FDA Acts to Prevent a Shortage Situation for an Emergency Drug

On May 13, 2014, the FDA took the third in an unusual series of evaluations to extend the expiration date of certain lots of the drug DuoDote Autoinjectors (atropine and pralidoxine chloride), a drug indicated for the initial treatment of poisoning by organophosphorous nerve agents and insecticides.  While this is the first step in treatment for poisoning or exposure to such agents, additional treatment by trained healthcare professionals is required.

The manufacturer of the drug product notified FDA of problems relative to under-dosing or failure to activate associated with a small number of its autoinjectors.  The FDA responded with a letter (here) indicating that the Agency would exercise enforcement discretion and would, based on information provided by the firm, extend the expiration date for one year beyond the current established expiration date.  FDA also noted that the firm would not need to revise the expiration date on the actual packaging.

There was a modification of expiration date in March 2014 and now, in its latest Alert, FDA has yet extended the date of other lots of the drug product to 2 years beyond their expiration dating period.  FDA noted:

FDA is alerting health care professionals and emergency responders that two more lots (8AE795 and 9AE306) of DuoDote auto-injectors, manufactured by Meridian Medical Technologies, can be used for up to two years beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored under their labeled storage conditions.

This updates FDA’s March 28, 2014 alert, which notified health care professionals and emergency responders of a two-year extension of the labeled expiration date of certain lots of DuoDote auto-injectors. The table below is an updated list of DuoDote auto-injector lots and new use dates. This new list includes each of the lots listed in FDA’s March 28, 2014, posting and December 24, 2013, posting, and September 5, 2013, memorandum and also includes the two new lots.

If replacement DuoDote product becomes available during the two-year extension period, then it is expected that the DuoDote lots in this updated table will be replaced and properly disposed of as soon as possible.

FDA rarely provided expiration date extensions in this manner and will typically only do so in potential shortage situations or for emergency treatment drugs when no other option is viable.  The current FDA alert can be viewed here in its entirety.