New health alert in Spain. The Spanish Agency for Medicines and Health Products (AEMPS) under the Ministry of Health has issued an alert of withdrawal on a medicine for hospital use against cancer.
Is about Wyeth Methotrexate 1gan injectable solution drug manufactured by Haupt Pharma Wolfratshausen GMBH and distributed by the company Wyeth Farma.
It belongs to a group of medicines called folic acid antagonist antimetabolites. In high doses it is used for treat many types of cancer. While in lower doses, it can also be used against psoriasis and rheumatoid arthritis, according to your leaflet.
Specifically, the pharmaceutical product on which the health change is directed is:
- METHOTREXATE WYETH 1 g INJECTABLE SOLUTION, 10 vials of 40 ml (NR: 57415, CN: 639609)
As the agency lets you know, the withdrawal is due to the detection of certain defects in the manufacturing process. Thus, it is described 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 level 3 defect classification, the lowest in terms of the risk it poses. (The level is classified as the highest and class 2 medium level).
The Wyeth methotrexate is a drug commonly used in chemotherapy treatmentsby preventing cell division, thus combating the growth of certain tumors.
It 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, and its use is limited to the hospital setting.
Also used for rheumatoid arthritis when it does not respond adequately to other forms of treatment, both in monotherapy and in combination with other measures. Similarly, it happens with juvenile chronic arthritis, psoriasis and psoriatic arthritis.
Among the precautionary measures adopted, the AEMPS indicates all distributed units of the affected lot have been withdrawn from the market. It also underlines that it has been returned to the laboratory through the usual channels.