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FDA says Zithromax can cause fatal irregular heart rhythm

admin » 12 March 2013 » In Defective Products, FDA, Mass Tort » 10 Comments

zithromax

FDA says Zithromax can cause fatal irregular heart rhythm

The Food and Drug Administration warned on Tuesday that the antibiotic azithromycin, sold as Zithromax, can cause a potentially fatal irregular heart rhythm in some patients.

A study in the New England Journal of Medicine last May compared the risk of cardiovascular death from different antibacterial drugs and found that the drug, which is made by Pfizer Inc and is also sold by generic drugmakers, had a higher rate of death.

In its warning, the FDA said the drug can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal heart rhythm known as prolonged QT interval, in which the timing of the heart’s contractions becomes irregular.

The FDA said doctors should use caution when giving the popular antibiotic to patients known to have this condition or who have certain risk factors. Those who may be at risk include people with low levels of potassium or magnesium, a slower than normal heart rate, or people who take certain drugs used to treat abnormal heart rhythms, or arrhythmias. The drug could also cause problems in people with torsades de pointes, a specific, rare heart rhythm abnormality.

However, the FDA noted that other drugs in the same class as azithromycin known as macrolides also have the potential for causing QT prolongation, as do non-macrolide antibiotics, such as fluoroquinolones, and doctors need to consider all of these risks when choosing an antibiotic.
Pfizer officials were not immediately available for comment.

Shares of Pfizer were down 0.5 percent at $28.10 on Tuesday morning on the New York Stock Exchange.

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J&J Must Pay $8.3 Million Over Defective Hip, Jury Says

admin » 08 March 2013 » In Defective Products, Legal News » No Comments

Johnson & Johnson (JNJ)’s DePuy unit defectively designed a metal-on-metal hip implant, a California jury decided in the first of 10,750 lawsuits over the device to go to trial.
The Los Angeles jury awarded a total of $8.3 million in damages to Loren “Bill” Kransky, a retired Montana prison guard who alleged DePuy’s design of its ASR hip caused his injuries. Jurors said J&J was negligent even though the company properly warned of the risks, and didn’t owe punitive damages.

J&J, the world’s largest seller of health-care products, recalled 93,000 of the implants in August 2010, when it said 12 percent failed within five years. Last year, 44 percent failed in Australia within seven years. Analysts say the lawsuits could cost J&J billions of dollars to resolve.

“This is not an imperfect hip, this is a public health disaster,” Kransky’s attorney Michael Kelly said in closing arguments on Feb. 28. “Somebody needs to tell them, ‘Don’t make Bill Kransky come to court. Build these things right. Don’t let this happen again.’”

Patients such as Kransky complain in lawsuits of dislocations, pain, and follow-up surgeries known as revisions. Kransky’s lawyers argued that DePuy failed to test the device adequately before selling it in the U.S. in 2005, buried surgeon complaints of mounting failures, and studied a redesign of the ASR before scrapping that effort in 2008.
Medical Expenses
Kransky’s lawyer Brian Panish had asked for compensatory damages of $5.3 million and punitive damages of as much as $179 million. The jury’s verdict, which came on the sixth day of deliberations, included $338,136 in damages for medical expenses and $8 million for physical pain and emotional suffering.

“This is the first day of reckoning for DePuy,” Panish said after the verdict. “We’ve learned a lot from this trial. We’ll get punitive damages in the next trial.”

One juror, David Vega, said after the verdict that “I wanted punitive damages” based on the evidence that DePuy found the problem and took so long to resolve it.

J&J, based in New Brunswick, New Jersey, says the ASR isn’t defective and the company adequately warned doctors of the risk of injury.

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