Makers of drugs approved to treat Attention Deficit Hyperactivity Disorder (ADHD) have been instructed by the US Food and Drug Administration (FDA) to notify patients of certain health risks.
The manufacturers affected include Eli Lilly and Co, Novartis AG, Johnson & Johnson, and Shire plc.
The ADHD drug manufacturers have been instructed to produce Patient Medication Guides that tell patients about possible risks of adverse cardiovascular and psychiatric symptoms and the precautions they should take.
Director of the Center for Drug Evaluation and Research (CDER), Dr Steven Galson, said that “Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well.”
“In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns,” he added.
According to the FDA, ADHD affects around 3 to 7 per cent of schoolchildren and 4 per cent of adults. The main symptoms are hyperactive behaviour, difficulty paying attention, and low impulse control.
Children and adults with ADHD tend to have low self-esteem, problems at school and work, and difficult relationships with family and peers.
Patient Medication Guides are leaflets that accompany the drug when it is given to the patient. They are aimed at patients, their families and caregivers. The information is FDA approved and is intended to prevent potentially serious side-effects.
The FDA advises doctors to look carefully at patients’ health history (including family history) and current status to assess cardiovascular or psychiatric symptoms and risk before recommending a treatment plan that includes ADHD drugs.
The Patient Medication Guide should be read fully before the medication is taken, and any questions or concerns should be discussed with the doctor.
The FDA has reviewed reports of a small number of patients with underlying serious heart conditions on normal doses of ADHD drugs who have suffered strokes and heart attacks, which in a few cases have been fatal.
The FDA has also conducted a separate review that showed a small increased risk of 1 in 1,000 of adverse psychiatric events linked to ADHD drugs. The adverse psychiatric events include hearing voices, becoming manic, or becoming suspicious for no reason. These events have even happened to people with no history of psychiatric conditions.
In 2006 the FDA directed manufacturers to revise their labelling to take into account these concerns about cardiovascular and psychiatric risks. This new notification is to help patients understand these risks via the Patient Medication Guide.
The new instruction affects 15 products, including various forms of Adderall, Concerta, Daytrana, Dexedrine, Focalin, Metadate, Methylin, Ritalin, and Strattera.
The FDA has been criticized for failing to notify the public sooner. On the other hand, there also fears that this action will stop people who need the drugs from taking them.
Written by: Catharine Paddock
Writer: Medical News Today