The FDA issued a press release on October 15, 2012 regarding the ongoing fungal meningitis outbreak in the United States that is suspected to be associated with contaminated epidural steroid injections manufactured by the New England Compounding Center (“NECC”) since May 21, 2012. The latest reported count of cases of fungal meningitis in the United States associated with NECC products (as of October 15, 2012) was 214 (212 cases of fungal meningitis plus 2 peripheral joint infection (e.g. knee, hip, shoulder, elbow) cases) in 15 states resulting in 15 deaths, according to the CDC. Source
Until recently, the fungal meningitis cases involving NECC products reportedly were associated with the injectable steroid methylprednisolone acetate. The FDA now reports that another NECC-produced epidural injectable, triamcinolone acetonide, may be associated with a possible case of fungal meningitis.
Additionally, the FDA’s press release reports that two cardiac patients who were given NECC-produced cardioplegic solution during their surgeries (which is used to induce paralysis of the cardiac muscle to prevent injury to the heart during open heart surgery) have been infected with Aspergillus fumigatus.
The FDA warns in its press release that “FDA continues to evaluate these reports, and when the agency obtains additional information, it will be promptly relayed to the public. FDA has not confirmed that these three infections were, in fact, caused by an NECC product. At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection.”
What Are The Signs And Symptoms Of Meningitis?
The FDA states that the signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for other possible infections may include fever; swelling, increasing pain, redness, warmth at injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest).
Medical malpractice attorneys in the states in which cases of fungal meningitis have been reported are getting calls from patients and their families who may be effected. If you suspect that you or a family member may have been injured as a result of a contaminated drug manufactured by NECC or another drug manufacturer, distributor, or supplier, you should promptly consult with a medical malpractice attorney in your state who may be able to assist you with your drug claim.
Click here to visit our website or telephone us toll-free at 800-295-3959 to be connected with medical malpractice lawyers (drug claim lawyers) in your state who may be willing to investigate your possible drug claim for you and represent you in a medical malpractice/drug case, if appropriate.
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