Hundreds of thousands of women in Spain have faced difficulty obtaining hormone treatments for menopause after a shortage of the estradiol spray Lenzetto created wider pressure on the market. Spanish authorities expect supplies of some medicines to improve from November, but the country’s medicines regulator says the timing remains uncertain.
The disruption has become a wider European public-health issue as demand for alternative patches, gels and other hormone replacement therapy products exceeds available manufacturing capacity. The European Medicines Agency is considering whether coordinated EU action could help limit the impact.
What is causing the menopause medicine shortage?
Lenzetto is a transdermal estradiol spray used to relieve symptoms associated with menopause. Spain’s Medicines and Medical Devices Agency, known as Aemps, began receiving reports of difficulties finding the product in February and contacted its manufacturer, Gedeon Richter.
The manufacturer later said demand had risen beyond its production capacity and that there had also been problems involving the device used to administer the spray. Gedeon Richter has said the shortage is not linked to the quality or safety of the medicine.
In Spain, the number of Lenzetto units distributed rose from approximately 13,000 in 2018 to around 123,000 in 2024. The rapid increase placed additional pressure on production and supply chains.
Aemps has also stated that the manufacturer did not meet its obligation to provide advance notification of incidents that could affect continuous supply. Gedeon Richter says it is increasing existing production capacity, developing additional manufacturing options and suppliers, and establishing a new plant and production line.
How the Lenzetto shortage affected other treatments
When Lenzetto became difficult to obtain, many patients and prescribers turned to other estradiol products. That sudden rise in demand affected medicines including Evopad, Estradot and Bijuva.
The result has been a chain reaction across pharmacies, with patients searching for available products and authorities examining alternative ways to maintain treatment. The supply situation varies between medicines and presentations, meaning an improvement for one product will not necessarily resolve the wider shortage.
- Evopad: Aemps expects new batches of some presentations in October and a return towards normal supply from November.
- Lenzetto: New units are expected to reach Spanish pharmacies during November, although supply constraints may continue through 2027.
- Other estradiol medicines: Availability differs by product and is being managed mainly by national authorities.
Why the shortage has European significance
The problem is not limited to Spain. Spain’s Secretary of State for Health, Javier Padilla, said demand had exceeded manufacturing capacity in several European countries. Aemps describes the issue as an international supply problem affecting EU member states to different degrees.
The European Medicines Agency has confirmed that it is aware of the Lenzetto supply problems and is considering possible coordinated measures at EU level. The issue is expected to be discussed by the European group responsible for medicine shortages.
The EMA has also been informed of shortages involving other estradiol-based medicines in the European Union. However, those cases have not been classified as critical at EU level and remain under the management of national authorities.
What is Spain doing to improve access?
The Spanish Health Ministry has explored several measures. It raised the regulated price of the treatment in an attempt to encourage supply to the Spanish market, but the change did not resolve the shortage. Officials said the core difficulty was manufacturing capacity rather than price alone.
The ministry also contacted manufacturers of alternative products that are not reimbursed by Spain’s National Health System. It indicated that public funding could be considered if this helped widen access, but companies reportedly said they could not increase production sufficiently, even with reimbursement.
No reimbursement requests for these alternatives had been formalised at the time covered by the report.
Patients and women’s organisations demand action
More than 25,000 people supported a petition calling for urgent action on the medicine supply problems. The petition asks the government to prepare earlier for future shortages and to ensure that patients can access suitable alternatives regardless of where they live.
Cost is a central concern because some alternative treatments are not covered by the public health system. Patients may therefore face the full expense of switching medicines while also dealing with uncertainty over availability.
Spain’s Institute of Women has separately urged the Health Ministry and Aemps to treat the problem as an urgent priority. It said complaints had been received from individuals and women’s organisations about both interrupted treatment and the cost of alternatives.
Could pharmacies compound estradiol treatments?
Catalonia is preparing a possible contingency measure under which pharmacies could make individualised estradiol formulations from the active ingredient when industrial products are unavailable. Such magistral formulas would require a medical prescription.
The proposal has prompted differing views. Aemps considers compounded treatments a last-resort option because absorption may be more variable than with authorised medicines. The General Council of Official Pharmacists’ Associations supports their use during the current shortage.
The Health Ministry is also examining other measures with scientific societies and pharmaceutical companies, including whether treatment could be prioritised for particular patients if supply becomes more limited.
When will the shortage end?
There is no confirmed date for a complete return to normal supply. Spain’s Health Ministry expects conditions to begin improving in November, while Gedeon Richter has said Lenzetto should return to pharmacies during the second half of that month.
However, Aemps has warned that previous forecasts from the manufacturer have not always been accurate. Gedeon Richter has also acknowledged that it may not fully satisfy demand throughout 2027, although it expects to move gradually towards meeting demand from the second half of that year.
The immediate takeaway is that November may represent the start of a recovery rather than the end of the crisis. Patients should speak with their doctor or pharmacist before changing or interrupting prescribed treatment, particularly where an alternative medicine or compounded formulation is being considered.
The shortage illustrates how quickly a disruption affecting one medicine can spread through a wider market when replacement products have limited spare capacity. Spain’s response, and any coordinated action considered by EU medicines authorities, will determine whether patients gain more reliable access in the months ahead.
