By Sarah Mirando  |  February 4, 2013

Category: Pharmaceuticals
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FDA Warning Could Bolster Zithromax Lawsuits

By Andrea Gressman

 

Zithromax FDA warningIt has been previously reported that the U.S. Food and Drug Administration (FDA) sent a warning letter to Pfizer Inc. over “false or misleading” statements it used in a brochure to advertise the antibiotic Zithromax, also referred to as Z-Pak or azithromycin. The FDA stated that the brochure made unsupported claims about what benefits Zithromax provides and did not include important side effect risk information.

According to the FDA, Pfizer misrepresented the effect Zithromax can have on a patient. The agency also addressed the following problems in the brochure:

  • Minimizes important side effect risk information
  • Makes claims that are unsubstantiated and claim superiority over other antibiotics
  • Does not include important facts
  • Expands the indications for the antibiotic
  • Makes claims that are misleading regarding efficiency
  • Makes claims that are unsubstantiated claims for Z-Pak


The FDA concluded that the advertisements have misbranded Zithromax and Z-Pak in violation of the Federal Food, Drug, and Cosmetic Act. Zithromax received its approval from the FDA as a treatment option for bacterial infections that have been classified as mild to moderate and can cause acute bacterial sinusitis. Zithromax was also approved by the FDA as a treatment option for community-acquired pneumonia.

The FDA expressed concerns because the Zithromax brochure “omits the important risk of QT prolongation” that has been linked to Zithromax and Z-Pak use.  The QT interval is the recovery period between the heart beat and if the patients that suffer from prolonged QT intervals have the side effect risk of very serious cardiac arrhythmias that can be fatal.

The brochure also minimizes the side effect risk of the patient developing life-threatening allergic reactions such as Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) that Zithromax has previously been linked to causing.

As a part of the FDA’s warning level the agency has requested that Pfizer stop using the promotional material they have identified as false and misleading for Zithromax and Z-Pak.

Many Zithromax Patients Experience Side Effects without Proper Warning

There have been a number of patients that have experienced serious side effects after taking Zithromax. Many of them have filed Zithromax lawsuits. The statements that the FDA made regarding the misleading and false statements of the Zithromax brochure have certainly added to the credibility of the Zithromax lawsuits.

Do You Have a Zithromax Lawsuit?

If you or a loved one that took Zithromax, Z-Pak, or azithromycin and experienced negative side effects, you may be able to file a Zithromax lawsuit. Visit the Zithromax Class Action Lawsuit Settlement Investigation page right away. Provide your information and you will receive a free legal review from a qualified Zithromax lawsuit lawyer.

 

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Updated February 4th, 2013

 

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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