National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
July 14, 2009 • Volume 6 / Number 14

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FDA Update

Black Box Warnings Added to Two Smoking Cessation Drugs

The FDA now requires the addition of “black box” warnings to the labels of two popular smoking cessation drugs, varenicline (Chantix) and bupropion (Zyban). The new warnings caution users about the risk of “serious neuropsychiatric symptoms” associated with both drugs, according to a safety alert issued to clinicians by the FDA, including “hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.”

Varenicline and bupropion are on the list of recommended first-line medications in the U.S. Public Health Service’s clinical practice guidelines, Treating Tobacco Dependence and Use. A meta analysis found that both cessation drugs at least double the likelihood of long-term (more than 5 months) abstinence from smoking compared with placebo.

The addition of a warning label to both drugs stems from a review by FDA officials of reports to the agency’s Adverse Event Reporting System. Although the adverse event reports often included a “temporal relationship” between use of either of these drugs and suicidal thoughts or behavior “in patients with no history of psychiatric disease,” the report also noted that some of these symptoms may have been “confounded by symptoms typically seen in people who have stopped smoking and are experiencing withdrawal from nicotine.”

The alert advised health care professionals to recommend against continued use of these drugs in patients experiencing any of these symptoms or “any changes in behavior that are not typical of nicotine withdrawal,” along with continued monitoring until the symptoms resolve.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Agency Approves First Maintenance Chemotherapy Agent for NSCLC

The first-ever “maintenance therapy” for patients with certain subtypes of advanced or metastatic non-small-cell lung cancer (NSCLC) has been approved by the FDA. The drug, pemetrexed (Alimta), is already approved for patients with NSCLC whose disease has progressed after chemotherapy and as a first-line treatment for patients with advanced NSCLC.

The approval is based on results from a phase III clinical trial presented at the recent American Society of Clinical Oncology annual meeting, in which patients with subtypes other than squamous cell NSCLC had an improved median overall survival (15.5 months versus 10.3 months) when they continued to receive pemetrexed following the completion of standard chemotherapy compared with patients who received a placebo.

“This drug represents a new approach in the treatment of advanced non-small-cell lung cancer,” said Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.