New York, New York (PRWEB) July 11, 2012
Public Health Watchdog, a media outlet created to protect and warn consumers about the dangers of defective products, is warning consumers about the false and misleading statements that have been made in Pfizer’s Zithromax brochure. According to the U.S. Food and Drug Administration (FDA), Pfizer’s brochure misrepresents the antibiotic by overstating the benefits and minimizing the risks.
In a letter issued to Pfizer Vice President Brian E. Harvey, the FDA says that the company’s brochure has violated the Federal Food, Drug, and Cosmetic Act in several ways. The agency stated that the promotional materials were “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.”
For example, the brochure does not address the possibility of QT prolongation, a heart condition that can lead to cardiac complications such as arrhythmia and torsades de pointes. According to the FDA letter, the pamphlet also “minimizes the risks associated with Zmax by failing to disclose that severe and fatal allergic skin reactions have been observed with azithromycin.”
Pfizer’s brochure also violated regulations by claiming that Zmax is suitable for children because it is supposedly easy on the stomach, recommending that the antibiotic be taken without food. But the FDA pointed out that there are no studies to directly support this notion. The assertion also appears to be at odds with the prescribing information, which cites vomiting, diarrhea, loose stools and abdominal pain as the most commonly reported side effects in pediatric population.
According to the FDA, the brochure is misleading in both content and appearance. The agency says that the brochure overstates Zmax’s efficacy by presenting its benefits in “large bolded font size and in colorful text and graphics” against a vast white background. Meanwhile, “the risk information is placed in obscure locations, in block paragraph format, without the use of headers or other signals to alert readers to its significance.”
These examples are just some of the numerous violations cited by the FDA. Among other things, the agency has also reprimanded Pfizer’s brochure for suggesting that it is effective for unapproved uses and for making unsupported claims that were based on telephone surveys. In ordering Pfizer to stop distributing the materials, the FDA ordered the company to “immediately cease the dissemination of violative promotional materials for Zmax.”
In May, the New England Journal of Medicine published a study showing that Zithromax is associated with an increased risk of sudden death. By analyzing data from hundreds of thousands of patients, researchers linked Zithromax to an “increase in cardiovascular deaths” when compared to amoxicillin, ciprofloxacin, or no drug. Patients with a history of cardiovascular disease appear to have the highest risk. In response to these findings, the FDA is conducting a safety review of the drug and reminds physicians to “be aware of the potential for QT interval prolongation and heart arrhythmias” when prescribing the antibiotic.
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