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Researchers Cite Lack of Research into ADHD Drug Safety

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Jarod Cassidy3 years ago

A new analysis suggests that little research has been done to prove the long-term safety of medications for attention-deficit/hyperactivity disorder (ADHD), despite rising prescription rates.

Study Finds Lack of Research into ADHD Drug Safety

“We have too few long-term studies on the effects of these medications. There’s a big, big gap in our understanding of what the effect of these medicines might be. It’s worrisome.” – Dr. Sanford Newmark as published by Reuters Health

According to Reuters, the U.S. Centers for Disease Control and Prevention (CDC) estimates that roughly 6.4 million children between the ages of four and 17 in the U.S. have been diagnosed with ADHD as of 2011 – about half of those diagnosed were prescribed drugs to treat the disorder.

However, despite these high prescription rates, healthcare professionals have noted that there has been surprisingly little research into the long-term effects of ADHD drugs.

In fact, researchers from the Mario Negri Institute for Pharmacological Research in Milan, Italy found only six studies had examined ADHD medications for a period longer than 12 weeks. Further, the researchers determined that all six studies were funded by pharmaceutical companies.

The authors of the study noted that while the studies addressed most common side effects, including decreased appetite, insomnia, headaches and stomach pain, the studies appeared to miss adverse events that occur less frequently. These include suicidal thinking and long-lasting erections.

FDA Issues Warnings over Unreported Side-Effects

Reuters reports that both of the latter side effects, suicidal thinking and long-lasting erections, have been previously addressed by the U.S. Food and Drug Administration (FDA).

In 2005, the FDA ordered a black-box warning label for atomoxetine (Strattera) after a short-term studies revealed an increase risk of suicidal thinking in children and adolescents.

More recently, the FDA issued a warning this past December stating that ADHD stimulants such as Ritalin and Concerta could cause prolonged and painful erections. In few cases, the erections lasted so long they required surgery.

Other adverse events reported to the FDA include:

  • Aggression
  • Insomnia
  • Anxiety
  • Tremor
  • Suicide attempt
  • Completed suicide
  • Overdose
  • Hallucination
  • Depression
  • Hypertension
  • Chest pain
  • Mood swings


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