Pfizer manufacturing falls short on global Sarin antidote post-Syria

A manufacturing problem at a Pfizer Inc. division caused a flaw in prefilled syringes that contain antidotes to sarin nerve gas—one of the agents unleashed in Syria last month—and some U.S. public-health officials are concerned about getting adequate supplies at home.

Pfizer and the government have put priority on getting replacement syringes to the military, but there have been shortfalls for ambulances and hospitals that keep doses for first responders in the U.S., said John Dreyzehner, preparedness chairman for the Association of State and Territorial Health Officials.

The Food and Drug Administration said it was notified by Pfizer's Meridian Medical Technologies unit in mid-March that a small number of auto-injectors containing two drugs used to treat nerve-gas victims—atropine and pralidoxime—didn't contain enough of one or both of the drugs. Pfizer said the problem occurred at a Meridian plant in the U.S., but it declined to specify the location.

"Pfizer takes this matter very seriously and is working expeditiously to rectify this," said Pfizer spokesman Christopher Loder. He said there is no specific delivery date for replacements and declined to say whether manufacturing has resumed.

In August—more than five months after the initial notification to the FDA—Meridian sent a letter to health-care professionals and emergency personnel about "potential under-dosing or failure to activate" in DuoDote. It said the flaws occurred in about seven out of 1,000 units.

Rep. Andy Harris (R., Md.), a medical doctor who practiced at Johns Hopkins Hospital in Baltimore for 28 years, said he was concerned about the availability of injectors. "With the recent use of the chemical weapon sarin in Syria, the importance of having effective dosages of DuoDote available is of even greater importance," he wrote in a letter Thursday to Meridian.

Sarin, an odorless, colorless nerve gas inhaled or absorbed through the skin, can be fatal within minutes. It cripples the respiratory center of the central nervous system and paralyzes muscles around the lungs, which causes suffocation. Pralidoxime relieves muscle paralysis, and atropine relieves respiratory paralysis.

 

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