Drug Safety
The new maximum daily dose (MDD) of acetaminophen will soon be six dosage units (3,000 mg) for all Tylenol and acetaminophen-containing products, a reduction from the current MDD of eight dosage units (4,000 mg), says McNeil Consumer Healthcare of Johnson & Johnson.1 The MDD lowering recommendations are intended to reduce accidental overdoses from over-the-counter acetaminophen-containing products. In January, the U.S. Food and Drug Administration (FDA) asked manufacturers of prescription products to lower the total amount of acetaminophen in dosage forms to no greater than 350 mg. Both the MDD change and the maximum dosage change are planned for 2012. Prescribers and patients themselves are often unaware of the total daily acetaminophen amount that is consumed. This is often due to different products containing varied amounts. Hepatotoxicity from acetaminophen is more common than many prescribers realize, and this effort aims to improve medication safety.
Dronedarone, an antiarrhythmic agent approved by the FDA in July 2009, is used to reduce the risk of cardiovascular hospitalization in patients who are in sinus rhythm or who will be cardioverted but who also have paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors.2 The FDA is reviewing clinical trial data in patients with permanent AF, including data from one study that was terminated early after a twofold increase in death and a twofold increase in stroke and hospitalization for heart failure was noted. There were 32 deaths in the dronedarone arm and 14 in the placebo arm (P=0.009). The objective of the this study, known as PALLAS, was to assess the potential benefit of dronedarone 400 mg twice daily in patients over 65 years old with permanent AF in the reduction of major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction [MI], or cardiovascular death), unplanned cardiovascular hospitalization, or any cause of death. It is not clear how these results affect patients using dronedarone for its FDA-approved indications.
As recently reported in an ACR Hotline released June 29, 2011, rituximab was the subject of a Health Canada Safety Advisory related to information regarding fatal infusion reactions in rheumatoid arthritis (RA) patients.3 Officials reported that it was unclear whether patients were premedicated prior to rituximab infusion because analgesics, corticosteroids, and antihistamines are recommended prior to these infusions. They noted that health professionals should remain attentive for signs of hypersensitivity or anaphylactic reactions in patients receiving rituximab infusions and report any spontaneous reactions to authorities (e.g., the FDA Adverse Event Reporting Program, Health Canada).
New Drug and Device Information
A new subcutaneous injectable formulation of abatacept (Orencia) to treat moderate to severe RA in adults is slated to become available later this month.4 This new formulation was compared to the already available intravenous formulation and showed similar efficacy and safety at six months.