October 8, 2012 – The maker of a steroid that has been linked to a deadly fungal meningitis outbreak reported over the weekend that it is now recalling all of its drug products. In addition to the steroid medication recalled last week by the New England Compounding Center (NECC), the company has now issued nationwide recalls for acetaminophen suppositories, nipple ointments, morphine, vancomycin, and vitamin K. To date, at least 317 people have been diagnosed with fungal meningitis – including 24 people who died – after being treated with drugs prepared by NECC.
Compounding Pharmacy Recall Update 8/12/13: Texas-based compounding pharmacy Specialty Compounding, LLC, has issued a nationwide recall for all lots of medications it has processed since May 9. To date, at least 15 people have been diagnosed with a rare bacterial infection after being administered injections of calcium gluconate at a pair of Texas hospitals. In response to this and a number of other recent compounding pharmacy recalls, the FDA is asking Congress for increased oversight and authority over these operations.
Fungal Meningitis Update 1/30/13: This week, a federal judge ruled that assets of the company at the center of last year’s unprecedented fungal meningitis outbreak will be frozen indefinitely. An emergency injunction was placed on the New England Compounding Center (NECC) after the owners were accused of funneling more than $21 million out of the company’s assets before filing for bankruptcy in December.
What’s the problem?
According to a press release published on the FDA’s website, NECC is conducting this recall “out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Massachusetts Board of Registration in Pharmacy.”
The meningitis outbreak was originally linked to three lots of a steroid medication known as Methylprednisolone Acetate which is used to control back pain. According to the CDC, at least 317 people in 17 states have been affected, including the 24 who died. The hardest-hit state has been Tennessee, with 70 cases of meningitis linked to NECC products. Other states reporting injuries include Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, and Virginia.
The problem was discovered when FDA investigators reportedly found ‘foreign matter’ in an unopened vile of Methylprednisolone Acetate at NECC’s processing plant. The substance was ultimately determined to be a fungus, and microbiological testing is now being conducted to determine the exact type.
Fungal meningitis is a rare disease characterized by severe inflammation of the lining that surrounds the brain and spinal cord. This reaction is caused by fungal contamination, and can be life-threatening if not treated in a timely manner. Signs and symptoms of fungal meningitis may include:
- stiff neck or neck pain
NECC has put its day-to-day operations on hiatus while the FDA and CDC work to identify the source of the contamination. According to the CDC, there is still not enough evidence to say for certain what caused the outbreak.