The FDA wants Pfizer (the manufacturer of Chantix) and GlaxoSmithKline, (the maker of another commonly prescribed smoking cessation drug, Zyban), to amplify warnings about the serious reactions users of the drugs may experience. The agency announced today that it would require the drug companies to put boxed warnings on product labeling for Chantix and Zyban.

Chantix, also known as varenicline and marketed outside the U.S. as Champix, has been linked to behavioral changes and other symptoms. Agitation, hostility, depression, and suicidal thoughts and actions are possible side effects that users should be keenly aware of, the FDA warns. The FDA will require the same strong warnings on labeling for Zyban (bupropion hydrochloride, otherwise called Wellbutrin when prescribed as an antidepressant).

“People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their health care professional right away,” The FDA warns in its latest announcement.

The FDA also urges friends and family members to be observant of those using the medications, remaining vigilant for behavioral changes in particular. According to the FDA, observers who sense behavioral changes should “tell the person their concerns and recommend that he or she stop taking the drug and call a health care professional right away.”

Health officials, reluctant to withdraw smoking cessation drugs from the market even if the drugs prove to be dangerous, advise using Chantix and Zyban with extreme caution.

Smoking is the leading cause of preventable death in the U.S., a fact that helps keep these drugs on the pharmacy shelves despite their risks.

In addition to boxed warnings on product labeling, the FDA will also require all adverse risks to be described in the drugs’ Medication Guides. The same regulations will also apply to all generic versions of Zyban.

Analyses of both Chantix and Zyban users reveal disturbing patterns. The FDA notes that while many people stopped experiencing adverse affects once they discontinued the medication, others “continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.”

The FDA has also ordered the drug manufacturers to conduct new clinical trials to determine how frequently serious neuropsychiatric symptoms occur in patients undergoing various smoking cessation therapies. To help discern whether the drugs cause the symptoms or merely exacerbate them, the trials will include patients with and without psychiatric disorders.

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