Posts Tagged ‘safety review’

June 25th, 2014

FDA Completes Safety Review of Olmesartan

The FDA announced on Tuesday that it had completed its safety review of the antihypertensive drug olmesartan (sold as Benicar and other names). The investigation was initiated in 2010 when results from the ROADMAP trial showed that patients with type 2 diabetes taking olmesartan had an increased risk for cardiovascular death. Now the FDA says that […]

December 19th, 2011

FDA Adds New Warnings to Dronedarone (Multaq) Label

In an updated safety communication, the FDA announced on Monday that it is adding new warnings  to the dronedarone (Multaq, Sanofi) label. On the basis of results from the PALLAS trial, which was discontinued early due to safety concerns, the drug label will now warn: Healthcare professionals should not prescribe Multaq to patients with AF who cannot […]

April 15th, 2011

FDA Offers Cautious Support for Olmesartan (Benicar)

The FDA announced on Thursday that it had reviewed the results of the ROADMAP and ORIENT trials and had determined that the benefits of olmesartan (Benicar, Daiichi Sankyo) “continue to outweigh its potential risks” when used as indicated for the treatment of high blood pressure. In June 2010 the FDA had announced that it was […]

March 2nd, 2011

FDA Finds No Increased Risk For MI With Abacavir

An ongoing safety review by the FDA of the antiviral medication abacavir found no evidence for an increased risk for MI associated with the drug. The FDA said an increased risk for MI with abacavir had been seen in several observational studies and one randomized controlled trial (RCT), but not in other RCTs or in […]

September 17th, 2010

FDA Announces Safety Review of Pioglitazone

The FDA announced today that it was undertaking a safety review of pioglitazone (Actos). The review was initiated after the FDA received data from Takeda, the drug’s manufacturer, suggesting a possible increase in bladder cancer in patients taking the drug for more than 2 years. The data are taken from a planned 5-year analysis of […]