Parker Waichman LLP

FDA Black Box Warning for Ritalin and Other ADHD Drugs

ADHD Drugs Black Box Warning. In what many experts are viewing as an unusual turn of events, an FDA advisory panel has voted to recommend that the agency order the inclusion of the most serious “black box” warning on all stimulant ADHD medications due to evidence of a potential risk of heart attacks, strokes, and […]

ADHD Drugs Black Box Warning. In what many experts are viewing as an unusual turn of events, an FDA advisory panel has voted to recommend that the agency order the inclusion of the most serious “black box” warning on all stimulant ADHD medications due to evidence of a potential risk of heart attacks, strokes, and sudden death. The drugs include amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin, and Metadate.

What makes this action (by an 8-7-1) vote surprising to critics of what they see as an influence-riddled agency beholden to the pharmaceutical industry and a system that “rubber stamps” the fully-expected recommendations of supposedly independent panels is that the FDA is now faced with a vote that is clearly against the best interests of the drug companies.

Thus, rather than having a “safe” vote that the agency can simply endorse as its position on a drug, the FDA is already expressing its view of the vote in terms that strongly suggest it may not adopt the panel’s carefully considered recommendation. This has done little more than throw fuel on an already blazing fire.

ADHD drugs may be lined to as many as 25 deaths

The panel also voted 15-0-1 to recommend that the FDA require that the drugs include a medication guide for patients and parents. All of this controversy was prompted by data that showed that widely prescribed ADHD drugs like Ritalin may be lined to as many as 25 deaths that occurred between 1999 and 2003. Of these deaths, 19 involved children. In addition, the FDA was advised of 54 cases involving serious cardiovascular problems like heart attacks, strokes, hypertension, heart palpitations and arrhythmias in both adults and children taking these medications.

There is also the open issue of another 26 deaths between 1969 and 2003 in medicated ADHD patients involving suicide, intentional overdose, drowning, heat stroke, and underlying diseases.

The panel’s vote also caught the FDA off guard because the committee was convened to advise the agency  on how to design studies to assess possible risks associated with stimulant ADHD medications.

During the meeting, however, talk soon turned to the over-prescribing of these drugs and the public as well as many doctors were unaware of these serious potential risks. The panel then agreed to consider the enhanced-warning issue that was outside of its planned agenda.

In attempting to lay the foundation for ignoring the panel’s vote, officials said they would be reluctant to require a black box warning based on a “theoretical risk.”

Such warnings could unreasonably deter patients and doctors from using a drug that could benefit them, said Robert Temple, MD, director of medical policy at the FDA’s Center for Drug Evaluation and Research. He stated: “The absence of bona fide problems in your hand pushes against the box. We will also, frankly, worry about the possibility that overstatement can do active harm.”

Thus, Temple indicated the full FDA would wait for the recommendation a pediatric advisory committee scheduled for March before reaching any decision with respect to new warnings. That panel, which is made up of pediatricians and psychiatrists, is considered more likely to look favorably on the benefits of ADHD drug treatment as outweighing the potential risks.

Need Legal Help Regarding ADHD Drugs?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
First time with working with parker waichman. Excellent staff will recommend to my friends and family.
Benny G.
2 months ago
5 Star Reviews 150
Jamie Sussman
6 years ago
5 Star Reviews 150
Very good firm specially if you get helped by Frank Domado !!!
P “Ghost” O
a year ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038