We are going to look at how the Padcev drug label went from having no warning about Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) when approved by the FDA in December 2019 to the Padcev drug label having a “Black-Box” warning about the SJS and TEN skin side effects in July 2021, less than 2 years after Padcev came on the market
To start, Padcev (enfortumab vedotin-ejfv), an injection drug for intravenous use, was approved by the FDA in December 2019 for the treatment of certain adult patients with locally advanced or metastatic urothelial cancer (mUC), a type of bladder cancer.
Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are serious skin reactions that can be life-threatening and even fatal. In people who have developed SJS), the more severe skin reaction TEN is diagnosed when more than 30% of the skin surface is affected and the moist linings of the body (mucous membranes) have extensive damage. Put otherwise, toxic epidermal necrolysis (TEN) is a severe form of Stevens-Johnson syndrome (SJS). And, significantly, TEN is such a serious skin reaction that it can be fatal, causing patient deaths in some situations.
In the initial Padcev drug label (“Revised: 12/2019”) there was a warning about general, low-level Padcev skin side effects in the Warnings and Precautions section at 5.4 Skin Reactions.
The first label change to add warnings for the Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) came in March 2021. From the “Revised: 3/2021” Padcev drug label at 5.1 Skin Reactions:
Severe cutaneous adverse reactions, including fatal cases of Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later.
But only four months later, in July 2021, the FDA mandated increased warnings about the Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), in the form of a so-called “Black Box” warning with the bolded title WARNING: SERIOUS SKIN REACTIONS
Our law firm is investigating cases for patients who have suffered the Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) as possible drug injury lawsuits to be filed against Astellas Pharma US, Inc., the manufacturer of Padcev.
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