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drug spain health withdrawn alert depressant anti

Health alert - anti depressant drug withdrawn in Spain

Health alert: an antidepressant and anxiolytic drug sold in Spain is withdrawn.

The Spanish Agency for Medicines and Health Products (Aemps), under the Ministry of Health, has warned on its website about an unexpected effect on some batches of an antidepressant drug, social anxiety disorders and obsessive compulsive disorder (OCD). It is, specifically, the semonic product of 200 mg coated with film in its presentation of 30 tablets. Manufactured by Ferrer Internacional, the affected lot would be the 110122 with an expiration date of 31/07/2023.


According to the Agency, in one of the stability studies carried out on the pharmacological products marketed, "an out-of-specification result in the stability studies has been detected in another batch from the same bulk". The alert published by the state agency has been categorized as 'class 2', which implies that it poses an "intermediate risk" to the consumer. For this reason, withdrawal from the market of all distributed units of the affected lots.


This antidepressant, intended for adults and in some cases children, contains sertraline as the active substance. According to the package leaflet, it belongs to the group of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). "These medications are used to treat depression and/or anxiety disorders," the documentation states. Thus, it is prescribed as an antidepressant and the prevention of its reappearance; social anxiety disorder; post-traumatic stress disorder (PTSD); and distress disorder.

"Depression is a clinical-type disease with symptoms such as feelings of sadness, inability to sleep well or to enjoy life as you used to," the leaflet describes. "PTSD is a disorder that can occur after a very traumatic emotionally traumatic experience, and that has some symptoms similar to depression and anxiety."
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