Weight-Loss Drug Approved Despite Cancer Concerns
The FDA first approved prescription strength orlistat back in 1999. Orlistat induces weight loss by decreasing the intestinal absorption of fat. OTC orlistat is less potent than the prescription version. Now GlaxoSmithKline will manufacture OTC orlistat under the name Alli. The Alli is indicated for adult use in combination with a reduced-calorie, low-fat diet, and exercise program.
But not everyone is excited to see Alli hit the market.
Public Citizen cancer concerns
According to the Federal Registrar, Public Citizen asked the FDA to remove Xenical (a trademarked version of orlistat) from the market because of studies that suggested it caused an increase in aberrant crypt foci.
Aberrant crypt foci are microscopic lesions considered precursors to colon cancer. The group cited seven studies that linked investigational orlistat to the development of aberrant crypt foci.
Colon Scientific Advisory Board review
To address the concerns raised by the citizen petition, GlaxoSmithKline formed an independent Colon Scientific Advisory Board comprised of experts in the fields of cancer research, gastroenterology, toxicology and obesity. GlaxoSmithKline paid the panel to examine the validity of the link between colon cancer and orlistat.
After reviewing pertinent information for two days, the panel members agreed that the evidence does not prove that orlistat increases the risk of colon cancer in humans.
The FDA echoed the panel's findings as it responded to Public Citizen's letter the same day the agency approved OTC orlistat. The FDA explained that a review of available data of the drug's efficacy and safety did not warrant withdrawing the drug from the market.
Using orlistat for weight-loss
While OTC orlistat may soon be widely accessible in drug stores, it is not for people who have problems absorbing food or for those who are not overweight.
The 60 mg capsule can be taken up to three times a day with meals containing fat. But, because of the possible loss of certain nutrients, it is recommended that people using orlistat should also take a multivitamin at bedtime.
Altered bowel habits, which may include loose stools, are the most common side effect of the product. However, consuming a low fat diet mitigates the likelihood of this side effect. And, people who have had an organ transplant should not take OTC orlistat because of possible drug interactions.
The FDA added that it would continue to monitor the safety of orlistat while the drug is on the market.
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