FDA issues advisory for ADHD drug

A black-box warning results from reports of suicidal thinking among a small number of children who took the medication.

By Stephanie Stapleton — Posted Oct. 17, 2005

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

The Food and Drug Administration issued a public health advisory Sept. 29 regarding Strattera (atomoxetine), a medication for attention-deficit/hyperactivity disorder, to alert physicians about reports of suicidal thinking associated with this drug among children and adolescents.

Strattera, on the market since 2002 and used by more than 2 million patients, is currently approved to treat ADHD in children, adolescents and adults. It has not been studied in those younger than 6.

The FDA is advising physicians to closely monitor children and adolescents being treated with this drug, especially during the initial months of therapy when the dosage is often increased or decreased. Warning signs to watch for are clinical worsening, agitation, irritability, suicidal thinking and unusual changes in behavior.

Additionally, the agency directed manufacturer Eli Lilly to revise the drug's labeling to include a boxed warning. The company, according to a statement, is working with the FDA to finalize this content. It will also work with the agency to develop a medication guide for patients and caregivers.

"Lilly's top priority is to help doctors, patients and their families make informed treatment decisions, so we are reaching out extensively to educate physicians and the public about this product label change," said Alan Breier, MD, vice president and chief medical officer at Lilly, in a statement. Also important, he added, "is that Lilly continues to view Strattera as a safe and effective treatment option."

As part of a larger evaluation of psychiatric drugs and suicidal tendencies, the FDA requested that Lilly conduct a review of its database and clinical trials -- 1,357 patients receiving Strattera and 851 on placebo. The analysis showed that 0.4% of children treated with Strattera -- a small but statistically significant amount -- reported suicidal thinking compared with no cases from the placebo group. There was one suicide attempt by a patient taking the medication. But no indication of an increased risk in the adult population has been shown.

Back to top

External links

The Food and Drug Administration alert regarding atomoxetine (link)

Eli Lilly's update to Strattera's label (link)

Back to top



Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story

Read story


American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story

Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story

Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story

Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story

Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story

Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story

Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn