In continuing coverage from a previous briefing, CBS Evening News (2/1, story 12, 0:35, Couric) reported that the Food and Drug Administration (FDA) said on Friday that "there's more evidence of a possible link between the anti-smoking drug Chantix (varenicline) and serious psychiatric problems."

        The Wall Street Journal (2/2, Dooren) reported that as part of a "public health advisory issued on Friday," the FDA said that "it appears increasingly likely that there may be an association between" the drug, which is manufactured by Pfizer, and "serious neuropsychiatric symptoms." Just last month, Pfizer issued warnings that "Chantix users should be monitored for suicidal behavior, depressed mood, and other changes in behavior."

        According to the AP (2/2, Perrone), the drugmaker has "suggested that since nicotine withdrawal alone can cause mood swings and agitation, it may be impossible to determine" if the drug "aggravates those behaviors." Nevertheless, the "FDA said it found evidence of Chantix patients who experienced psychiatric problems even though they were still smoking." In its public advisory, the agency said that "patients taking Chantix should tell their doctor about any history of mental illness," while patients and their families "should watch for any changes in mood and behavior." The drug, which "work[s] by binding to nicotine receptors in the brain, [thereby] reducing the symptoms of withdrawal," may "cause worsening of current psychiatric illness, even if it is currently under control," the FDA statement read. In addition, the drug "may also cause an old psychiatric illness to reoccur."

        On Jan. 18, Pfizer said that "it was adding similar warnings to the drug's prescribing information," and stated on Friday that "it has suspended Chantix television ads," Bloomberg (2/1, Pettypiece) reported.

        Reuters (2/2, Dixon) notes that "Pfizer officials have maintained there is no evidence of a causal link," acknowledging "only that in some cases, an association could not be excluded."

        According to the UPI (2/2), "Chantix was approved by [the] FDA in May 2006 as a smoking cessation drug."

        The Philadelphia Inquirer (2/2, Stark) reported that approximately "4,000 people were treated with Chantix in clinical trials, and none of the suicidal or mood symptoms were noted at that time, the FDA said." Indeed, "[u]ntil recently, the biggest side effect was thought to be nausea, which affected nearly one-third of users."

        The BBC (2/3) pointed out that "FDA officials said they have received almost 500 cases of suicidal behavior and thinking, and 39 reports of completed suicides" associated with the drug.

        Nearly "five million patients have taken Chantix," HealthDay (2/2, Reinberg) quoted Pfizer officials as saying. According to FDA officials, patients taking the drug should report any "changes in mood and behavior to their" physician. Patients should also be alert for symptoms such as "anxiety, nervousness, tension, depressed mood, unusual behaviors, and thinking about or attempting suicide." For the most part, the symptoms present "while taking Chantix, but they can also appear after stopping the drug, the officials noted."

        WebMD (2/2, Zwillich) noted that in its "statement issued two weeks ago, Pfizer said any risks associated with Chantix should be balanced with the known risks of smoking." According to a company press release, "Chantix is a real breakthrough medicine that has helped many smokers who want to quit."

        Medscape (2/3, Waknine) pointed out that the FDA is presently working with Pfizer "to finalize a medication guide for patients." Nevertheless, "[f]urther safety labeling changes may be warranted," as the agency "continues its review of data and of new information regarding varenicline, and the risk for severe changes in mood and behavior."

        Even so, MedPage Today (2/2, Peck) reported that Bob Rappaport, M.D., director of the FDA's division of anesthesia, analgesia, and rheumatology products, said that the benefits of quitting smoking "might outweigh the risks" of taking the drug.

 

The Baltimore Sun (2/3, Schulte, Donovan) reported that Reckitt Benckiser Pharmaceuticals, Inc., "the manufacturer of buprenorphine, has provided the starkest evidence to date that misuse of the drug is growing in parts of the country where it is most widely prescribed as an addiction treatment." The drugmaker detailed "problems such as a rise in the number of children sickened by accidentally ingesting the pills; an increase, in some areas, of people taking the drug to get high; and commonplace street sales in some cities for as little as $2 per tablet." The FDA is currently reviewing the report, which "linked misuse and illicit sales to the federally sanctioned practice of allowing doctors to prescribe large quantities of the drug for patients to take at home." In particular, the report blamed "patients in treatment for opioid abuse...as major contributors to the street supply." According to the Sun, the federal government did not foresee such problems when it helped to develop buprenorphine, sold mainly as Suboxone. Regardless, some "specialists in addiction medicine believe that" Suboxone's "benefits have outweighed any problems."