight-loss drug that is approved for long-term use, is higher. They block roughly a quarter of the fat in foods from being absorbed by the body.
Public Citizen previously sought a ban of drugs using orlistat in 2006. Sales of both have suffered — prescriptions of Xenical dropped to 110,000 last year, versus 2.6 million a decade earlier — in part because of their tendency to create loose stools. In addition, the FDA warned last year of rare cases of liver problems associated with the use of the two drugs.
“Orlistat is a drug used to treat people who are either overweight or obese,” wrote Public Citizen in its petition. “Unfortunately, it has little clinical effectiveness and has the potential to damage a number of organs, including the liver, pancreas, and kidneys.”
Despite widespread concerns about obesity, the pharmaceutical industry has struggled unsuccessfully to come up with safe, new diet medications. In February, the FDA rejected the weight loss drug Contrave, which stood to be the first diet pill approved by the agency in more than a decade, because of concerns about harm to the heart.
According to the Associated Press, in response to Public Citizen’s petition, GlaxoSmithKline released a statement calling Alli “the most studied weight loss medicine. Its safety has been established through 100 clinical studies involving more than 30 thousand patients.”
A spokesman from Roche said that company officials had not seen the Public Citizen petition, but added, ”Patient safety is of utmost importance to Roche.”
The standard procedure for the FDA is to respond to petitions within six months, though it often takes much longer.
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