FDA Permits Restricted Use of Zelnorm for Qualifying Patients

The U.S. FDA announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation.

Zelnorm Back on the Market

The drug Zelnorm, manufactured by Novatis, was taken of the market in March because of a high risk of heart attacks, stroke, and chest pain.

Avandia Warnings Might Have Prevented a Death

"My father started taking Avandia shortly after it was approved in 1999 but we didn't hear about the dangers of this drug until June of this year," says Pender.

Hearings May Wait on Govs' Testimony in Vioxx Case

Arguments on two questions in federal Vioxx cases may wait on testimony from two governors who have worked in or for the drug industry about consultations with the FDA about drug label rules made last year.

Renowned Doctor Keeps Close Eye on Drugs

While Avandia has proven to be effective at lowering blood sugar, Nissen noticed problems with the drug and did not wish to keep this information to himself.

Hearing in Vioxx Federal Case Involving South Carolina Man

The maker of the painkiller Vioxx says a federal judge did a jury's job when he proposed a $1.6 million award to replace the $51 million judgment he said was excessive.

FDA to Ask if Avandia Should Stay on Market

The FDA will ask outside advisers if GlaxoSmithKline Plc's diabetes drug Avandia should be taken off the market or remain on sale with new warnings or limits.

Vioxx: More Evidence of Heart Damage

Yet more evidence has just come to light about the dangers of the painkiller Vioxx, which was withdrawn from the market in 2004 after it was found to cause heart failure.

FDA Weighs Pulling Avandia off Market

The Food and Drug Administration will ask outside experts next week whether the diabetes drug Avandia should be pulled from the market over concerns of heart attack risk.

Glaxo's Avandia Risks May Limit Use, FDA Staff Finds

GlaxoSmithKline Plc's best-selling diabetes pill Avandia has heart risks that will require restricting the drug's use, U.S. regulators said.