Bristol-Myers Squibb ($BMY) recalled 6 lots of 5 mg single-use vials of Coumadin (branded warfarin) for injection due to the presence of particulate matter, but the FDA said the issue does not affect the more prevalent oral formulation of the popular blood thinner.
"Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur," the FDA said in its safety alert. There have been no adverse event reports as a result of the particulate matter.
The product's labeling warns patients to inspect the vial for particulate matter and discoloration prior to use, but BMS still felt the need to take this step. Coumadin for injection was intended for patients who cannot receive oral medication, but was discontinued in April.
FDA recommends that anyone with the recalled product call BMS' recall vendor to arrange for its return. The alert contains the affected lot numbers, which were distributed to hospitals and pharmacies between November 2011 and January 2014.
The discontinued injectable version of Coumadin is a freeze-dried version of the traditional warfarin tablet that is delivered intravenously after it is reconstituted with water.
Coumadin tablets have been sold since the 1950's, but are coming under attack from a variety of new blood thinning anticoagulants like Boehringer Ingelheim's Pradaxa and Bayer and Johnson & Johnson's ($JNJ) Xarelto.
- read the safety alert