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January 06, 2012

J&J Halts Study of Doribax Antibiotic on Higher Death Rate

Quoted from http://www.bloomberg.com/news/2012-01-05/j-j-halts-study-of-doribax-antibiotic-on-higher-death-rate.html

 

J&J Halts Study of Doribax Antibiotic on Higher Death Rate

By Alex Nussbaum - Jan 5, 2012 5:21 PM ET

Johnson & Johnson (JNJ) halted a clinical trial of its antibiotic Doribax after more pneumonia patients who took the product died and fewer were cured, regulators said.

Doribax, already approved for urinary and abdominal infections in the U.S., is still considered safe and effective for those uses, the Food and Drug Administration said today in a statement on its website. The trial tested the drug in pneumonia patients who were on ventilators, an indication for which it’s approved in Europe.

J&J, the world’s second-biggest seller of health-care products, stopped the study of 274 people in May on the advice of an independent monitoring committee, said Shaun Mickus, a company spokesman. He declined to say why Doribax failed and said the New Brunswick, New Jersey-based company isn’t changing its advice for doctors or patients.

[Article continues at original source]

Posted at 08:09 AM in Doribax |

Tags: antibiotic, clinical trial, death rate, Doribax, drug injury, FDA, Johnson & Johnson, side effects

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