The widely-prescribed steroid medication Methylprednisolone Acetate has recently been linked to at least 24 deaths and 317 illnesses from fungal meningitis, a rare disease characterized by the inflammation of the lining that protects the brain and spinal cord. In response to this outbreak, New England Compounding Center Inc. (NECC), the pharmaceutical plant that processed the drug, has voluntarily recalled three lots – totaling over 53,000 vials – of Methylprednisolone Acetate. The drugs affected by this recall were distributed between July and September 2012, and have a shelf life of approximately 180 days.
Compounding Pharmacy Lawsuit Update 11/18/13: A bill that would grant the U.S. Food and Drug Administration (FDA) greater power in policing compounding pharmacies was cleared by Congress today, in what experts said was a critical step to ensuring a safer drug supply. The bill, known as the Drug Quality and Safety Act, was enacted to prevent events like last year’s meningitis outbreak that killed 64 and seriously injured hundreds more.
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 the Centers for Disease Control and Prevention (CDC), Methylprednisolone Acetate has been linked to the deaths of at least 24 people – as well as 317 severe illnesses – in 17 states. The outbreak was first noted in Tennessee, where nine of the deaths and 70 of the illnesses have been reported so far. The CDC said Methylprednisolone Acetate affected by this recall may have been administered to patients in 23 states.
“We do know there were over 700 patients in Tennessee who were exposed,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University School of Medicine in Nashville. “At the moment, fortunately, the attack rate looks pretty low – less than 1 percent — but we are still in the early days of defining this thing,” Schaffner said.
Methylprednisolone Acetate is typically administered by injection to patients suffering from severe bouts of back pain. NECC, the pharmaceutical compounding plant that issued the recall, has also voluntarily surrendered its license in response to the outbreak. The company’s website is currently unavailable, and company officials have yet to comment on these events.
The fungal contamination was reportedly identified through routine testing conducted on one of the sealed vials taken at the NECC plant. The same fungus was found in at least five patients who were administered Methylprednisolone Acetate, according to the FDA. Individuals who receive injections of the drug are at risk for developing meningitis for at least 30 days after their last exposure.
“There is a fairly long incubation period. … That hasn’t run out yet for many patients,” Schaffner said. “Over the next few weeks, we are going to see a progressive accumulation of cases.”
Signs and Symptoms of Fungal Meningitis
Meningitis is a rare disease characterized by severe inflammation of the lining that surrounds the brain and spinal cord. This inflammation is caused by fungal contamination, and can be life-threatening if not treated in a timely manner. Signs and symptoms of Methylprednisolone Acetate-induced fungal meningitis may include:
- stiff neck or neck pain
According to the CDC, approximately 76 facilities in 23 states may have received the tainted steroid medication. These states include: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia.
One facility alone, Surgicare Cross Pointe clinic in Evansville, Indiana, reportedly administered at least 560 patients with Methylprednisolone Acetate affected by this recall. So far, one of these patients has been conclusively diagnosed with meningitis, and 10 to 15 others have been advised to seek additional medical care for their conditions.
In Tennessee, the state worst hit by the outbreak, some patients are “really critically ill” and have been placed in intensive care units, said Dr. Marion Kainer of the state health department. Kainer declined to specify exactly how many patients were critical.
This is not the first time NECC has been accused of questionable medication processing. In 2002 and 2003, complaints about shoddy drug preparation resulted in an agreement with government agencies to correct the problems. Earlier this year, another complaint was made about the potency of an ingredient used in eye surgeries. That investigation is still being conducted, and more information will be revealed as it becomes available.