Health alert: A drug used in hospitals to treat cancer is withdrawn from the market

The Aemps has warned of its withdrawal after the detection of certain defects in the manufacturing process

It is used against psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, breast cancer, squamous cell carcinomas of the head and neck, bladder carcinoma, choriocarcinoma, acute lymphoblastic leukemia, non-Hodgkin’s lymphoma, psoriasis , bone sarcoma, and allogeneic bone marrow transplantation. It is Methotrexate Wyeth, a drug that belongs to the group of so-called folic acid antagonist antimetabolites.

The Spanish Agency for Medicines and Health Products (Aemps) has ordered the immediate withdrawal of the drug Methotrexate Wyeth 1g injectable solution, an injectable solution medicine manufactured by Haupt Pharma Wolfratshausen GMBH and distributed by the company Wyeth Farma.

This withdrawal is due to the detection of certain defects in the manufacturing process. It describes that this error corresponds to a result out of specifications in the appearance test at 24 months in batch CD65. This drug has obtained a classification of level 3 defects, according to the agency.

Methotrexate is used in high doses to treat many types of cancer. At lower doses, it can also be used to treat psoriasis and rheumatoid arthritis.

Methotrexate is indicated for the treatment of various tumor diseases such as gestational trophoblastic neoplasia, acute leukemia, breast cancer, head and neck cancer, urinary bladder cancer, osteosarcoma and non-Hodgkin’s lymphomas.

It is also used in the treatment of rheumatoid arthritis that does not respond adequately to other forms of treatment, both in monotherapy and in combination with other measures; in the treatment of juvenile chronic arthritis, psoriasis and psoriatic arthritis (only when severity requires it and other treatments have failed).

It is also indicated as prophylaxis against graft-versus-host disease in allogeneic bone marrow transplantation.


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