FDA warning on possible rare side effects
In 2007, the FDA required that all makers of ADHD medications develop Patient Medication Guides that contain information about the risks associated with the medications. The guides must alert patients that the medications may lead to possible cardiovascular (heart and blood) or psychiatric problems. The agency undertook this precaution when a review of data found that ADHD patients with existing heart conditions had a slightly higher risk of strokes, heart attacks, and/or sudden death when taking the medications.
The review also found a slight increased risk, about 1 in 1,000, for medication-related psychiatric problems, such as hearing voices, having hallucinations, becoming suspicious for no reason, or becoming manic (an overly high mood), even in patients without a history of psychiatric problems. The FDA recommends that any treatment plan for ADHD include an initial health history, including family history, and examination for existing cardiovascular and psychiatric problems.
One ADHD medication, the non-stimulant atomoxetine (Strattera), carries another warning. Studies show that children and teenagers who take atomoxetine are more likely to have suicidal thoughts than children and teenagers with ADHD who do not take it. If your child is taking atomoxetine, watch his or her behavior carefully. A child may develop serious symptoms suddenly, so it is important to pay attention to your child’s behavior every day. Ask other people who spend a lot of time with your child to tell you if they notice changes in your child’s behavior. Call a doctor right away if your child shows any unusual behavior. While taking atomoxetine, your child should see a doctor often, especially at the beginning of treatment, and be sure that your child keeps all appointments with his or her doctor.
In 2007, the FDA required that all makers of ADHD medications develop Patient Medication Guides that contain information about the risks associated with the medications. The guides must alert patients that the medications may lead to possible cardiovascular (heart and blood) or psychiatric problems. The agency undertook this precaution when a review of data found that ADHD patients with existing heart conditions had a slightly higher risk of strokes, heart attacks, and/or sudden death when taking the medications.
The review also found a slight increased risk, about 1 in 1,000, for medication-related psychiatric problems, such as hearing voices, having hallucinations, becoming suspicious for no reason, or becoming manic (an overly high mood), even in patients without a history of psychiatric problems. The FDA recommends that any treatment plan for ADHD include an initial health history, including family history, and examination for existing cardiovascular and psychiatric problems.
One ADHD medication, the non-stimulant atomoxetine (Strattera), carries another warning. Studies show that children and teenagers who take atomoxetine are more likely to have suicidal thoughts than children and teenagers with ADHD who do not take it. If your child is taking atomoxetine, watch his or her behavior carefully. A child may develop serious symptoms suddenly, so it is important to pay attention to your child’s behavior every day. Ask other people who spend a lot of time with your child to tell you if they notice changes in your child’s behavior. Call a doctor right away if your child shows any unusual behavior. While taking atomoxetine, your child should see a doctor often, especially at the beginning of treatment, and be sure that your child keeps all appointments with his or her doctor.
