This document, issued by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) in January 2025, outlines new safety information that must be added to the official product information (labeling) for two specific medicines.
The updates are based on the evaluation of “safety signals,” which are reports of potential new adverse reactions that require further investigation.
1. Update for Afatinib (a cancer medicine)
- Safety Issue: Abnormal eyelash growth (Aberrant eyelash growth).
- Update Details: This side effect has been officially added to the list of undesirable effects with a frequency of “uncommon” (may affect up to 1 in 100 people).
- Information for Patients: The package leaflet will now warn that this can include misdirected eyelash growth, which could potentially damage the surface of the eye.
2. Update for Lenvatinib (marketed as Lenvima and Kisplyx, a cancer medicine)
- Safety Issue: Tumor Lysis Syndrome (TLS). This is a serious condition caused by the rapid breakdown of cancer cells, which can lead to kidney failure and be fatal.
- Update Details:
- Warnings Section: A new warning has been added. It states that Lenvatinib can cause TLS and that patients with a high tumor burden or kidney problems are at higher risk. Doctors are advised to monitor these patients closely and consider preventive measures like hydration.
- Side Effects Section: TLS has been added as a “rare” adverse reaction (may affect up to 1 in 1,000 people) for the medicine when used alone or in combination with other drugs (pembrolizumab or everolimus). It is noted that some cases have been fatal.
- Information for Patients: Patients are told about the risk of TLS and instructed to contact their doctor immediately if they experience symptoms like nausea, shortness of breath, irregular heartbeat, cloudy urine, or severe tiredness.
Overall Purpose
This document demonstrates the continuous process of pharmacovigilance. Even after a medicine is approved, regulatory bodies like the EMA monitor its safety in the real world. When new risks are identified, they mandate updates to the product information to ensure doctors and patients are fully informed, thereby promoting safer use.
