This week in the British Medical Journal, a review was published which notes that antidepressants appear to be more dangerous for kids than previously thought. Some of the initial published data under-reported instances of suicide and aggression. The review included five antidepressants: Cymbalta (duloxetine), Effexor (venlafaxine), Paxil (paroxetine), Prozac (fluoxetine) and Zoloft (sertraline). This information is not entirely new, as back in 2004, the U.S. Food and Drug Administration (FDA) issued a warning about the increased risk of suicide in children and teens treated with SSRIs (selective serotonin reuptake inhibitors), including Paxil, Prozac, Zoloft and others. In 2007, the FDA revised this “black box warning” to include adults < 25 years old.
This new study concluded that the risk of aggression and suicide doubled in kids, which had not been previously reported. There was no similar association found in adults. Additionally the risks to children from antidepressants included deaths, suicidal thoughts and attempts, as well as aggression and akathisia. The researchers also found that published reports from clinical trials appeared to mis-classify deaths and suicidal events in people taking antidepressants. In fact, 4 deaths were misreported by a pharmaceutical company, in all cases downplaying the role of the antidepressant. Even more alarming is that more than half of the suicide attempts and suicidal thoughts were mis-coded in the earlier trials as “emotional lability” or “worsening of depression,” which significantly downplayed these serious adverse effects. In summary trial reports from Eli Lilly and Co., almost all deaths were noted, but suicidal attempts were missing in 90 percent of instances, and information on other outcomes was incomplete. Lastly, the authors note that the risks to children may be even greater than what was just reported in the new analysis. Clinical data could not be obtained for all drug trials and all antidepressants, and individual listings of adverse outcomes for all patients were available for only 32 trials.
The Pharmaceutical Research and Manufacturers of America (PhRMA) responded to the study by noting that a revised set of principles for responsible clinical drug trial data sharing that went into effect for its members in 2014. “While we cannot comment on the specific clinical trials of various companies, our members are committed to sharing data,” a spokesperson said.
What’s the bottom line?
Clinical data supplied to regulators cannot be totally be trusted. Though it’s disturbing that data was manipulated, just knowing this information should empower you to be extremely cautious when considering antidepressant use in children. An integrative or functional medicine practitioner can suggest alternative treatments, such as vitamin & mineral deficiencies, as well as modifications in diet, sleep, stress and exercise.
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Drug Watch. October 12, 2015. Accessed on January 31, 2016 at: http://www.drugwatch.com/ssri/suicide/