Antidepressant Warning Labels Are Long OverdueApr 7, 2004 | www.thebatt.com
People constantly ignore warnings on cigarettes, alcohol and even parachutes, accepting the potential danger of death associated with using such products in return for certain benefits. Not to include these warnings on the basis that they might scare someone away from use would be irresponsible and dangerous.
While antidepressants may seem to fall in a different category because they are not something used recreationally, the U. S. Food and Drug Administration has rightly decided that these drugs, too, warrant a danger-of-death warning. To ignore their potential for exacerbating suicide tendencies would be as careless as withholding the fact that smoking causes lung cancer.
The warnings should not be read as an indictment against the selective serotonin reuptake inhibitors (SSRIs), such as Prozac, Luvox, Zoloft and Paxil, among six other antidepressants that would be affected by the warnings, as the Atlanta Journal-Constitution urged readers. Instead, the warnings should be taken as a call for closer supervision by doctors and family members of those taking the drugs.
The decision to increase warnings is, in part, a reaction to a jury's recent decision in Cheyenne to award $6.4 million in damages to the remaining family of a man who murdered his wife, daughter and granddaughter and then committed suicide in 1998. He was taking Paxil at the time, according to The Associated Press.
While a warning may not have deterred the man from taking the drug or from taking lives, it may have alerted his family to watch for signs of trouble or prompted him to seek closer psychiatric monitoring.
"The problem with this drug is that it's prescribed by a lot of people who are not physicians with psychiatric training," Cheyenne attorney Jim Fitzgerald told the AP about Paxil.
The solution to successful and safe treatment with antidepressants is to make patients aware of the inherent risks, but to also remind them that the risks are dwarfed by the benefits. Awareness, coupled with therapy and close contact with a therapist are the best safeguards against suicide and violence.
Many people across the nation, including some doctors, have protested the FDA decision because they fear it will frighten already-depressed patients away from the taking the medicine, perpetuating the depression and leading to the suicide that the warning was designed to prevent, according to The New York Times.
However, doctors should be able to ease patients' fears about the drugs by encouraging responsible use, meaning that doctor and patient keep in close contact when a new medicine is started or dose changed, and that patients never stop taking the drugs when they decide they are no longer needed and without the doctor's consent.
If patients are afraid, they should be reminded that the suicide rate has decreased since the introduction of SSRIs 15 years ago, according to the Atlanta Journal-Constitution. Furthermore, people already taking the drugs are not likely to suddenly develop suicidal tendencies, though the risk is higher when first starting the drugs or when dosage changes.
Opponents also complain that the warnings are unfounded. "The thing that's so striking about this FDA action is the lack of science behind it," Dr. Harold Koplewicz, director of the Child Study Center at New York University, told the Atlanta Journal-Constitution.
This is just not true. While the "passionate testimonies from parents" may have "stimulated these warnings," as Koplewicz suggests, they were not without scientific backing.
In 2003, the British government issued an advisory that paroxetine, known as Paxil in the United States, should not be taken by anyone under the age of 18. A study that confirmed increased suicidal thoughts among teenagers taking paroxetine provided the impetus for the British advisory, but until now has been largely ignored in the United States, as reported in the Atlanta Journal-Constitution.
Furthermore, one of the killers in the Columbine High School massacre, Dylan Klebold, was taking the antidepressant Luvox at the time.
While it may be hard to differentiate in these cases whether the mental illness or drug is at fault, scientific evidence does point to increased suicidal thoughts as a result of taking SSRIs, and a warning could only make patients and their families more attuned to safely monitoring drug usage.
As Cheyenne psychiatrist Angelina Montoya told the AP, the warnings will likely encourage doctors to see patients more often, and "If that keeps people safe, and people feel more comfortable, that's what we need to do."