Attention Drug to Get New Warning

Strattera, a drug used to treat attention-deficit (hyperactivity) disorder, is getting an updated warning label to highlight the risk that it might contribute to severe liver problems in some patients, the government said Friday.

The new warning says the medication should be discontinued in patients who develop jaundice or show laboratory evidence of liver injury.

“The labeling warns that severe liver injury may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients,” the Food and Drug Administration said.

The updated labeling follows reports of liver problems in an adult and a teenager who had been treated with Strattera for several months. Both recovered, the FDA said, offering no details.

Strattera has been dispensed to more than 2 million patients since it went on the market in 2002. No signs of liver problems were seen in the drug’s clinical trials, which involved 6,000 patients, the FDA said.

Eli Lilly & Co., the manufacturer, agreed to send doctors a letter alerting them to the risk, the FDA said. It also agreed to update an insert for patients in the drug package and to add a boldface warning to the label. The company confirmed Friday that it was taking those actions.

Strattera is among a new generation of attention-deficit drugs that require only a morning dose, a boon in schools where kids have had to take afternoon doses of their medications. Normally, the main side effects are reduced appetite and slower growth.

The FDA said the package insert explained some of the signs of possible liver problems, including jaundice, dark urine, unexplained flu-like symptoms, upper right-side abdominal tenderness and a form of itchy skin known as pruritus.