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What Are the Dangers of Focalin XR?

By Rachel Elizabeth ; Updated August 14, 2017

Focalin, a brand name version of dexmethlyphenidate hydrochloride, is a stimulant medication prescribed to children to alleviate symptoms of attention deficit hyperactivity disorder, or ADHD. According to the National Resource Center on ADHD, it can help improve a child’s ability to pay attention, concentrate, and control impulsive or hyperactive behavior. Focalin XR is the extended release form of the drug.

Delayed Growth

Children who take Focalin XR for an extended period of time may experience slowed growth and development. The U.S. Food and Drug Administration found that children who consistently took Focalin in its short acting form over a three-year period had a delay in both height and weight gain. Over this time frame, children taking stimulants grew 2 cm less in height and gained 2.7 kg less in weight than children who were not medicated.

Seizures

In individuals who have a history of seizures, the use of Focalin XR could trigger the onset of seizures once again. It is rare that individuals with no seizure history experience these symptoms while using the drug. The FDA recommends that in the presence of seizures, Focalin XR should be stopped.

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Psychotic Symptoms

Children taking Focalin XR are also at increased risk for worsened behavior or mood problems when they have preexisting psychiatric diagnoses. In particular, stimulant medications taken by a child with bipolar disorder may lead to manic symptoms. The development of new psychotic symptoms such as paranoia, mania or euphoric mood, and hearing voices, may also occur. The FDA reports that over several studies, the emergence of new psychotic symptoms occurred in 0.1 percent of the population being treated with stimulants.

Sudden Death with Preexisting Heart Conditions

As reported by the FDA, a serious side effect of Focalin XR use is the risk of sudden death in children with preexisting heart conditions or abnormalities. Stimulants like Focalin should not be prescribed to children who have heart disease, abnormal heart rhythm, or other abnormalities. There are also risks of increased blood pressure and heart rate when taking Focalin XR, which should be monitored by a physician.

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