FROM: U.S. DEFENSE DEPARTMENT
DOD, Manufacturer Address Issue with Antidote Autoinjector
By Cheryl Pellerin
American Forces Press Service
WASHINGTON, Sept. 13, 2013 - Defense Department and interagency officials are working closely with the Maryland-based manufacturer of an autoinjector for deployed troops that contains a two-drug antidote for some kinds of nerve agents, a military official said.
In March the company, Meridian Medical Technologies, a Pfizer Inc. subsidiary, found after an internal inspection that a small number of the autoinjectors -- seven out of 1,000 -- were not completely filled with antidote. The company also notified the Defense Department in March.
Since then, Meridian has been working with the Food and Drug Administration, which licensed the product in 2006, to improve product-quality issues in the manufacturing process, and with government agencies on a priority replacement plan.
There are no plans to recall the equivalent civilian product, called DuoDote, or the military product, called Antidote Treatment Nerve Agent-Autoinjector, or ATNAA, the official said. In the meantime, nothing has changed for service members in the field who are issued the product when a threat looms, the military official said.
With the current ATNAA product, the military official said, "warfighters are protected and there is no operational impact. The FDA has opined that all autoinjectors are safe and effective and can be used under current tactics, techniques and procedures."
The autoinjector is a spring-loaded syringe designed to overcome the hesitation someone might show when self-injecting even a small needle. To user removes a cap on the back, puts the front end on the outer thigh or buttocks, pushes until the device activates, then holds it in place for 10 seconds.
The ATNAA autoinjector has two internal chambers, one on top of the other. The top chamber contains the drug atropine, and the bottom chamber holds pralidoxime chloride. When the injector activates, the drugs flow together through a syringe and into the body.
Nerve agents are fast-working and deadly, andinhibit a range of physiological processes in the nervous system, causing pinpoint pupils, eye pain, sweating, drooling, tearing, vomiting and seizures.
Atropine reduces secretions in the mouth and respiratory passages, relieves respiratory passage constriction and spasms, and may reduce respiratory paralysis caused by toxic agents on the central nervous system.
Pralidoxime chloride relieves paralysis of respiration muscles and is always used with atropine to treat nerve-agent poisoning.
For the Defense Department to date, Meridian has put 1.1 million ATNAA autoinjectors through a process of remediation that includes first a visual examination by trained technicians and then weighing the autoinjectors to make sure they're properly filled with antidote, the military official said, adding that improperly filled devices are being rejected.
The Defense Logistics Agency is working through the contractual details about how Meridian will replace the defective devices, the official added.
"There are two lines of effort: new manufacturing and remediation. We're hopeful the FDA will approve the enhancements to [Meridian's] manufacturing process within the next 12 weeks, and then as soon as DLA works through the details on acceptance of the remediated product, it will be available [to DOD]," the military official said.
In addition to DLA, the Joint Program Executive Office forChemical and Biological Defense is working in close coordination with the FDA, the Army Medical Research and Materiel Command, and the Army Office of the Surgeon General to help resolve the issue.
The military official said Meridian is working closely with regulators from the FDA and internally to make sure a more rigorous quality-control process is in place so the problem won't happen again.
"The company has made a good-faith effort to remediate the issues, both with current product and in the future," Pentagon spokeswoman Jennifer D. Elzea said, "so from the department's perspective, they've been cooperative."
