Why is pomalidomide banned?

Although Pomalidomide is one of the irreplaceable drugs in modern multiple myeloma (MM) treatment strategies, its use is strictly restricted in some cases and is even considered a banned drug. The main reason for its ban is its teratogenic risk. As an immunomodulator homologous to thalidomide, pomalidomide has clear embryotoxicity, so it must be used in accordance with a strict pregnancy risk management plan whether at home or abroad. Pomalidomide is absolutely contraindicated in women who may be pregnant, patients who are not taking effective contraceptive measures, or men whose spouses may be pregnant, and dual contraception and pregnancy monitoring are required before prescription.

In addition to the teratogenic risk, pomalidomide may be considered contraindicated in certain disease states or physiological conditions. For example, patients with severe hepatic insufficiency, allergic patients who cannot tolerate immunomodulators, and those who have had severe skin reactions to similar drugs in the past will usually not continue to use pomalidomide. In addition, in patients with uncorrected severe hematologic abnormalities, such as extremely low neutrophil or platelet counts, the use of pomalidomide may result in more severe myelosuppression and may be temporarily or permanently contraindicated.

In terms of the cardiovascular system, although pomalidomide is less cardiotoxic than some targeted drugs, doctors may also disable pomalidomide based on safety concerns if the patient has a serious risk of thrombosis, uncontrolled heart disease, or requires long-term use of drugs that affect coagulation. Some countries also have strict registration systems for their distribution. If patients cannot comply with follow-up requirements, complete pregnancy tests, or ensure drug storage and use regulations, they may also be restricted from obtaining prescriptions.

Reference materials:https://en.wikipedia.org/wiki/Pomalidomide