FDA Update on Anesthesia Drug Shortages
(January 29, 2009)
ASA recently obtained the following update from the FDA regarding anesthesia drug shortages: Propofol injection
: All three manufacturers are back in full production and are shipping product each week as soon as it is released. Shipments each week are back to historical amounts, however the manufacturers are predicting it will be several weeks before the supply chain is refilled completely. FDA is continuing to hear of areas where there are spot shortages being reported. The imported Propoven which APP made available during the shortage is still available this week in the 20 ml vial size and can be accessed by pharmacies placing direct orders with APP or drop shipment orders through their wholesalers. FDA has continued to work with all 3 manufacturers on maximizing supplies and we will continue to do so. Neuromuscular blocking agents Vecuronium
: is being released by Bedford but supplies are not meeting demand. Teva had manufacturing delays and plans on releasing product in mid-February. A newly approved generic manufacturer, Sun Pharmaceuticals (distributor is Caraco Pharmaceuticals), is planning to have additional supplies this month. Atracurium
: is a sole-source product from Bedford, which has the 5 ml vials available and plans on additional releases this week and into February. Cis-Atracurium (Nimbex):
is a sole-source product from Abbott. The manufacturer is reporting production delays and plans to have product available in March 2010. Rocuronium (Zemuron):
Both brand name and 3 different generic versions are readily available. Succinylcholine:
is currently available from both manufacturers in good supply. Other Drugs:
: is a sole-source product from Bedford. The firm reports production delays as the reason for the shortage and they anticipate having supplies again by mid February. FDA recognizes that this is a widely used, sole-source product and is working with the company to expedite the availability of the drug Ephedrine injection
: one manufacturer of the drug, Hospira, is reporting that product is unavailable due to production delays. The company anticipates having product available in February. Akorn continues to have their 1 mL ampules (NDC 17478-0515-00) in packages of 10 available and pharmacies may call their wholesalers to order this product or they may call Akorn directly at 847-279-6100. Parenta is the third manufacturer of ephedrine injection and has experienced increased demand due to Hospira's outage. Their vials, in packages of 25 (NDC 66758-0008-02), are on intermittent back order and they report they are releasing product as soon as it becomes available.
FDA will continue to monitor the availability of these products and assist the manufacturers with any issues related to increasing supplies.
In addition, the agency will continue to keep its Drug Shortage website updated with any new information. The link to the website is as follows: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
If you, your practice or your pharmacy is experiencing any drug shortage, difficulties obtaining products or has any questions, please contact the FDA’s Drug Shortage Program at email@example.com
THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS
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