View Full Version : New FDA Press Release on ADD Medications

02-21-07, 01:01 PM

FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events <!-- #EndEditable -->

<!-- #BeginEditable "Body of Text" --> The U.S. Food and Drug Administration (FDA) today directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.

"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER). "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns."

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:

Adderall (mixed salts of a single entity amphetamine product) Tablets
Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
Concerta (methylphenidate hydrochloride) Extended-Release Tablets
Daytrana (methylphenidate) Transdermal System
Desoxyn (methamphetamine HCl) Tablets
Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
Focalin (dexmethylphenidate hydrochloride) Tablets
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
Methylin (methylphenidate hydrochloride) Oral Solution
Methylin (methylphenidate hydrochloride) Chewable Tablets
Ritalin (methylphenidate hydrochloride) Tablets
Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
Strattera (atomoxetine HCl) Capsules
The draft Patient Medication Guides for each product can be found at For more information please visit (

02-21-07, 05:31 PM
sorry I read and saw it was and deleted it

02-21-07, 10:06 PM

U.S. health officials told manufacturers of all ADHD drugs Wednesday to develop patient medication guides warning of possible cardiovascular and psychiatric risks.
"We issued letters earlier today to manufacturers of all the ADHD products asking them to implement medication guides to alert patients and their families to certain risks that may be associated with these drugs when taken at usual doses," said Dr. Tom Laughren, director of the psychiatry products division at the Center for Drug Evaluation and Research with the U.S. Food and Drug Administration (FDA), at a Wednesday teleconference.

Experts hailed the move.

"A warning like this is important because it makes people think twice before they do this, and it stimulates more investigation," said Dr. Steven Lipshultz, chairman of the pediatrics department at the University of Miami Miller School of Medicine. "I think this is excellent and can only be beneficial."

According to the FDA, ADHD affects 3 percent to 7 percent of school-aged children and about 4 percent of adults. An estimated 2.5 million U.S. children and 1.5 million adults now take medications for the treatment of ADHD -- a field that has seen its share of controversy.

Spiraling growth in use of these medicines -- the number of adults aged 20 to 44 using ADHD drugs surged more than 139 percent from 2000 to 2005 -- has already prompted safety questions.

One drug, Strattera, is now required to carry a black-box warning that it might prompt suicidal thoughts in children. Last year, Health Canada briefly pulled another drug, Adderall, from the market because of reported cardiac risks. And in the United States, Adderall XR carries a warning that patients with heart conditions should not to use the drug.

Last year, an FDA pediatric advisory panel recommended against putting "black box" warnings about psychiatric and cardiac risks on ADHD drugs. Instead, the panel recommended that the medications use simpler language and include more information on the label.

A month before that, however, another FDA advisory committee, the Drug Safety and Risk Management Committee, reached the opposite conclusion when it called for a "black box" warning on ADHD drugs because of possible cardiac risks.

The FDA essentially followed the advice of the pediatrics committee and new warning language was incorporated into the labels by last fall.

Wednesday's action is also a result of those meetings last year.

"It has taken us longer to develop language for the medication guides, and we expect that the companies will quickly implement the new language," Laughren said. In fact, companies have 30 days to comply with the directive.

The patient medication guides address two areas of concern.

The first is cardiovascular adverse events in patients with underlying heart problems or defects along with reports of stroke and heart attack in adults with certain risk factors.

"It's possible that the events might have been caused by the underlying disease, but the advisory committees advised us to alert clinicians to the possibility that the drugs might have had a role," Laughren said.

The second area of concern involves psychiatric events, primarily psychotic symptoms such as hallucinations or delusional thinking or the emergence of manic symptoms, even in patients who have no history of psychiatric problems. The occurrence of these events is roughly one in 1,000 people treated.

Officials hope that the guides, which are given to patients at the time the drug is dispensed, will alert doctors and patients to the importance of taking a careful medical history, doing a physical exam and carefully monitoring patients for symptoms that may indicate a problem.

The medications affected by the action include Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin, Ritalin, Ritalin SR, Ritalin LA and Strattera.

Laughren emphasized, however, that ADHD drugs do provide real benefit for certain patients.

"In no way do we consider this a general prohibition against using these drugs," he said. "We view the drugs as quite safe and effective, and in no way are we trying to inhibit appropriate prescribing."

"We just want prescribers and patients to be aware of certain risks, so patients can be safely treated," he added.

02-21-07, 10:35 PM
I found a similar article on AOL this afternoon. Posted it here: