Fentanyl, Morphine Other Drugs Losing Potency in Certain Syringes, FDA Warns

Federal drug regulators are warning that certain types of syringes, used for compounded or repackaged drugs, may cause some medications like fentanyl and morphine to lose their potency. 

The FDA issued a warning to health care professionals this week, indicating that 3 milliliter (ml) and 5ml syringes manufactured by Becton-Dickson (BD) should not be used unless there is no other suitable alternative. The agency says that possible interaction with the rubber stopper used with the syringes may cause a reduction in the potency of the drugs.

The warning came after the FDA received several reports that compounded and repackaged drugs, including morphine, fentanyl, methadone and atropine, lost potency when stored in the 3ml and 5ml syringes. It also comes following an alert issued by the Institute for Safe Medication Practices (ISMP) on July 30.

The agency warns that the loss of potency could be a chemical reaction with the stopper and may affect other compounded and repackaged drugs.

The agency warned that the 10ml, 20ml and 30ml BD syringes may also use the same stoppers. The agency notes that these types of syringes are not cleared for closed-container storage use.

“If you have been using products packaged in these syringes, be aware that using a substitute product may require a dosage adjustment in case the patient has been receiving a subpotent product, or adverse consequences could occur,” the FDA warned.

The FDA recommends that hospital and pharmacy staff check their inventories and remove drugs stored in the general purpose BD 3ml and 5ml syringes. The syringes can be identified by a BD logo at the base.

The agency noted that the FDA does not know how long the drugs can be stored in these syringes before the loss of potency occurs. However, the warning does indicate that there is nothing suggesting that there is a problem when the drugs are administered right after the syringes are filled. The warning also does not apply to products approved by the FDA to be marketed as pre-filled syringes.