Pharmacy Focus

FDA requires stronger warning, receives trial results

Stronger warnings required for TNF blockers

The FDA now requires stronger warnings regarding the risk for opportunistic fungal infections in patients treated with tumor necrosis factor (TNF) blockers.

TNF blockers represent a major step forward in the treatment of many chronic inflammatory diseases. These agents are associated with increased risk for reactivating latent tuberculosis infection, but the risk for other serious infections is not as widely recognized.

The FDA recently announced that the manufacturers of TNF blockers must strengthen existing warnings and educate prescribers about the risk for fungal infections in patients. This announcement was based on 21 reports of initially unrecognized histoplasmosis that resulted in 12 deaths in patients who were being treated with TNF blockers. Most of these patients lived in the Ohio and Mississippi River valleys, where histoplasmosis is endemic.

This report should serve as a reminder to subspecialists or general pediatricians of the broad immunosuppressive nature of TNF blockers. Practitioners in the Ohio and Mississippi River valleys need to remember that histoplasmosis causes acute pulmonary disease and can disseminate to liver, spleen, bone marrow, and mucosal surfaces. In the Pacific southwest, coccidiomycosis causes pulmonary disease as well as osteomyelitis, meningitis, and skin and soft-tissue diseases. Doctors should be aware of local epidemiology and their patients' travel histories. They should also maintain a high index of suspicion when children who are treated with TNF blockers have unexplained illnesses.

For more information, visit http://www.fda.gov/bbs/topics/NEWS/2008/NEW01879.html

Data: No increased stroke risk with tiotropium

Results of a clinical trial of Spiriva HandiHaler showed there was no increased risk of stroke with tiotropium bromide compared to a placebo, according to the FDA.

The data came from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium) - a large, four-year, placebo-controlled clinical trial in roughly 6,000 patients with chronic obstructive pulmonary disease.

Two recent publications had reported an increased risk of cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes.

The FDA expects to receive the complete report for UPLIFT next month. Results from the trial should help address some of the issues raised in the two publications.

For more information, visit
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium