withdraw a drug used in cancer treatment

The Spanish Agency for Medicines and Health Products (AEMPS) has warned of the immediate withdrawal of a well-known drug used in cancer treatments. Is about Methotrexate Wyeth 1g solution for injectionan injectable solution medication manufactured by Haupt Pharma Wolfratshausen GMBH and distributed by the company Wyeth Pharma.

This withdrawal is due to the detection of certain defects in the manufacturing process. Thus, the AEMPS alert describes that this error corresponds to a result out of specifications in the appearance test at 24 months in the lot CD65. This drug has obtained a classification of level 3 defects, according to the body dependent on the Ministry of Health.

The AEMPS has left all units of the affected batch of this drug off the market. Now the goal is return them to the lab through the usual channels and that the autonomous communities are responsible for certifying that this process is carried out properly.

What is Methotrexate and what is it used for?

Wyeth Methotrexate is a antimetabolite drugcommonly used in the chemotherapy, as it prevents cell division, preventing the growth of certain tumors. Specifically, this drug is indicated for the treatment of some types of cancer such as gestational trophoblastic neoplasia (choriocarcinoma), a tumor directly associated with pregnancy.

Consumption of this drug can also cause side effects, although not all people suffer from them. Among the possible problems that can derive from its use are the following: breathing problems, blood when spitting or coughing, severe peeling or blistering of the skin, bleeding and bruising, nausea, diarrhea, abdominal discomfort, sores, black stools, blood in urine or stools, fever, red pinpoint skin, yellowing of the skin (jaundice), painful urination, fits (convulsions), loss of consciousness, blurred vision, or severe tiredness.


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