JÄLLEEN VAROITUS YHDESTÄ LÄÄKKEESTÄ

[Bb]

Lähettäjä: Soijuv Lähetetty: 20.12.2004 17:52

Strattera-niminen lääke jota käytetään sekä lapsille että aikuisille esim. ADHD:n oireisiin, saattaa aiheuttaa joillekin vakavia maksavaurioita:


Lilly Warns Doctors About Strattera

By LEILA ABBOUD
Staff Reporter of THE WALL STREET JOURNAL
December 17, 2004 6:09 p.m.

Drug maker Eli Lilly & Co. warned that Strattera, its new drug taken by children and adults with attention-deficit/hyperactivity disorder, causes serious liver side effects in a small number of patients.

Lilly has put a warning in bold print on the drug's label and will also send a letter to doctors informing them of the side effect.

Strattera was launched in January 2003, and has the potential to be a blockbuster for Lilly.

The company received reports about two patients who developed the liver problems. Both reports were submitted to the Food and Drug Administration as required by law. After examining the two cases, Lilly and the FDA agreed to add the label warning.

The first case involved a 14 year-old boy who developed persistent symptoms of the flu after being on the appropriate dose of Strattera for about four months. Blood tests done by the boy's physician showed that his liver wasn't functioning properly.

He immediately stopped taking the drug, and recovered in several weeks without major liver damage. But the boy went back on Strattera in April because it seemed to alleviate his ADHD better than other drugs he had tried. A month later, he had to be hospitalized because he developed jaundice, another serious liver problem. His condition improved after he was taken off the drug.

Such a scenario, when a person develops a side effect again after going back on the drug, raises immediate red flags and increases the likelihood that the problem was caused by the drug.

A second case involving a 31-year-old woman surfaced in early December. She developed flu symptoms and jaundice after being on Strattera for a month, but recovered after stopping the drug.

The liver side effect wasn't picked up in the 6,000 patients in the clinical trials that Lilly conducted before approval. Side effects often crop up only after millions of people start using a drug. Lilly estimates that about two million people have used Strattera.

Strattera's main competitors are Johnson & Johnson's Concerta and Shire Pharmaceuticals Group's Adderall. Strattera had $483.3 million in sales in the first three quarters of this year. Lehman Brothers analyst Anthony Butler forecasts Strattera sales of $770 million next year. Lilly doesn't provide forecasts.

Since Strattera is the only ADHD drug approved for both children and adults, Lilly plans a marketing push for next year focused on adults. The effort will include new television advertisements and would increase promotional visits by drug salesmen to family doctors.

Unlike most other drugs for ADHD, Strattera isn't a stimulant, so it can be sold and advertised more freely than its competitors. By law, patients who take stimulants must get a new prescription from their doctor each month and can't pick up refills from the pharmacy. However, Strattera does take longer than the competing drugs to start working.