Alli Warning Issued by GSK: Bottles May Have Been Tampered With

GlaxoSmithKline is warning consumers about the potential risk that certain bottles of the weight loss drug Alli may have been tampered with and may contain a variety of other pills along with the intended drug.  

The Alli warning was issued by the drug maker on March 26, after consumers purchased bottles of of the medication in Alabama, Florida, Louisiana, Mississippi, New York, North Carolina, and Texas that contained other drugs. No illnesses have been reported in connection with the incidents.

The company indicates that the outer carton may look authentic, but the bottle may not have a label and the tamper evident seal may not be intact, may not be made of foil or may not have the authentic “Sealed for your Protection” print. Lot numbers and expiration dates on the outer cartons and the bottles may not match.

“The bottle may contain a range of tablets and capsules of various shapes and colors,” GlaxoSmithKline warned in its press release. The authentic Alli capsule is turquoise blue with a dark blue band and in labeled bottles with an inner foil seal imprinted with the words “Sealed for your Protection.” The bottle and carton should have the same lot number and expiration date.

To date, tampering has been reported with the following carton lots and expiration dates:

• Carton Lot 14372, Expiration: 02/28/2016
• Carton Lot 14395, Expiration: 02/28/2016
• Carton Lot 14124, Expiration: 09/30/2015
• Carton Lot 14267, Expiration: 01/31/2016
• Carton Lot 14442, Expiration: 04/30/2016

GlaxoSmithKline and the FDA are investigating the incident.

Alli (orlistat 60mg) is an over-the-counter obesity drug approved by the FDA in 2007 which prevents the absorption of fats and is meant to be used alongside a reduced caloric diet. The active ingredient orlistat has been linked to concerns in recent years about a potential risk of liver damage, resulting in investigations by agencies in the United States and Europe.

In 2009, the FDA issued a warning about the potential risk of liver damage from Alli, and the stronger prescription version, Xenical, after an analysis of 32 case reports conducted between 1999 and 2008. The FDA warned consumers of rare reports of serious liver injury after use of the drugs. At least 13 cases of severe liver injury with Alli and Xenical were found during the investigation, including two incidents where patients died and three other incidents requiring patients to receive a liver transplant.

The types of drugs found in the compromised bottles of alli were not named, but there are always serious concerns about taking unknown drugs. Consumers could experience unexpected drug interactions, may be unable to tolerate certain drugs or may experience other, potentially fatal, side effects.

The company warns consumers who believe they have bottles that have been tampered with not to take the pills. If they have consumed products that they believe may not have been actual Alli capsules, they should contact their healthcare provider.

Anyone who suspects they have purchased tampered Alli bottles should call the company’s consumer relations line at (800) 671-2554 for further instructions and should retain all packaging materials.