Severe and Potentially Life-Threatening Complications Linked to Enfortumab Vedotin (Padcev)
Padcev lawsuits are legal claims brought by patients or by the families of those who have been harmed by Padcev and are seeking economic compensation for their losses, pain and suffering. According to medscape.com, Enfortumab Vedotin (Padcev) has been linked with toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and deaths. Parker Waichman LLP is offering a free case review when you contact us by live chat, by filling out our online form, or by calling 1-800-YOUR-LAWYER (1-800-968-7529).
Enfortumab Vedotin (Padcev) is a medication that is used for the treatment of metastatic urothelial cancer. The medication was approved by the FDA less n two years ago. According to the U.S. Food and Drug Administration’s Division of Pharmacovigilance, cases of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and deaths were linked to Enfortumab Vedotin (Padcev) during the agency’s routine surveillance. The findings were published on the JAMA Dermatology website on September 8, 2021.
Recently, the U.S. FDA updated its boxed warning on enfortumab vedotin-ejfv to include severe, life-threatening skin reactions, including Toxic Epidermal Necrolysis, Stevens-Johnson syndrome, and pneumonitis. The most common types of adverse reactions, including:
- glucose increased,
- aspartate aminotransferase increased,
- creatinine increased,
- peripheral neuropathy,
- lymphocytes decreased,
- decreased appetite,
- hemoglobin decreased,
- hemoglobin decreased,
- diarrhea, pruritus,
- sodium decreased,
- phosphate decreased,
- alanine aminotransferase increased,
- albumin decreased,
- anemianeutrophils decreased,
- lipase increased,
- urate increased,
- platelets decreased,
- dry skin, and
- weight loss.
The FDA’s Adverse Event Reporting System (FAERS) has received eight reports of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis. Five of those cases were later confirmed by biopsy findings. In five of the cases, Stevens-Johnson syndrome / Toxic Epidermal Necrolysis diagnosis has been confirmed by either a dermatologist examination and/or biopsy findings.
The average time of the Stevens-Johnson syndrome / Toxic Epidermal Necrolysis was only 11 days. Some cases appeared in only nine days after the patient received their first dose. In four of the reported cases, the patients’ deaths were connected to Stevens-Johnson syndrome / Toxic Epidermal Necrolysis. The researchers said, “Other serious outcomes included admission to the burn unit in 4 cases,” they write.
Enfortumab Vedotin is a unique medicine that works to prevent cell adhesion molecule nectin-4, which is positioned on the surface of cells and can be profoundly affected by bladder cancer. The medication is an antibody conjugate, which antibodies direct to cells and then frees cytoxic monomethyl auristantin E.
In December of 2019, the U.S. FDA granted Enfortumab Vedotin accelerated approval based on the response data from an EV-201 study, and the results were exhibited at the American Society of Clinical Oncology’s annual meeting. According to the EV-201 study, the overall response rate (ORR) was 44%, 32% had a partial response, and 12% of patients achieved a complete response. The study also reported that the median duration of response was about 7.6 months.
According to Michelle Nadeau Nguyen, PharmD, BCOP, BCPS, and members from the FDA’s Division of Pharmacovigilance, there have been cases of “severe skin reactions now being reported come from post-marketing surveillance.” The team reviewed data provided by FAERS, PubMed, and Embase from December 18, 2019, through October 7, 2020.
Although Stevens-Johnson syndrome / Toxic Epidermal Necrolysis cases are rare, these diseases are very serious, and are the cases are clinically significant. The team also disclosed that the “number of cases over a 12-month period is a concerning observation and is higher than would be expected.”
FDA revised the new prescribing information to include Stevens-Johnson syndrome / Toxic Epidermal Necrolysis warnings and for doctors to stop prescribing Enfortumab Vedotin-EJFV when cases of Stevens-Johnson syndrome / Toxic Epidermal Necrolysis are suspected.
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