Two additional drugs made by a Massachusetts compounding pharmacy may be connected to the fatal meningitis outbreak that has claimed the lives of 15 people, the Food and Drug Administration said Monday.
The FDA is investigating a case of possible meningitis associated with an epidural injection of triamcinolone acetonide, a steroid solution made by the New England Compounding Center (NECC).
In addition, two transplant patients who were administered an NECC cardioplegic solution during surgery have been reported to have Aspergillus fumigatu, a fungal infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.
Until now, the fungal meningitis outbreak has only been linked to methylprednisolone acetate, a steroid usually injected into the spine for back pain. NECC shipped as many as 17,000 vials of the steroid around the country. The FDA has already advised health care professionals not to use any NECC products.
“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 said in a statement.
Products made by NECC can be identified by markings that indicate the New England Compounding Center by name, its acronym (NECC) or the company logo. A complete list of the company’s recalled products can be found here. Thousands of medications are involved, including some widely used painkillers such as morphine, fentanyl, lidocaine and hydromorphone.
The Centers for Disease Control and Inspection reported Monday that the meningtiis outbreak has sickened 214 people in 15 states.
Meningitis is an inflammation of the protective membranes that cover the brain and spinal cord. Symptoms include headache, fever, nausea, and stiffness of the neck. People with fungal meningitis may also experience confusion, dizziness, and discomfort from bright lights. Some patients in the current outbreak have suffered strokes.
Nearly 9 million epidural steroid injections are performed in the U.S. annually and complications are rare.
“The procedure is extremely safe when it is performed with proper diagnosis, indication, and medical necessity, in a well-trained, qualified physician’s hands, in a sterile setting, using the drugs appropriately,” said Laxmaiah Manchikanti, MD, an interventional pain physician and chair of the American Society of Interventional Pain Physicians,
Manchikanti told Everyday Health that spinal steroid injections were effective in about half of patients as an alternative to surgery. They do not treat the underlying problem, but do provide temporary relief from pain.
Manchikanti also said pregnant women shouldn’t worry about having epidurals to control pain during labor.
“Pregnant women receiving epidural injections can only contract meningitis if there is a break in the sterile technique, a systemic infection, or if the local anesthetic used for the procedure or intravenous fluids are contaminated. Consequently, contracting meningitis after an epidural injection for delivery is extremely rare,” he said