The FDA has issued a recall of a single lot of the drug warfarin, an anti-coagulant often prescribed to prevent the formation of blood clots. The recalled bottles are mislabeled as containing 3 mg of the drug, when in fact they contain 10 mg tablets – more than three times the labeled dose. An overdose of this drug can lead to dangerously uncontrolled bleeding.
A single bottle of Jantoven Warfarin Sodium, USP, was found to contain the wrong dosage. Though no more mislabeled bottles have yet been discovered, manufacturer Upsher-Smith Laboratories issued a recall on February 17 of all bottles from lot #284081. On February 21, the FDA expanded the recall to other brand names of warfarin: Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, and Oxybutynin. These products have been sold to family practice doctors and individual consumers through wholesalers as well as retail chain and independent pharmacies across the U.S.
Blood clots that form inside a blood vessel can lead to thrombosis, an obstruction of blood flow. If this clot breaks free, it can cause an embolism, blocking most or all of the circulation to a certain part of the body. If the embolism occurs near the heart or lungs, it can be fatal. Even embolisms at other sites, if left untreated, can cause tissue death from lack of blood. Warfarin thins the blood, which keeps these clots from forming, but also prevents the body from stopping the flow of blood from a cut or other injury. Too great a dose of warfarin greatly increases the risk of life-threatening hemorrhage.
The tablets themselves are labeled correctly, imprinted with the number 10. Additionally, the 10 mg tablets are white, whereas the 3 mg tablets are tan, though both also feature the letters WRF and the number 832 on the reverse. Pictures of the tablets, as well as further details on the recall, are available at the FDA’s website. Doctors, patients, or pharmacists who have these mislabeled bottles are urged to call Upsher-Smith’s medical information line at 1-888-650-3789 from Monday through Friday between the hours of 8:00 am and 5:00 pm, EST.
U.S. Food and Drug Administration. (February 21, 2011) “Warfarin sodium tablets (Jantoven), 3 mg: Recall – mislabeled bottles containing higher dosage.” Retrieved March 3, 2011 from FDA.gov.