The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have confirmed the presence of a fungus known as Exserohilium rostratumin in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three lots made by a Massachusetts compounding pharmacy suspected in an outbreak of rare fungal meningitis that has killed 19 people and infected 245 others across 15 states.

Methylprednisolone acetate is an injectable steroid commonly used to treat back pain. Nearly 18,000 vials of the medication were mixed at New England Compounding Center (NECC), and distributed beginning in late May to 73 medical clinics in 23 states. Health authorities estimate as many as 14,000 may have received the contaminated shots. The FDA says 97 percent of patients who received the shots have been contacted and advised to seek immediate medical attention if they notice symptoms of meningitis such as severe headache, stiffness in the neck, fever, nausea and dizziness.

Meningitis is a life threatening infection of the membrane surrounding the brain and spinal cord. It is usually caused by bacteria or viruses. Fungal meningitis is rare, but unlike other forms of the infection, it is not contagious. It does, however, have an incubation period of up to five weeks. If left untreated, fungal meningitis can cause permanent neurological damage and death.

NECC recalled the contaminated shots as well as all products sold by the company, and ceased operations. FDA criminal investigators and federal agents raided the center and collected evidence to determine the source of the contamination and to determine whether other products may be contaminated.

As a result of an ongoing investigation of NECC, the CDC and FDA found that a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance. Triamcinolone acetonide is another type of steroid shot made by NECC.

In addition, one transplant patient with Aspergillus fumigatus infection who was given NECC cardioplegic solution during surgery has been reported. Investigators initially thought two patients who had received the solution had gotten ill but the number has been revised to one. An investigation of this patient is ongoing. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.

At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection.

Source:FDA



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