Medication Safety - Formulary

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Medication Safety

Bivalirudin associated with lower risk of bleeding compared to other antithrombotics in PCI

December 1, 2011

Patients undergoing percutaneous coronary intervention (PCI) have a lower risk of bleeding when bivalirudin is used compared with either unfractionated heparin (UFH) alone or in combination with a glycoprotein IIb/IIIa inhibitor (GPI).

FDA mandates enhanced safety check on TNF blockers

December 1, 2011

FDA is requiring that manufacturers of tumor necrosis factor (TNF) blockers perform enhanced safety surveillance in children, teenagers, and young adults, the agency said on November 3 in an ongoing safety review of this class of biologic products.

FDA requires several changes to bevacizumab label to include safety information

November 1, 2011

Safety information chagnes to the package insert for bevacizumab were issued by FDA on September 30, 2011.

FDA warns methylene blue, linezolid may cause serotonin syndrome when co-administered with certain psychiatric medications

November 1, 2011

Two Drug Safety Communications providing updated warnings regarding potentially serious interactions when methylene blue or linezolid are co-administered with certain serotonergic psychiatric medications were released by FDA on October 20, 2011.

Zoledronic acid (Reclast) prescribing information to list renal dysfunction as contraindication

October 1, 2011

FDA is requiring the zoledronic acid (Reclast, Novartis) prescribing information to now include a warning not to use the drug in those with renal dysfunction.

Labels for TNF-alpha blockers to warn of potential for infection

October 1, 2011

In a safety communication released September 7, 2011, FDA announced it is requiring the prescribing information for all tumor necrosis factor-alpha blockers to include a black-boxed warning regarding an increased risk of infection from 2 bacterial pathogens, Legionella and Listeria.

Meta-analysis: anti-IL-12/23 agents or anti-tumor necrosis factor-alpha treatments have no effect on the cardiovascular risk of chronic plaque psoriasis patients

October 1, 2011

Biologic agents have no effect on the rate of major adverse cardiovascular events in patients suffering from chronic plaque psoriasis.

Dronedarone increases risk of death and serious cardiac events in patients with permanent atrial fibrillation

September 1, 2011

Spurred by the results of the Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy trial, FDA informed prescribers about its ongoing review of dronedarone's cardiovascular safety.

FDA reviews data regarding association between oral bisphosphonate therapy and esophageal cancer risk

September 1, 2011

FDA released a safety communication regarding its ongoing review of data to evaluate whether bisphosphonates are associated with an increased risk of esophageal cancer.

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