The shot heard round the healthcare world may have multiple casings, the FDA and the CDC revealed Oct. 15 during a briefing about the current, crippling fungal meningitis outbreak.[See also: Meningitis outbreak takes 8 lives; causes NECC to voluntarily recall all drugs]
Contaminated methylprednisolone steroid injections produced by the New England Compounding Pharmacy (NECC) — by which 15 people have died thus far — may not be the sole infection perpetrators, experts caution.
One reported instance of possible fungal meningitis may have been facilitated by a different NECC steroid product, triamcinolone acetonide, health officials said; meanwhile, two other patients who received open heart transplant surgery have also become infected after being administered a third NECC product while on the operating table. Although the FDA remains unsure if the heart patients contracted the illness from another source, investigation into more of the NECC’s inventory is underway.
"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," the FDA’s statement reads.[See also: Non-profit group reminds physicians to stick with needlestick safety ]
In response to news that even more patients could suffer potential infection, William Schaffner, MD, an infectious diseases expert at the Vanderbilt University Medical Center in Nashville, told CBS This Morning: "We were concerned that there might be other medications that might be contaminated coming from that pharmacy. The FDA has given us a heads up that that looks to be the case. We'll have to notify many more patients across the country that they may have been exposed to a fungal infection."
"I think we're still in the middle," Schaffner added regarding the progression of the outbreak and its pending containment. "We're nowhere near the end of this problem. And we will see more patients reporting in ill and we'll have to treat many more going forward."
The CDC, at the week’s inception, reported that a total of 214 people from 15 states are now infected. States with reported fungal meningitis cases include: Florida, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Jersey, New Hampshire, North Carolina, Ohio, Tennessee, Texas and Virginia.
States that received methylprednisolone injection shipments include: California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia. It should be noted, however, that NECC products are licensed in all 50 states and thus, could have potentially been used outside shipment zones.
Suspect medication is limited to sterile drugs delivered via injection and not NECC lotions, creams, eye drops or suppositories, the FDA confirmed. As such, it is suggested that physicians who are receiving calls from patients worried about their susceptibility stick to professional discretion when considering symptoms and medication histories.
With 14,000 patients in the red zone for meningitis exposure due to NECC products, physicians should correspond with all those who received an injectable and prompt them to seek treatment immediately if any of the following symptoms (promoted by the CDC and WebMD News) arise:
- Increasing pain, redness or warmth at injection site
- Changes in vision (if injection was in the eye)
- Pain, redness, or discharge from the eye (if injection was in the eye)
- Chest pain (if drug was used during heart surgery)
- Drainage from the surgical site (infection within the chest, if drug was used during heart surgery)
- Sensitivity to light
- Stiff neck
- Sudden weakness or numbness in any body part
- Slurred speech
- New or worsening headache
- Increased pain, redness or swelling at injection site