The Food and Drug Administration (FDA) believes that prescription diet pill Xenical may pose significant risks to those who take it without a prescription. Regulators made this statement after reviewing GlaxoSmithKline’s request to market their prescription weight loss pill as an over-the-counter medication.
The FDA worries that people with diabetes and transplant patients would be at risk for incorrectly using this weight loss drug, thus, increasing the risk of serious drug side effects. The effectiveness of Xenical (orlistat) may also be reduced in the lowered doses that would be made available over-the-counter.
GlaxoSmithKline wants to sell this drug without a prescription in hopes that more people will use the diet pill, which generated nearly $500 million in sales worldwide in 2004 alone. Corporate profit seems to be the primary focus of this request, rather than patient safety.
The FDA believes that non-prescription labeling of orlistat will not adequately convey the risk information associated with this diet pill. In their review, regulators found that only 35 percent of people taking diabetes medications realized Xenical was not safe for their use, even after reading warning information. Half of those patients taking blood thinners or immunosuppressants recognized that taking Xenical was unsafe for them.
While the FDA has not made their final decision regarding over-the-counter Xenical, it will become the first FDA-approved non-prescription diet drug, if the agency decides to grant GlaxoSmithKline’s request.
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