FDA Advises Patient Notification for Those Treated with Ophthalmic Drugs Purchased from Pharmacy Implicated in Meningitis Outbreak
From the American Academy of Ophthalmology
The U.S. Food and Drug Administration in alerting ophthalmologists to notify patients who have been treated with injectable ophthalmic drugs including bevacizumab (Avastin) or those used in conjunction with eye surgery from a compounding pharmacy that has been implicated as the source in a deadly fungal meningitis outbreak. The FDA warns that: “The sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery (from New England Compounding Center as of May 21)…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 instructs that: “You should inform patients who received the NECC products…of the symptoms of possible infection and instruct them to contact you or another healthcare provider immediately if they experience any of these symptoms.” Products from NECC can be identified by markings that indicate the company by its full name or acronym, and/or its logo. The FDA has provided a complete list of all products subject to this recall. The FDA said it, “does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eye drops not used in conjunction with surgery) and suppositories.”
At this time, no cases of infection have been reported in connection with any ophthalmic drug produced at the Framingham, Mass.-based pharmacy, but the FDA believes this class of products could present potential risks of infection. NECC previously announced a voluntary recall of all products compounded at and distributed from its facility.
These actions are an expansion of an initial voluntary recall by NECC related to lots of products used for intrathecal administration. The Centers for Disease Control and Prevention has confirmed 15 deaths out of the 214 reported cases in 15 states. While there is no indication at this time of contamination in other NECC products, the FDA is communicating that this recall is being taken as a precautionary measure.
Adverse reactions or quality problems experienced with the use of any product may be reported to the FDA's MedWatch program at 800.332.1088.