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.

Call Moll Law Group About a TEPEZZA Claim

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.

The manufacturer of Tepezza, Horizon Pharmaceuticals, has faced an increasing number of claims regarding the hearing loss complication from Tepezza injections. These lawsuits allege that side effects weren’t appropriately disclosed on the drug’s first warning labels.

Importantly, Tepezza has been linked to permanent hearing loss since the drug was in clinical trials, long before the FDA required the new warning. In the journal Endocrine Practice, a study showed that 20 (or 16%) of 121 patients reported that they suffered hearing problems such as hearing loss, hyper or hypoacusis, tinnitus, eustachian tube dysfunction, and autophony.

If you suffered hearing loss that you believe was triggered by Tepezza, you may be able to recover damages in a dangerous drug lawsuit. You can sue for damages when you are harmed by a drug that is defective in its manufacturing, marketing, or design. Failure to warn or inadequate warnings are a common type of marketing defect. It may be appropriate to pursue damages under a theory of strict liability, negligence, breach of warranty, or breach of contract.

Damages that may be recovered if we’re able to establish liability include economic damages and noneconomic damages. Economic damages may include medical expenses, lost wages, replacement services, medical equipment, and out-of-pocket costs. Noneconomic damages may include loss of enjoyment of life, mental anguish, pain and suffering, and lost earning capacity.

Contact Trusted Chicago-based Product Liability Attorneys

If you or a loved one developed hearing loss or another injury due to the vision drug, you should call the experienced Chicago-based Tepezza lawyers of Moll Law Group for a consultation to determine whether you have a viable product liability claim. Our firm fights for injured consumers and patients around the United States. Complete our online form or call us at 312.462.1700.