FDA Issues Drug Safety Statement Over Meridian Medical Technologies Auto-Injectors

meridian-duo-dote-injector-extended-expire-dateThe U.S. Food and Drug Administration (FDA) just announced that it has been made aware of a supply disruption of auto injectors for Atropen (atropine),
DuoDote (atropine/pralidoxime chloride),
morphine sulfate,
pralidoxime chloride, and 
diazepam. The auto injectors involved are manufactured by Meridian Medical Technologies, which is a Pfizer Inc. company.

The agency concluded that scientific data supports that some lots of DuoDote can be used for one more year beyond the manufacturer’s original labeled expiration date. The FDA indicated that it continues to assess if these identified lots of DuoDote may receive expiration date extensions, if needed, and if additional lots of DuoDote may have their expiration date extended.

The agency is reviewing data for the potential use of the following drugs beyond their labeled expiration dates so that potential shortages of these medically necessary auto injectable drugs may be mitigated:

  • Atropen (atropine)
  • DuoDote (atropine/pralidoxime chloride)
  • Morphine sulfate
  • Pralidoxime chloride
  • Diazepam

The FDA stated that it would provide additional information on the use of these auto injector products beyond the indicated, labeled expiration dates in the next few weeks. Until that time, the agency indicated that the expired auto injectors may be used for patient care under emergency situations and in cases when no other product is available.

In the meantime, health care providers and emergency response personnel in possession of these Meridian auto-injectors that are near to or beyond their labeled expiration date should retain the products until the agency is able to provide additional information concerning the continued use of these drug products.

According to Meridian, DuoDote is used for the treatment of poisoning by organophosphorous nerve agents and organophosphorous insecticides. Atropen is used for the treatment of poisoning by susceptible organophosphorous nerve agents with cholinesterase activity and organophosphorous or carbamate insecticides. The morphine sulfate auto injector is, according to Meridian, used for intramuscular injection for pain management. The pralidoxime chloride auto-injector is specifically indicated for intramuscular use as an adjunct to atropine for the treatment of poisoning by nerve agents with anticholinesterase activity. Diazepam, which is a benzodiazepine, is used to treat anxiety, muscle spasms, and seizures.

Health care providers and emergency response personnel with additional questions should contact Meridian’s customer service, toll-free, at 1.866.478.6277.

Health care providers and consumers should report any adverse events associated with the use of any of these products to either Pfizer Safety, toll-free, at 1.800.438.1985 or the FDA’s MedWatch Adverse Event Reporting program.

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