FDA Adds New Warnings to the Label of TEPEZZA
The Food and Drug Administration recently updated the warning label on Horizon Pharmaceutical’s TEPEZZA. The label now includes that one of the “major recent changes” for warnings and precautions is “hearing impairment including hearing loss.” Hearing loss is just one of four warnings. The others are hyperglycemia, exacerbation of preexisting inflammatory bowel disease and infusion reactions. If you suffered hearing loss or other harm, you should call the trusted Chicago-based dangerous drug lawyers of Moll Law Group. Billions have been recovered in lawsuits around the country with which we’ve been involved.
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Tepezza is a drug prescribed to improve symptoms of thyroid eye disease, which is a rare condition in which fatty tissue and muscles located behind the eye become inflamed such that the eye is pushed to the front and bulge outwards. The drug is supposed to mitigate the effects of double vision, proptosis, and chronic bulging eye. Unfortunately it is a drug that carries significant risks.
The new Tepezza warning provides that it can cause serious hearing impairment including hearing loss that could be permanent. Doctors are advised to evaluate a patient’s hearing before, during and after treatment with the drug and also weight the risks and benefits of treating a patient with the drug. The warning came a little less than a month after the Brazilian Health Regulatory Agency approved its use as a thyroid eye disease treatment.