What should the FDA do when a drug might make someone depressed or even suicidal? The agency has wrestled with this dilemma for decades.
When reports surfaced in the 1990s that the antidepressant Prozac might trigger “intense, violent suicidal preoccupation,” the FDA responded that depressed people sometime commit suicide. Regulators resisted the notion that antidepressants could cause the very problem they were supposed to prevent.
After years of bitter wrangling, the agency revised the official labeling for popular antidepressants. It began by cautioning that children and adolescents might be at greater risk of suicide when given medications like Paxil, Prozac or Zoloft.
Later, the FDA decided that the “black box warning” for such medications should be extended to include young adults, to the age of 24. It states that patients started on antidepressant therapy should be observed closely in case their condition worsens, their behavior becomes weird or they start to be preoccupied with suicide. Families are urged to monitor loved ones closely.
There are still many psychiatrists who find this advice objectionable. Nevertheless, the FDA has determined that the data support such a warning.
Now, the FDA has discovered that other kinds of medication may also increase the risk of depression and suicide. An advisory has been issued for the stop-smoking medicine Chantix (varenicline): “Healthcare professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. [In some cases] “symptoms developed following withdrawal of varenicline therapy.”
At first many people assumed that their irritability was related to stopping smoking. Nicotine withdrawal is notoriously unpleasant. But we have received scores of messages to the web site www.peoplespharmacy.com suggesting that the Chantix effect goes beyond the usual difficulties of quitting.
Although most people noted that Chantix did help them stop smoking, many also suffered horrifying side effects: “I was on Chantix for about 5 to 6 weeks. The drug helped me quit smoking but I had nausea, severe abdominal pain and low back pain. Soon after I stopped taking it, I started feeling severely depressed and attempted suicide by overdosing on muscle relaxants. I was taken to the hospital for treatment. I have two teenage daughters and had never thought about suicide in my whole life before taking Chantix.”
The most recent unexpected warning from the FDA involves the asthma medicine Singulair. The agency has issued an early communication that Singulair has been associated with mood changes, suicidal thinking and suicide. Although it is not clear that Singulair causes depression, the FDA is being far more cautious these days than in past decades.
Hundreds of prescription medicines can cause depression as a side effect. Anyone who experiences deteriorating mood or thoughts of suicide should discuss such symptoms with a physician promptly.
