New Health Warnings Urged for ADHD Drugs
Pharmaceutical companies who make Ritalin, Adderall, Strattera and other ADHD drugs have been advised to give patients and parents additional warnings about the potential for serious psychiatric and heart problems. Patients would be given a 2-page medication guide with each new prescription.
Drug companies are expected to comply with the new requirement within 30 days. The announcement covers 15 drugs, including those offered in extended-release, patch and chewable versions.
Serious side effects for ADHD drugs are rare. However, the new warnings advise calling a physician immediately in case of chest pain, shortness of breath, fainting or hallucinations. A sudden change in behavior should also be noted and promptly reported.
Of the 3.3 million children taking ADHD medications, more than 2,500 went to emergency rooms in 2004. About a fourth of them had serious heart or blood pressure problems, according the Centers for Disease Control. Of the 25 deaths thought to be linked to the drugs, 19 involved children. In the 54 patients who experienced serious heart problems, some had prior heart conditions.
Proposed guidelines are to state that these amphetamine-based drugs have been linked to stroke and heart attacks in adults and sudden death in patients with heart problems or defects. A few children and teens reported hearing voices, growing suspicious or becoming manic while on ADHD medication. About 1 child in 1000 may experience hallucinations.
It is vital that patients give doctors a full history of cardiovascular or mental problems. In addition, they should make it known if they take antidepressants, seizure medications or blood thinners. The FDA emphasizes that persons with heart disease, blood pressure problems, hyperthyroidism or glaucoma should not take ADHD medications.
The FDA emphasizes that new requirement for expanded warnings is precautionary and should not discourage patients from taking these drugs, which are safe in appropriate patients.
Source: San Francisco Chronicle; Feb. 22, 2007 (article from Baltimore Sun)
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