Cumberland gets FDA OK for Acetadote formulation
NASHVILLE, Tenn. — The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.
Cumberland Pharmaceuticals announced Thursday that the agency had approved a version of Acetadote (acetylcysteine) injection that does not contain preservatives or stabilization and chelating agents, and will replace the currently marketed version. The drug originally was approved in 2004.
Acetaminophen, which appears in numerous over-the-counter and prescription drugs for treating pain, cough and cold, is the leading cause of poisonings reported by hospital emergency rooms in the United States. The FDA recently adopted a rule requiring acetaminophen in prescription painkillers not to exceed 325 mg due to the risk of serious liver injury in patients who overdose on the drug.
Aurora to get federal recognition for EHR adoption
MILWAUKEE — Aurora Health Care said it would be the first healthcare system in Milwaukee to receive federal recognition for adopting electronic health records, the organization said.
Beginning this month, hospitals and other healthcare providers can register their intent to achieve “meaningful use” of EHRs and qualify for federal incentive payments, part of the American Recovery and Reinvestment Act of 2009.
Six of Aurora’s hospitals are registered in the incentive program. The organization also runs a network of retail pharmacies in the region.
FDA warns consumers of liver injury risk when taking Multaq
SILVER SPRING, Md. — The Food and Drug Administration and drug maker Sanofi-Aventis are warning healthcare professionals and patients about the possibility of severe liver injury in patients taking a Sanofi heart drug.
The FDA said Friday that it had found cases of liver injury, including two cases of liver failure requiring transplants, in patients taking Multaq (dronedarone), a drug used to treat abnormal heart rhythm. Multaq was approved in July 2009 with a Risk Evaluation and Mitigation Strategy, or REMS, designed to prevent its use by patients with heart failure. Since then, around 147,000 patients have filled prescriptions for the drug at retail pharmacies, according to SDI.
The announcement comes a day after a new FDA requirement for prescription painkillers containing acetaminophen to contain no more than 325 mg of the drug, also due to the risk of liver injury in patients who take more than 4,000 mg of the drug daily.