Pharmacists Ordered to Distribute Medication Guides About Serious Heart, Psychiatric Problems Linked to Attention Deficit Drugs

Earlier this year, the Food and Drug Administration (FDA) ordered pharmacists to inform people taking attention deficit hyperactivity disorder (ADHD) drugs – or their parents – about serious heart and psychiatric risks associated with the drugs.

As of Feb. 21, the FDA announced that it is requiring pharmacists to distribute written safety information with each new and refill prescription for all ADHD drugs sold in the US.

The FDA directed ADHD drug manufacturers to write medication guides alerting patients to the drugs’ heart and psychiatric risks. The guides should also advise patients of precautions that can be taken. (The FDA is authorized to mandate the distribution of medication guides for drugs that are deemed to present a serious public health concern. Medication guides are written by the drug manufacturers, but they are edited and approved by the FDA.) Medication guides for ADHD drugs can be found on the FDA’s Web site at: www.fda.gov/cder/drug/infopage/ADHD/default.htm.

The FDA’s decision to require medication guides for these drugs is stronger than the agency’s previous attempts to warn the public of ADHD drugs’ potential risks by including the warnings in professional product labels because patients are more likely to see medication guides. In contrast, professional product labels (package inserts) that contain black box warnings for these drugs are inconsistently distributed to patients and are designed for doctors, not patients. Unseen or inappropriate information does consumers little good.

Cardiovascular side effects of ADHD drugs
Patients using these drugs sometimes experience increases in blood pressure and heart rate. Sudden death has been reported with the use of ADHD drugs in patients with pre-existing heart problems or heart defects. The professional labeling for these drugs now includes warnings such as:

[ADHD drugs] generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy [heart muscle damage], serious heart rhythm abnormalities or other serious cardiac problems. ... Sudden deaths, stroke and myocardial infarction have been reported in adults taking [ADHD drugs] at usual doses for ADHD. Although the role of [ADHD drugs] in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease or other serious cardiac problems.

Patients taking drugs approved for ADHD should seek medical attention as soon as possible if they experience any signs of heart problems, including chest pain, shortness of breath or fainting.

Before starting on these drugs, children should be checked for heart problems.  Children should have their blood pressure and heart rate checked regularly while taking ADHD medication. 

Psychiatric side effects of ADHD drugs
There have been reports in patients of all ages taking these drugs of new or worsening thought problems such as suicidal thoughts; new or worsening aggressive behavior or hostility; and new or worsening bipolar illness.

Some children and adolescents using these drugs experienced new psychotic symptoms such as hearing voices; believing things that are not true; becoming suspicious; and developing new manic symptoms.

Patients using atomoxetine (STRATTERA) should be aware of the increased risk of suicidal thoughts. This information will appear in the drug’s medication guide as follows:

Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from STRATTERA clinical studies with over 2200 child or teenage ADHD patients suggests that some children and teenagers may have a higher chance of having suicidal thoughts or actions.

What You Can Do
  
Patients currently taking drugs approved for the treatment of ADHD who experience any of the side effects mentioned in this article are advised to seek medical attention immediately.