J&J Halts Study of Doribax Antibiotic on Higher Death Rate
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.
“The bottom line is Doribax is safe and effective when used according to its approved label,” Mickus said in a telephone interview.
Patients receiving Doribax in the trial died 21.5 percent of the time, compared with 14.8 percent for a control group using different drugs, according to the FDA statement. Doribax patients were cured of pneumonia between 45.6 and 49.1 percent of the time, compared with 56.8 percent to 66.1 percent for the control group, the agency said.
Johnson & Johnson doesn’t release sales figures for Doribax, Mickus said.
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