FDA Warns of Fake Alli Weight Loss Pills

The FDA has issued a warning to consumers about counterfeit Alli weight loss pills sold on the internet, which contain a different active ingredient that could react badly with other medications.

The warning was issued on Monday, indicating that laboratory tests by GlaxoSmithKline have shown that the fake Alli pills do not have orlistat, the active ingredient in real over-the-counter diet pills. Instead, they have a controlled substance known as sibutramine.

Counterfeit pills were first noticed by consumers and sent to GlaxoSmithKline last month. The FDA did not provide information on who was manufacturing the pills or through which websites they were being sold.

Alli (orlistat 60mg) is a weight-loss product that was approved by the FDA in 2007 for sale over-the-counter to help promote weight loss when used together with a low-calorie, low-fat diet. During its first full year on the market in the United States, Alli generated $131 million in sales for GlaxoSmithKline and has been viewed as a very important product for pharmaceutical company.

Sibutramine is an appetite suppressant used in the brand-name weight loss drugs Reductil, Sibutrex and Meridia, by Abbot Laboratories. It was made a controlled substance due to abuse by people suffering from eating disorders. Sibutramine is contraindicated for people suffering from bulimia nervosa, anorexia nervosa, serious depression, mania, uncontrolled hypertension and pulmonary hypertension, people with hyperthyroidism, and those who have suffered strokes, heart disease, heart failure or other conditions that may have damaged the heart. It should not be used with monoamine oxidase inhibitors (MAOIs) or opioids.

The FDA warning indicates that the counterfeit Alli bottles look very similar to the real products, but there are a few differences that consumers can spot. The outer cardboard packaging is missing a lot code and the expiration date includes the month, day and year, while the authentic Alli expiration date only contains the month and year. The fake Alli bottles are slightly taller with a wider cap with more coarse ribbing, and the foil inner safety seal is blank with no printed words. Authentic Alli will have the words “SEALED for YOUR PROTECTION’ printed on the foil. The capsules themselves are slightly larger than real Alli pills and contain a white powder. Authentic Alli pills are filled with small white pellets.

The FDA has recalled a number of products throughout last year that billed themselves as “herbal supplements,” which included sibutramine. One study by European researchers revealed that Chinese herbal supplements being sold in Europe contained twice the amount of the recommended dosage.

Any consumers who believe they have purchased counterfeit Alli pills are being asked to contact the FDA’s Office of Criminal Investigations.

The counterfeits come as the FDA is reviewing potential liver damage concerns with Alli and Xenical, a prescription version of the drug. The FDA has received 32 reports of liver injury among users of orlistat weight loss drugs, including 27 cases that resulted in hospitalization and six that involved liver failure. The most common symptoms reported were jaundice, weakness or fatigue and stomach pain. GlaxoSmithKline has refuted that there is any Alli liver damage side effect associated with their product.