FDA’s Handling of Xenical and Alli Investigation Signals New Era for Embattled Agency

With yesterday’s announcement of an ongoing investigation into dozens of reports of liver failure and liver damage in users of the popular weight-loss drugs Xenical and Alli, the Food and Drug Administration sent a strong message to drug manufacturers and consumers.

The FDA took an aggressive, proactive stance to a potential problem rather than waiting for more user injuries to occur. In the past, the FDA might have waited for months and even years before announcing it was looking into reports of consumer injuries caused by dangerous defective drugs, contaminated food, or other hazards. Only after a product recall had been announced did consumers know the problem existed. The FDA has been roundly criticized for its slow and ineffective handling of past outbreaks of contaminated food and controversial approvals of new drugs and medical devices.

But with the handling of the Xenical and Alli situation, the FDA has indicated that the old way of doing things may no longer apply. By notifying consumers of the investigation into reports of liver failure and damage in users of the drugs early on, the FDA is giving people timely, relevant information they can use to protect themselves and their loved ones.

It’s a welcome change from the former FDA policies, which unnecessarily exposed thousands, if not millions, of consumers to dangerously defective drugs, medical devices, and food.

Drugs Linked to Dozens of Liver Injury Reports

Xenical and Alli are the brand names of the drug orlistat. Xenical is the prescription-strength version made by Roche and approved by the Food and Drug Administration in 1999. Alli is the lower-dose brand-name drug made by GlaxoSmithKline and the only over-the-counter version diet pill approved by the FDA since 2007.

From 1999 through October 2008, orlistat was behind 32 reports from consumers who said they suffered liver failure or liver damage while taking either Xenical or Alli. Among those reports, there were six cases of liver failure and 27 cases in which patients required hospital treatment, officials said.

Xenical and Alli are commonly used by patients along with reduced-calorie and low-fat diets after losing weight. The drugs can help people keep the weight off. Xenical and Alli are different from most weight-loss drugs, which either boost metabolism or suppress appetite. Instead, Alli and Xenical work by preventing the digestive system from absorbing dietary fat, which reduces daily caloric intake and limits weight gain.

Yay! For the FDA

We applaud the FDA for announcing its ongoing investigation of orlistat problems at the early stages and giving consumers and physicians all the information they need to make informed decisions on healthcare. We hope it is the beginning of a new day at the FDA and a glimpse into the future of the agency charged with ensuring the safety of our drugs, medical devices, and food supplies.

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