FDA Panel Recommends Against Strongest Warnings for ADHD Drugs

The FDA’s advisory panel’s decision was reported by PsycPort: “Instead of having the ‘black-box’ warnings, the drug labels should caution users about possible dangers in plain language that they can understand”. According to the article:

In February, the FDA’s Drug Safety and Risk Management advisory committee voted to recommend the agency add the strongest possible warning to some of the drugs regarding their potential cardiovascular risk.

The FDA then asked the pediatric panel to examine that same issue, as well as reports that psychosis or mania can occur in some juvenile patients at normal doses of any ADHD drug.

Adding black-box warnings to some or all the drugs, which also include Adderall and Strattera, could cause more harm than good, some experts told the panel.

“I suggest confusion, polarizing viewpoints, initial press hysteria. But then what?” said Julie Zito, a University of Maryland associate professor in pharmacy and psychiatry.

The FDA has struggled since last year with the question of how to communicate the potential risks associated with ADHD drugs. It now appears likely the warnings will come in the form of highlighted language on drug labels, as well as guides distributed to patients.

Psychiatrists and mental health advocates said leaving the disease untreated could rival the risks the drugs may pose.

“It is important to not let the discussion of ADHD medications overshadow the public health crisis of untreated mental health disorders in children,” said Cynthia Wainscott of the National Mental Health Association. Her 16-year-old granddaughter has ADHD.

Rate this post?

(No Ratings Yet)

 Loading ...