FDA questions diet-pill plan
Agency sees risk in allowing sales over the counter
WASHINGTON -- GlaxoSmithKline PLC's Xenical diet pill may pose a risk if people take it without a prescription or a doctor's supervision, federal regulators said yesterday.
Diabetics and transplant patients may not use an over-the-counter version of the weight loss drug correctly, the Food and Drug Administration said in a review of Glaxo's application. The drug, known chemically as orlistat, also may not be as effective at the lower doses that would be available without a prescription, the agency said.
Glaxo is hoping more Americans will use the diet pills, which generated $497 million in worldwide sales in 2004, if they can be sold without a doctor's being involved.
If the FDA agrees the treatment can be used safely and effectively, Xenical would become the only agency-approved nonprescription diet drug.
''It is vital that labeling of nonprescription orlistat adequately communicate risk information," FDA reviewers wrote. ''However, preliminary evidence suggests that nonprescription labeling may not adequately direct the safe use of orlistat."
Only 35 percent of people taking medication for diabetes realized Xenical was unsafe for them even after reading a fact sheet that aims to guide Xenical's nonprescription use, the agency report said. About half of patients taking drugs to thin their blood or suppress the immune system also failed to realize they shouldn't take the weight loss medication, the FDA said.
The briefing documents were prepared for an advisory panel of medical experts gathering Monday to consider the evidence on Xenical and make a recommendation on whether it would be appropriate to sell the drug without a prescription.
In another development, the FDA yesterday released a report critiquing the agency's handling of safety issues that arise with medical devices after they are on the market and offering changes to address the concerns.
The critique, which was reported on the website of The Wall Street Journal, said the FDA's Center for Devices and Radiological Health doesn't get full information about problems that arise with devices after they are approved and isn't always able to properly analyze the data it does get.
