The Partnership for Safe Medicines
Weekly Update February 1, 2010
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FDA Alert Regarding Counterfeit Alli

The U.S. FDA released an updated public health alert regarding counterfeit Alli being sold over the internet.

According to the FDA, here's what you need to know:

  • Alli is an FDA-approved, over-the-counter weight loss drug.
  • FDA lab tests have confirmed that counterfeit versions of the drug do not contain the FDA-approved active ingredient; rather, they are made with varying amounts of the stimulant sibutramine.
  • Sibutramine can be particularly harmful to those who have a history of cardiovascular disease and can lead to elevated blood pressure, stroke or heart attack.
  • The counterfeit drugs have been identified as Alli 60mg capsules (120 count refill pack)

If you take Alli, it's important that you check it for:

  • Missing lot numbers on the outer cardboard packaging;
  • An expiration date that includes a month, day and year-expiration dates on legitimate packages include the month and year only;
  • A wordless inner safety seal-the real product contains the words "SEALED FOR YOUR PROTECTION" on its inner seal;
  • Large capsules containing white powder instead of the small white pellets; and
  • A taller bottle with a wider, coarser cap than real Alli packaging

See photos of counterfeit Alli next to the real thing.

If you think you're in possession of counterfeit Alli, you're asked to contact the FDA's Office of Criminal Investigations (OCI) at 800-551-3989 or via their Web site.

Top News


Using Counterfeit Weight-Loss Drug May Lead to Overdose


Consumers taking a counterfeit version of the over-the-counter weight-loss drug Alli may be exposed to three-times the daily dose of the prescription weight loss drug, putting some people at risk for heart attacks and strokes. Earlier this week the Food and Drug Administration (FDA) warned consumers about the fake Alli, purchased over the Internet, noting that counterfeit versions of the drug didn't contain the active ingredient and instead contained sibutramine. The FDA's Office of Compliance is continuing to investigate the source of the counterfeit Alli, but there is no evidence it was purchased in retail stores. "FDA: Fake Versions Of Drug Alli Dangerous For Some Consumers," Wall Street Journal,  January 24, 2010; Story here)

World News


United States: Counterfeit Botox Presents Deadly Threat


An unknown cosmetics trader selling a seemingly limitless supply of fake Botox has prompted the search for his supplier, a potentially illegal factory in Chechnya, which could be churning out raw botulinum toxin, the key ingredient in the beauty drug and one of world's deadliest poisons. A speck of toxin smaller than a grain of sand can kill a 150-pound adult. Al-Qaeda is known to have sought botulinum toxin, and other terrorist organizations have bought and sold counterfeit drugs to raise cash. Now, with the emergence of a global black market for counterfeit Botox, terrorism experts see an opportunity for a deadly convergence. A search for the maker of the highly lethal toxin continues across a widening swath of Eastern Europe, the Middle East and Asia. ("Officials Fear Toxic Ingredient in Fake Botox Could Become Terrorist Tool," Washington Post, January 25, 2010; Story here)



South East Asia: Millions of Counterfeit Drugs Intercepted


Police have seized 20 million counterfeit or illegal medical products in cross-border operations in South East Asia, arrested 30 people and closed down more than 100 pharmacies and illicit drug outlets. The operation was carried out in eight countries -- Cambodia, China, Indonesia, Laos, Myanmar, Singapore, Thailand and Vietnam -- between July and November of last year under the framework of the World Health Organization's International Medical Products Anti-counterfeiting Task Force.The seized products included antibiotics, anti-malarial and birth control medicines, anti-tetanus serums, aspirin and lifestyle drugs. ("Fake medicines seized in Asia, 30 arrested: Interpol," Agence France-Presse, January 27, 2010; Story here)



Nigeria: Officials Attempt to Control Flow of Counterfeit Drugs


Nigeria's National Agency for Drug Administration and Control (NAFDAC) has begun a crackdown on local pharmacies selling counterfeit drugs. NAFDAC's Deputy Director, Anyakora Clementina, said it has become necessary to deal with the issue of fake drugs in the country given its hazardous nature and their effects on the health of the people. The counterfeit drugs uncovered during recent raids include Lonart, Amoxil, Ampiclox, Fammiol, Eurosumate, Augmentin, Amalar and Metakefin.The seized fake drugs, NAFDAC officials said, would be subjected to several laboratory tests and the dealers would be prosecuted. ("Nigeria Seizes Fake Drugs," Afrol News, January 27, 2010; Story here)

About the Partnership for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit