FDA Warns Cardiac Patients May Be at Risk for NECC Cardioplegia Solutions
Update (October 16): On Tuesday the FDA revised its initial report and said that only one transplant patient who had received the NECC cardioplegia solution had developed fungal meningitis.
The FDA said on Monday that it had identified two transplant patients with Aspergillus fumigatus infection who received cardioplegia solution during surgery. The solution was manufactured by the New England Compounding Center (NECC), which has been at the center of a broad investigation after the death of several patients from fungal meningitis due to contaminated vials of methylprednisolone acetate injection.
The FDA said is had also identified a patient who may have developed meningitis from an epidural injection of another injectable steroid made by NECC, triamcinolone acetonide. The FDA said “there may be other explanations” for the infections in the transplant patients and that it has not confirmed that the three cases were caused by NECC products.
Out of “an abundance of caution” the FDA recommends that patients who received any injectable drugs manufactured by NECC “should be alerted to the potential risk of infection.” The FDA said this recommendation extends to patients who received injectable ophthalmic drugs made by NECC, although no infections have been reported with these drugs. The FDA says patients should be told about the symptoms of meningitis and instructed to immediately report if they have any of these symptoms.
For victims of this outbreak in Tennessee the 2011 damages cap law passed by the Tennessee legislature will limit non-economic damages to $750,000 in death or injury cases. Our firm has filed (the first) constitutional challenge to the 2011 law capping non-economic damages. Gummo v. Ward U.S. District Court, Middle District of Tennessee.
If you take or received the steroid methylprednisolone acetate and suffered serious injury or death, cancer, contact our Tennessee Meningitis lawyers for a free consultation toll-free (800) 394-2119 or fill out our form.