In the United States, the psychostimulant drug Dexedrine (dextroamphetamine) has been approved since 1997 to treat narcolepsy (a chronic sleep disorder), attention-deficit hyperactivity disorders (ADHDs), obesity, and depression. Another brand name of dextroamphetamine is Dextrostat. Dextroamphetamine is also the active metabolite in Vivanse, and makes up over 70 percent of Adderall.
In August 2006, five months after a US Food and Drug Administration (FDA) panel recommended that Dexadrine should contain a warning on its label concerning a possible heart risk, the drugs maker GlaxoSmithKline finally agreed to add such a warning. The new packaging eventually included warnings about:
- sudden death
- increased blood pressure
- psychiatric adverse effects such as mania and hallucinations
- long-term growth suppression
- visual disturbances
The FDA also required that GlaxoSmithKline develop a MedGuide (patient medication guide) for this drug.
A new study, however, then found that certain drugs used to treat ADHD including Dexedrine may increase the risk of sudden cardiac death in children. The FDA asserted that the study had limitations that make it difficult to draw such a conclusion, and that it would not change its recommendations on how these medications should be prescribed.
The FDA also does not currently recommend that parents discontinue their childrens ADHD medication based on this study. Instead, parents should discuss any concerns over the use of the medication with the prescribing health care professional.
Fortunately, additional studies are under way. Current studies are comparing the rates of stroke and heart attack in children and adults who take stimulant medications for ADHD with those of populations not on ADHD medications.
Meanwhile, if you or your loved one has suffered any adverse effects you suspect are as a result of taking an ADHD medication, you may wish to discuss your case with a qualified pharmaceutical injury attorney.