The doctors prescribe these drugs, but that does not mean they are necessarily safe, says the Federal Drug Administration which is currently looking at placing strong warnings on stimulant ADD medications like Ritalin, Adderall and Concerta.



An FDA advisory panel voted in February to recommend that all stimulant ADHD drugs carry a "black box" warning - the strongest possible safety warning - to indicate that the drugs may increase the risk of heart attacks, strokes and sudden death.

Black box warnings are intended to alert physicians and patients that a drug may carry significant risks. The FDA advisory panel ruled on this black box warning after reviewing data concerning death and other negative heart problems associated with stimulant drug medication use. Although data varies between reporting agencies, 25 to 51 deaths have been attributed to ADHD medication use. Experts estimate that less than 10 percent of serious drug reactions are reported to the FDA, so the deaths and serious adverse effects are undoubtedly much higher.

Of the reported deaths studied by the advisory panel, 19 were children. Other reports described 54 cases of high blood pressure, chest pain, heart attacks, strokes, irregular heart beats and fainting. The number of arrhythmia has been surprising. It is believed to be the pathway for the sudden, unexplained deaths. And because adults have a higher risk of heart disease and stroke to begin with, any increase in risk caused by these drugs could affect a large number of people.

One committee member stated that not disclosing the risks associated with taking these drugs is unethical. Because of the gravity of the side effects, namely sudden death, physicians need to be clearly aware of the serious side effects before prescribing these drugs to their patients. The panel, while expressing concern about the over prescribing of ADHD medications, stated that they want physicians to pause before writing prescriptions for stimulant medications. The FDA advisory committee also unanimously recommended that the FDA include medication guides with all stimulant ADHD drugs warning about the risks.

FDA is not required to follow recommendations given by the advisory committee, though the FDA usually does follow recommendations. The FDA awaits advice from its pediatric panel in March before reaching a decision. The FDA plans to refer the issue to another advisory panel that deals with psychological problems in children. Additionally, the FDA is planning a new study of ADHD drugs that will take approximately 18 months to complete. Some are adamant that the FDA should not wait for the results of this study. The FDA has been criticized in the past for being slow to respond to evidence of health risks associated with such things as drugs, including painkillers and antidepressants.

At least two million children and one million adults take prescription ADHD medication every month. Opponents of this black box warning - the strongest warning in the industry - say that they've found less than one death or injury for every 1 million prescription filled. It is true that the number of deaths caused by ADHD medications make up an incredibly small percent of people using the drug. However, if that one death is someone you love, that fact is little consolation.

One thought is that a black box warning will help the out of control rate in which doctors prescribe ADHD drugs. Many experts believe stimulants like Adderall and Ritalin are being over prescribed, especially to adults, and the public and doctors are largely unaware of the potential risks. They say the chemical structure of stimulants were structurally similar to drugs like ephedrine, that have proven cardiovascular risks. Besides the 25-51 deaths reported between 1999 and 2003, the council also discovered there were 54 cases of cardiovascular problems, which included heart attacks, strokes, and hypertension.

If you or someone you love is currently taking a stimulant ADHD medication for Attention Deficit Disorder, you might want to consider alternatives to ADHD medications. These alternatives can include diet modification, exercise regimes, family therapy, biofeedback and other alternatives that show promise in easing the symptoms of Attention Deficit Disorder.