Question:

Dear Shari;

I heard on the news that the FDA may “black box” medications for AD/HD. What does “black box” mean? Are these medications dangerous? Should I think about taking my son off the medications?

Elaine

Answer:

Much concern has been expressed about this issue lately. On February 9, 2006, a panel recommended to the Food and Drug Administration (FDA) that a severe warning be placed on stimulant medication prescribed to treat AD/HD. A “black box” warning is the most severe warning that the FDA can place on a medication. However, be careful not to jump to conclusions until the FDA has reviewed all the pertinent information or taken any action.

The FDA stated that it would not act on the recommendations anytime soon. Another advisory panel, composed of psychiatrists and pediatricians, is scheduled to meet and make additional recommendations in March.

The FDA originally requested a panel to recommend ways to research whether possible heart attacks are associated with stimulant medications but the panel, composed primarily of drug safety specialists, went further. By a narrow margin vote of 8-7 with one abstention, they recommended the severe warning and unanimously agreed that manufacturers should provide patients with a written safety guide.

The members of the panel were concerned because twenty-five deaths over a four year period were reported among people taking stimulant medication. Nineteen of these deaths were children. The report stated that it is impossible to determine with certainty whether the deaths and injuries were a direct result of the medications. Some of the deaths might have been related to pre-existing conditions. Also, the percentage of sudden deaths was small, never exceeding one in a million for any stimulant drug.

Even though the percentage was small, the panel recommended the warnings because of concerns that the medications have been over- prescribed, particularly for adults. Since the 2003 FDA approval of Strattera and Adderall to treat adult AD/HD, the incidence of treated adults has increased. A Medco study in September 2005, found that use doubled in adult men and women and rose by 56% among children. The study also found that the incidence of AD/HD among adults is about 4% and about 1% of adults are receiving medication for the condition.

Stimulant medications are to raise blood pressure and heart rates. Increased blood pressure is linked to cardiac problems such as strokes, cardiac arrest and heart palpitations particularly in adults. Because the medications have been used for many years, most patients tend to assume they are safe. Members of the panel suggested that many adults may not be aware of the cardiac risks and felt that providing a warning would encourage doctors and patients to carefully consider their need for medication.

The drugs concerned include Ritalin, Adderall, Concerta, Methylin and Metadate. Ritalin has been in use since 1955 and dozens of studies have found it safe and effective. However, no studies have been done over a long enough period of time or included enough participants to evaluate possible long-term effects on the heart.

Most experts recommend waiting until the FDA has heard all the information and made a decision before taking any action. According to a report by the Surgeon General, medication is effective for 80% of people with AD/HD and discontinuing medication without full information may be a mistake.

Resources

“Adult Use of ADHD Drugs Up.” The Associated Press. September 15, 2005. available at: www.cbsnews.com

 “FDA Panel Suggests Adding Black Box Warning to ADHD Medications About Risk of Sudden Death, Heart Problems.” Kaiser Daily Health Policy Report. February 10, 2006. available at www.kaisernetwork.org

“FDA Warning on AD/HD Medications ‘Premature’; National AD/HD Advocacy Group Urges Further Research.” CHADD What’s New. February 15, 2006. available at: www.chadd.org

Harris, Gardiner. “Warning Urged on Stimulants Like Ritalin.” The New York Times. February 10, 2006.

Hitti, Miranda. “ADHD Drugs: Adult Use Doubled in 4 Years.” September 16, 2005. from Medco press release. MedicineNet, Inc. available at: www.medicinenet.com

Vendantam, Shankar. “Warning Urged for ADHD Drugs.” Washington Post. February 10, 2006.