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FDA extends warnings on compounded drugs in syringes

As reported by Digital Journal, medicines held in 3 milliliter (ml) and 5ml syringes manufactured by Becton-Dickinson (BD) were deemed to be unsuitable because medicines held in these types of syringes could lose potency over a period of time. This meant drug efficacy could potentially be compromised. This alert was issued by the U.S. Food and Drug Administration during August 2015.

The U.S. drugs regulator has now issued follow-up advice. The agency is extending its alert to a greater range of BD products and the warning now covers 1 mL, 10 mL, 20 mL, and 30 mL BD syringes, and BD oral syringes. FDA has also indicated which lots of syringes are affected, via a drug safety notice.

FDA’s first warning was about compounded or repackaged drugs stored in two types of BD syringes. The alert has been broadened following reports from the syringe manufacturer that an interaction with the rubber stopper in some batches of syringes of other sizes could potentially result in drugs held in the syringes losing potency. This only applies to syringes filled and not used immediately.

It is unknown what happens when active molecules in drugs come into contact with the rubber material. This may cause a reaction to occur which results in the drug becoming less effective. This is something that can potentially happen over time and may be affected by storage temperature. Many pharmaceutical manufacturers would conduct stability trials before release to ensure that a drug is compatible with its holding material. However, for some hospital pharmacy applications, it is convenient to take a drug held in a vial and to transfer it into a syringe as this is easier for the clinician to use. Where this is carried out immediately, the risk of loss of potency is relatively low. Where this is carried out in advance, then the effect on the drug is, in many cases, unknown.

Further information from BD indicates that certain types of drugs will be most greatly affected through contact with the rubber closures. These are: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanyl. FDA warns that other drugs may also be affected; however, no further data is available.

The FDA’s advice to hospital pharmacy units is not to “administer compounded or repackaged drugs that have been stored in any of these syringes unless there is no suitable alternative available.”

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Written By

Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, business, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

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