FDA says Medicines Co. recalling intravenous hypertension drug that contains bits of steel

Thursday, December 17, 2009

FDA warns docs about tainted hypertension drug

WASHINGTON — Federal health regulators are warning doctors about 11 recalled lots of an intravenous hypertension drug made by the Medicines Co. that are contaminated with bits of steel.

The Parsippany, N.J.-based company recalled the affected lots of Cleviprex on Wednesday after detecting tiny particles of stainless steel during a routine inspection.

The Food and Drug Administration said in a notice Thursday that the particles could potentially disrupt blood flow to the brain, kidney, liver heart and lungs.

Company shares fell 30 cents, or 3.7 percent, to close at $7.84 on Thursday.

Cleviprex is used to lower excessively high blood pressure in patients who cannot take pills. It is distributed to doctors for injection in patients who are undergoing surgery.

In a letter to health care professionals, the company recommends doctors inspect vials of the drug for possible contamination before using them.

Medicines Co. says it has not received any reports of health problems connected with the issue.

Company Vice President Mary Frances Harmon said the cause of the contamination is still unclear. She said the company has not determined how many vials of the drug were affected by the problem because the lots vary by size.

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