Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, reports that on June 19, 2012, the U.S. Food and Drug Administration (“FDA”) sent a warning letter to Pfizer, criticizing the company for downplaying or omitting serious Zmax side effects in a promotional brochure.  Pfizer manufactures the popular antibiotic Zmax, commonly known as Zithromax or Z-Pak.  According to the FDA letter, the brochure:

  • Omits and minimizes important risk information;
  • Makes unsubstantiated superiority claims;
  • Omits material facts;
  • Broadens the indication for drug use;
  • Makes misleading efficacy claims; and
  • Makes unsubstantiated claims for Zmax.

The FDA also noted that the company presented the limited risks and warnings in the brochure in a misleadingly minimizing format by placing Zithromax risks in obscure locations, in block paragraph format without headings or signifiers to bring to the attention of the reader.

Misleading Brochure Omits Possible Zmax Side Effects

Moreover, the FDA determined that the brochure fails to warn readers about the risk of Zithromax heart risks, such as QT prolongation, which may cause cardiac arrhythmia and torsades de pointes, potentially fatal heart problems.  Another Zithromax risk left out in the brochure is a serious allergic reaction called Stevens-Johnson syndrome (“SJS”).  Other misleading claims and omitted facts include the inaccurate suggestion that Zithromax is a more effective antibiotic in dosage and that the drug can treat a broader array of ailments than it is approved to treat.

The FDA has ordered Pfizer to stop distributing the Zithromax brochure and required a response from the company by July 3, 2012.  A Pfizer official stated that the company stopped using the brochure prior to receiving the FDA notice.

Zmax side effects have been the center of mounting concern after a study published in The New England Journal of Medicine on May 17, 2012 found an increased risk of sudden death from cardiac events in patients taking azithromycin, especially those already suffering from a cardiovascular condition.  At that time, the FDA announced that it would launch its own investigation into Zithromax risks and communicate its findings upon completion.  Pfizer conducted its own review of Zithromax risks on May 21, 2012.

The lawyers at Bernstein Liebhard LLP are currently investigating claims on behalf of individuals who experienced Zithromax side effects.  Individuals who experienced Zmax side effects such as heart problems may be entitled to compensation for medical expenses, pain and suffering, lost wages and other injuries.  To learn more about Zithromax lawsuits, watch this Zmax side effects video or visit our website,

About Bernstein Liebhard LLP

Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products.  The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past nine consecutive years.  Only two firms in the country have been selected for the Hot List nine years in a row.

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Published July 11, 2012 by