WASHINGTON, DC - Bipartisan House Energy and Commerce Committee leaders this week sent a letter to the Acting Commissioner of the Food and Drug Administration regarding safety concerns with the blood-thinner Coumadin and the generic version, warfarin.
The bipartisan leaders write, “A recently published ProPublica analysis found that from 2011 to 2014, at least 165 nursing home residents were hospitalized or died after errors involving Coumadin or warfarin. According to ProPublica, there are thousands more injuries every year that are never investigated by the government. These findings demonstrate how important it is that the drug be carefully calibrated. In too large a dose, the drug can cause the patient to bleed uncontrollably. If the dose is too small, the patient can develop life-threatening clots. …"
The bipartisan leaders continue, “While the committee recognizes that FDA has no role in overseeing the safety and health requirements for nursing homes, or the practice of medicine, the problems identified in the ProPublica report have prompted the committee to consider whether there are any further actions FDA could take to decrease the incidence and severity of adverse events related to the use of Coumadin and/or warfarin."
The committee leaders are seeking information regarding FDA’s understanding of these events and any steps it has taken or considered to limit these risks.
The letter was signed by Chairman Fred Upton (R-MI), Ranking Member Frank Pallone, Jr. (D-NJ), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), and Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO).
Read the complete letter online HERE.
