Thalidomide Today

Authorized uses of thalidomide

Despite the tragedy associated with the drug, thalidomide and its derivatives are back on the market for the treatment of specific conditions, including certain leprosis complications and cancers, for which it represents an alternative to relieve patients. In most Western countries where it is licensed, access to the drug is strictly controlled and its use is restricted to specific cases. However, in many developing countries, drug control is deficient and babies continue to be born with birth defects, while it could be avoided.



Authorized uses of thalidomide in Canada

Since August 4, 2010, the use of thalidomide (THALOMID®) is authorized in Canada for the treatment of patients aged 65 or older who suffer from multiple myeloma, a type of bone marrow cancer. Two thalidomide derivatives are also authorized: REVLIMID® and POMALYST®.

Under the practice of medicine a physician can prescribe this drug for a condition other than multiple myeloma.

Thalidomide is only available through a controlled distribution program called RevAid®. The drug is strictly contraindicated for pregnant women and women at risk of becoming pregnant. Only program-certified physicians and pharmacies are authorized to prescribe thalidomide and patients that are using it must be registered in the program.

Before 2010, canadian physicians could have access to thalidomide for the treatment of their patients, but exclusively through Health Canada’s Special Access Program.

You can read Health Canada’s fact sheet on the authorization of the drug THALOMID®.

Also, we encourage you to read the details on the drug THALOMID® on Health Canada‘s website.

As of January 31, 2018 the warnings and precautions published on Health Canada’s website regarding THALOMID® were as follows:

Serious Warnings and Precautions

THALOMID® should only be prescribed by a doctor experienced in the use of anti-cancer drugs and registered with the RevAid® controlled distribution program.

Serious side effects with the use of THALOMID® include:

  • birth defects (deformed babies), or death of an unborn baby and spontaneous abortion
  • peripheral neuropathy (damage to peripheral nerves resulting in numbness, tingling, loss of sensation and pain)
  • blood clots in the veins and arteries
  • In some cases, a higher risk of liver problems which may lead to death.

THALOMID® is only available under a controlled distribution program called RevAid®. BEFORE you use THALOMID® talk to your doctor or pharmacist if you:

  • are pregnant or are planning to get pregnant
  • are breastfeeding
  • have blood problems
  • have liver problems
  • have or have had heart problems (fainting spell (syncope), slow heart beat)
  • have had a seizure
  • take other medications that make you feel sleepy
  • feel numbness, tingling or pain or a burning feeling in your feet or hands
  • have a history of hypersensitivity (an allergic reaction) to thalidomide, or any ingredient in THALOMID®. In rare cases, severe allergic reactions (anaphylactic reaction and/or angioedema) have been reported in patients taking THALOMID®. Talk to your doctor immediately if you have symptoms of allergic reactions.
  • smoke, have high blood pressure or high cholesterol levels.
  • have had previous hepatitis B or C virus infection (a viral infection of the liver).

THALOMID® may cause birth defects. In order to take this drug you must meet the following conditions:

  1. Females who can get pregnant:
    • Discuss contraception (birth control) with your health care provider.
    • Use at least two effective methods of contraception at the same time.
    • Use these two effective methods of contraception:
      • For at least 4 weeks before starting THALOMID® treatment
      • During interruptions of THALOMID® treatment
      • During THALOMID® treatment
      • For at least 4 weeks after stopping THALOMID® treatment
    • You must have two negative pregnancy tests before starting treatment:
      • The first 7-14 days prior to starting treatment
      • The second within 24 hours of starting treatment.
    • You must have negative pregnancy tests during treatment:
      • Once weekly for the first 4 weeks
      • Once every 4 weeks (or once every 2 weeks if your period is irregular) for the duration of treatment and during treatment interruption
    • You must have a final pregnancy test 4 weeks after stopping THALOMID®.
  2. Males:
    • THALOMID® is present in the sperm of males who take this drug. Use a condom every time you have sexual intercourse with a woman who is pregnant or can get pregnant. This must be done even if you have undergone a successful vasectomy. The condom must be used while:
      • You are taking THALOMID®
      • During interruptions of treatment
      • For 4 weeks after stopping THALOMID®
    • Do not donate sperm while taking THALOMID® and for 4 weeks after stopping THALOMID®.
    • Inform your sexual partner who can get pregnant that:
      • You are taking THALOMID®
      • There is a risk of birth defects, stillbirths, and spontaneous abortions if a fetus is exposed to your sperm.
      • You must use a condom.

    You should contact your doctor immediately if you think your female partner becomes pregnant while you are taking THALOMID®.

  3. All Patients:

    THALOMID® may cause birth defects and any method of birth control can fail. You should contact your doctor immediately if you think you or your female partner may be pregnant. You should also contact your doctor if you miss your period or experience unusual menstrual bleeding.

    • Do not give blood while you take THALOMID® and for 4 weeks after stopping THALOMID®.
    • Do not share THALOMID® with other people.

    Do not take THALOMID® if you are not enrolled in or do not meet the requirements of the RevAid® controlled distribution program.

    Second cancers, namely acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), which are types of blood cancer, have been reported in a small number of patients taking THALOMID® in combination with melphalan and prednisone. Patients should talk to their doctors if they have any concerns about their own increased risk of getting other cancers.

    THALOMID® is not recommended for use in children under 19 years of age.

    If you are older than 75 years of age there is a possibly greater risk for serious side effects of THALOMID®.

    THALOMID® causes drowsiness and sleepiness. Do not drive or operate machinery until you know how THALOMID® affects you.

    Alcohol may increase drowsiness and sleepiness caused by THALOMID®.

Authorized uses of thalidomide in the United States

Since July 16, 1998, the Food and Drug Administration (FDA) of the United States authorizes the use of thalidomide (THALOMID®) in the treatment of certain forms of leprosy complications.

Since Octobre 26, 2006, its use is also authorized in cases of multiple myeloma.

Thalidomide is accessible on prescription only through a Risk Evaluation and Mitigation Strategy (REMS) know as THALOMID REMS®. The drug is strictly contraindicated for pregnant women. For women of age to conceive, thalidomide can be prescribed, provided that their physician checks for pregnancy during the treatment and informs the patient adequately. Only physicians and pharmacists certified by the program are allowed to prescribe and distribute THALOMID®.

You can get more information from the FDA on thalidomide here.

TVAC’s point of view on the use of thalidomide today

Our association has actively consulted with all associated with the return of thalidomide to remind them of the dangerous properties of the drug. We have lobbied for changes in educational material and packaging to be sure that patients and physicians know the severity and reality of all side effects (not only the teratogenic properties, but the irreversible nerve damage issues as well).

TVAC also lobbied for a picture of a thalidomide baby to be included on the package. We lobbied for the drug to always be called “thalidomide”, no matter the brand/trade name. We reviewed and offered input into the system proposed by the drug company to prevent foetal exposure.

Teratogenic drugs must only be used for conditions proven to be legitimate through clinical trials. It should be the condition that drives the prescription and not the discretion of many doctors with varied experience. Teratogenic drugs such as thalidomide must be drugs of last resort!

The system developed for the return of thalidomide is complex.Thalidomide is now the most regulated drug in North America.

TVAC was consulted during the authorization process of thalidomide in North America. You can read our position paper on the return of thalidomide (1998) and our position paper on the possible marketing of a generic to thalidomide (2007).