The Spanish Agency for Medicines and Health Products (Aemps) has ordered the withdrawal of several batches of the well-known medicine Duloxetine, used against depression and anxietyas “an impurity above its established limit” was detected in the drug.
The medicine is marketed in Spain by Sandoz Farmacéutica SA and specifically, the withdrawn references are the following:
- Duloxetine Sandoz 30 Mg Gastro-Resistant Capsules, Hard EFG, 28 Capsules (NR: 79569, CN: 705511)
- Duloxetine Sandoz 60 Mg Gastro-resistant hard capsules EFG 56 capsules (NR: 79570, CN: 729570)
- Duloxetine Sandoz 60 Mg Gastro-resistant hard capsules, 28 capsules (NR: 79570, CN: 705512)
And within them, the lots affected are:
- Batch: R77, expiration date 01/31/2024
- Batch: R975, expiration date 04/30/2024
- Lot: S0024, expiration date 01/31/2025
- Batch: S0595, expiration date 04/30/2025
- Batch: R1214, expiration date 07/31/2024
- Batch: R76, expiration date 12/31/2023
- Batch: S0482, expiration date 03/31/2025
- Batch: R1073, expiration date 04/30/2024
- Batch: R133, expiration date 12/31/2023
- Lot: S0199, expiration date 01/31/2025
What happens if I have purchased part of an affected Duloxetine batch?
The Duloxetine is used to treat depression in adults and generalized anxiety disorder (excessive worry and tension that disrupts daily life and lasts for 6 months or more) in adults and children 7 years of age and older. It belongs to a class of drugs called selective serotonin and norepinephrine reuptake inhibitors. Its action is to increase the amount of serotonin and norepinephrine, natural substances in the brain that help maintain mental balance and stop the movement of pain signals in the brain.
The Spanish Agency for Medicines and Health Products clarifies that the affected batches “do not pose a serious or vital risk to the patient.” Is about a fairly common medication among patients with a depressive-anxious picture. If a patient has received a portion of the lots affected by the recall, she should contact her doctor to receive a new prescription.
Duloxetine is also used to treat pain and tingling caused by diabetic neuropathy (nerve damage that can develop in people who have diabetes) in adults and the fibromyalgia (a long-term disease that can cause muscle pain, stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep) in adults and children 13 years of age and older.
It is also used in adults to treat ongoing bone or muscle pain, such as lower back pain or osteoarthritis (joint pain or stiffness that may worsen over time). Duloxetine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). Its action is to increase the amount of serotonin and norepinephrine, natural substances in the brain that help maintain mental balance and stop the movement of pain signals in the brain.
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