Zithromax lawyers at Pintas & Mullins report that labels for popular antibiotic Zithromax, commonly referred to as Z-Pack or Zmax, will soon change to include new warnings about the possibility of experiencing deadly heart rhythms. This change proceeds similar label changes in Canada.
The new warning labels in the U.S. will include information from an exhaustive study conducted by researchers at Vanderbilt University that focused on this drug, which is one of the most widely prescribed antibiotics in the country.
In their 14-year study, Vanderbilt researchers examined health records and data on millions of antibiotic prescriptions given to about 540,000 patients in Tennessee. Among those patients, nearly 30 died from heart-related events during the five-day antibiotic treatment, all of whom had taken Zithromax. By the end of the study in 2006, Zithromax patients were more than twice as likely die from cardiac events than those who took a different antibiotic, amoxicillin, or who took none at all.
Using this data, researchers calculated that the number of deaths per 1 million antibiotic patients would be about 85 for those who took Zithromax (versus 32 among those taking amoxicillin and 30 who took nothing). That is 47 extra deaths per million compared to amoxicillin.
The immense popularity of Zithromax, and perhaps the reason for its heightened dangers, is due to its shortened dose time. Typical antibiotic treatments, such as amoxicillin, take about ten days to complete, whereas Zithromax takes five. This also enables the manufacturer, Pfizer, to charge an extra few dollars per pill. In 2012, total sales of the drug reached about $464 million. In response to the Vanderbilt study, Pfizer affirmed that it would thoroughly review the data and continue to monitor the safety and efficacy of Zithromax.
The FDA issued its first warning about Zithromax in May 2012, and updated that warning in March of 2013. The most recent health alert is reportedly the result of a study conducted by Pfizer, although the FDA's statement does not mention Pfizer nor cite the study.
It was affirmed that Pfizer and the FDA updated Zithromax's labels in collaboration, as the new labels regard information on specific heart rhythm abnormalities. Pfizer was quick to note that these cardiac events were most common in patients with risk factors such as QT interval prolongation, low levels of potassium or magnesium, slow heart rates, and who use certain drugs to treat arrhythmias.
Zithromax is also associated with a rare but very serious adverse reaction known as Stevens-Johnson Syndrome (SJS). Our attorneys have written extensively on this condition, which is often caused by NSAIDs, such as Motrin, and sulfa-based antibiotics, such as ciprofloxacin.
SJS is a horrific skin reaction that causes large parts of the skin to slough off, along with affecting the eyes, throat and lungs. Patients who experience this often have to be medically induced and spend months at a time in hospital burn units. The reaction sometimes causes patients suffer from permanent, life-changing side effects from SJS development, such as blindness, decreased lung capacity, and inability to eat or drink.
In 2007 one family was awarded $63 million in compensatory damages after their daughter, who was only seven at the time, took Children's Motrin and experienced an SJS reaction. The little girl lost about 90% of her skin from the drugs, and was permanently blinded. The SJS spread to her lungs, brain and other internal organs, causing them to swell and forcing doctors to place her in a medically-induced coma.
A Zithromax patient, Katie Niemeyer, shares a similar story with that little girl. Niemeyer was prescribed Zithromax for strep throat, however she quickly developed painful ulcers on her skin, which were identified as the beginning manifestations of SJS. Over the next few weeks her body was ravaged with blisters and she was forced to stay in the burn unit of Barnes Hospital in St. Louis for several weeks for treatment.
Zithromax lawyers at Pintas & Mullins are currently investigating cases involving Zithromax heart attacks and SJS development. If you or a loved one was seriously injured by a defective or dangerous drug, you have important legal rights, and may be entitled to significant compensation through a lawsuit against the manufacturer.