back drug used in eye recalled by FDA

FDA Concern about Eye Drugs

Dr. Kisling Uncategorized Leave a Comment

Serious Infections From Injections For Back Pain Lead To Recall

On October 4th this year the FDA announced possible problems with the New England Compounding Center’s (NECC) Framingham, Massachusetts facility. Subsequently, cases of meningitis have been thought to have a p[possible association with these steroid injections of an NECC product, methylprednisolone acetate. Doctors feel the number of cases will continue to rise for a while.

The FDA Expresses Concerns About Injectable Eye Drugs

 

After the series of infections from the injectable eye drug eye drug bevacizumab (Avastin) this last year, the FDA appears to have ongoing concerns about this issue. If you read the recent statement below you will notice the concern applies to all injectable eye drugs, not just the ones from NECC.

“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. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo”

 

 

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