[3] The American Heart Association removed bretylium from their 2000 ECC/ACC guidelines due to its unproven efficacy and ongoing supply problems.
Many have cited these supply problems as an issue of raw materials needed in the production of Bretylium.
[4][5] On June 8, 2011 bretylium tosylate was announced as unavailable in the US after request of Hospira Inc. to withdraw its NDA from the market.
Bretylium will remain on the FDA's discontinued drug list since its withdrawal was not the result of a safety or effectiveness concern.
Bretylium should be used only in an ICU or emergency department setting and should not be used elsewhere due to its dramatic actions and its predominant side effect of hypotension.