Fungal Meningitis Investigation Launched By Congress, As 19 Dead
Lawmakers are calling on the FDA to turn over inspection reports related to the compounding pharmacy believed to be behind a deadly fungal meningitis outbreak, which has sickened more than 250 people throughout the United States and caused 19 deaths.
The U.S. House of Representatives Energy and Commerce Committee sent a letter (PDF) to the FDA Commissioner, Margaret Hamburg, on October 17, looking for documentation on inspections involving the New England Compounding Center (NECC) going all the way back to 2004.
Epidural steroid injections and other medications mixed at the NECC compounding pharmacy have been linked to fungal meningitis infections in at least 15 states, but additional cases continue to be discovered every day by state and federal health officials.
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The request came as part of a congressional probe into the compounding pharmacy’s practices, as the company reportedly shipped more than 17,500 potentially contaminated epidural steroid injections to 76 facilities in 23 states.
Compounding pharmacies are supposed to supply local hospitals with needed drugs on a per-prescription basis when they cannot get those drugs from commercial drug manufacturers. However, NECC appears to have been working as a below-the-radar drug manufacturer, sending out sales representatives and producing drugs large-scale.
NECC has since stopped all operations and surrendered its compounding pharmacy license in Massachusetts. It has also had its license to do business in Tennessee revoked. That state has been hardest hit by the outbreak.
The number of illnesses related to the fungal meningitis outbreak is expected to continue to increase over the next couple weeks due to a latency period of up to four weeks between the time someone is exposed and when they could begin showing symptoms.
The U.S. Centers for Disease Control and Prevention estimates that about 14,000 people in the U.S. received the shot, and the FDA suspects there may be two more drugs that were contaminated as well. All NECC injections have been recalled.
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. As the disease progresses, symptoms may become severe, resulting in seizures, coma and death.
NECC is facing an increasing number of fungal meningitis lawsuits over the outbreak, including both individual injury claims and potential class action suits. The complaints accuse the company of negligence in allowing contaminated drugs onto the market.
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