A new oral anticoagulant, rivaroxaban, is being studied to treat atrial fibrillation as well as deep vein thrombosis (DVT).18 It is also being investigated to prevent recurrent DVT and pulmonary embolism in patients undergoing total knee and/or total hip replacement surgery. Rivaroxaban was compared to enoxaparin and warfarin and has shown comparable efficacy. It will likely be the second oral anticoagulant to garner FDA approval—second to dabigatran, which recently was FDA approved—in a long line of oral anticoagulants currently in the FDA pipeline.4,19
Drug Safety
In the next few years, the focus of new approvals will likely trend towards more biologics and/or specialty agents, with safety [strategies] and manufacturer REMS in place to ensure that a product’s risks do not outweigh its benefits.
The FDA is working with the Institute for Safe Medication Practices (ISMP) and the National Association of Boards of Pharmacy (NABP) to decrease the number of emergency department visits related to unintentional and intentional acetaminophen overdoses.20–23 Annually, there are more than 5,000 visits to emergency departments because patients intentionally increase their dose of acetaminophen or take different products that contain acetaminophen because they are unaware of the “duplicate” therapy and potential for serious toxicity. In view of this situation, clearer and stronger warnings appear needed on prescription and over-the-counter (OTC) product labels related to maximum safe doses. Harm can potentially be avoided if patients are better educated. In late 2009, the FDA launched the Safe Use initiative to reduce preventable medication harm in collaboration with healthcare stakeholders. These stakeholders include but are not limited to federal agencies, pharmacies, hospitals, health professionals, and professional societies. In mid-2010, two of the main goals of this initiative related to acetaminophen were to decrease confusion by encouraging the avoidance of using “APAP” as an acetaminophen abbreviation and increase awareness and education related to acetaminophen use. Patient responsibilities include identifying that their prescription or OTC analgesics contain acetaminophen; comparing active ingredients on their prescription and OTC product labels; and avoiding use of two or more medications that contain acetaminophen, which can potentially lead to hepatoxicity.
Last summer, the NABP sent a letter to the state boards of pharmacy recommending that the abbreviation “APAP” be prohibited on prescription labels and that acetaminophen be spelled out. Healthcare providers are being asked to appropriately counsel patients that APAP is acetaminophen and that they should not take different OTC or prescription medications that contain acetaminophen without first discussing it with their prescriber or their pharmacist. Patients need to be educated about how acetaminophen can cause hepatoxicity when too much is taken at one time or if it is taken within too short an interval. In another measure to curb acetaminophen-induced hepatoxicity, the FDA recently asked manufacturers of prescription acetaminophen combination products to limit the maximum amount to 325 mg per dosage unit. The FDA believes that limiting the amount of acetaminophen per dosage unit will decrease the risk of acetaminophen overdoses. Although many OTC products are available, too much acetaminophen can lead to hepatic failure, transplant, and/or death.