The New York Times reported that according to the US Food and Drug Administration (FDA), “Vials of five different Genzyme drugs for rare diseases may be contaminated with tiny particles of steel, rubber or fiber that could potentially harm patients.” However, “the FDA and Genzyme said that there had been no reports of patients being harmed by particles and that the problem affected less than one percent of the vials.” Although Dr. Jason Woo, an FDA official, stated, “We do not believe this is a wide-scale problem, but we do not have information that fully defines the scope,” patients and doctors are concerned.
According to the report, the FDA has confirmed that “the products would remain on the market, because there are few alternative treatments,” the AP (11/14, Perrone) reported. The agency has strongly advised physicians to “closely inspect vials for particles before injecting them into patients.” If exposed to contaminated vials, patients may experience “potential allergic reactions, blood clots, and other problems,” states the report.
About the author:
Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all lawyers in the Washington metropolitan area. The magazine also describes him as “one of Washington’s best–most honest and effective lawyers” who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications. He has also been named a “DC Super Lawyer” by Super Lawyer magazine (March/April 2009)–a national publication that honors the top lawyers in America. If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.