Shire to pull blood pressure drug cited by FDA

Regulators say data lacking on its effectiveness

August 18, 2010|Matthew Perrone, Associated Press

WASHINGTON — Shire PLC said yesterday that it will pull a blood pressure drug off the market following warnings from federal regulators, who said the drug has not been proven to be effective.

The Irish drug maker said it will withdraw ProAmatine by the end of September. The announcement came one day after the US Food and Drug Administration threatened to bar the drug because of a lack of data about its effectiveness.

The FDA approved ProAmatine in 1996, based on promising early results in treating low blood pressure. But the FDA said Shire never established the long-term benefits of the drug, as required under the agency’s so-called accelerated approval system.

Shire said in a statement that it completed the studies required by the FDA, but the agency “viewed these trials as inconclusive.’’

The company also said it notified the FDA and physicians last year that it would pull the drug from the market effective Sept. 30.

On Monday, the FDA issued a letter to Shire and several other drug makers that market generic versions of ProAmatine, proposing a withdrawal of the drug from the market. FDA spokesmen said the letter marked the first time the agency has threatened to pull a drug off the market because of missing follow-up data, though it has long held that power.

“This proposal is necessitated by Shire’s failure to conduct postmarketing clinical trials that verify and describe the clinical benefit’’ of ProAmatine, the agency stated.

Generic manufacturers of the drug include Mylan Pharmaceuticals and Sandoz Inc. Their generic products would also be subject to a market withdrawal, unless the manufacturers complete the studies requested by the FDA.

About 100,000 US patients received prescriptions for ProAmatine or generic versions last year, according to the FDA. The drug was approved to treat orthostatic hypotension, a type of low blood pressure that causes patients to become dizzy or faint when standing.

READER COMMENTS »

View reader comments » Comment on this story »