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FDA Medwatch Alert: Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates

Posted 25 Nov 2013 by Drugs.com

including Auto-Injectors for Atropen (atropine) DuoDote (atropine/pralidoxime chloride) morphine sulfate pralidoxime chloride diazepam   [Posted 11/22/2013] ISSUE: FDA is aware of a disruption in supply to health care providers and emergency response personnel of Atropen (atropine), DuoDote (atropine/pralidoxime chloride), morphine sulfate, pralidoxime chloride, and diazepam auto-injectors manufactured by Meridian Medical Technologies, a Pfizer Inc. company. FDA and Meridian are working together to resolve the disruption as quickly as possible, but it is unclear how long this disruption may persist. FDA concluded that it was scientifically supported that certain lots of DuoDote can be used for an additional year beyond the manufacturer’s original labeled expiration date. FDA is continuing to assess whether these identified lots of DuoDote can receive further expiration date extensions i ... Read more

Related support groups: Morphine, Valium, Diazepam, MS Contin, Kadian, M O S, Avinza, MSIR, Roxanol, Morphine IR, MS/S, Statex, Oramorph SR, Diastat, M-Eslon, Morphine LP Epidural, Diastat AcuDial, Roxanol-T, Morphine Sulfate SR, Valrelease

FDA Approves Pediatric Use of Protopam Chloride Chemical Poisoning Treatment

Posted 13 Sep 2010 by Drugs.com

SILVER SPRING, Md., Sept. 9 /PRNewswire-USNewswire/ – The U.S. Food and Drug Administration has approved the pediatric use of Protopam Chloride (pralidoxime chloride), a drug used to treat poisoning by organophosphate pesticides and chemicals (e.g., nerve agents). The drug is approved to be administered either by intravenous (IV) or intramuscular (IM) injections. "We know this drug has been widely used for many years to treat poisoning in pediatric patients in emergency situations," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Improving the drug's label with new dosing information for children will give health care professionals better guidance on how to use this drug safely and effectively." "It can be difficult to use IV drugs in children, particularly in emergency situations, so having the new option ... Read more

Related support groups: Pralidoxime, Protopam Chloride

Chemical Poisoning Treatment Approved for Children

Posted 13 Sep 2010 by Drugs.com

FRIDAY, Sept. 10 – A treatment for poisoning from pesticides and similar chemicals has been approved by the U.S. Food and Drug Administration for use in children, nearly 50 years after it was first approved for adults. Pralidoxime chloride (Protopam Chloride) was approved by the FDA in 1964 as an antidote to pesticides and other chemicals in the organophosphate class. The injected antidote slows the attachment of the poisonous chemical to a person's nerve endings, the agency said in a news release. The FDA acknowledged the drug already has been used "for many years" as an emergency antidote in children, and that approving it for pediatric use would "give health-care professionals better guidance on how to use this drug safely and effectively." Organophosphates are commonly used at farms and by licensed exterminators, the agency said. Symptoms of ingestion could include mild reactions ... Read more

Related support groups: Pralidoxime, Protopam Chloride

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Further Information

Related Condition Support Groups

Organophosphate Poisoning, Nerve Agent Poisoning, Anticholinesterase Overdose

Related Drug Support Groups

Protopam Chloride

Pralidoxime Patient Information at Drugs.com