Fungal Meningitis Symptoms May Take Weeks To Appear, CDC Warns

The number of people sickened or killed from a fungal meningitis outbreak caused by tainted drugs is expected to keep climbing, due to the long latency period of the illness and difficulty testing for the infection.  

The injections, manufactured and distributed by the New England Compounding Center (NECC), were reportedly distributed between May 2012 and the end of September 2012.

It can take a month or more for symptoms of fungal meningitis to appear, meaning that there may be people who received contaminated epidural steroid injections who do not get sick until late October or early November 2012.

The CDC estimates that about 14,000 people received shots directly to the spine for pain relief that may have been contaminated. Originally, the CDC said about 13,000 people received the shots, but increased that estimate on October 11.

More Than 170 Diagnosed With Fungal Meningitis

As of Friday morning, the U.S. Centers for Disease Control and Prevention (CDC) reports that at least 14 people have died and 170 have fallen ill as a result of New England Compounding Center’s recalled epidural steroid injections. However, a substantial number of people are currently receiving treatment for symptoms of meningitis and awaiting test results.

In addition to the delayed onset of symptoms after exposure, federal health officials indicate that many cases may also be missed because tests used to check for fungal meningitis are not always accurate.

Fungal meningitis is a non-contageous form of meningitis caused by mold that somehow tainted vials of the epidural injections. It causes inflammation of the spinal cord and protective membranes covering the brain. The inflammation generally causes an infection of the fluid surrounding the brain and spinal cord and can also be caused by parasites, viruses and bacterial infection. Individuals with a weakened immune system may be at a particularly high risk of contracting fungal meningitis.

Symptoms of meningitis following an epidural steroid injection may include fever, headache, stiff neck, nausea, vomiting, increased sensitivity to light and mental confusion. Signs of meningitis usually develop within three to seven days after exposure. As the disease progresses, symptoms may become severe, resulting in seizures, coma and death.

Second Pharmacy Shuts Down Amid Calls for Criminal Probe

While the outbreak and initial recall were only linked to three lots of methylprednisolone acetate, New England Compounding Center has shut down all of its operations over concerns about its manufacturing process.

On Wednesday, a second Massachusetts compounding pharmacy, Ameridose, also shut down, raising concerns about the safety of medications mixed by the facility. Ameridose and New England Compounding Center have the same principal owners. However, company officials indicate that they do not share manufacturing, distribution or storage facilities or practices. No drugs from Ameridose have been linked to the outbreak

The developments came as anger began to rise over the outbreak and what appears to have been a gross overstepping of New England Compounding Center’s license with the state of Massachusetts.

Compounding pharmacies are supposed to fill critical drug needs for local health care facilities when drug manufacturers cannot. They generally step in to fill drug shortages or to create specialty drugs for specific patients.

State officials say that appears to have not been the case with New England Compounding Center and accuse the company of being a stealth large-scale drug manufacturer. Massachusetts Governor Deval Patrick suggested the pharmacy may have intentionally misled regulators about the type of work being done there.

New England Compounding Center was able to create and distribute drugs cheaper and faster than recognized drug manufacturers because compounding pharmacies have few regulations and little FDA oversight. Acknowledged drug companies, however, have to get FDA approval to develop and sell drugs. They also have restrictions on how those drugs are marketed.

U.S. Senator Richard Blumenthal, from Connecticut, has called for a federal criminal probe into New England Compounding Center. He says he does not know if the company broke any laws, but believes there are enough credible allegations to send the Justice Department into action.

Not the First Time New England Compounding Center Accused of Bad Drugs

The fungal meningitis outbreak is not the first time New England Compounding Center has faced legal problems over potentially contaminated drugs.

In 2006, the company reached a settlement in a wrongful death lawsuit brought by the family of William Koch, who received a shot in 2002, which the family said was contaminated. He died of bacterial meningitis in 2004. Details of the settlement remain confidential.

As a result of this most recent outbreak, New England Compounding Center is expected to face substantial liability from contaminated epidural injection lawsuits filed by individuals diagnosed with fungal meningitis. However, it is unclear how much insurance coverage is available or what assets may be available to cover any judgement or settlements.