Following their 16‑year‑old son’s suicide, a Pennsylvania couple brought a federal lawsuit against the manufacturer of the antidepressant drug Paxil. The parents claimed that the manufacturer knew of the specific risks of teen suicides from Paxil but neglected to warn doctors, parents, and teens about the risks.
The family doctor had initially treated the teenager for acne, prescribing a strong prescription drug, Accutane, that has been linked to mood changes and suicides in teenagers. The teenager returned to the family doctor for further treatment, complaining of nausea and redness of his skin. The family doctor then diagnosed the teenager with body dysmorphic disorder, a psychological condition where a “normal‑appearing” person is preoccupied with some imagined defect in appearance.
Concerned that the boy’s body dysmorphic disorder could worsen into depression and lead to suicidal or hostile behavior, the family doctor prescribed the antidepressant Paxil, despite the fact that it is not approved for use by children and teenagers. The teenager took Paxil for several months, stopped for several months, and then resumed taking Paxil without ever telling the family doctor of his having stopped. Three days after resuming the Paxil, the boy committed suicide by a self‑inflicted gunshot. At the time the doctor prescribed Paxil, the package insert did not include any warnings of increased risk of suicide and did not include any pediatric dosage recommendations.
The drug company denied any liability and claimed that since the Food and Drug Administration (FDA) did not require suicide warnings on Paxil packaging, no warnings were necessary. The company denied that Paxil caused or contributed to the teen’s suicide.
Adult Use Only
But the teenager’s parents based their claims on the fact that the FDA has never approved Paxil for children or teenagers, so the FDA warnings cover only adult usage. In refusing to dismiss the lawsuit, the federal judge noted that, while the FDA firmly dismissed any links between Paxil and adult suicides, the FDA had not addressed warnings for children and teenagers because Paxil simply is not FDA‑approved except for adult use. The judge decided that if the drug manufacturer “indeed possessed information, not available to the FDA, upon which it could have unilaterally added a warning to its labeling,” a jury could find the manufacturer liable for the teenager’s death.
“Black Box” Warnings
Following the teenager’s death and the lawsuit and based on the increased national public inquiries and concerns, the FDA issued a broad statement warning that there may be an increased risk of suicide in pediatric use of many antidepressants, including Paxil. In addition, the FDA has revised “black box” warnings that now headline the package insert for many mental health drugs, cautioning that children and teenagers may be at risk for suicide.
The FDA developed the new black box warning because it cannot prohibit or prevent “off‑label” use by doctors. Doctors often discover effective off‑label uses for prescription drugs and are free to prescribe drugs for purposes other than those approved by the FDA. Doctors can legally prescribe adult drugs for children, despite the fact that the FDA has not approved their use by children. Doctors who prescribe such drugs for off‑label uses risk malpractice liability but are not subject to FDA prosecution-the FDA regulates drugs, not doctors.
The FDA currently warns that the use of prescription antidepressants by children and young people may increase their risk of suicide, and the agency is actively studying the issue. Drug manufacturers and the FDA have issued strong warnings that children and teenagers, even people in their early twenties, should never abruptly stop taking antidepressants.
Adults, children, or teenagers who are discontinuing the use of an antidepressant must manage doing so carefully and with the active involvement of a qualified physician.