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Baum Hedlund attorneys have been handling drug injury and death cases since the late 1980s. Baum Hedlund has experience litigating many cases against Eli Lilly as we represented Prozac suicide victims from 1990-2000.

Public Health Advisory

Atomoxetine (marketed as STRATTERA)

FDA Alert [09/05]: Suicidal Thinking in Children and Adolescents

The Food and Drug Administration (FDA) directed Eli Lilly (Lilly) to revise the labeling for Strattera to include a boxed warning and additional warning statements regarding an increased risk of suicidal thinking in children and adolescents being treated with this drug. In addition, a Medication Guide will be prepared to provide directly to patients, their families, and caregivers information about the risks mentioned above. The Medication Guide is intended to be distributed by the pharmacist with each prescription or refill of a medication.

Strattera is currently approved in the United States to treat ADHD in children, adolescents, and adults. Strattera has not been studied in children under 6 years of age.

On Thursday, September 29, 2005, the Food and Drug Administration (FDA) issued a warning to the public about suicide risk associated with Strattera. Strattera, manufactured by Eli Lilly, is prescribed in cases of attention deficit hyperactivity disorder (ADHD). Strattera (atomoxetine HCl), is a selective norepinephrine reuptake inhibitor (SNRI) approved for the treatment of attention-deficit/hyperactivity disorder.

Concerns about a suicide-related side effect of Strattera emerged more than a year prior to the warning issued. In the journal Pediatrics (PEDIATRICS Vol. 114 No. 3 September 2004, pp. 895-896) physicians documented that within a pool of 153 patients (10.5 ± 3.74 years old) treated with atomoxetine in outpatient settings in Denver, Colorado, and North Branch, Minnesota extreme irritability, aggression, mania, or hypomania induction were observed in 51 cases (33%).

According to the drug's label insert, the clinical trials prior to Strattera's FDA approval showed between 2% and 5% of patients experienced mood swings, with 8% experiencing irritability and another 1% who discontinued the trials due to aggression or irritability. Until the Sept 2004 study release many clinicians were anecdotally aware of increased hostility, aggression and mania exhibited by some atomoxetine patients.

Strattera's association with mood destabilization is a psychiatric side-effect the FDA has been aware of. Earlier this year the agency said it planned to add cautionary language about side effects, including aggression and suicidal thoughts, to the labels of several of the medicines, including Johnson & Johnson's Concerta, a time released form of Ritalin.

In 2004, the FDA and its European counterpart issued warnings that SSRI and SNRI antidepressants increase the risk of suicidal thoughts and behavior in children and adolescents.

Patients using psychiatric drugs should be carefully monitored for possible mood destabilization, including suicidal thoughts. The FDA warned last year that a class of antidepressants called SSRIs have been shown in clinical trials to double the risk of suicidal thinking and behavior in children and adolescents compared with those given a placebo. About 4% of patients on SSRIs experienced such symptoms, compared with 2% on dummy pills. Pfizer's Zoloft and GlaxoSmithKline's Paxil are the two most notable SSRI examples.

Strattera Side Effects

FDA is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed (either increased or decreased). Patients and caregivers who have concerns or questions about these symptoms should contact their healthcare provider.

FDA Issues Public Health Advisory on Strattera (Atomoxetine) for Attention Deficit Disorder

Lilly Announces Important Strattera® Label Update

Strattera (atomoxetine) - FDA directs Eli Lilly and Company to revise prescribing information for Strattera (atomoxetine) to include a boxed warning, additional warning statements of the risk of suicidal thinking in children and adolescents, and a Patient Medication Guide (MedGuide). (Posted 09/29/2005)

Lilly warns of drug's suicide risk

Firm says there is potential for suicide by users of attention deficit drug Strattera.

September 29, 2005

CHICAGO (Reuters) - Eli Lilly and Co. said Thursday it will add strong warnings to its label for Strattera, used to treat attention-deficit/hyperactivity disorder, including the risk of suicidal thoughts among children and adolescents.

Strattera will now carry a "black box" warning, the strongest required by U.S. regulators.

Lilly said there were no suicides among children, adolescents or adults taking the medication during Strattera clinical trials, but there was one suicide attempt by a patient using the drug.

The warning came after the Food and Drug Administration asked Lilly to submit an analysis of adverse event data from its Strattera clinical trials database, which identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents.

Lilly said it is working with the FDA to finalize the product label. It also is working with regulators outside the United States.

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