The so-called “black box” warning is the most serious the Food and Drug Administration can assign to a drug. But it has caused controversy.
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Some parents believe they’ve been under-informed about the risks. Doctors, though, fear over-emphasis of the warning scares off patients whose lives could be saved and improved by these drugs.
The Dayton Daily News' Path Forward project digs into the most pressing issues facing the Miami Valley, including rising concerns about youth mental health. Teen suicide rates in Ohio are at the highest they've been since at least 2000.
KEEP READING: How Dayton region can stop record increase in teen suicides
Sean Polete is one local parent who shared his concerns about antidepressants and whether a prescription contributed to the suicide death of his 16-year-old son, Jacob Polete, on Nov. 30, 2018.
“(The doctor) didn’t mention anything about a black label. He didn’t mention this was an off-label use,” he said. The drug he received wasn’t approved to treat depression in teens, but that doesn’t mean doctors can’t prescribe it.
“I didn’t do the research because I felt like, well, I’m just happy to have somebody giving us some advice,” the Oakwood father said. It wasn’t until after his son died that he started reading about the warnings attached to antidepressants.
“These antidepressants and things have significantly different effects on a child’s brain and it’s much different than the adult brain,” Sean Polete said.
For most children, the drugs work, said Dr. Grace Matheson, a child psychiatrist at Dayton Children's Hospital.
“We don’t want them to be afraid of the medicine,” she said.
Black box warning
In 2004 the FDA added the warning, which appears in a black box on the information packet with each prescription of antidepressant medications.
It stems from several studies of clinical trials in the United Kingdom and United States in which it was found that about 4% of patients younger than 18 experienced increased suicidal thoughts while on antidepressant drugs compared to 2% on placebos.
None of the patients in the clinical trials that were reviewed died by suicide.
In 2006 the FDA expanded the warning to include 36 antidepressants and raised the age of the warning to 24 years old.
Since those trials were done and the warning was added, doctors and researchers have seen some evidence that the warning might scare off patients who would benefit from taking antidepressant drugs.
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“An increasing number of reports have questioned the actual validity of the FDA warning, especially considering a decline in the prescription of antidepressant drugs associated with an increase in the rate of suicidal events among people with severe depression,” a 2019 study in Frontiers in Psychiatry says.
In other words, some data indicates prescriptions for antidepressants in young people declined after the warning was added, while youth suicides have been on the rise. But other studies point out that the rate of prescription has come back up in recent years.
“The vast majority of cases, the medication will really help the child feel better,” Matheson said. “And if they are having suicidal thoughts as part of their depression, it will relieve those in most cases. But there are those kids who have the adverse effects.”
The majority of research agrees that the warning is warranted, and parents simply need to be better educated about the true risks and benefits of these medications.
“There are people who, because they’ve heard about increased suicides, they’ve heard these medicines don’t work, (they’ve been) scared off,” said T.J. Grimm, retail and ambulatory director for University Hospitals in Cleveland, and president elect of the Ohio Pharmacists Association. “Their first call isn’t to their physician or pharmacist but to WebMD.”
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A goal of the warning was to strengthen safeguards for children by encouraging close monitoring while they are on antidepressants. But a 2008 study in the American Journal of Psychiatry found the frequency of doctor visits by juvenile patients with new prescriptions for antidepressants didn’t increase after the warning was issued. There is no evidence that the warning has increased communication between patients, their parents and their doctors overall.
Nationwide Children’s Hospital in Columbus hosts the Center for Suicide Research and Prevention. Researchers there confirmed the FDA’s findings of overall increased risk of suicidal thoughts and attempts in young people on antidepressants but found that the benefits outweigh the risks.
Future research should focus on how to best monitor children taking antidepressants, that study says, which could increase the confidence of parents and doctors in using the drugs.
‘We were not prepared’
Jacob Polete wasn’t new to behavioral health medication. He’d taken attention deficit hyperactivity disorder medications when he was younger and complained of having dark thoughts, his father said.
As he got older, the Oakwood high school student developed a love of music, science and the outdoors. He conducted sometimes questionable chemistry experiments, like taking caffeine he’d distilled himself. He was an intelligent and inquisitive kid whose grades didn’t reflect his smarts, according to his dad.
Jacob had been seeing a therapist to talk through issues, including his parents’ divorce. But he didn’t disclose that he was having suicidal thoughts until he was hospitalized following the caffeine incident.
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His parents met with his doctor before he was given an antidepressant. Sean Polete, a Navy veteran who said he has struggled with depression himself, asked some questions about whether that was the right medication for his son.
But the black box warning was never brought up, Sean Polete said, neither was the fact that the drug prescribed is not FDA-approved for patients younger than 25 and therefore was “off-label.”
“This was an adult medication,” Sean Polete said.
He later learned that the first six weeks on a new psychiatric medication are the riskiest.
“We were not prepared for that,” he said.
When Jacob came home on the medication, his father said he seemed to do better and even wanted to return to school quickly. Three weeks later, he killed himself.
Sean Polete said he’s not sure how much the medication contributed to his son’s death, but he wished the family had had more information.
“He was more troubled than we knew, or the medication sent him for a loop and exacerbated his symptoms,” he said.
Doctors say it's important for parents to ask questions about the medications prescribed to their children.
“The important thing is that people are aware that this can happen,” Matheson said. “I usually tell people if you see that your kid is feeling worse instead of better, make sure you’re calling the doctor.”
Sometimes a child prescribed antidepressants actually has a form of bipolar disorder that wasn’t detected, she said. In those cases, the medication can make them manic, which increases the risk of suicide.
“The parents need to be watching out for any of these changes,” Matheson said. “Since we don’t see the child every day, the parent is going to be the eyes and ears.”
Pharmacists can be a resource to ask questions as well.
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“People need to ask their pharmacists to tell them about the medicine every time they get a new prescription,” Grimm said.
The existence of a warning on antidepressants does not obligate a pharmacist to discuss the potential risks with a patient. Pharmacy groups have debated whether that discussion should be mandatory, but no policy changes have been settled on.
Sean Polete recommends that parents develop trust with their child’s doctor and get as much information as possible, so they feel comfortable with the action plan.
“Have the doctors help you craft a plan,” Sean Polete said, including how the family will be involved in monitoring and supporting the patient, especially during the first six weeks on a new medication.
He also wishes doctors would only choose off-label uses of medication as a last resort.
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Matheson said many antidepressants are not approved by the FDA for use by children but are very commonly prescribed off-label or for a different use than indicated by the FDA. She starts children on lower doses and builds up.
“In general the reason why one would be approved and not another just has to do with whether somebody has done the randomized controlled trial,” she said. Doing trials on children is tricky, so many medications haven’t gone through that process, even though they’ve been seen to work and written up in literature.
“Most of them work in a very similar way, so we can sort of extrapolate from the adult data,” Matheson said. “It doesn’t mean that it’s not safe or it doesn’t work.”
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