F.D.A. Confirms Widespread Shortages of Adderall and Its Analogues from June 2017 through April 2018
The Food and Drug Administration (F.D.A.) approves three new drugs for the treatment of a specific type of attention deficit/hyperactivity disorder, after a comprehensive review of safety and effectiveness.
The agency announced Friday that it’s found no conclusive evidence that the two previously approved drugs, Concerta and Adderall Xtreme, are associated with any increased risk of harm, and added that the two drugs’ effects are very similar. The new drugs are approved for the treatment of adults with ADHD aged 8 to <18 years who can’t tolerate stimulant medication.
The approval of the new drugs brings the total number of approved ADHD drugs for both children and adults to 391. For children, the drugs approved are Concerta XR (the new version of a previously approved drug, Concerta), Adderall XR, and Adderall XR with extended release. Adults can take the drugs, but must be on a combination of medications that include at least one ADHD medication.
The FDA approved the new ADHD drugs on a vote of 4 to 1, and said that their labeling would include updated information on their side effects and their interactions with drugs used to treat other medical conditions, including heart disease, diabetes and obesity.
Adderall XR and Adderall XR with extended release were previously approved for the treatment of adult ADHD patients ages 12 and older.
The drug label will be updated to include warnings on the possibility of a dangerous adverse event, including respiratory depression — a state of temporary impairment of a person’s ability to breathe, with potentially fatal consequences. That’s a potential side effect of the new drugs.
The FDA also said that the new drugs have been shown to significantly improve ADHD symptoms in adult patients when used with the most common treatment medication, methylphenidate hydrochloride, when the drugs are used concurrently.
Drug manufacturers must submit a new drug application to FDA for approval of a new drug. The application