As of Tuesday, October 16, 2012, contaminated steroids produced by a Massachusetts compounding pharmacy have been linked to 233 cases in 15 states and a total of 15 deaths.
The fungal meningitis outbreak linked to steroids produced by a Massachusetts compounding pharmacy continues to grow as more cases are reported to public health officials. As of Tuesday, October 16, 2012, the Centers for Disease Control and Prevention (CDC) reported
that 233 cases in 15 states have caused a total of 15 deaths.
The infections have been traced back to 3 lots of preservative-free methylprednisolone acetate produced by the New England Compounding Center (NECC) in Framingham, MA. Patients received the medication as a pain-relieving steroid injection into the spinal area or a joint space such as the knee, shoulder, or ankle. (Of the 233 cases, 231 have been fungal meningitis, and 2 have been joint infections.) The company sent approximately 17,000 vials of the steroid to pain doctors in 23 different states.
In a conference call held with reporters on October 11, 2012, the CDC estimated that almost 14,000 patients had received the potentially contaminated medication. More than 12,000 of these patients have been contacted by public health officials and cautioned that they may develop symptoms in the coming weeks. The onset of meningitis seems to be 1 to 4 weeks after injection, although in some cases symptoms can take longer to appear. Common symptoms include fever, headache, nausea, or neurological impairment consistent with a deep brain stroke. The infection is not contagious.
The fungus causing the infection has been identified as of the genus Exserohilum
in 13 cases and Aspergillus
in 1 case. Fungus has also been detected in approximately 50 vials of steroid from the company and clinics that received it. Before the current outbreak, no meningitis cases had ever been connected with Exserohilum
fungus. The CDC recommends that fungal meningitis cases be treated with voriconazole and liposomal amphotericin B for a minimum of 3 months and possibly longer. Both are powerful anti-fungal agents and can be difficult for patients to tolerate over lengthy treatment periods.
NECC has produced no methylprednisolone since September 26, 2012, when the Massachusetts Board of Pharmacy inspected the company. On October 3, 2012, the company ceased operations and surrendered its pharmacy registration in the wake of a joint inspection by the state pharmacy board and the FDA. On October 4, 2012, the FDA advised providers not to use any products produced by NECC, and on October 6, 2012, the company announced a recall of all its products.
On October 15, 2012, the FDA advised
health care providers to contact all patients who have received any injectable drug produced by NECC. The warning came in reaction to reports of infections possibly associated with 2 additional drugs produced by the company. One patient developed possible meningitis that was potentially associated with injection of another steroid produced by NECC, triamcinolone acetonide. In addition, a transplant patient with Aspergillus
infection had received an NECC cardioplegic solution, which is used to stop the heart during open-heart surgery. The FDA notes that there may be another explanation for the latter infection.
They typical role of compounding pharmacies is to formulate medications to a doctor’s specifications when a given drug is not available. Doctors can also call on them to produce drugs that use alternative delivery methods, incorporate flavorings, or exclude specific ingredients. But some compounding pharmacies, such as NECC, have expanded their operations to function more as small drug manufacturers than as custom compounders. In doing so, NECC seems to have violated the terms of its state license, which allowed it to produce individual prescriptions for individual patients. According to emails obtained by Reuters
, the company marketed its medications in bulk and trumpeted potential cost savings from buying in bulk.
In general, compounding pharmacies are regulated by state boards of pharmacy, while drug manufacturers are regulated by the FDA. In response to the current outbreak, a number of members of Congress have vowed to introduce legislation imposing greater oversight on compounding pharmacies, but previous efforts to do so have been frustrated. A 2002 Supreme Court decision declared unconstitutional a portion of a law enabling the FDA to regulate marketing by compounding pharmacies, and in 2009 a Colorado court blocked the FDA from regulating a compounding pharmacy that it claimed was behaving as a drug manufacturer.
For the latest updates on the outbreak from the CDC, click here