Anti-Smoking Drugs Can Still Pose Psychiatric Risk, Philadelphia Citizens Warned

Philadelphia’s fight against tobacco has yielded significant successes in recent years. As the Philadelphia Enquirer reported last year, the smoking rate among adults dropped from 27.3 percent in 2008 to 22.4 percent in 2015, while youth smoking declined from 10.7 percent to 7.5 percent over the same seven-year period.

The gains of the last seven years all occurred during a time when the U.S. Food and Drug Administration (FDA) required stark high-profile warnings on two of the most popular smoking-cessation medications. The FDA recently reversed that rule, though it is as yet unclear how that decision will impact the community-wide effort to reduce smoking in Philadelphia.

FDA Changes Rules for Chantix, Zyban

The packaging for Chantix and Zyban, two prescription medications that are used in smoking-cessation programs to help people overcome an addiction to nicotine, will no longer feature the stark “black box” warning that informed users that the drug could cause a wide range of damaging side effects.

However, experts caution that this regulatory decision does not mean that taking either of these medications is a risk-free experience.

Chantix, which is manufactured by pharmaceutical company Pfizer, contains varenicline, a drug that interacts with the receptors in the brain that are also triggered by nicotine. Zyban, which is sold by GlaxoSmithKline, contains bupropion, an antidepressant that also relieves the urge to smoke.

On Dec. 16, 2016, Philadelphia-based website PhillyVoice reported that the FDA was rescinding its requirement that Chantix and Zyban packages feature clearly worded warnings that the use of these medications can lead to increased hostility, suicidal tendencies, depression, and other distressing psychiatric symptoms.  Such warnings had been required on Chantix and Zyban packages since 2009.

Studies Suggest Minimal Risk

In a Dec. 16 article on the website of the Philadelphia Business Journal, reporter John George wrote that the FDA’s decision to change the labeling requirements for Chantix and Zyban was based in large part upon the results of a smoking cessation clinical trial involved more than 8,000 individuals.

The clinical trial, which was funded by Pfizer and GlaxoSmithKline, determined that individuals who had no history of mental illness were not at increased risk for psychiatric disturbances after using Chantix.

While the removal of the high-profile warning was good news for Pfizer and GlaxoSmithKline, George noted, the results of the clinical trial did not convince the FDA to permit the companies to remove all warnings about possible side effects from the use of their medications.

“Chantix’s updated label will still carry a warning of potential adverse events such as psychosis, hallucinations, paranoia and anxiety and other neuropsychiatric problems,” George wrote. “The difference is those events will not be highlighted in a ‘black box’ warning, the FDA’s sternest warning for an approved medicine.”

Getting Help for Mental Health Concerns

Regardless of what causes a person to experience anxiety, paranoia, or any other symptoms of a mental or behavioral health disorder, it is essential that the individual complete a thorough assessment, receive an accurate diagnosis, and follow a personalized treatment plan.

Depending upon a host of factors, including the nature and severity of a person’s symptoms, the presence of any co-occurring disorders, and the individual’s treatment history, a qualified healthcare provider may determine that optimal care for anxiety, depression, aggression, psychosis, and other mental health disorders should occur at the inpatient, partial hospitalization, intensive outpatient, or traditional outpatient level.

In Philadelphia, throughout Pennsylvania, and across the United States, mental health disorders continue to devastate individuals, families, and communities. But help is available, treatment works, and with effective professional care, individuals who struggle with mental health disorders can achieve significant improvements in both substance and quality of life.

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