Drugmaker GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) has asked U.S. pharmacists to warn patients about the unpleasant side effects that may occur with a potential over-the-counter diet drug.
U.S. regulators are considering Glaxo's application to sell a low-dose version of prescription medicine Xenical at retail pharmacies. The drug works by preventing fat from being absorbed by the body, a process that can cause oily stools, excess gas and rectal discharge.
"GlaxoSmithKline is really targeting pharmacists. They met with Walgreen pharmacists last week to really get them on board," according to Jennifer McFee, faculty coordinator and pharmacist at Walgreen Co., (WAG.N: Quote, Profile, Research) the biggest U.S. drugstore chain by revenue.
"If a patient experiences these unpleasant side effects, they will likely discontinue use," McFee added, speaking on non-prescription therapies at a three-day conference on obesity at the Cleveland Clinic.
If approved, the drug would be the only weight loss drug endorsed by the U.S. Food and Drug Administration available without a prescription. It comes as the market heats up with the pending arrival of the most-highly anticipated prescription diet drug in years, a Sanofi-Aventis (SASY.PA: Quote, Profile, Research) drug called Acomplia.
Sanofi said earlier this month that it expects FDA approval of Acomplia by the end of the year. It is already approved in Europe.
GlaxoSmithKline spokeswoman Brian Jones said the company is educating pharmacists to let patients know they must follow a low-fat diet and exercise to avoid these side effects.
"If you keep to a low-fat diet, you won't notice them. But if you continue with a high-fat diet," the effects are likely to emerge, he said.
Glaxo officials have said the drug could help stem soaring obesity rates in the United States, where nearly two-thirds of the population is overweight or obese. Some express concern, though, about a weight rebound after they stop using the drug. The drug can also lead to hepatitis, gallstones and kidney stones.
British drugmaker Glaxo bought the U.S. nonprescription rights to Xenical from Swiss drugmaker Roche Holding AG (ROG.VX: Quote, Profile, Research). Glaxo expects nonprescription Xenical, called Alli, to be launched in the first half of 2007.
Xenical is one of the two major prescription diet drugs on the U.S. market. Abbott Laboratories Inc.'s (ABT.N: Quote, Profile, Research) Meridia suppresses appetite.
Acomplia, for its part, "is likely to make this a new era in obesity therapy," said Donna Ryan, an obesity specialist at the Pennington Biomedical Research Center in Baton Rouge, Louisiana, who led a panel on new drug therapies here. "Our current toolbox is limited.
In clinical trials, the drug has demonstrated not only an ability to help patients shed pounds and waist size, but it appears to reduce bloodstream fats known as triglycerides and to raise levels of the so-called "good" cholesterol, known as HDL.
Side effects include nausea and vomiting and patients with severe depression are not advised to take the drug. (Additional reporting by Debra Sherman)
Diet Pill fear
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