FDA Warning Letter Calls Zithromax Zmax Brochure False & Misleading

By Sarah Pierce

 

The U.S. Food and Drug Administration has sent Pfizer, Inc. a warning letter over "false and misleading" statements made in a brochure advertising the antibiotic Zmax -- a single dose version of its controversial drug Zithromax (known generically as azithromycin and popularly as Z-Pak). The warning letter was sent right before the agency announced it is reviewing Zithromax heart attack risks in light of hundreds of Zithromax lawsuits and numerous Zithromax class action lawsuits filed by users who were injured from Z-Pak side effects such as heart problems, liver damage, eye infections, and more. The announcement came after a study revealed that Zithromax/Zpak/azithromycin users are twice as likely to die from a heart attack or sudden cardiac event compared to those on the antibiotic amoxicillin.

 

According to the FDA warning letter, promotional materials for Zmax omit the risk of QT prolongation associated with Zmax use -- which is the heart's recovery period between beats. People with a prolonged QT interval are at risk for severe, life-threatening cardiac arrhythmias. The FDA also said the Zmax brochure minimizes the risks of fatal allergic and skin reactions, as well as made unsubstantiated claims about the drug's superiority. Zithromax side effects such as these have been the subject of numerous Zithromax lawsuits and Z-Pak lawsuits.

 

FDA Says Pfizer Downplayed Zmax Side Effects

 

According to the FDA Zmax warning letter, Pfizer's "1 Day. 1 Dose" Brochure for Zmax (azithromycin extended release) "is false or misleading because it omits and minimizes important risk information, makes unsubstantiated superiority claims, omits material facts, broadens the indication for the drug product, makes misleading efficacy claims, and makes unsubstantiated claims for Zmax."

 

The FDA concluded that the brochures misbrand Zmax in violation of the Federal Food, Drug and Cosmetic Act by failing to prominently display Zmax risk information while highlighting its efficacy claims. This presentation "undermines the communication of important risk information, minimizing the risks associated with Zmax, and misleadingly suggests that Zmax is after than has been demonstrated," the FDA said.

 

The FDA also said it was not aware of any well-controlled studies comparing Zmax to other antibiotics that would support the brochure's claim about the drug's superiority. The brochure also implied that Zmax would be easier on a child's stomach, when in fact the most common adverse reaction in children was vomiting, diarrhea, loose stools, and abdominal pain, the FDA said. The agency called this claim "misleading" and "particularly concerning."

 

Pfizer was asked to immediately discontinue promotional materials containing the problems cited in the Zmax warning letter.

 

Zithromax Side Effects Lead to Lawsuits 

 

A May 2012 Zithromax study published in the New England Journal of Medicine found that patients using the 5-day course of Z-Pak/Zithromax/azithromycin were twice as likely to die from a heart attack or sudden cardiac event compared to those on the antibiotic amoxicillin. The highest risks for Z-Pak death were in patients with existing heart problems. According to the FDA, azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects, including a type of abnormal heart rhythm that can be fatal. The agency warned physicians to be aware of the potential heart arrhythmias when prescribing Zithromax, and that it is in the process of updating risk information on Z-Pak drug labels.

 

This may be too little too late for many Z-Pak users who have already suffered serious Z-Pak side effects such as heart attack, liver failure, Stevens-Johnson Syndrome, Trachoma/eye infections/blindness, Toxic Epidermal Necrolysis, or other cardiovascular problems after taking Zithromax.

 

If you or a loved one has been injured by Zithromax, Z-Pak, Zmax or azithromycin, you should speak with a Zithromax compensation consultant who can provide a free consultation to determine if you have a case. This may include filing an individual Zithromax injury lawsuit, individual Z-Pak injury lawsuit, or a Zithromax class action lawsuit. A Z-Pak attorney will help you determine what's best for you and your family.

 

If you would like more information about filing a Z-Pak class action lawsuit or would like to file an individual Z-Pak lawsuit, just go to the Zithromax, Z-Pak, Azithromycin Class Action Lawsuit Investigation page. You can submit your information, or your loved one's, to Zithromax attorneys who are actively investigating all claims regarding Zithromax heart attacks, Stevens-Johnson Syndrome, liver failure, Trachoma, Toxic Epidermal Necrolysis, and other cardiovascular problems. Z-Pak attorneys are waiting to talk to you now and the consultation is free. These lawyers don't get paid unless you win or settle.

 

Updated July 16th, 2012

All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.

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