Infarmed Portugal has issued an official alert regarding a nationwide shortage of Tromalyt, a widely prescribed cardiovascular medication, due to manufacturing problems, with availability expected to resume by July 31, 2026. The antiplatelet drug, containing acetylsalicylic acid 150 mg in modified-release capsule form, is essential for thousands of Portuguese patients managing secondary prevention of ischemic heart disease and stroke.
Why This Matters
• Cost burden ahead: Substitute medications are not state-reimbursed, meaning patients will pay full price out-of-pocket during the shortage.
• Limited monthly supply: Pharmacies can only dispense one month of treatment at a time to ration available alternatives.
• No doctor visit required: Existing prescriptions for Tromalyt can be automatically swapped for generic acetylsalicylic acid tablets at the pharmacy counter.
What Caused the Supply Gap
The Portugal National Authority of Medicines and Health Products (Infarmed) confirmed in a circular published on its official website that the disruption stems from production-related issues at the manufacturing level. While the regulator did not specify whether the problem involves the active ingredient supply chain, quality control failures, or facility capacity constraints, the timeline suggests a structural bottleneck rather than a temporary logistics hiccup.
Tromalyt is classified as an antiplatelet agent, a category of drugs that prevents blood clots by inhibiting platelet aggregation. It plays a critical role in secondary prevention strategies—meaning it is prescribed to patients who have already experienced a cardiovascular event, such as heart attack or ischemic stroke, to reduce the risk of recurrence.
Approved Substitutes and How to Access Them
To ensure treatment continuity without requiring patients to schedule new medical appointments, Infarmed has temporarily authorized pharmacists to substitute Tromalyt prescriptions with two alternative formulations of acetylsalicylic acid 150 mg:
• Standard tablets (National Pharmaceutical Code: CNPEM 50055070)
• Gastro-resistant tablets (National Pharmaceutical Code: CNPEM 50057103)
Both alternatives contain the same active ingredient and dosage but differ in release mechanism. The gastro-resistant version is designed to dissolve in the intestine rather than the stomach, potentially reducing gastrointestinal side effects—a feature that may matter for patients with sensitive digestion or a history of ulcers.
However, there is a significant financial catch: neither substitute is covered by the National Health Service reimbursement scheme. Patients accustomed to paying only the co-payment portion for Tromalyt will now shoulder the full retail price, which can vary depending on the pharmacy and brand. For many retirees and those on fixed incomes, this could represent a meaningful monthly expense increase.
Rationing Measures and Pharmacy Guidelines
Infarmed has instructed pharmacies across Portugal to dispense acetylsalicylic acid 150 mg substitutes for no more than one month of treatment per dispensation. Pharmacists are also required to consult the patient's medication history before handing over the substitute to verify treatment continuity and avoid overstocking by individual patients.
The regulatory body explicitly appealed to pharmacies to avoid hoarding large quantities of the alternative medications in their inventories. This rationing strategy is designed to ensure equitable distribution across the country and prevent localized shortages caused by panic buying or speculative stockpiling.
The guidance reflects a pragmatic approach to managing scarcity: by capping both individual patient supply and pharmacy reserves, Infarmed aims to stretch available stock across the affected patient population until Tromalyt production resumes or stabilizes.
Impact on Cardiovascular Patients
Acetylsalicylic acid, commonly known as aspirin, is a cornerstone of secondary cardiovascular prevention. For patients who have survived a heart attack, undergone coronary angioplasty, or experienced a non-hemorrhagic stroke, daily low-dose aspirin significantly reduces the risk of subsequent thrombotic events.
The shortage of Tromalyt does not eliminate access to the active ingredient, but it introduces friction and financial strain. Patients will need to:
• Confirm with their pharmacy that the substitute is in stock before refilling.
• Budget for the additional out-of-pocket cost each month.
• Potentially adjust to a different tablet formulation, which may have different gastrointestinal tolerance profiles.
For elderly patients managing multiple chronic conditions, the added complexity of navigating substitutions, checking stock availability, and absorbing unplanned medication costs can create adherence challenges. Research consistently shows that cost-related medication non-adherence increases the risk of adverse health outcomes, particularly in cardiovascular populations.
Broader Context of Drug Shortages in Portugal
The Tromalyt disruption is the latest in a series of medication supply challenges that have tested Portugal's pharmaceutical resilience over the past year. In 2025, Infarmed investigated shortages of diabetes medications, including Ozempic and Trulicity, partly driven by off-label prescribing for weight loss. Inspections uncovered suspected overcharging to the National Health Service, resulting in referrals to the Public Prosecutor's Office.
Pancreatin-based medications, critical for patients with pancreatic insufficiency, have also faced manufacturing difficulties extending into 2026, according to notifications sent to the European Medicines Agency. A 2025 report from the Pharmaceutical Group of the European Union identified more than 600 medicines in shortage across one-third of member states, with cardiovascular, oncology, and antibiotic therapies among the hardest hit.
In response, Infarmed has rolled out structural reforms to strengthen supply chain resilience:
• Exemption from annual price reviews for essential medicines priced below €30, aimed at keeping low-cost generics financially viable for manufacturers.
• Temporary export bans on 35 critical medications, including vaccines, antibiotics, and HIV treatments, to prioritize domestic supply.
• Fast-track approval for source changes, allowing companies to quickly switch active ingredient suppliers or manufacturing sites, including facilities in Portugal.
• A new regulatory framework for managing availability crises, including controlled distribution, stock allocation, and coordinated prescribing guidelines.
What Happens Next
Infarmed stated it will continue monitoring the Tromalyt situation and update guidance as circumstances evolve. The authority has not indicated whether the manufacturer has committed to a specific restart date or whether alternative suppliers are being sought.
Patients currently taking Tromalyt should consult their pharmacist during their next refill to transition smoothly to one of the authorized substitutes. Those experiencing financial hardship due to the loss of reimbursement may wish to discuss the situation with their prescribing physician, who could explore whether other antiplatelet agents covered by the National Health Service—such as clopidogrel—might be clinically appropriate alternatives.
For now, the message from Portugal's drug regulator is clear: the active ingredient remains available, the treatment pathway is preserved, but patients will need to absorb the cost and navigate the substitution until Tromalyt returns to pharmacy shelves by the end of July 2026.
