American pediatric health advisers warned that about Concerta suicide risk in children taking the ADHD medication. Several members of an advisory committee to the FDA asked the agency to change the label to reflect this risk. The FDA approved this drug for children aged 6 or older.
Approved in 2000 by the FDA, Concerta was first made by Alza Corporation before Johnson & Johnson purchased it. The medication was one of the first extended-release versions of methylphenidate (generic Ritalin) to treat ADHD. It is active for 12 hours. This time period helps ensure kids receive the medication during school hours. This extended release replaced the 3 daily doses previously needed.
Experts Caution About Concerta Suicide Risk
The FDA often follows the advice of its committees like this group of pediatric health advisers. However, it is not required to. The agency received multiple reports of suicidal thoughts for children or adolescents who took the drug over the past six years. Doctors on the panel urged the FDA to consider the seriousness of this side effect. Whereas, the FDA didn’t seem to see the link.
The number of children diagnosed with ADHD has skyrocketed in recent years. This condition now affects 3 to 5 percent of kids globally. Children with ADHD are excessively restless, impulsive and easily distracted, and often have trouble at home and in school. There is no cure, but the symptoms can be kept in check by a combination of behavioral therapy and medication like Concerta.
Over 1.8 million children use Concerta. Yet, the label does not warn about suicidal thoughts. Out of other ADHD drugs, only Strattera’s label mentions thoughts of suicide as a side effect, as part of a restrictive “black box” warning. The FDA monitors reports of side effects from medicines after they’ve been approved in order to discover potential safety problems. For pediatric drugs, the agency must regularly review their safety.
We Want to Help Concerta Victims
Undeniably, it is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. We want to also help send a message that this is not acceptable if they don’t warn you.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. They are responsible for harming your child. Therefore, they should be held accountable for all the pain and suffering caused by your child taking his or her own life. Our consultations are free and without obligation.
If a jury finds the conduct of a drug company responsible for the death of your child, they may award punitive damages. These damages aim to punish the company and deter similar conduct in the future. Therefore, if your child attempted or committed suicide after taking Concerta, please speak to us to learn more about your rights.