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Thalidomide

Thalidomide

Thalidomide

In the 1950s and the early 1960s, thalidomide was used to treat morning sickness during pregnancy. But it was found to cause severe birth defects. Now, decades later, thalidomide is being used to treat a skin condition and cancer. It's being investigated as a treatment for many other disorders.

Thalidomide was first marketed in 1957 in West Germany under the trade name Contergan. The German drug company Chemie Grünenthal developed and sold the drug. Primarily prescribed as a sedative or hypnotic, thalidomide also claimed to cure "anxiety, insomnia, gastritis, and tension".[3] Afterwards, it was used against nausea and to alleviate morning sickness in pregnant women. Thalidomide became an over-the-counter drug in West Germany on October 1, 1957. Shortly after the drug was sold in West Germany, between 5,000 and 7,000 infants were born with phocomelia (malformation of the limbs). Only 40% of these children survived.

Creating a safer thalidomide

Drugs that work like thalidomide but have fewer side effects may one day be available. Researchers are working on drugs chemically similar to thalidomide (thalidomide analogs).

Thalidomide analogs include:

Lenalidomide (Revlimid), which is approved for treating myelodysplastic syndrome (with 5q- syndrome), multiple myeloma and mantle cell lymphoma.

How is this medicine (Thalidomide) best taken?

Use thalidomide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

If taking once daily, take with water at bedtime at least 1 hour after the evening meal.

Swallow whole. Do not chew, break, or crush.

Wear gloves when touching thalidomide.

Side effects other than birth defects

People taking thalidomide might also experience other side effects, such as:

  • Peripheral neuropathy
  • Blood clots
  • Drowsiness
  • Rash
  • Dizziness
  • Take your medication exactly as prescribed by your doctor. Check with your doctor before taking any other prescription or over-the-counter medications.

Why is this medication prescribed?

Thalidomide is used along with dexamethasone to treat multiple myeloma in people who have been recently found to have this disease. It is also used alone or with other medications to treat and prevent skin symptoms of erythema nodosum leprosum (ENL; episodes of skin sores, fever, and nerve damage that occur in people with Hansen's disease [leprosy]). Thalidomide is in a class of medications called immunomodulatory agents. It treats multiple myeloma by strengthening the immune system to fight cancer cells. It treats ENL by blocking the action of certain natural substances that cause swelling.

OVERDOSE

Overdosages of up to 14.4 g have been reported in the literature. No fatalities have been reported and all overdosed patients recovered without sequelae. There is no specific antidote for a thalidomide overdose. In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure and respiratory status.

Drug Description

If thalidomide is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. Thalidomide should never be used by females who are pregnant or who could become pregnant while taking the drug. Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects.

WARNINGS

Thalidomide is a powerful human teratogen that induces a high frequency of severe and life-threatening birth defects, even after a single dose. Mortality at or shortly after birth has been reported in about 40% of infants. When there is no satisfactory alternative treatment, females of reproductive potential may be treated with thalidomide provided adequate precautions are taken to avoid pregnancy. THALOMID® (thalidomide) is only available through the THALOMID REMS program [see THALOMID REMS Program].

Interactions

There are no expected pharmacokinetic interactions between thalidomide and other medicines due to its neutral effects on p-glycoprotein and P450 cytochromes. It may interact with sedatives due to its sedative action. It may also interact with bradycardic agents due to its bradycardia-inducing effects. The risk of peripheral neuropathy may be increased by concomitant treatment with other agents known to cause peripheral neuropathy.[15] The risk of venous thromboembolisms with thalidomide seems to be increased when patients are treated with oral contraceptives or other cytotoxic agents (including doxorubicin and melphalan) concurrently. Thalidomide may interfere with the contraceptive effects of various contraceptives and hence it is advised that women of reproductive age use at least two different means of contraception to ensure that no child will be conceived while they are receiving thalidomide.

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