Diet :: Diet drug pill may pose a risk – Xenical – orlistat

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.

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.


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