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July 12, 2012 — Pfizer has been given a warning letter from the U.S. Food and Drug Administration (FDA) over false and misleading statements in its promotional brochure for Zmax (also known as Zithromax or azithromycin).

An FDA review of the advertisement found that Pfizer over-stated the drug’s benefits but failed to include risk information, made misleading statements about the drug’s indications and efficacy, and more.

According to the FDA warning letter, Pfizer’s advertisement for Zmax contained the following violations:

  • Minimized risk and side effect information
  • Made misleading claims about the drug’s benefits and efficacy
  • Claimed superiority to other antibiotics, though there is no evidence of this
  • Omits facts
  • Implies broader indications for the drug
  • Makes unsubstantiated claims

The FDA has warned Pfizer that they are in violation of the Federal Food, Drug, and Cosmetic Act because the advertisements misbrand Zmax.

Zmax is a liquid-suspension antibiotic medicine that is approved for the treatment of community-acquired pneumonia and acute bacterial sinusitis caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

The FDA found that the “the brochure omits the important risk of QT prolongation associated with Zmax use.” This is one of the most serious side effects of Zmax. The QT interval is the recovery time between each heartbeat. When a person has a prolonged QT interval, they could develop fatal irregular heart rhythm.

In fact, in May 2012, the New England Journal of Medicine published a study regarding this danger. Zithromax was associated with a higher risk of sudden cardiac death, compared to patients treated with ciprofloxacin, amoxicillin, or no treatment. The researchers found that people who had a history of heart problems were more likely to die suddenly when given Zithromax. The FDA is currently reviewing Zithromax, and the agency has warned doctors to “be aware of the potential for QT interval prolongation and heart arrhythmias.”

Another problem the FDA found was that the brochure implied Zmax would be easier on a child’s stomach. In fact, Zmax carries a strong “Warnings and Precautions” label because gastrointestinal problems were the most common Zmax side effect in children — including diarrhea, vomiting, loose stools, and pain in the abdomen. The FDA said this misrepresentation was “particularly concerning.”

According to the FDA, drug promotional materials are “misleading” if risk information is not clear and prominent. On the Zmax ads, the promotional claims were bold, colorful, and large. However, the risk information was in small print, obscurely located, in block-paragraph format, and had no headers. When risk information is presented this way, it “undermines the communication of important risk information, minimizing the risks associated with Zmax, and misleadingly suggests that Zmax is safer than has been demonstrated.”

The Warning Letter requested that Pfizer should immediately stop distributing Zmax promotional material with the violations and notify the FDA of their corrective action.

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