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Pharmaceutical Company Tapped to Alleviate Methotrexate Shortage Cited for Bugs in Drugs

Filed March 2nd, 2012 Laurie

Federal regulators have warned a major manufacturer about problems involving bugs in vials of sterile drugs, pointing the spotlight on a major dilemma plaguing the US drug supply. The warning comes on the same day health officials allowed APP Pharmaceuticals LLC to increase production of scarce medications for children with cancer.

On Tuesday, the Food and Drug Administration posted a warning letter to the firm citing violations at one of its plants in New York, including the discovery of insects in clean rooms and in vials of distributed drugs, as well as failure to report vials contaminated with glass and foreign matter and other violations. According to the agency’s warning, the firm also had issues with documenting sterile technique and was marketing unapproved drugs. The same day, the firm announced it had received FDA approval to market supplies of preservative-free methotrexate to help ease a critical shortage of the medication used to treat childhood leukemia.

Had APP not been allowed to increase production, the FDA said hospitals could have run out of the drug within two weeks, jeopardizing the lives of children acute lymphoblastic leukemia, or A.L.L., as well as patients with other illnesses.

“This is what I mean when I keep talking about quality issues,” said Erin Fox, manager of the Drug Information Service at the University of Utah, citing ongoing manufacturing problems at several U.S. plants, including APP. “All of these companies have had quality issues, yet they make the majority of drugs used in our country.”

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