Drug Injury Watch

Valtrex Associated With Serious Skin Reaction DRESS Side Effect That Can Be Fatal, Says Health Canada

Canadian Product Monograph for Valtrex Now Warns About Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Valtrex (valacyclovir) is a long-established treatment for cold sores, genital herpes, and herpes zoster, having been initially approved by the FDA in 1995. According to the Health Product InfoWatch December 2022 edition released by Health Canada on December 22, 2022, cases of Valtrex-associated DRESS have been reported as a drug side effect.

In more detail, from the Valtrex part of the "New health product safety information" section of this December 2022 Health Canada document:

• [Drug reaction with eosinophilia and systemic symptoms (DRESS)] has been reported in association with [Valtrex (valacyclovir)] treatment. DRESS is a serious skin reaction that may affect one or more organs and can be life-threatening or fatal.

• Patients should be monitored closely for skin reactions and advised of the signs and symptoms of DRESS, including fever, severe rash, peeling skin, facial edema, lymphadenopathy, flu-like feeling, jaundice, dyspnea, dry cough, chest pain or discomfort, dehydration, and eosinophilia.

• If signs and symptoms suggestive of DRESS appear, [Valtrex (valacyclovir)] should be withdrawn immediately and an alternative treatment considered, as appropriate.

• If a patient has developed DRESS with the use of [Valtrex (valacyclovir)], treatment with valacyclovir must not be restarted in this patient at any time.

Further, therein, it is reported that GlaxoSmithKline Inc. has updated the Canadian product monograph for Valtrex to add information about the risk of Valtrex-associated DRESS.

In comparison, the Full Prescribing Information document for Valtrex in the United States does not currently have any discussion of or warning about Valtrex-associated DRESS as a possible side effect. We will watch to see whether the FDA follows the lead of Health Canada and require a Valtrex drug label change to add information about drug reaction with eosinophilia and systemic symptoms (DRESS).

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Tepezza Hearing Loss: Cases of This Drug Side Effect Reviewed in Various Medical Journal Articles

This Treatment for Thyroid Eye Disease Was Approved by FDA in 2020, With Hearing Problems Reported Soon Thereafter

 

(Posted by Tom Lamb at Drug Injury Watch)

 

We recently wrote about Tepezza hearing loss cases in this October 2022 article, "Tepezza Hearing Side Effects Include Deafness, Sound Sensitivity, and Tinnitus, Resulting in Tepezza Drug Injury Lawsuits".  Therein we noted that case reports in medical journal articles show that Tepezza (teprotumumab) has been linked to hypoacusis, hyperacusis, autophony, and other hearing problems, which sometimes may be irreversible and permanent. We went on to point out that the (then) current Tepezza Full Prescribing Information (Revised: October 2021) document does not include any mention of hearing side effects in the "Warnings and Precautions" section nor in the "Adverse Reactions" section.  And that is still the situation with the updated Tepezza Full Prescribing Information (Revised: December 2022) document that came out today.

In this follow-up article, we present four medical journal articles discussing Tepezza hearing loss cases and provide the Conclusions part of the Abstract from each of those Tepezza medical journal articles:

1.  "Hearing Loss and Teprotumumab"

[Tepezza (teprotumumab)] is a promising new therapy for active moderate to severe thyroid eye disease. Providers should consider performing a baseline audiogram with PET testing and performing audiograms with PET testing for patients that develop hearing symptoms during or after therapy. Hearing loss is a concerning adverse event and its mechanism and reversibility should be further studied.

2.  "Hearing Dysfunction After Treatment With Teprotumumab for Thyroid Eye Disease"

Hearing loss is a concerning adverse event of [Tepezza (teprotumumab)], and its mechanism and reversibility should be further studied. Until risk factors for hearing loss are better understood, we recommend baseline audiometry with PET testing and repeat testing if new otologic symptoms develop. Screening, monitoring, and prevention guidelines are needed.

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3.  "Sensorineural Hearing Loss After Teprotumumab Therapy for Thyroid Eye Disease: A Case Report"

There are currently no formal guidelines for routine audiograms before, during, and after infusion of [Tepezza (teprotumumab)]. Given that such guidelines exist for ototoxic medications such as gentamicin and cisplatin, we strongly encourage audiometric monitoring for patients undergoing treatment with [Tepezza (teprotumumab)].

4.  "Teprotumumab and Hearing Loss: Case Series and Proposal for Audiologic Monitoring"

[Tepezza (teprotumumab)] may cause a spectrum of potentially irreversible hearing loss ranging from mild to severe, likely resulting from the inhibition of the insulin-like growth factor-1 and the insulin-like growth factor-1 receptor pathway. Due to the novelty of [Tepezza (teprotumumab)] and the lack of a comprehensive understanding of its effect on hearing, the authors endorse prospective investigations of hearing loss in the setting of [Tepezza (teprotumumab)] treatment. Until the results of such studies are available, the authors think it prudent to adopt a surveillance protocol to include an audiogram and tympanometry before, during and after infusion, and when prompted by new symptoms of hearing dysfunction.

We are investigating possible Tepezza drug injury cases where the patient, while using Tepezza, started to experience hearing loss or other hearing problems, such as:

• Hearing loss, ranging from impairment to deafness (Hypoacusis and Sensorineural Hearing Loss)
• Sound or noise sensitivity that makes it hard to deal with everyday sounds (Hyperacusis)
• Ringing in the ears in the absence of an external source (Tinnitus)
• Unusually loud hearing of one’s own voice, breathing, and other bodily sounds (Autophony)
• Sensations of ears being “plugged” or “full” resulting in muffled hearing (Eustachian Tube Dysfunction)

If you or someone you know has a possible Tepezza hearing loss case, we encourage you to submit a Drug Injury Case Evaluation Form — it is free, confidential, and there is no obligation.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)