FDA warning on fake versions of GSK’s weight loss drug

The US Food and Drug Administration has issued a warning about a counterfeit “and potentially harmful version” of GlaxoSmithKline's over-the-counter weight-loss product Alli.

Consumers began reporting suspected counterfeit Alli,a lower-dose, OTC formulation of Roche’s Xenical (orlistat), to GSK early last month and the company says these fake versions have been sold on the internet. Preliminary laboratory tests revealed that the counterfeit did not contain orlistat, but sibutramine, the active ingredient in Abbott Laboratories’ prescription weight-loss drug Meridia.

The FDA said that the latter is a drug that “should not be used in certain patient populations or without physician oversight”. Sibutramine can also “interact in a harmful way with other medications the consumer may be taking”, the agency added, noting that “there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores”.

The fake looks similar to real Alli, but there are a “few notable differences”, the FDA concluded. For example, the outer packaging is missing a "Lot" code, and the counterfeit also has an expiration date that includes the month, day and year. Authentic Alli has an expiry date with just the month and the year.

Emerging markets growth
Meantime, a GSK director responsible for the area has told Bloomberg that the company is expecting sales growth of as much as 10% in the Asia-Pacific region this year, in line with the market and last year’s 9% increase.

Christophe Weber said the strongest growth will come from Southeast Asian nations such as Indonesia and the Philippines, adding that sales of cervical cancer vaccine Cervarix have increased ten-fold. He also noted that GSK is reinvesting 20% of its earnings from poor countries into health infrastructure developments, such as building hospitals and projects for clean water and sanitation.