Research shows the Attention Deficit Hyperactive Disorder (ADHD) drug dexmethylphenidate hydrochloride—sold under the brand names Focalin and Focalin XR—might cause psychiatric side effects and allergic reaction side effects.
What Is Focalin? When Is It Prescribed?
Focalin is the brand name for the drug dexmethylphenidate hydrochloride made and sold by the Swiss pharmaceutical company Novartis. It is a prescription medication that is used to treat ADHD. The U.S. Food and Drug Administration (FDA) approved Focalin in November 2001 and Focalin XR in May 2005. Focalin comes in the form of oral tablets usually taken twice daily, and Focalin XR is an extended release capsule. Focalin has been a very successful drug for Novartis; in 2010 pharmacies dispensed 2.5 million Focalin XR prescriptions, amounting to $415 million in revenue for Novartis.
Scientists believe that dexmethylphenidate hydrochloride is a “monoamine reuptake inhibitor,” which means it prevents the absorption of released neurotransmitters. Specifically, it belongs to the norepinephrine-dopamine reuptake inhibitor (NDRI) drug class. Both norepinephrine and dopamine regulate stress levels in the human brain, and a shortage of dopamine inhibits cognition. By increasing their presence, Focalin eases ADHD symptoms.
Focalin Psychiatric Side Effects
In November 2011, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research Office of Surveillance and Epidemiology published a review of post-market adverse events in pediatric (aged 0-16 years) Focalin users. It found that of 167 Focalin adverse events reported to the FDA, 19 were for hallucinations, seven for depression, and eight for suicidal ideations and behaviors. One of the three Focalin fatalities occurred when a seven-year-old child hanged himself, though the report did not place the sole cause on Focalin.
In early 2012, an FDA advisory committee recommended that the FDA revise the Focalin label to include a warning about potentially fatal psychiatric side effects. The FDA declined to do so, which is unusual because the agency frequently adopts its advisory committees’ recommendations. It might still do so in the future.
Focalin Angioedema and Anaphylaxis Side Effects
The Office of Surveillance and Epidemiology’s review also classified one of the 167 adverse events as caused by angioedema, which is a rapid, potentially fatal swelling of the skin. A similar possible side effect is anaphylaxis, which is an allergic reaction that can include angioedema as a symptom. In contrast to the Focalin psychiatric side effects, the FDA did incorporate angioedema and anaphylaxis warnings into Focalin’s drug label, most recently revised in May 2012.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers of the Rottenstein Law Group believe that obtaining legal satisfaction from those who have harmed you or your child shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Focalin lawsuit on your behalf if necessary.
If you or a loved one took Focalin and believe it caused an injury, contact RLG today.