Pharmaceutical company Infarmed halts promotion of their antidepressant drug.
The National Medicines Authority (Infarmed) in Portugal has ordered the immediate suspension of the sale of certain batches of the antidepressant Fluoxetine 20mg Capsules. The affected batches are 24BN150A (expiring in March 2027), 24IN128A (expiring in September 2027), 24KN015A and 24KN014A (expiring in November 2027), due to an impurity issue.
The recall was initiated by Generis Farmacêutica, S.A., the manufacturer of these batches. The issue is an analytical result found to be above acceptable limits for an impurity. Entities with these batches in stock should return them to the supplier.
Patients using medicine from these batches should not stop their treatment abruptly. Instead, they should contact their doctor to discuss switching to an alternative medication.
When Fluoxetine capsules are suspended or withdrawn, physicians often prescribe alternatives based on the patient's medical history, tolerability, and treatment goals. Some common alternatives to Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), include other SSRIs such as Sertraline, Paroxetine, Citalopram or Escitalopram, and Fluvoxamine. Venlafaxine, a serotonin-norepinephrine reuptake inhibitor (SNRI), and Duloxetine, another SNRI, may also be considered.
To identify the most appropriate alternative specific to the Infarmed and Generis Farmacêutica situation, a healthcare provider or pharmacist should be consulted, considering the reason for the suspension, batch details, and patient needs. If regulatory authorities like Infarmed have issued official guidance or a list of alternatives, that would be the best source for this information. You may consult Infarmed’s website or contact a local pharmacist or healthcare provider for up-to-date recommendations.
Infarmed continues to advise caution regarding the use of Fluoxetine 20mg Capsules due to quality concerns. The suspension of sale of these batches remains in effect. The suspension is due to a voluntary recall by Generis Farmacêutica, S.A.
It is essential to prioritise patient safety and follow the advice of healthcare professionals during this time. If you have any questions or concerns, do not hesitate to reach out to your doctor or pharmacist.
