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Thalidomide

THALIDOMIDE

What are the aims of this leaflet?

This leaflet has been written to help you understand more about thalidomide. It tells you what it is, how it works, how it is used to treat skin conditions, and where you can find out more about it.

What is thalidomide and how does it work?

Thalidomide was first used in the 1950s as a gentle sedative tablet that can also control severe morning sickness in pregnant women without apparent side effects on the mother. However, after it was discovered to cause severe birth defects when taken in pregnancy, it was withdrawn from use.

Later, thalidomide was discovered to be helpful for certain skin reactions caused by leprosy (erythema nodosum leprosum), and it was then found to have other beneficial anti-inflammatory effects. This has led to its carefully controlled use in the treatment of some skin disorders for which other medication has not worked. All use of thalidomide must be carefully monitored, with particular attention paid to avoid its use in pregnancy.

What skin conditions are treated with thalidomide?

Thalidomide has been used by dermatologists as an unlicensed medication for several skin diseases, including nodular prurigo, Behçet’s disease, lupus erythematosus, pyoderma gangrenosum, actinic prurigo and cutaneous sarcoidosis. Thalidomide is usually only considered when other treatments have failed.

What does “unlicensed” mean in relation to a drug?

An unlicensed drug is one that has not been awarded a market authorisation from the UK Medicines Healthcare Products Regulatory Agency (MHRA). When a pharmaceutical company applies for a drug license, the MHRA has a rigorous process of evaluating the information about a drug’s benefits and side-effects. Once a license has been awarded, the drug can then be marketed and sold in the UK. When a drug does not have a license (unlicensed) this does not necessarily mean that it is not a useful treatment, rather, that there is insufficient information to satisfy the regulators. Your dermatologist is licensed by the GMC to prescribe ‘unlicensed’ medicine if it is for the benefit of the patient.

Will thalidomide cure my skin condition?

Thalidomide does not work for everybody, but it may improve and control certain skin diseases. It is not a cure and the condition usually recurs when treatment is stopped.

How often/when should I use thalidomide?

Thalidomide causes drowsiness so it should be taken at bedtime. It may be taken with or without food.

What dose of thalidomide should I take?

The dose of thalidomide will depend on your skin disease and whether you have other medical conditions. The dose may be adjusted depending on how well it works and any side effects.

When should thalidomide be avoided?

    Pregnancy: Anybody planning a pregnancy must not take thalidomide. Women must not take thalidomide, if they are planning a pregnancy or think they may be pregnant. Men must not father children or donate semen whilst on thalidomide and for one week after stopping, as thalidomide is present in semen. For the same reason, men taking thalidomide should use condoms if their partner is pregnant.

  • Risk of deep vein thrombosis: If you have a history of blood clots (deep vein thrombosis or pulmonary embolism) or other risk factors for this, such as smoking, high blood pressure or high blood fats, the potential benefits of thalidomide need to be carefully considered as this drug increases the risk of getting blood clots.

  • Peripheral neuropathy (a condition in which the nerves in hands and/or feet are not working correctly) may be made worse by thalidomide.

  • Thalidomide is only for use by the person for whom it has been prescribed, and must never be shared with anyone. At the end of the treatment course, any un-used medication should be returned to the pharmacy.

Thalidomide and pregnancy

Thalidomide causes serious damage to an unborn baby. It must never be taken during pregnancy. Babies born to mothers who took small doses of thalidomide during pregnancy have suffered with serious physical disability such as absent limbs (phocomelia) and learning disability.

All women who are at risk of conceiving will be entered into a pregnancy prevention programme before starting thalidomide to minimise the risk of pregnancy. This involves the following:

    For at least 4 weeks before starting thalidomide, women of child-bearing potential must use at least one, and preferably two, forms of adequate contraception. This needs to be continued throughout treatment and for 4 weeks after stopping thalidomide.

  • Usually one form of contraception will need to be a barrier method such as condoms or a cap. The progesterone-only pill (‘The Minipill’) is not considered effective enough alone.

  • The combined oral contraceptive pill should be avoided due to the increased risk of blood clots. Specialist advice on contraception is available at family planning clinics.

  • Women will need to sign a form stating that they understand the harmful effects of thalidomide on an unborn baby and that they agree to take part in the pregnancy prevention programme.

  • Thalidomide should be started on day 2 or 3 of the menstrual cycle.

  • The maximum supply of medication is for 30 days and the prescription is only valid for 7 days after being signed. A negative pregnancy test is required before each prescription.

  • Women must avoid becoming pregnant whilst taking thalidomide, and for a month after stopping treatment.

  • A final pregnancy test is checked 5 weeks after finishing treatment.

  • If a pregnancy occurs or is suspected whilst taking thalidomide, the drug must be stopped immediately. Contact your doctor, so you may be referred for specialist obstetric advice.

Do all women and men have to enter the pregnancy prevention programme?

Women who are beyond the menopause or who have been sterilised may be excluded from the pregnancy prevention programme.

The pregnancy prevention programme also affects men, who must agree to avoid fathering children during treatment with thalidomide and for one week after stopping. This is necessary because the drug is secreted in semen. Men taking thalidomide should use condoms if their partner is pregnant.

Will thalidomide affect fertility or future pregnancies?

Thalidomide does not affect fertility and there is no long-lasting effect on future pregnancies. However, pregnancy must be avoided for a month after completing treatment to avoid exposing an unborn baby to any medication that might still be present in the woman’s body.

What are the common side effects of thalidomide?

Thalidomide causes tiredness, fatigue and drowsiness so it should be taken at bed time. Do not drive or operate machinery if you develop these side effects. Alcohol should be avoided as it may increase the possibility of drowsiness. Other common side effects include a dry mouth and constipation.

Thalidomide can cause peripheral neuropathy, which means damage to the nerve endings. This may result in numbness, tingling, pain and weakness in the hands, arms, legs and feet. Any of these symptoms should be reported as soon as possible to the prescriber.

What are the rarer side effects of thalidomide?

Thalidomide can reduce the number of white blood cells (neutropaenia), which may result in an increased risk of getting infections. If you develop prolonged symptoms of mouth ulcers, a sore throat or a fever, you need to inform your doctor.

Thalidomide can also reduce the number of platelets (thrombocytopaenia), which may result in an increased chance of excessive bruising or bleeding.

Thalidomide can cause damage to the liver, which may not cause symptoms, so it is important to have regular blood tests as advised by your doctor.

Thalidomide can lead to the formation of blood clots (thromboembolism). Sudden breathlessness or chest pain, or unexplained pain and swelling of an arm or leg, may be a sign of a blood clot. If you develop any of these symptoms you should seek urgent medical advice. Smokers are at increased risk of blood clots and should make every effort to stop smoking.

Thalidomide can slow the heart rate causing dizziness and fainting so the pulse and blood pressure should be checked regularly. It may also increase the risk of heart attack and stroke.

Very rarely, thalidomide can cause a severe allergic rash with skin blistering. It should be stopped immediately if a new widespread rash appears. Other rare side effects include an underactive thyroid.

How will I be monitored for the other side-effects of thalidomide treatment?

Regular blood tests to check the kidney, liver, white blood cell count and platelets are required. If symptoms such as numbness or strange sensation in the hands or feet, difficulties with coordination, or weakness, develop, examination of the nervous system and nerve conduction studies may be needed.

Can I give blood if I am taking thalidomide?

Patients on thalidomide must not give blood.

May I drink alcohol while taking thalidomide?

Drinking alcohol will increase the sedating effects of thalidomide and will increase tiredness. It will impair thinking and reactions and therefore decrease the ability to drive or operate machinery.

Because of the risk of liver damage, alcohol intake should be limited whilst taking thalidomide.

Can I take other medications at the same time as thalidomide?

Any other medicine that may cause drowsiness may make a person more sleepy when taken with thalidomide. This includes some over-the-counter cold or hay fever medications, sleeping tablets, some anti-depressants, muscle relaxants, seizure treatment and pain killers. (Please ask your pharmacist if in doubt.)

Any drugs which may slow the heartbeat, for example blood pressure medication or tricyclic antidepressants, can aggravate this side effect when taken with thalidomide. This may lead to dizziness or fainting.

Because many drugs may interact with thalidomide, always discuss with your doctor before starting any new medication.

Where can I get more information about thalidomide?

Web links to detailed leaflets:

https://www.medicines.org.uk/emc/medicine/21005

https://www.medicines.org.uk/emc/PIL.22442.latest.pdf

http://dermnetnz.org/treatments/thalidomide.html

http://www.emedicinehealth.com/drug-thalidomide/article_em.htm

For details of source materials used please contact the Clinical Standards Unit (clinicalstandards@bad.org.uk).

This leaflet aims to provide accurate information about the subject and is a consensus of the views held by representatives of the British Association of Dermatologists: individual patient circumstances may differ, which might alter both the advice and course of therapy given to you by your doctor.

This leaflet has been assessed for readability by the British Association of Dermatologists’ Patient Information Lay Review Panel

BRITISH ASSOCIATION OF DERMATOLOGISTS

PATIENT INFORMATION LEAFLET

PRODUCED JULY 2015

REVIEW DATE JULY 2018

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