AlQa'dah 30, 1433, Oct 16, 2012, SPA - Health officials are warning that more people may be at risk from contaminated drugs made by a Massachusetts company linked to a growing meningitis outbreak. The Food and Drug Administration reported on Monday that the company's products may have also caused other types of infections in patients who have had eye operations or open-heart surgery. The new warning is based on only two cases, and it was not known for sure whether the company's drugs had caused the infections. Officials did not say how many people may be at risk, but the number is potentially significant, and a statement from the agency warned doctors, “The F.D.A. recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of today's announcement." The company, the New England Compounding Center in Framingham, Mass., has already been linked to a meningitis outbreak that has killed 15 patients and infected 199 others in 15 states. The drug implicated in that outbreak is methylprednisolone acetate, a steroid used in spinal injections for back and neck pain. The drug is believed to have been contaminated with a fungus called Exserohilum, which causes a type of meningitis that is severe but not contagious. Now, several other drugs made by the company are also possible suspects in infections. A heart-transplant patient exposed to a product that is used during open-heart surgery developed a chest infection with a different fungus, Aspergillus, the Food and Drug Adminstration said. The product is a cardioplegic solution, which is chilled and poured into the opened chest to stop the heart while surgeons work on it. Such solutions have caused problems in the past, according to the F.D.A., which reported that it issued a warning letter in 2006 to a firm that had produced a solution that caused fatal infections in three heart-surgery patients. The agency emphasized that the heart case was still being investigated, and that it was possible that the infection had come from a source other than the cardioplegic solution. A second heart-surgery patient who had an Aspergillus infection and was initially reported to have received a solution made by the New England Compounding Center had been treated with solution made by another company. Another patient contracted meningitis after receiving a spinal injection of another one of the company's steroid solutions, triamcinolone acetonide. The statement from the F.D.A. also warned of possible contamination in drugs made by the company that are injected into the eye or used during eye surgery. The agency is recommending to doctors that all patients exposed to any of these products from the New England Compounding Center be notified of the risks and told to be on the alert for signs of infection, even though it is not clear whether the products caused the two additional infections.
