U.S. Pharmaceutical Company Linked to Meningitis Breakout
The Food and Drug Administration (FDA) is currently investigating the New England Compounding Center (NECC), urging doctors through 23 states to contact an estimated 14,000 patients who were prescribed tainted pharmaceutical products. The Massachusetts-based pharmacy recalled all of its products on October 6th after dozens of people were infected with meningitis. Health officials have recently identified two new drugs which may also be linked to the meningitis outbreak.
Meningitis has a long incubation period, which can complicate efforts to identify patients that may be affected. One patient did not develop any systems for over 40 days after receiving a tainted steroid injection. So far 214 cases and a total of 15 deaths have been reported and these numbers are increasing daily.
This meningitis outbreak has raised concerns and a call to action for tighter regulations for the loosely controlled pharmaceutical compounding industry. Critics believe that the drug manufacturers have found a way to sidestep costly and strict regulations by classifying themselves as pharmacies, which are not governed nearly as strictly for mixing drug compounds for patients.
NECC was warned by the FDA back in 2006 that its practices were violating regulations and has been under investigation by state health authorities. Several lawmakers have responded to the meningitis outbreak with promises to introduce new legislation to help bring stricter regulations to the pharmaceutical compounding industry and potential criminal investigations against any violators.
It is unknown how many patients may still be at risk now that two additional drugs have been linked to the meningitis. According to FDA spokesperson, Sarah Clark-Lynn, “The FDA continues to work with NECC to get more information on the distribution of their products. As part of the ongoing investigation, FDA continues to work with the CDC as well as state health officials to determine the scope and severity of this public health concern.”
The FDA also cautioned that it has not yet confirmed that the NECC products were the cause of the meningitis outbreak.
Patients who believe that they received an injection or other product compounded by NECC after May 21st of this year are urged to be on alert for any signs or symptoms of infection, including meningitis. This can include fever, headache, stiff neck, nausea, vomiting, sensitivity to light, swelling, slurred speech, chest pain, weakness or stiffness in joints and altered mental states. If you experience any of these symptoms and were injected with medication recently, be sure to contact your doctor right away.
California has been identified as one the 23 states that received the steroid injection called methylprednisolone from NECC. However, no cases of infection have been reported in California, although the California Department of Public Health estimates that 500 to 600 patients may have been injected with the recalled steroid.
This investigation is long from over as they continue to look into the NECC’s facilities and practices. It has brought to light a much bigger issue about the regulation of this industry and as more details begin to unfold and a cause for the meningitis outbreak is determined and the responsible party is confirmed, victims will surely have rights to hold the parties responsible for the death and illness of those affected. Stay tuned…
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