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Actions are Put Into Place to Stop Fungal Meningitis Outbreak
A deadly, multistate outbreak of fungal meningitis has placed Americans on high alert. As the Federal Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) look for plausible solutions to prevent further deaths, patients who have possibly received infected medication are left waiting for answers. Not only are patients’ lives in jeopardy, but one pharmaceutical compounding company must also face the consequences of infecting hundreds, possibly thousands, of people with a deadly disease.
Fungal meningitis is a rare disease that is cause by the spreading of a fungus through the blood stream into the spinal cord. People with a weak immune system or those who have taken medications such as steroids or anti-TNF medications that weaken your immune system are at the highest risk for this disease. If infected, treatment options are available; however, meningitis is an aggressive disease that can also result in death.
The October 2012 outbreak of fungal meningitis has been traced back to a pharmaceutical compounding company located in Framingham, Massachusetts. The New England Compounding Center (NECC) is responsible for compounding seventeen thousand vials of triamcinolone acetonide, an injectable steroid used to reduce back pain, that are now thought to be laced with a fungus that can cause meningitis.
How the fungus entered the NECC is still unknown and is currently under investigation. What is known, however, is that all confirmed cases of fungal meningitis so far have been linked to medications compounded at this facility. The investigation has so far proved that the NECC had previously been warned by the FDA about cleanliness and was not licensed to mass-produce drugs. The NECC now has forced the FDA and CDC to take action in order to end the outbreak.
The first step in preventing further spread of the fungus, was recalling the three lots of injections thought to contain the fungal infection on September 26 followed by a recall of all NECC products that had been distributed in 2012 on October 6. The FDA has strict regulations that all these products should be retained, secured, and withheld from use.
Medical professionals have been advised by the FDA to follow-up with patients whom received treatment through any NECC product after May 21, 2012. The products of main concern are currently injectable products that could transport the fungus through the blood stream and into the spine. Steroid shots, as well as an ophthalmic drug used in conjunction with eye surgery, have been noted as the cause of infection in several cases. The FDA, along with the CDC, has been working diligently to make the public aware of the concerns as well. Patients who think they are at risk for fungal meningitis are encouraged to discuss their concerns with their physician.
Healthcare professionals are doing all they can to help diagnose and treat patients in the early stages of the disease. The early symptoms of fungal meningitis may be looked over as an average headache, the beginning of a cold, or the “stomach flu”. Patients with these symptoms now have to take a blood test to be examined in the laboratory in states where the contaminated medications were shipped. If a patient test positive, he or she will be treated with high dosages of antifungal medication over a long period of time. During treatment, patients usual remain in the hospital and receive treatment through IV.
This outbreak has not only caused the FDA to work to end the spread of the disease, but also has drawn attention to possible issues with all compounding pharmacies. Prescriptions that need to be specially mixed or altered are considered compounded medications. This process is intended to be done to suit each individual’s needs. However, NECC was mass producing compounded medications to twenty-three different states. The FDA as well as government officials are now working on creating more regulations in regards to compounded prescriptions in hope of diminishing the chances of an event such as this to occur again.
The carelessness of one compounding company has caused so much distress and pain to patients across the nation. The toll of the outbreak as of October 19, 2012 was two hundred and seventy-one cases of meningitis have been reported resulting in twenty-one deaths in sixteen different states. As the days pass, hopefully a solution will be found to put an end to the rising death toll and regulate the compounding of prescription medications to prevent another outbreak.
Works Cited
"CDC - HAI - Multistate Fungal Meningitis Outbreak Investigation Current Situation." Centers for Disease Control and Prevention, 15 Oct. 2012. Web. 16 Oct. 2012.
"CDC - Meningitis - Fungal Meningitis." Centers for Disease Control and Prevention, 12 Oct. 2012. Web. 16 Oct. 2012.
“Four More Die in Fungal Meningitis Outbreak.” NBC News Online, 2012.Web. 18 Oct. 2012.
"New England Compounding Center Product Recall Information." U S Food and Drug Administration Home Page, 10 Oct. 2012. Web. 16 Oct. 2012.
Rabin, Roni Caryn. “A Spotlight on Compounded Medicines.” NYTimes Blogs. 15 Oct. 2012. Web. 16 Oct. 2012.
"Update on Fungal Meningitis." U S Food and Drug Administration Home Page, 16 Oct. 2012. Web. 16 Oct. 2012.
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