A collection of drug advisories from Health Canada and the US Food and Drug Administration (FDA) is available from CMAJ at www.cmaj.ca/misc/advisories.xhtml. Here are some recent postings:
-
Health Canada is conducting a safety review of aliskiren, an antihypertensive agent. The ALTITUDE study investigating the effects of aliskiren on cardiovascular and renal events in patients with renal impairment and diabetes was recently halted by Novartis because of concerns about lack of clinical benefit and possible adverse events.
-
Use of chronic, high-dose (400 to 800 mg) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with birth defects in infants. This risk does not appear to be associated with a single low dose (150 mg) to treat vaginal yeast infection, states the FDA.
-
The product monograph for Multaq (dronedarone) has been revised, advises Health Canada, based on a safety review following the premature termination of the PALLAS trial in patients with permanent atrial fibrillation. Dronedarone should not be used in patients with permanent atrial fibrillation of any duration, a history of or current heart failure, or certain conduction abnormalities, such as complete bundle branch block. Other restrictions are detailed in the monograph.
-
The FDA continues to receive reports of hepatosplenic T-cell lymphoma in adolescents and young adults being treated for Crohn disease and ulcerative colitis with tumour necrosis factor blockers, azathioprine or mercaptopurine or both. The FDA recommends that physicians educate patients about and monitor for the possible emergence of malignancies when these medications are used.
-
The blue safety release on EpiPen and EpiPen Jr should be removed by pulling straight up. The device may spontaneously activate or fail to work if the release is twisted, bent or pulled sideways, cautions Health Canada.
-
Bisphosphonate medications are associated with a slightly increased risk of atypical fractures of the femur, concludes a review by Health Canada. These can occur with minimal or no impact to the thigh area and may progress from a partial to complete fracture over weeks to months. They may be bilateral. Health Canada recommends that clinicians evaluate patients taking bisphosphonates who report new hip, thigh or groin pain to rule out a fracture of the femur.