Pfizer plant has issues with DuoDote injectors for sarin gas antidote

The nerve gas attack that killed 1,500 in Syria has put sarin back in the news. But it also has led to attention to manufacturing problems at a Pfizer ($PFE) plant that makes a dual drug antidote injector used by the military and others for such attacks.

According to The Wall Street Journal, Pfizer has made priority of getting replacement syringes to the military after its Meridian Medical Technologies unit in March notified the FDA that about 7 out of 1,000 of the auto-injectors containing atropine and pralidoxime didn't contain enough of one or both of the drugs. The injectors also could malfunction. There is no shortage in the military, the Pentagon tells the newspaper, but some first responders such as ambulance crews have run out of the injectors.

In an Aug. 27 letter, the company notified civilian customers that it was working on a replacement plan with the FDA for the DuoDote injectors and suggested they hold onto whatever supplies they have, even if they're past a recent expiration date. The injectors can be used for some insecticide poisoning, as well as for nerve gas. The letter details how to give additional injections if an injector fails. The company said no adverse reactions have been reported.

"Pfizer takes this matter very seriously and is working expeditiously to rectify this," spokesman Christopher Loder told the newspaper. Loder couldn't say when replacements would be available and would not say whether manufacturing has resumed.

The Journal says that Republican Rep. Andy Harris of Maryland, a physician who practiced at Johns Hopkins Hospital in Baltimore, has written to Meridian to ask about availability. "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," Harris wrote.

The FDA is taking steps to help. The DuoDote injectors have a four-year shelf-life, The Wall Street Journal reports, but the agency this month extended the expiration date by one year. The two antidote drugs also can be purchased in separate doses.

Pfizer picked up the Meridian business in its 2010, $3.6 billion, buyout of King Pharmaceuticals. That unit has had other manufacturing issues this year. It began recalling its thyroid drug Levoxyl after getting complaints of odors from the bottles tied to a new formulation, a move that threatened to lead to a shortage of the drug. But when the subsidiary returned to making the older formulation, it ran into potency issues and had to recall 84 lots of the product.

- read the Wall Street Journal story (sub. req.)
- here's the Meridian letter (PDF)