Federal health advisers have voted to recommend over-the-counter sales of a weight-loss pill which is currently sold only with a prescription. But the question is, will it be safe to use as an OTC drug?
GlaxoSmithKline Consumer Healthcare is Orlistat's manufacturer. Orlistat would be the first OTC (over-the-counter) diet drug to gain approval from the FDA (Food & Drug Administration).
Although the drug company still needs final FDA approval before it can sell an over-the-counter version of Orlistat called Xenical, the FDA usually follows the recommendations of its advisory panel.
Orlistat, the fat-blocking pill, was approved by the FDA in 1999. On Monday, an FDA advisory committee voted 11-3 to recommend approval, but a final decision could take months.
According to The Associated Press, in six-month clinical trials, obese people who took Orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills.
“We are excited about the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss,” said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America.
“I think the drug is safe enough to be OTC. It’s an OTC indication. Although there are some i’s that need to be dotted and t’s crossed, it’s suitable for OTC use,” panel chairman Dr. Alastair Wood said following the vote.
Orlistat helps the overweight slim down only when combined with a diet and exercise regimen. The drug’s actual effect on weight loss is “gradual and modest,” according to Steve Burton, Glaxo’s vice president of weight control.
The drug's manufacturer's Research and Development department notes that,“There is no magic pill for weight loss and Orlistat is not a magic pill. Orlistat is a tool that will help people control their calorie intake and modify their diet.”
Mixed Reactions
Public Citizen's Dr. Sidney Wolfe, said the the watchdog group urged the FDA panel to reject the company’s application, calling it a “desperate attempt to revive this barely effective drug by an OTC switch.”
Lawyers across the United States will also be watching closely. Many drug companies have paid millions of dollars in jury awards and settlements as a result of people suffering signiicant damages and adverse reactions frrom consuming diet drugs. Evidence has shown that drug companies often times rush to market with new drugs before conducting adequate research or tests, misinform the FDA of the research that has been conducted, or misrepresent to the public the true facts and benefits of the drugs being marketed. Of course, diet drugs that promise quick lose with no side effects and no adverse consequences could be a billion dollar business.
Read more about Orlistat and its FDA Approval here.
For more information on the FDA Approval Process, Over The Counter Drug Safety or Dangerous Drugs, visit www.jrlawfirm.com
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