Audience: Cardiovascular Surgery, Anesthesia, Pharmacy
ISSUE: FDA notified healthcare professionals of a recall of two lots of NeoProfen (ibuprofen lysine) Injection because the product failed to meet a visible particulate quality requirement. NeoProfen is a non-steroidal anti-inflammatory therapy indicated to close a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The recall includes product lots 1734991 (expiration date: April, 2011) and 1922319 (expiration date: March, 2012).
BACKGROUND: Particulate matter has the potential to obstruct blood vessels which could induce pulmonary emboli or activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with intravenous injection of particulate matter include foreign body granulomas, and local irritation of blood vessels. The potential adverse events resulting from the use of a sterile injectable product with particulates can be very serious and potentially fatal.
RECOMMENDATION: These two lots are the only lots currently available to prescribers. As NeoProfen stock is being replenished by the manufacturer, there will be a product shortage that is expected to be temporary. FDA drug shortage information is located at: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the firm's Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220798.htm