The FDA has approved a risk mitigation and evaluation strategy (REMS) for more than 20 manufacturers of extended-release/long-acting opioids for chronic pain management.4 Under the new REMS, these manufacturers are required to make education programs available to prescribers based on an FDA blueprint. It is expected that this will happen through educational grants for continuing medical education programs, with topics such as weighing opioid risks and benefits; appropriately choosing patients for opioids; monitoring and managing patients; counseling patients on the safe use of long-acting opioids; how to recognize evidence of and the potential for opioid misuse, abuse, and addiction; and both specific and general opioid drug information. It is anticipated that these activities will begin by March 1, 2013. Patient education is also a component of the new REMS. Patient counseling information has been updated with consumer-friendly information on the safe use, storage, and disposal of these agents, as well as other useful patient information, such as how to prevent accidental exposure.
The FDA Watch List
The FDA has added 16 drugs to its quarterly Watch List of agents identified in the last quarter of 2011.5 These agents have potential signs of serious risks or new safety information, identified through the Adverse Event Reporting System (AERS). The FDA continues to monitor these agents to determine if a causal link exists. If a causal link is established, the FDA will then consider a regulatory response such as assembling more information to better differentiate the risk, updating the medication label (e.g., package insert) or requiring a REMS. Some of the identified agents and their potential reactions include: fluoroquinolones and peripheral sensorimotor neuropathy; gabapentin and increases in blood creatinine phosphokinase levels and rhabdomyolysis; milnacipran and homicidal ideation; and pegloticase and anaphylaxis/infusion reactions.
In the Watch List from the third quarter of 2011, eight drugs were identified, five of which underwent label changes. Two of these agents were adalimumab and golimumab. Both received updated warnings and precautions sections of their labeling, related to the development of optic neuritis.
Drug Approvals/Modifications
On January 13, 2011, the FDA asked pharmaceutical manufacturers to limit the strength of acetaminophen in prescription-drug products to 325 mg per dosage form in order to make them safer for patients.6 The deadline for complying with this new limit is January 14, 2014. Abbott Pharmaceuticals has decided to comply in advance, and will be relaunching its combination hydrocodone bitartrate/acetaminophen products (Vicodin) with 300 mg of acetaminophen beginning in the third quarter of this year.7 The amount of hydrocodone bitartrate will remain the same as in prior formulations (e.g., Vicodin plain, ES, and HP), but all will contain 300 mg of acetaminophen. Patients who use acetaminophen for pain relief should regularly be informed that hepatotoxicity risk increases when different products which contain acetaminophen are taken at one time, and that exceeding 4,000 mg in a 24-hour period is not recommended.
