April 25, 2024

FDA Warning Issued On ADHD Drug Due To Painful Priapism

A type of stimulant accustomed to treat add disorders can result in the introduction of long-lasting and sometimes painful erections, the Food and Drug Administration (FDA) said in a written warning released .

The condition, known as priapism, was linked in an FDA review to males between 8 to 33 years of age who took drugs containing methylphenidate, the active component in Ritalin and Concerta.

“Patients who take methylphenidate and develop erections lasting longer than four hours should seek immediate treatment to prevent long-term issues with your penis,” the FDA cautioned. “If not dealt with right away, priapism can lead to permanent harm to the penis.”

“Younger males, especially those who’ve not yet reached puberty, might not recognize the problem or might be embarrassed to tell anyone whether it occurs,” the statement continued.

The FDA said its review found certain cases of priapism were in the context of methylphenidate withdrawal and some of those patients taken care of immediately restarting a regimen from the drug. Two cases within the review required surgical intervention, with one requiring the use of a shunt and the other requiring needle aspiration of erectile tissue.

The federal agency said the priapism risk may be higher with immediate-release types of the methylphenidate drugs due to their short half-life in circulation.

Due towards the risk for potential harmful side effects, the FDA said hello was ordering the right changes be made to drug labels and patient guides for that products under consideration. The agency added physicians should be careful when switching their patients off methylphenidate-containing drugs.

“The chance of priapism may cause some health care professionals toconsider [sic] switching patients towards the non-stimulant drug Strattera (atomoxetine), another drug used to treat ADHD; however, atomoxetine has also been related to priapism in young children, teenagers, and adults,” the FDA statement said. “Priapism seems to be more prevalent in patients taking atomoxetine compared to patients taking methylphenidate products. Medical professionals should be cautious when considering changing patients from methylphenidate to atomoxetine.”

The agency said hello had received reports of amphetamine products used to treat ADHD causing priapism in four patients. However, it noted the role of these amphetamine products in the event of priapism was unclear.

Treated via a number of medications, ADHD is one of the most common childhood brain disorders. Marked by symptoms for example difficulty staying focused, difficulty controlling behavior, and hyperactivity, ADHD can continue into adulthood. Medications, such as methylphenidate, benefit patients by causing increased focus, lower impulsivity, and boosting overall social functioning. The FDA recommends patients who’re going for a regular medication for ADHD don’t stop their regimen without first talking to their health care professional.

The percentage of children being diagnosed with the condition has increased with time, from 7.8 percent in 2003 to 9.Five percent in 2007 and also to 11 percent in 2011, according to the Centers for Disease Control and Prevention (CDC). Boys happen to be more likely than girls to get an ADHD diagnosis 13 percent when compared with 6 %.