Menopause medicine crisis goes beyond Spain

The shortage of Lenzetto has had a domino effect on other menopause hormone treatments in Spain and other European countries. Spain’s Health Ministry expects supplies to improve in November, but Spain’s Medicines watchdog warns the timetable is still unclear.

Hundreds of thousands of Spanish women have spent months encountering problems getting hold of some of the hormone treatments used to relieve menopausal symptoms.

What began as an issue with a single medicine — Lenzetto, a transdermal estradiol spray — has finally triggered a domino effect in the market for hormone replacement therapies (HRT).

The shortage of Lenzetto drove up demand for other estradiol formulations, such as patches and gels, which were not prepared to absorb it. Over recent months, Aemps has recorded supply issues affecting medicines such as Evopad, Estradot and Bijuva.

The result has been months of supply problems, patients searching for their medication from pharmacy to pharmacy, and authorities trying to find alternatives.

November could mark the start of an improvement, although there are still doubts about when supply will truly return to normal.

The Secretary of State for Health, Javier Padilla, told Euronews on the sidelines of the European Health Forum Gastein in Austria that the situation should start to ease from next month.

Spain’s Medicines and Medical Devices Agency (Aemps), however, warns that the forecasts communicated by Lenzetto’s manufacturer, Gedeon Richter, “have not always been accurate”.

Gedeon Richter confirmed to Euronews that it expects Lenzetto to be available again in Spanish pharmacies starting in the second half of November. However, the company acknowledges it may not be able to fully meet demand throughout 2027 due to global supply constraints, though it expects to gradually meet demand starting in the second half of 2027.

European issue

The problem is not confined to Spain. According to Padilla, a sharp surge in demand has outstripped manufacturers’ production capacity in several European countries. Aemps also considers this to be an international supply issue affecting, to varying degrees, different European Union member states.

The European Medicines Agency (EMA) has confirmed to Euronews that it has been informed of the supply issues regarding Lenzetto and is considering possible coordinated measures at the EU level to mitigate the impact. The matter will be addressed in upcoming meetings of the European group responsible for medicine supply issues.

The EMA further notes that it is aware of recent supply problems involving other estradiol-based medicines in the EU. However, these cases have not been deemed critical at the European level and are being managed by national authorities.

The crisis mainly affects women who use these therapies to alleviate symptoms associated with the menopause, although estradiol is also used in other clinical situations, including the prevention of osteoporosis and gender-affirming hormone treatments for trans women.

From Lenzetto to a domino effect

The crisis was brewing for months. Aemps began receiving reports from users about difficulties in finding Lenzetto in February and contacted pharmaceutical company Gedeon Richter at that point. Initially, the company insisted it was meeting demand as normal.

The situation changed soon afterwards. The laboratory reported that it was facing a surge in demand it could not meet immediately and problems with the device used to administer the medicine. Weeks later it announced that it had run out of stock and that the issue was affecting all its markets throughout 2026.

Aemps also maintains that the company failed to meet its obligation to notify in advance of incidents that could disrupt the continuous supply of the medicine. Consumption of Lenzetto had risen very rapidly. In Spain, distributed units rose from around 13,000 in 2018 to about 123,000 in 2024.

Gedeon Richter explained to Euronews that demand had outstripped its manufacturing capacity and that the availability of the applicator used to administer the medication could not keep pace with the growth. The company emphasises that the shortage is unrelated to any quality or safety issues with the medication.

To increase supply, the company states that it is maximising its current capacity and developing new manufacturing options and suppliers. Furthermore, it is establishing a new plant and a new production line.

Spain raised the price, but it was not enough

The government has tried various ways to increase the availability of these medicines. Among them, as Padilla explained, raising the regulated price in an attempt to attract more supply to the Spanish market. But the measure failed to resolve the problem. The Secretary of State stressed that the difficulty goes beyond price: manufacturers do not have sufficient capacity to cope with the sharp rise in demand.

The Health Ministry then explored another option. It contacted manufacturers of alternative treatments that are not reimbursed by the National Health System and signalled its willingness to consider funding them in order to widen the options available to patients.

According to Padilla, this route has also not delivered the expected results so far. The companies told the government that they did not have enough production capacity to increase supply, even if their products were to be publicly funded. Aemps confirms that the Health Ministry has held talks with the holders of these alternatives, although no reimbursement requests have yet been formalised.

More than 25,000 signatures reach the Health Ministry

While the authorities look for solutions, patients have begun to mobilise. More than 25,000 people have supported, in barely three weeks, a petition calling on the government to take urgent action over the supply problems. Its organiser, 49-year-old Rebeca Marín, who uses hormone replacement therapy, is due to submit the signatures this Tuesday, 6 October, at the Health Ministry.

The petition calls on the authorities to act preventively in the face of future supply problems and to ensure that when a medicine is unavailable, there are accessible alternatives for patients regardless of where they live. The financial aspect is particularly important. Some of the existing alternatives are not covered by the public system, forcing patients to bear the full cost.

The Institute of Women demands “urgent” action

The issue has also reached the Institute of Women, which has asked the Health Ministry and Aemps to tackle “as a priority and urgently” the supply problems. The body acted after receiving complaints from individuals and women’s associations concerned both about the difficulty of maintaining their treatments and about the price of some of the available alternatives.

Catalonia turns to pharmacies

In view of the prolonged shortage, Catalonia has decided to prepare an alternative solution. The regional government plans to allow pharmacies to prepare magistral estradiol formulas if supply problems persist.

The measure would allow individualised treatments to be made up from the active ingredient and on the basis of a medical prescription. Compounding pharmacies have estradiol in stock as a raw material, so this route could serve as an alternative when industrially produced medicines are unavailable.

The proposal has, however, opened up a divide between health authorities and pharmacists. Aemps believes magistral formulas should be used only as a last resort, as their absorption can be more variable than that of authorised medicines. The General Council of Official Pharmacists’ Associations, by contrast, advocates their use in the current shortage.

The Health Ministry is also studying, together with scientific societies and laboratories, other measures to tackle the shortage, including the possibility of setting criteria to prioritise certain patients if necessary.

When will the shortage end?

For now there is no definitive answer. The situation differs from one medicine to another. For some Evopad presentations, Aemps expects new batches in October and a return to normal from November.

The outlook for Lenzetto is more uncertain. Gedeon Richter has informed Aemps that it will distribute new units over the course of November and will gradually resume supply from that month and throughout 2027.

It is precisely this uncertainty that qualifies the forecast passed on by Padilla to Euronews. November may mark the beginning of recovery, but not necessarily the end of the crisis.

Source: www.euronews.com