| -- End Ad Box ---> | | | | stimulant ADHD drugs warning about the risks. |
| At least 3.3 million Americans currently take | | | | FDA is not required to follow recommendations given |
| medications to ease the symptoms of Attention Deficit | | | | by the advisory committee, though the FDA usually |
| Disorder. The majority of these medications are | | | | does follow recommendations. The FDA awaits |
| amphetamine-based stimulants. The doctors prescribe | | | | advice from its pediatric panel in March before |
| these drugs, but that does not mean they are | | | | reaching a decision. The FDA plans to refer the issue |
| necessarily safe, says the Federal Drug Administration | | | | to another advisory panel that deals with psychological |
| which is currently looking at placing strong warnings on | | | | problems in children. Additionally, the FDA is planning a |
| stimulant ADD medications like Ritalin, Adderall and | | | | new study of ADHD drugs that will take approximately |
| Concerta. An FDA advisory panel voted in February | | | | 18 months to complete. Some are adamant that the |
| to recommend that all stimulant ADHD drugs carry a | | | | FDA should not wait for the results of this study. The |
| "black box" warning - the strongest possible safety | | | | FDA has been criticized in the past for being slow to |
| warning - to indicate that the drugs may increase the | | | | respond to evidence of health risks associated with |
| risk of heart attacks, strokes and sudden death. | | | | such things as drugs, including painkillers and |
| Black box warnings are intended to alert physicians | | | | antidepressants. |
| and patients that a drug may carry significant risks. | | | | At least two million children and one million adults take |
| The FDA advisory panel ruled on this black box | | | | prescription ADHD medication every month. |
| warning after reviewing data concerning death and | | | | Opponents of this black box warning - the strongest |
| other negative heart problems associated with | | | | warning in the industry - say that they’ve found |
| stimulant drug medication use. Although data varies | | | | less than one death or injury for every 1 million |
| between reporting agencies, 25 to 51 deaths have | | | | prescription filled. It is true that the number of deaths |
| been attributed to ADHD medication use. Experts | | | | caused by ADHD medications make up an incredibly |
| estimate that less than 10 percent of serious drug | | | | small percent of people using the drug. However, if that |
| reactions are reported to the FDA, so the deaths and | | | | one death is someone you love, that fact is little |
| serious adverse effects are undoubtedly much higher. | | | | consolation. |
| Of the reported deaths studied by the advisory panel, | | | | One thought is that a black box warning will help the |
| 19 were children. Other reports described 54 cases of | | | | out of control rate in which doctors prescribe ADHD |
| high blood pressure, chest pain, heart attacks, strokes, | | | | drugs. Many experts believe stimulants like Adderall |
| irregular heart beats and fainting. The number of | | | | and Ritalin are being over prescribed, especially to |
| arrhythmia has been surprising. It is believed to be the | | | | adults, and the public and doctors are largely unaware |
| pathway for the sudden, unexplained deaths. And | | | | of the potential risks. They say the chemical structure |
| because adults have a higher risk of heart disease | | | | of stimulants were structurally similar to drugs like |
| and stroke to begin with, any increase in risk caused | | | | ephedrine, that have proven cardiovascular risks. |
| by these drugs could affect a large number of people. | | | | Besides the 25-51 deaths reported between 1999 and |
| One committee member stated that not disclosing the | | | | 2003, the council also discovered there were 54 |
| risks associated with taking these drugs is unethical. | | | | cases of cardiovascular problems, which included heart |
| Because of the gravity of the side effects, namely | | | | attacks, strokes, and hypertension. |
| sudden death, physicians need to be clearly aware of | | | | If you or someone you love is currently taking a |
| the serious side effects before prescribing these drugs | | | | stimulant ADHD medication for Attention Deficit |
| to their patients. The panel, while expressing concern | | | | Disorder, you might want to consider alternatives to |
| about the over prescribing of ADHD medications, | | | | ADHD medications. These alternatives can include diet |
| stated that they want physicians to pause before | | | | modification, exercise regimes, family therapy, |
| writing prescriptions for stimulant medications. The FDA | | | | biofeedback and other alternatives that show promise |
| advisory committee also unanimously recommended | | | | in easing the symptoms of Attention Deficit Disorder. |
| that the FDA include medication guides with all | | | | |