Heart Patients Warned Against Using Meridia, an Anti-Obesity Drug

From The New York Times:

European and American drug regulators had two starkly different reactions this week to data on an obesity drug. The raw data from the study indicated that people with certain health problems who took the prescription diet drug Meridia had more heart attacks, strokes and other cardiovascular problems than people getting a placebo.

On Thursday, the European Medicines Agency advised doctors and pharmacists to stop prescribing and dispensing European equivalents of Meridia. The Food and Drug Administration, looking at the same study data on Thursday, took a less forceful step and asked Abbott Laboratories, the maker of Meridia, to put a stronger warning on its label.

The F.D.A. said the new warning should indicate that the drug was not to be used by people who have a history of heart attacks or strokes, or who have uncontrolled high blood pressure.

Abbott, which sells Meridia in Europe under various brand names, including Reductil and Ectiva, indicated Friday that it would comply with the F.D.A.’s labeling request and with the European advisory by suspending sales of the drugs in Europe.

Meridia contains the ingredient sibutramine, which works by increasing neurotransmitter activity in the brain, helping people to feel full after a meal and thereby reducing their food intake. The company said the drug was safe and effective when used in appropriate patients.

The study, called the Scout trial, was the first test to see if a diet drug could reduce the risks of heart attacks.

Some experts said the finding that Meridia actually increased such risk in some high-risk patients rather than reduce it could raise questions about the safety of other diet drugs. The findings might also raise the safety hurdle for new obesity drugs to win approval. However, some experts said the problems might be unique to Meridia, which clearly raises blood pressure and heart rate.

In any case, the significantly different actions by the two health authorities is stirring debate among drug makers and consumer advocates. Did the European agency act too quickly on a set of preliminary data — or was it moving more forcefully to defend consumer health than its American counterpart?

Meanwhile, the F.D.A. said it planned to wait for the company’s complete report on the study, due in March, before considering further action on the drug.

Posted: 1/27/2010 9:01:00 AM

Tags: , , , , ,

Warning: Counterfeit Alli

From the U.S Food and Drug Administration:

The Food and Drug Administration (FDA) is warning the public about a counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) being sold over the Internet, particularly at online auction sites.

The counterfeit product is illegal and unsafe. FDA advises people who believe that they have a counterfeit product not to use the drug and to dispose of it immediately. There is no evidence at this time that the counterfeit Alli product has been sold in retail stores.

The counterfeit Alli looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:
  • a missing LOT code on the outer cardboard packaging
  • an expiration date that includes a MONTH, DAY, and YEAR—the expiration date of the real Alli only contains a MONTH and a YEAR
  • a plain foil for the inner safety seal without any words on it—the safety seal of the real Alli has the words “SEALED FOR YOUR PROTECTION” prominently printed on it.
  • large capsules with white powder, as opposed to small white pellets found in the real Alli
  • a slightly taller plastic bottle with a wider cap and coarser ribbing on the cap than what is seen with the real Alli
Alli is an FDA-approved, over-the-counter weight-loss drug that contains orlistat as its active ingredient. The counterfeit version of Alli does not contain orlistat; instead it is made with varying amounts of sibutramine, a stimulant drug.

Although sibutramine is the active ingredient in another FDA-approved prescription weight-loss drug, it is only to be used in specific doses and under the supervision of a physician.

Posted: 1/26/2010 10:20:00 AM

Tags: , , , , ,