Pharmaceutical Industry Black Box Warnings Insufficient?
The pharmaceutical industry’s black box warnings appear on drug labels to warn of possible severe and life-threatening drug side effects, but some in the medical profession question whether the warnings are sufficient to prevent unintended consequences from taking antidepressant drugs. Black box warnings, sometimes referred to as boxed warnings, appear on a drug’s label as highlighted areas, and are specifically formatted to catch the reader’s attention.
The U.S. Food & Drug Administration (FDA) began requiring all makers of antidepressant drugs to add black box warnings to their labels in 2004, after issuing a public warning that the use of antidepressants might increase the risk of suicide among adolescents. The boxed warnings were originally intended to apply specifically to patients younger than 19, but the warning was expanded in 2007 to include adults younger than 25.
The high-profile suicide of 63-year-old comic, Robin Williams, on Aug 14, 2014, revitalized a controversy surrounding black box warnings and antidepressant drug side effects. The labels and prescribing information for selective serotonin reuptake inhibitor (SSRI) drugs do in fact list the possibility of increased suicidal ideation, among numerous other side effects. Clinicians are taught to thoroughly educate their patients about side effects of SSRIs, or any drug, both when initially prescribing the drug and whenever the dose is changed.
Research published in the British Medical Journal in June 2014, suggested that boxed warnings may have unintended consequences, or backfire. The study reported that, in the two years following the FDA’s initiation of the black box warning, antidepressant use fell by 31 percent while adolescents’ attempted suicides increased by 21.7 percent. During the same time period, among people aged 18 to 29, attempted suicides increased by 33.7 percent. Interestingly, this is not the first time the pharmaceutical industry has weathered the storm of the FDA’s black box warnings being called insufficient. The backfire argument was also made in 2007, by a study in the American Journal of Psychiatry, which showed that although SSRI prescriptions in the U. S. and the Netherlands decreased by 22 percent in both countries after the black box warnings were issued, youth suicide rates increased by 14 percent between 2003 and 2004. The data for the 2007 study was collected by Robert D. Gibbons and his colleagues at the University of Illinois, Chicago.
The rest of the world noticed the wisdom behind the FDA’s black box warnings, recognizing the FDA’s efforts as important enough to duplicate within the international pharmaceutical industry. In a 2008 review of the FDA’s antidepressant safety data assessment, the United Kingdoms’s Medicines and Healthcare Regulatory Agency (MHRA) concurred that the risk of suicide among young people taking antidepressants had in fact increased. Subsequent to these findings, the MHRA began revising the labels on a list of antidepressants sold in the U. K.
When mentioning SSRI side effects, it is worthy of note that one of the original, key research scientists whose discoveries led to the development of the of the selective serotonin reuptake inhibitor class of drugs, the late Dr. Candace Pert, made public statements late in her career about the dangers of antidepressant drugs, referring to the SSRI mode of action as a “monster” and cautioning against long-term use of antidepressant drugs.
The black box warning is the strongest warning the FDA issues on drug labels, and other drugs in addition to SSRIs carry black box warnings as well. For example, the injectable contraceptive, Depo-Provera, carries a black box warning because its long-term use has been shown to weaken bones, causing an increased risk of fractures and osteoporosis.
Meanwhile, the most frequently prescribed prescription drugs are still antidepressants. Between 2005 and 2008, 11 percent of Americans older than age 12 were taking prescription antidepressants, according to research data released after 2008 by the Centers for Disease Control and Protection’s (CDC) National Center for Health Statistics.
Most healthcare professionals are of the opinion that it is important that consumers are aware of the serious nature of all drug side effects. This way they can make their own informed decisions, especially regarding medications labeled with black box warnings. As the pharmaceutical industry continues to produce antidepressants, clinicians will continue to prescribe them in accordance to the cautions in the black box warnings. Ultimately, it will be up to the individual patient to decide if these actions are insufficient.
By Lane Therrell