Pfizer Screw Up Leads to Nerve Gas Antidote Shortage

Pfizer Screw Up Leads to Nerve Gas Antidote Shortage

September 16th, 2013 // 3:07 pm @

Latest FDA and cGMP Compliance News

If you are wondering how using chemical gas in Syria has an effect on the US, here you go. A division of Pfizer is having trouble making enough pre filled syringes that have antidotes for sarin nerve gas. Some US public health experts are worried that the US will not be able to get enough of them.

Pfizer and the government are making it a top priority to get enough replacement syringes for the US military, but there have been a number of shortages for hospitals and ambulances that stockpile the syringes for the use of first responders in the states.

Back in early 2013, Pfizer, which has a division called Meridian Medical Technologies, told FDA that some of its auto injectors didn’t have enough of the drugs to properly treat nerve gas victims (atropine and pralidoxime). The injector is called the DuoDote, and it was approved back in 2006 as a treat a nerve agent that has organophosphorus, which causes heart attacks and respiratory failure.

According to a Pfizer spokesperson, the company takes the matter seriously and is trying to fix the problem. It has not said if manufacturing of the nerve gas antidote has started again. There is no delivery date given to get replacements. Pfizer says that the problem happened at a plant in the US, but we do not know where.

Meridian did not alert health care professionals and ER management personnel until last month, however, about the potential for under dosing or failing to activate. Meridian says that improper dosing is unusual, and it only happened in seven of 1000 injectors.

The shelf life for the injector is 48 months, but FDA sent a memo this year that is extending the date by a year. This means that older lots are able to be used safely. FDA is reviewing DuoDote performance data but is not issuing a recall.

Many first responder kits on ambulances and in ERs use these injectors. Supplies are short in some locations because the expired lots were destroyed. This could be due to the lag of time between when Meridian notified the agency, and the letter it sent out to doctors last month.

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