Along with the rest of the nation, our team is following the recent headlines linking an outbreak of fungal medication to contaminated medications. As a Panama City dangerous drugs law firm, we believe that Americans in the twenty-first century should be able to rest assured that medications are safe. However, the recent outbreak is a harsh reminder that this ideal is not always met.
An Overview of the Outbreak
According to a report by CNN, at least fifteen people have died due to fungal meningitis. Authorities have traced the outbreak to a contaminated drug, specifically a steroid called methylprednisolone acetate produced by the New England Compounding Center ("NECC"). Massachusetts-based NECC is a compounding pharmacy, which means they combine ingredients to make a medication specifically for a given patient. The Center for Disease Control ("CDC") estimated that 14,000 people received relevant steroid formulations that may have been contaminated. As of the CNN article, the CDC identified 214 cases of meningitis, spread across fifteen states, linked to the contaminated drugs.
Meningitis is a condition in which protective membranes that cover the brain and spinal cord become inflamed. In most cases, the root cause of the inflammation is either a virus or a bacterial infection. Less often, meningitis stems from another pathogen such as the fungus that is the cause of the current outbreak. The fungal form is often very serious. In addition to the usual symptoms associated with meningitis, including nausea, headache, fever, and stiff neck, patients infected with fungal meningitis may also experience dizziness, confusion, and trouble dealing with bright lights. Not all patients will exhibit all symptoms. While many forms of meningitis are contagious, the fungal type is not so others who have had contact with the infected patients are not at risk.
Government Response to Meningitis Outbreaks Tied to Contaminated Medicine
Congress has opened an investigation into the outbreak. A committee from the House of Representatives sent a notice to the Massachusetts Board of Registration in Pharmacy noting that this is not the first time overseers have raised concerns about NECC. In 2006, the Food and Drug Administration ("FDA") sent a warning letter to the Framingham, MA-based company detailing significant violations witnessed by agency investigators over the previous year. Responding to the current problems, Massachusetts Governor Deval Patrick also accused NECC of misleading regulators and going beyond the company's license by shipping large amounts of compounded products across the country. The state's pharmacy board is also issuing a new mandate that requires compounding pharmacies operating in Massachusetts to sign an affidavit verifying compliance with regulations requiring that medications are mixed specifically for use by particular patients.
Additionally, FDA investigators are looking into concerns that other NECC products may have been contaminated. The agency noted that a patient who received an injection of another NECC compound (triamcinolone acetonide) may also have meningitis. Another patient who underwent an open-heat procedure using an NECC produced cardioplegic solution has reportedly contracted a different form of fungal investigation. The FDA noted that the investigation into that case is ongoing and that the fungus may have come from another source.
In response to the meningitis outbreak, NECC announced a recall of all of its products. Given the contamination concerns, the FDA has stated that all patients who received the medications should be notified of the potential risk of infection.
Helping Victims of Contaminated Drugs in Panama City
We hope that no more patients fall ill as a result of the current outbreak and that those currently battling infection are successfully brought back to health. If you or someone you love has fallen ill due to an NECC product or another contaminated medication, please call our office. Our Panama City defective pharmaceuticals attorney has experience working with the victims of dangerous drugs and can help you seek justice.
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