On August 3, 2026, the European Medicines Agency (EMA) published the Pharmacovigilance Risk Assessment Committee (PRAC) recommendations on safety signals adopted at its July 6 to 9, 2026 meeting (EMA/PRAC/155652/2026), endorsed by the Committee for Medicinal Products for Human Use (CHMP) at its July 20 to 23 plenary. The package adds a new meningioma contraindication to all desogestrel and etonogestrel contraceptives, tightens the Jaydess intrauterine system label on ectopic pregnancy, and triggers supplementary information requests across CGRP migraine, anti-infective, oncology and anaesthesia products.
For marketing-authorisation holders (MAHs), the document is directly actionable: variations are due within two months of publication, a Direct Healthcare Professional Communication (DHPC) must reach prescribers by August 6, 2026, and five supplementary information submissions fall due between August 26 and October 14, 2026. Under Article 16(3) of Regulation (EC) No 726/2004 and Article 23(3) of Directive 2001/83/EC, MAHs must keep product information aligned with PRAC conclusions (EMA PRAC recommendations, July 6 to 9, 2026).
What changed for desogestrel and etonogestrel products?
PRAC concluded that prolonged desogestrel use is linked to a small increased risk of meningioma, and that the finding extends to etonogestrel because desogestrel is metabolised to it. All MAHs of desogestrel and etonogestrel products, which are nationally authorised, must submit a variation within two months of publication adding:
- a new section 4.3 contraindication: meningioma or history of meningioma;
- section 4.4 wording warning that current, prolonged use (one year or longer) carries a small increased risk, rising with duration and with prior exposure to progestogens linked to meningioma;
- a section 4.8 entry under "Neoplasms benign, malignant and unspecified" at a frequency of "not known".
The evidence is a case-control study showing an odds ratio of 1.3 (95% CI 1.1 to 1.5) for intracranial meningioma requiring surgery with desogestrel 75 micrograms use of one year or more, a number needed to harm of 67,300 women, rising to an odds ratio of 2.1 (95% CI 1.5 to 2.9) at seven years or more. Excess risk was greater in women previously exposed to a high-risk progestogen (odds ratio 3.3, 95% CI 2.6 to 4.1) and was no longer observed one year after discontinuation. Organon must also distribute a DHPC to healthcare professionals by August 6, 2026.
What must Bayer do for Jaydess?
For the levonorgestrel 13.5 mg intrauterine system Jaydess (EPITT 20251, non-centralised), PRAC found that post-authorisation observational data show higher ectopic pregnancy incidence than with other IUSs and copper IUDs. Bayer must submit a variation within two months of publication updating section 4.4 to flag the higher real-world rates, and section 4.8 to add a French nationwide cohort study: one-year ectopic pregnancy incidence of 0.18 per 100 person-years for the 13.5 mg IUS versus 0.10 for the 19.5 mg IUS, 0.04 for the 52 mg IUS, and 0.07 for copper IUDs, a hazard ratio of 2.57 (95% CI 1.92 to 3.43) versus copper IUDs. The package leaflet is updated to counsel women that real-world studies report higher risk with Jaydess than with other IUSs and copper IUDs.
Which other MAHs must act, and by when?
PRAC issued supplementary information requests to MAHs across several drug classes, each with a fixed submission deadline. National competent authorities oversee adherence for nationally authorised products, and the CHMP assesses the corresponding variations for centrally authorised products. Non-compliance carries regulatory consequences.
| Active substance | Signal | MAH(s) | Action by |
|---|---|---|---|
| Oseltamivir, intravenous zanamivir | Safety in critically ill influenza patients | Roche, GSK | August 26, 2026 |
| Sacituzumab govitecan | Interstitial lung disease | Gilead | September 23, 2026 |
| Sevoflurane | Acute encephalopathy (m.11232T>C carriers) | AbbVie, Baxter, Piramal | September 23, 2026 |
| Atogepant | Insomnia (assess in ongoing PSUR) | AbbVie | September 30, 2026 |
| Atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, rimegepant | Raynaud's phenomenon | AbbVie, Lilly, Lundbeck, Novartis, Pfizer, Teva | October 14, 2026 |
| Selpercatinib | Intestinal lymphangiectasia (next PSUR) | Lilly | January 17, 2027 |
Venlafaxine (Viatris) is flagged for cardiotoxicity monitoring in the next PSUR but carries no separate submission deadline.
Take advantage of this real-time watch
What to do next
Confirm whether your portfolio includes desogestrel or etonogestrel products, Jaydess, or any substance in the table above; if it does, calendar the applicable deadline now, draft the variation or submission against the exact SmPC, section 4.8 and leaflet wording PRAC specifies, and brief regulatory affairs and pharmacovigilance together so the DHPC and variation move in lockstep. The two-month variation window for desogestrel, etonogestrel and Jaydess runs from the August 3, 2026 publication, leaving a narrow margin before the October 2026 expiry. Continuous, per-jurisdiction real-time monitoring surfaces PRAC signal recommendations the moment EMA publishes them, so Obsidian keeps pharmacovigilance teams ahead of every affected product and deadline without manually trawling the EMA site.
