Federal drug regulators have announced that new warnings will be added to Attention Deficit and Hyperactivity Disorder (ADHD) medications, such as Adderall, Concerta, Daytrana and Ritalin, indicating that the drugs may cause a severe form of muscle injury and kidney damage, known as rhabdomyolysis.
On May 13, the FDA Center for Drug Evaluation and Research approved safety labeling changes for ADHD drugs, to add rhabdomyolysis to the list of possible adverse reactions that may be caused by amphetamine-based medications. The warning comes as the drugs continue to be prescribed to children at increased rates.
Rhabdomyolysis is a side effect associated with several different types of medications, which causes muscle fibers to begin to break down, releasing a protein called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream.
Symptoms of rhabdomyolysis include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism, however these drugs are prescribed heavily to children and young adults. Over time, rhabdomyolysis can lead to kidney damage and even kidney failure. Some may require dialysis or a kidney transplant.
The list of drugs that must now carry the rhabdomyolysis warning includes Adderall, Adderall XR, Concerta, Daytana, Desoxyn, Dexedrine, Focalin, Focalin XR, metadate CD, Methylin, Quillivant XR, Ritalin, Ritalin LA, Ritalin SR, Strattera and Vyvanse.
Concerns About ADHD Drug Overuse
The new FDA label warnings comes amid increasing concerns over the perceived overprescribing of ADHD drugs and their potential health risks.
In April, the U.S. Centers for Disease Control and Prevention (CDC) released the first national study on the treatment of ADHD in children. The CDC found that 40% of children diagnosed with ADHD were being treated with medication, compared to only 10% receiving therapy alone and only 30% receiving a combination of therapy and drug treatment. About 10% received no treatment at all while another 10% were treated with dietary supplements alone.
Another study, published in July 2014 by Danish researchers, found that children taking Ritalin, Dexedrine, Concerta and other amphetamines for ADHD showed increased rates of hypertension, heart disease, and arrhythmias, among other heart problems. Their findings indicated a dose-specific response between ADHD drug use and cardiovascular problems.
About 15% of all high school-age children in the United States have been diagnosed with ADHD, but some experts say that number should be closer to 5%.
One early advocate of stimulate treatment for children with ADHD, Dr. Keith Conners of Duke University, said that the rate of children now being diagnosed with ADHD and placed on drug treatments is “preposterous” and called ADHD an epidemic manufactured by drug companies.
Conners and others say that the inflated diagnoses and prescriptions are the result of a 20 year effort by the pharmaceutical industry to cash in on concerned parents hoping that poor grades and typical childhood behavior can be cured with drugs.
While some manufacturers paid off doctors to speak on their drugs behalf, others have gone as far as releasing comic books encouraging children to take medication to address ADHD. At some point since 2000, Conners noted that the FDA has cited every major ADHD drug manufacturer for false and misleading advertising about their ADHD drugs.
Those efforts led to $9 billion in sales for the ADHD drug industry in 2012, and 3.5 million children using ADHD medications.