Phentolamine Concerns Heard
The American Association of Orthopaedic Surgeons joined eight orthopaedic specialty societies in sending a letter to the Acting FDA Commissioner Stephen M. Ostroff in April 2015, expressing concern over a nationwide shortage of phentolamine and asked FDA to post a letter on their drug shortage website stating that providers can seek out of country sources of this drug for their patients.
Phentolamine is the only alpha blocker that is an antagonist to adrenaline vasoconstriction. This is very important to hand surgeons and emergency room clinicians. Accidental EpiPen injections into fingers can cause ischemic changes for several hours and severe ischemic reperfusion pain for three months or more. Phentolamine has been shown to reliably reverse epinephrine vasoconstriction in the human finger, and is the antidote for prolonged epinephrine induced vasoconstriction caused by EpiPen injuries or wide awake hand surgery.
The last American supplier of phentolamine stopped its production in January 2015. Reserves of phentolamine could be found in Canada, available through Paladin Pharmaceuticals. However, it is illegal to import a drug into the United States from abroad unless the FDA posts a letter on their Drug Shortage website stating that health providers can seek out of country sources of drugs no longer available in the U.S.
FDA agreed to post a drug shortage letter for phentolamine on their website shortly after receiving the AAOS letter asking them to do so.
FDA subsequently worked with drug manufacturers and just notified AAOS that Westward Pharmaceuticals is planning to distribute phentolamine to pharmacies in the United States the first week of November. The Westward phentolamine injection is FDA-approved and pharmacies should be able to order this, using the NDC number on the FDA website, from their wholesalers the first week of November.
Information can be obtained at the following links:
Additional comments or questions can be sent to Captain Valerie Jensen R.Ph., Associate Director FDA CDER Drug Shortage Staff at Valerie.Jensen@fda.hhs.gov.