FDA Warnings

FDA Warnings

The FDA has recently issued stronger warnings on a number of commonly used drugs:

Propoxyphene and Overdose Risk

Propoxyphene-containing pain medications including Darvon^® and Darvocet^® have been a focus of the FDA because of data linking propoxyphene to fatal overdoses. The FDA is requiring a new box warning emphasizing the potential for overdose and is requiring manufacturers to provide a medication guide for patients stressing the importance of using the drugs as directed. The agency is particularly concerned about use of propoxyphene in the elderly and is planning on studying the safety profile of propoxyphene vs other pain relievers in this group. At the same time, the FDA denied a petition from the public interest group Public Citizen requesting a phased withdrawal of pro-poxyphene from the market. In January, an FDA subcommittee narrowly approved a recommendation to ban propoxyphene outright, a step that the European Medicines Agency, Europe's equivalent of the FDA, took in June. Still the FDA feels that propoxyphene has a role and is useful enough to remain on the market, at least for now.

Omalizumab for Allergic Asthma

The FDA announced in July that it is evaluating interim safety findings from an ongoing study of omalizumab (Xolair^®), which is used to treat adults and adolescents with moderate-to-severe persistent allergic asthma not adequately controlled on inhaled steroids. Interim data from a study of 5000 treated patients presented to the FDA suggest a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic, and thrombophlebitic events in patients treated with omalizumab compared with placebo. The FDA currently has no recommendations on changing prescriber information and is not advising patients to stop using the drug at this time.

Smoking Cessation and Psychiatric Effects

The smoking cessation drugs varenicline (Chantix^®) and bupropion (Zyban^®, Wellbutrin^®) must carry new box warnings regarding the risk of serious neuropsychiatric symptoms associated with use of the drugs. The FDA advises patients to stop taking these drugs immediately if they develop changes in behavior, hostility, agitation, depression, and suicidal thoughts or behavior. Patients with pre-existing psychiatric illness may be at particular risk.