Thalidomide was developed as a non-barbiturate sedative (non-addictive sleep aid) in Germany during the 1950s. It was removed from the market in 1961 after it was linked to major birth defects in children whose mothers took thalidomide during pregnancy. This incident spurred the extensive drug testing policies now in place all over the world.
Thalidomide has been used in a fairly large number of people with the type of lupus that affects their skin (discoid lupus, subacute cutaneous lupus, lupus profundus, tumid lupus). Although antimalarial drugs are still the first choice in treatment of lupus skin lesions, thalidomide has become an accepted second-line treatment for those individuals who do not respond to other therapy.
Thalidomide often is highly effective in treating lupus-associated skin lesions. Studies show that even people who are resistant to other types of treatment respond very well to thalidomide.
On average, significant improvement in skin lesions occurs in 75-90 percent of those treated with thalidomide, and 54-75 percent of these individuals have complete clearance of their skin lesions.
Most people begin noting improvement in their skin lesions within the first month of starting therapy, with continued improvement over the next three to six months. Relapses usually occur within one to two months of drug withdrawal, but frequently are less severe.
Although thalidomide is highly effective for lupus-associated skin disease, it has significant side effects that must be considered before starting therapy.
1) Thalidomide is definitively linked to severe birth defects. Pregnant women or women considering pregnancy in the near future may not take thalidomide. If a woman on thalidomide is of childbearing potential, she must use two forms of birth control. Birth control also must be continued for three months after the drug is stopped. Finally, patients of childbearing potential must have monthly pregnancy tests while on thalidomide, or the drug cannot be refilled.
2) Thalidomide can cause severe and irreversible neuropathy (nerve injury) which commonly appears as numbness and tingling of toes and fingers. Neuropathy occurs in 10-50 percent of patients who take thalidomide. There is some evidence that older age and greater doses increase the risk of neuropathy. Most physicians obtain a series of nerve tests before patients start thalidomide and while they are on the drug, to monitor for this side effect.
3) Drowsiness is commonly associated with thalidomide therapy, especially at higher doses. Drowsiness is usually minimized by taking the medication in the evening. Most patients develop tolerance to this side effect after one to three weeks. Constipation is also associated with thalidomide therapy, especially when high doses are used. Other common reactions include dizziness, irregular menstrual bleeding, and headache.