The European Union health authority recommended GlaxoSmithKline add a warning to alli nonprescription weight-loss drug, advising patients taking levothyroxine or antiepileptic drugs, or those with kidney disease, to consult a doctor before using.

The ¹ recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use marks the second regulatory action in three months that could taint public perception of GSK's product.

The firm will distribute alli (orlistat 60 mg) in EU markets with the amended label, a spokeswoman in GSK's London office said.

The warning also notes oxalate nephropathy and pancreatitis have been reported in a number of patients using orlistat. An identical warning already appears on Roche Pharmaceuticals' Rx, 120-mg version of the drug, Xenical , sold in the EU.

The EMEA panel's recommendation comes as FDA investigates a possible risk of livery injury related to orlistat. FDA said Nov. 3 that its orlistat review is continuing.

Both actions could dissuade some consumers from using alli due to safety concerns (² Also see "FDA Alerts Public To Ongoing Safety Review Of Orlistat In GSK, Roche Drugs" - Pink Sheet, 31 August, 2009.).

GSK touts alli as the No. 1 weight-loss product in Europe, but third-quarter European sales were $47.4 million, down 48 percent from the second quarter.

Third-quarter U.S. sales were $30.7 million, essentially flat compared to the year-ago quarter. For fiscal 2008, U.S. sales of alli dropped 53 percent to $139 million after the product's June 2007 launch (³ Also see "GSK Upbeat On Alli In EU As Global Consumer Sales Show Healthy Gains" - Pink Sheet, 27 July, 2009.).

CHMP Recommendation Follows Assessment

According to an Oct. 30 report on CHMP's meeting for the month, the EMEA panel recommended the warning following "an assessment of information related to levothyroxine, antiepileptics interactions and adverse events related to pancreatitis and oxalate nephropathy associated with alli."

GSK also will follow CHMP's recommendation to distribute a letter advising health care professionals of the alli label change. CHMP and Glaxo agreed on a "Direct Healthcare Professional Communication" with the updated information, according to EMEA.

GSK's London spokeswoman said the firm submits information to EMEA and other regulatory agencies on an ongoing basis to provide comprehensive safety data on all its products. The alli label update "expands the information available to consumers and health care professionals to help facilitate product use," she said in an e-mail.

GSK also contends orlistat "is the most studied weight-loss medicine" and has a safety profile established through 100 clinical studies involving more than 30,000 patients, according to the spokeswoman.

The label change comes nine months after the European Commission cleared alli for nonprescription sales in the 27 EU countries, marking the first centrally approved drug switch (⁴ Also see "In Europe, Centralized OTC Switch Still Has A Few Bugs" - Pink Sheet, 15 June, 2009.).

However, each EU member has authority to say whether a nonprescription drug is distributed by pharmacies, over-the-counter or general sales. GSK says alli is available from pharmacies to adult consumers in each EU country in which the product has launched.

In the U.S., alli is available OTC to consumers 18 years and older. GSK says more than 6 million U.S. consumers have used alli.

That total includes people buying the product since the August announcement that FDA is investigating a possible risk of liver injury related to orlistat. The agency said it received 32 reports of serious liver injury in patients taking orlistat between 1999 - when it first approved Xenical - and 2008.

FDA initially reported online in June that it was evaluating rare reports of hepatitis and liver-related abnormalities in patients taking orlistat.

The agency said it was investigating the adverse events for a possible causal link. Separately, FDA said in February that it was investigating reports of rectal bleeding linked to use of the drug.

- Malcolm Spicer ( ⁵ m.spicer@elsevier.com )

Glaxo Adds Alli Warning Label In Europe

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