2024-01-18 11:30:00
On January 11, the National Agency for the Safety of Medicines and Health Products (Ansm) warned of the risks of adverse skin effects of the drug adagrasib (Krazati®). This warning comes following the death of a 67-year-old patient, who suffered from toxic epidermal necrolysis, or Lyell syndrome, one of the most serious forms of allergic manifestation. This acute dermatological disease results in a sudden destruction of the superficial layer of the skin and mucous membranes, and is most often induced by a drug.
Use of adagrasib temporarily suspended
In France, adagrasib is only available as part of a compulsive access program including patients with non-small cell lung cancer (NSCLC) with a KRAS G12C mutation. This device allows the therapeutic use of drugs that do not have marketing authorization for patients who are at a therapeutic impasse.
Following analysis, four cases of serious skin reactions and one non-serious case of “skin toxicity“, correlated with the use of adagrasib alone or in combination, have been identified. “Additional investigations are underway to evaluate this signal and take appropriate measures”, we can read in the Ansm document. At this time, this medication has been temporarily suspended.
Adagrasib: an emergency consultation for signs of skin toxicity
As recalled by the organization, patients benefiting from this treatment should consult a doctor promptly if they experience symptoms of skin toxicity such as generalized skin pain, a rapidly spreading rash, skin blisters and /or large areas of skin peeling off as well as inflammation followed by hemorrhagic erosions on the mucous membranes (mouth, nose, eyes, anus, genital areas).
If toxic epidermal necrolysis is suspected, treatment should be stopped immediately, and the patient should be referred urgently to a dermatologist. In a press release published in November 2023, the High Authority for Health (HAS) recommended directly contacting the SAMU “in the face of signs of hemodynamic or respiratory seriousness, and/or directly contacting one of the sites (coordinator, constituent or decompetence) of the national center reference ‘Toxic Bullous Dermatoses and Serious Toxidermia TOXIBU'”.
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