A warning on antidepressant drugs intended to inform patients of an increased risk of suicidal thoughts has caused prescription rates to plummet and may have contributed to a rise in attempted suicides, according to a study published Wednesday in the medical journal BMJ.
In the years following the introduction of a warning by the U.S. Food and Drug Administration about the link between antidepressant medication and an increased risk of suicide, the rate of prescriptions for the medication among adolescents ages 10 to 17 declined by more than 30 per cent, according to the study.
Suicide attempts rose by 22 per cent in the same time. The study, however, found the level of completed suicides stayed the same across all ages.
For the authors, the study highlights the risks of under-prescribing medication.
“Antidepressants are used to treat depression and other mood disorders. If those conditions are not appropriately treated, they themselves may become a cause of suicide or a suicide attempt,” said Christine Lu, one of the lead authors of the BMJ study and a researcher at Harvard Medical School.
Both the FDA and Health Canada took strong stances on antidepressant drugs around 2004, when research revealed a link between antidepressant drug use and suicidal ideation in youth. The FDA issued what’s known as a “boxed warning” on the packaging of drugs. Health Canada issued a public advisory. Both measures received widespread coverage in the media.
Research since then has consistently demonstrated a significant drop in prescription rates for the drugs. The new Harvard study highlights the role played by U.S. media in amplifying the FDA warnings, saying they became “frightening alarms to clinicians, parents and young people.”
“We do want the awareness but we don’t want overreaction,” said Lu. “It’s not just one-sided information about drug risk, or highlighting the risks of drugs, but we need to consider the risks of drugs and the risk of under-treatment.”
The study, which looked at health data for 7.5 million Americans obtained from health plan administrators, found antidepressant use dropped 31 per cent among those aged 10 to 17 and 24.3 per cent among those aged 18 to 29 in the second year of the warnings, which targeted youths.
The study found a significant jump in psychotropic drug poisonings — which Lu said account for 40 per cent of suicide attempts — in adolescents and young adults, but not in adults.
“It’s important that people not infer that the warnings, which clearly led to a reduction in the prescribing of antidepressants, were the cause of deliberate overdoses in the same population,” said Dr. David Juurlink, a drug safety specialist and head of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre.
The increase in overdoses could come from any number of factors, he said.
The study, however, does point to a concern that “patients and physicians can sometimes overreact” to information that was intended to help them make good decisions, Juurlink said.
The U.S. study backs up results found in a similar study done in Manitoba in 2008, which charted a rise in suicides following Health Canada’s introduction of the warnings. Both studies looked at trends in large population groups and show a correlation between the drop in prescriptions for antidepressants and unintended negative side effects. Neither, however, prove causation.
The Manitoba study, led by Dr. Laurence Katz, found that after Health Canada warnings were delivered, antidepressant use by children and adolescents dropped by 14 per cent in Manitoba and suicides among those age groups went up by 25 per cent.
“(The Harvard) study just emphasizes the conclusion that we came to in our studies. … we have to be mindful that our method of communication and the content of our communication can have unintended effects,” Katz told the Star.
“What I hope is out of this study and the study we did is that attention is drawn to the issue of communication, education of both physicians and the public about health care interventions,” he said.
The FDA said in an emailed response that “nothing indicates a need for change” in the warnings about antidepressants. The agency said that while it is aware of the studies of the antidepressant warning labels, it has not conducted any studies on the effectiveness of the labels.
When asked if there is any effort to review the warnings on antidepressants or revisit the policy, Health Canada was unable to answer despite being given more than 24 hours to do so.
Muhammad Mamdani, the director of the applied health research centre at St. Michael’s Hospital, says the two studies demonstrate that there is a risk to warnings that should be considered by regulators like Health Canada.
“These are messages with the intent of changing prescribing behaviour. While theoretically we have a sense of what should happen, as we can see by this study and other studies, many other things can happen that we did not intend,” said Mamdani. “It would be wise for any regulatory body to step back and look at the consequences of its warnings.”
By: Tim Alamenciak
Published on Wed Jun 18 2014
The Newhawks Crew
Dear Drugs-Forum readers: We are a small non-profit that runs one of the most read drug information & addiction help websites in the world. We serve over 4 million readers per month, and have costs like all popular websites: servers, hosting, licenses and software. To protect our independence we do not run ads. We take no government funds. We run on donations which average $25. If everyone reading this would donate $5 then this fund raiser would be done in an hour. If Drugs-Forum is useful to you, take one minute to keep it online another year by donating whatever you can today. Donations are currently not sufficient to pay our bills and keep the site up. Your help is most welcome. Thank you.