According to a report from SFGate.com, the U.S. Food and Drug Administration (FDA) has issued a warning to drug manufacturer, Pfizer due to its Zithromax brochure overstating the benefits and minimizing the risks of this antibiotic.
The benefits being reported in the brochure are not substantiated. Additionally, risks of taking the medication haven’t been included.
One of the severe risks not addressed in the brochure is a heart condition called QT prolongation, a serious cardiac complication. Additionally, allergic skin reactions have been linked to the drug, with some effects being severe or even fatal.
There is no evidence to support claims that it is safe for children to take without food. The company has also indicated it’s appropriate for other uses that have not been approved.
The FDA has ordered Pfizer to stop distribution of the brochure. This comes on the heels of a recent study in May that indicated Zithromax had been linked to an increased risk of sudden death. Those who have heart problems appeared to have the highest risk.
Meanwhile, a safety review of the drug is being conducted. Doctors have been informed to take the potential side effects into consideration when prescribing this antibiotic.
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