A bottle of Ritalin. The drug may cause painful erections in boys and men who use it, the FDA cautions.
Some of the most popular medications used to treat ADHD have a surprising and unwanted side effect: long-lasting, painful erections, Food and Drug Administration officials said Tuesday.
Drugs that contain methylphenidate, including widely used medications such as Ritalin and Concerta, have been associated with the condition known as priapism, which can cause permanent damage to the penis, a new review of the products showed.
Another drug, Strattera, or atomoxetine, has been associated with priapism in children, teens and adults. The condition can occur in males of any age and happens when blood gets trapped in the penis, leading to abnormally long-lasting and painful erections.
It seems to happen more often in people taking Strattera, but FDA officials said they don't know how often priapism occurs in boys and men taking either type of product.
There were 15 cases of priapism linked to methyphenidate drugs between 1997 and 2012, the FDA said.
Patients were on average just 12 when they suffered the side-effect while taking methyphenidate, the FDA found, with an age range of 8 to 33. In a few patients, the problem occurred after an increase in dosage, but it also occurred when the drug doses were delayed, or when the drug was stopped either temporarily or permanently. Two patients required surgery, one required a shunt and the other had to have the blood removed using needle aspiration.
Health officials should talk to patients and parents about the signs and symptoms of the condition and stress the need for immediate treatment. Boys, especially those who have not reached puberty, may not recognize the problem or be too embarrassed to tell anyone about it.
Drugs that may cause the problem include DAytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant XR, Ritalin LA/Ritalin SR.
Drugs to treat ADHD are among the most widely prescribed. About 11 percent of children ages 4 to 17, or 6.4 million kids, have been diagnosed with ADHD as of 2011, according to the Centers for Disease Control and Prevention.
First published December 17 2013, 10:23 AM