Federal drug regulators are expanding recent warnings about the risk of problems with Becton-Dickinson (BD) syringes, which have a rubber stopper that may impact the potency of some drugs, particularly painkillers like fentanyl and morphine.
The FDA announced that it is expanding a warning regarding BD syringes on September 8, to include additional sizes, as well as oral syringes. The original warning involved certain drugs that may be stored in the 3 mL and 5 mL syringe sizes. The expanded warning includes the 1 mL, 10 mL, 20 mL, and 30 mL syringes as well.
The FDA has determined that a number of drugs can lose potency when stored in the syringes, including fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanyl.
The warning came after the FDA received several reports that compounded and repackaged drugs. It also came 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.
A statement issued by BD indicates that the safety alert mainly applies to drug compounders and other customers who are storing medications in the syringes, which are not designed for drug storage.
The FDA recommends that hospital and pharmacy staff check their inventories and remove drugs stored in the general purpose BD syringes. The syringes can be identified by a BD logo at the base.
The BD statement also includes a search program that uses catalog and lot numbers to help its customers determine if their BD syringes were made with these particular rubber stoppers.
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.