F.D.A. to Severely Restrict the Diabetes Drug Avandia

- NY Times
09/23/2010 - In a highly unusual coordinated announcement, drug regulators in Europe and the United States said Thursday that Avandia, the controversial diabetes medicine, will no longer be widely available.

The drug’s sales will be suspended entirely in Europe, while patients in the United States will be allowed access to the medicine only if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of the drug’s substantial risks to the heart.

The suspension and restrictions all but ensure that Avandia’s sales — $1.19 billion last year, and $3.2 billion as recently as 2006 — will plunge to almost nothing, as regulatory authorities around the world are bound to follow with similar restrictions.

GlaxoSmithKline, Avandia’s maker, has long defended its drug as safe and a needed option for diabetics.The Food and Drug Administration also announced that it would order Glaxo to end a controversial study comparing Avandia and Actos, a similar medicine made by Takeda. Called the Tide trial, the study was a point of contention at an advisory panel meeting in July, and the F.D.A. had earlier ordered GlaxoSmithKline to stop recruiting new patients into the trial, although current patients could continue.

Avandia was once the biggest-selling diabetes medicine around the world, but its sales abruptly declined in 2007 after a study by Dr. Steven Nissen, a Cleveland Clinic cardiologist, found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.

More studies intensified the controversy, so the F.D.A. held another advisory meeting in July. This time, a majority of experts — many of whom had supported Avandia’s continued sales in 2007 — decided that either the drug should be withdrawn or its sales should be severely restricted. With Thursday’s announcements, the F.D.A. and Europe are following that panel’s advice.

Approved in 1999, Avandia helps control blood sugar levels in diabetics by making patients more sensitive to their own insulin. It is one of a class of three drugs, the first of which, Rezulin, was withdrawn because it caused liver damage. Actos, the last remaining drug in the class, appears safe in part because it seems to affect a different set of genes than either Rezulin or Avandia.

The end of Avandia marks a new era in the treatment of diabetes, a disease that is reaching epidemic proportions in much of the industrialized world. From now on, drug regulatory authorities are unlikely to approve medicines simply because they help diabetics control blood sugar levels — the standard for more than 80 years. Instead, authorities are likely to insist that companies prove that their medicines improve the quality or length of diabetics’ lives.

The Avandia story also marks a new and unsettling period for pharmaceutical companies because Avandia’s risks became known only after Dr. Nissen analyzed data from myriad trials that GlaxoSmithKline had been forced to post on its Web site as a result of a legal settlement. Such public postings are increasingly the norm, which means that drug makers can no longer easily hide or control scientific information about their medicines.

Also on Thursday, the F.D.A. ordered GlaxoSmithKline to conduct an independent assessment of the Record trial, a landmark study of Avandia’s heart effects that an F.D.A. medical officer found was riddled with what he said were unpardonable errors that seriously biased the trial’s conclusions.

Senate investigators found that GlaxoSmithKline spent years hiding from regulatory authorities clear indications that Avandia increased heart risks. In July, GlaxoSmithKline took a $2.3 billion liability charge related to legal cases involving Avandia and another medicine, Paxil. At the time, investors cheered the news as the company’s attempt to set a ceiling for its liability surrounding the medicine.

But the twin announcements by European and American regulators, along with a string of troubling findings about the company’s conduct by Senate investigators, may increase the company’s legal exposure.

The differing paths taken by European and American drug regulators reflect, in part, their differing powers. In Europe, drugs never gain permanent approval, and sales can rather easily be suspended. Except in its accelerated approval program, the F.D.A. does not have the power to give drugs conditional approval or to suspend sales. Restricted distribution programs, on the other hand, are becoming increasingly common in the United States but are rarely offered in Europe.

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