In May of 2012, a study published in the New England Journal of Medicine warned of a potential risk of heart failure associated with taking the popular antibiotic Zithromax. The study claimed that people who take Zithromax were twice as likely to die of a heart attack or sudden cardiac event, than those people who take Amoxicillin.
Zithromax, commonly known as Z-Pack, has been prescribed for the past 20 years. It has been popular among patients in part, due to the shortened duration required to take the pill to effectively eliminate a bacterial infection. Needless to say, its popularity has generated huge profits for its manufacturer Pfizer. In 2011 alone, Zithromax reportedly generated sales in excess of $450 million dollars.
The FDA was admittedly aware of the study published in May 2012 in the New England Journal of Medicine and has been "investigating" ever since. Now almost one full year later, the FDA has issued a warning about heart related risks associated with taking Zithromax, similar to those set forth in the study published in May 2012. In addition, the FDA has required a label change for Zithromax, to include a specific warning of heart related risks. Although many related lawsuits have already been commenced regarding Zithromax, the recent FDA warning has effectively opened the litigation flood gates against Pfizer.
But more than Pfizer's imminent legal nightmare, the warning issued by the FDA raises some other serious questions. If there are such heart risks associated with taking Zithromax, then why did it take 20 years and an independent study for the FDA to become aware of them? Why wasn't a more extensive study that would have produced these findings, conducted prior to the FDA approving this drug for sale to the very public it is designed to protect? Is there a history of the FDA and Pfizer having "shared employees"? Why, now that the FDA has come to believe there are serious heart risks associated with Zithromax, did it merely issue a warning and a label change instead of taking the drug off the market?
Perhaps the answer to these questions and many others, will be revealed in the litigation that is destined to follow. Our legal system, as imperfect as it may be, strives to achieve equity and accountability. Perhaps the time has come to hold the agency responsible for safeguarding the food and drug health of Americans, to a higher standard of care.
Long Island Lawyer
Paul A. Lauto, Esq.