Drug Defects: September 2009 Archives

September 29, 2009

FDA Orders Black Box Warning for Generics of Wyeth's Phenergan

The U.S. Food and Drug Administration (FDA) has ordered manufacturers of the promethazine hydrochloride injection to include a black box warning regarding potential dangers associated with the administration of the drug.  Promethazine hydrochloride was formally manufactured by pharmaceutical giant Wyeth under the name Phenergan.  Promethazine is used to treat nausea, vomiting, and pain after surgery and anesthesia, as well as allergy symptoms, motion sickness, and other ailments.

According to the FDA, the warning only applies to the injectable form of the drug which presents a serious risk of tissue damage if improperly administered.  The FDA warns that gangrene and other tissue injuries can be caused by administering promethazine in an artery or under the skin.  Because Phenergan, or promethazine, can potentially leach out of a vein and damage surrounding tissue during intravenous administration, the drug should be injected deep into muscle according to the FDA.

The black box warning label ordered for promethazine follows a March 4, 2009, U.S. Supreme Court decision in the landmark case Wyeth v. Levine.  In Levine, Diana Levine, a musician, had her arm amputated after Phenergan was injected into her vein using the "IV-push" method, entered her artery, and caused gangrene.  A state jury found that Wyeth failed to provide adequate warning of the dangers of such administration and awarded Ms. Levine $6.7 million in compensatory damages.  Wyeth appealed claiming that federal law pre-empted Levine's claim because the warning label had been approved by the FDA and it would be impossible to comply with both state and federal law.  The Supreme Court found against Wyeth and upheld the state court decisions in favor of Ms. Levine.

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September 22, 2009

Trasylol Increases Death Rate Among Heart Surgery Patients

Bayer's drug trasylol, also known under the generic name aprotinin, was widely administered during heart surgery to control bleeding, but research indicates that it may be responsible for a multitude of deaths.

A 2006 study in the New England Journal of Medicine reported that trasylol increased patients' risks of kidney failure, heart attack, and stroke. The researchers concluded that the drug accounted for $1 billion in annual dialysis costs as a result of the 10,000 to 11,000 cases of kidney failure attributed to its use.

Additional studies in the United States and Canada revealed that patients receiving trasylol incurred a much higher death rate than those who had received other drugs

According to a report on CBS News' 60 Minutes, trasylol was given to 52-year-old Joseph Randone in January 2008 to decrease the bleeding risk during what should have been routine heart valve replacement surgery. Shortly after the surgery, he suffered two heart attacks and kidney failure. Eventually, his legs had to be amputated, his eyes sewn shut, and a pacemaker implanted in his heart before his eventual death. His surgeon indicated that he believed trasylol caused the complications.

Bayer allegedly concealed information from one of its own studies about the dangers of using trasylol during an FDA advisory hearing in September 2006. In the face of mounting evidence of the drug's adverse effects, the FDA requested in November 2007 that Bayer stop sales. However, it was not until May 2008 that Bayer recalled any remaining supply of the drug from the market.

On April 25, 2008, Bayer announced that 78 trasylol lawsuits were filed. The first trasylol trial consolidated in a multidistrict litigation is now scheduled to begin on January 18, 2010 in the U.S. District Court for the Southern District of Florida.

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