Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a safety alert concerning compounded drugs stored in Becton-Dickinson (BD) 3 millilitre (3ml) and 5ml syringes.

FDA is alerting health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3 ml and 5ml syringes manufactured by BD unless there is no suitable alternative available. Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe.

FDA gives the following recommendations:

• Hospital and pharmacy staff should check supply stocks and remove drug products that were filled by pharmacies or outsourcing facilities and stored in general purpose BD 3ml and 5ml syringes. These syringes are marked with the BD logo at the base of the syringe. At this time, FDA does not have information on how long drugs can be stored in these syringes before degrading. There is no information to suggest that there is a problem with potency or drug degradation when medication is administered promptly after the syringes are filled.
• This warning does not extend to products approved by FDA for marketing as pre-filled syringes, because as part of the approval process, FDA has determined that these products have been shown to maintain stability in the syringe container through the expiration date on the product.

The FDA is continuing to investigate this issue and will provide more information when it is available.

For details, please refer to the FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm458955.htm
http://www.fda.gov/Drugs/DrugSafety/ucm458952.htm

Posted on 19 August 2015