Warning for ADHD drug Strattera

Threatening side effects of the drug Strattera (Atomoxetine)

12/19/2011

In a so-called Rote-Hand-Brief, the pharmaceutical manufacturer Lilly Germany points out that the drug Strattera (active substance atomoxetine) can cause considerable side effects on blood pressure and heart rate. For patients with cardiovascular disease, special care should be taken when taking the product.

The current warnings regarding the treatment of attention-deficit / hyperactivity disorder (ADHD) drug Strattera are up to 12 percent higher in the risk of clinically significant adverse effects on blood pressure and heart rate. The pharmaceutical company Lilly Germany has therefore informed the doctors about possible side effects of the drug Strattera and tightened the recommendations for use accordingly.

Clinically significant changes in blood pressure and heart rate
A spokeswoman for the pharmaceutical company confirmed to the news agency on Saturday „dpa“ the reports of the news magazine „FOCUS“ to the warnings for the drug Strattera. As the spokeswoman for Lilly Germany explained, about 30,000 physicians were informed about possible side effects of this medicine approved for the treatment of ADHD in children and adults. According to the Rote-Hand-Brief, which was also published online by the responsible Federal Institute for Drugs and Medical Devices (BfArM), recent data analysis on existing clinical trials has shown that around six to twelve percent of patients undergo a change in heart rate during Strattera treatment more than 20 beats per minute and clinically significant increases in blood pressure (by more than 15 millimeters Hg).

Atomoxetine with serious side effects
Therefore, physicians are advised to limit the use of the ADHD medication Strattera in patients with hypertension, cardiac arrhythmias, regular palpitations or heart stumbling, severe cardiovascular or cerebrovascular diseases. In addition, affected patients must always be screened for potential cardiac disease prior to treatment. In addition, the heart rate and blood pressure should be measured and recorded at regular intervals of a maximum of half a year, according to the recommendations in the current Rote-Hand-Brief with the title: „Important safety-related information about Strattera® (atomoxetine) and the risk of bluttruck and heart rate increase“. According to the announcement of "Lilly Deutschland GmbH", must „in patients who develop symptoms suggestive of cardiac disease promptly undergoing examination by a cardiologist.“

Furthermore, the previous warnings from previous Red Hand letters, which warn of possible psychological consequences (aggressiveness, suicidal thoughts) of the active substance atomoxetine in adolescents also apply. As the Lilly spokeswoman explained, most of the warnings have been included since the drug was approved in the relevant specialist information on strattera for doctors and pharmacists. However, the current red hand letter sharpens the recommendations. In case of uncertainty, the affected patients or their parents should, according to the spokeswoman of Lilly Germany urgently contact their doctor to discuss the further use or, if necessary, a dismissal of Strattera. (Fp)

Also read:
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Trend reversal in ADHD therapy?
ADHD: concentration through noise
ADHD genetically conditioned?
Environmental factors hardly investigated in ADHD
ADHD: Prescription of Ritalin is restricted

Picture: Andrea Damm