In addition, very common (reported in more than 10% of people) adverse effects include tremor, dizziness, tingling, numbness, constipation, and peripheral edema. As it kills cancer cells, it can cause tumor lysis syndrome. It tends to make people sleepy, which creates risk when driving and operating other machinery.
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Thalidomide can cause liver damage and severe skin reactions like Stevens–Johnson syndrome. Thalidomide has several adverse cardiovascular effects, including risk of heart attacks, pulmonary hypertension, and changes in heart rhythm, such as syncope, bradycardia, and atrioventricular block. The drug can also damage nerves, causing potentially irreversible peripheral neuropathy. There is also a risk of anemia via lack of red blood cells. There is also a high risk that thalidomide can interfere with formation of various kinds of new blood cells, creating a risk of infection via neutropenia, leukopenia, and lymphopenia, and risks that blood will not clot via thrombocytopenia. There is a high risk that thalidomide can cause excessive blood clots. Food and Drug Administration (FDA) and other regulatory agencies have approved marketing of the drug only with an auditable risk evaluation and mitigation strategy that ensures that people using the drug are aware of the risks and avoid pregnancy this applies to both men and women, as the drug can be transmitted in semen. See also: List of thalidomide side effects It should be used with caution in people with chronic infections like HIV or hepatitis B. Those allergic to thalidomide should not take it. The prescribing doctor is required to ensure that contraception is being used, and regular pregnancy tests are taken.
Thalidomide should not be used by men or women who are trying to father or conceive a child, or who cannot or will not follow the risk management program to prevent pregnancies, or by women who are breastfeeding or pregnant. It is recommended only as a third line treatment in graft-versus-host-disease in adults because of lack of efficacy and side effects observed in clinical trials. It is used as a second-line treatment to manage graft versus host disease and aphthous stomatitis in children and has been prescribed for other conditions in children, including actinic prurigo and epidermolysis bullosa the evidence for these uses is weak. Thalidomide may be helpful in some cases where standard TB drugs and corticosteroids are not sufficient to resolve severe inflammation in the brain. The bacterium that causes tuberculosis (TB) is related to leprosy. Thalidomide is used as a first-line treatment in multiple myeloma in combination with dexamethasone or with melphalan and prednisone to treat acute episodes of erythema nodosum leprosum and for maintenance therapy. It is on the World Health Organization's List of Essential Medicines. It was approved in the United States in 1998 for use as a treatment for cancer. The birth defects caused by thalidomide led to the development of greater drug regulation and monitoring in many countries. Its initial entry into the US market was prevented by Frances Kelsey, a reviewer at the FDA. Those who survived had limb, eye, urinary tract, and heart problems. The total number of infants affected by use during pregnancy is estimated at 10,000, of whom about 40% died around the time of birth. While it was initially thought to be safe in pregnancy, concerns regarding birth defects arose until the medication was removed from the market in Europe in 1961. When first released, thalidomide was promoted for anxiety, trouble sleeping, "tension", and morning sickness. Thalidomide was first marketed in 1957 in West Germany, where it was available over the counter. It is an immunomodulatory medication and works by a number of mechanisms, including stimulating T cells and decreasing TNF-α production. In males who are taking the medication, contraception is essential if a partner could become pregnant. Use in pregnancy may harm the fetus, including resulting in malformation of the limbs. Severe side effects include tumor lysis syndrome, blood clots, and peripheral neuropathy. Ĭommon side effects include sleepiness, rash, and dizziness. While it has been used in a number of HIV-associated conditions, such use is associated with increased levels of the virus. Thalidomide, sold under the brand names Contergan, Thalomid among others, isĪ medication used to treat a number of cancers (including multiple myeloma), graft-versus-host disease, and a number of skin conditions including complications of leprosy.
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