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Precautions and Warnings With Thalidomide

Strict rules surround the prescribing and dispensing of thalidomide, as this medication has some potentially life-threatening complications associated with it. These safety precautions with thalidomide include specific warnings for women of childbearing potential; this drug can cause birth defects and fetal death if taken by a pregnant woman. Other risks apply to people who have a history of blood clots, seizures, or other medical issues.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking thalidomide (Thalomid®) if you have:
 
  • Had a blood clot in your lungs or veins
  • Human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
  • A low level of white blood cells
  • An abnormally low heart rate (bradycardia)
  • A history of seizures
  • Not had a hysterectomy or been in menopause for at least 24 months (for women)
  • Any allergies, including to foods, dyes, or preservatives.
 
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Thalidomide Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • Thalidomide is a pregnancy Category X medication because it can cause birth defects or even death in an unborn child (see Thalomid and Pregnancy). Your healthcare provider will make sure you are not pregnant before you begin treatment.

Women of childbearing potential must agree to abstain from heterosexual sex or use two forms of birth control while taking this medicine. To prevent exposing pregnant women to thalidomide, there are strict rules and regulations for prescribing and dispensing this medication (see Thalidomide Dosage for more information).

  • This drug can make you drowsy, which could affect your reaction time and mental alertness. Do not drive, operate heavy machinery, or make important decisions until you know how the medicine affects you. Also, avoid taking other medicines or substances that cause drowsiness, as this will increase your risk for extreme sedation (see Drug Interactions With Thalidomide).
 
  • Thalidomide can cause nerve damage (neuropathy), which could be permanent. Your healthcare provider will monitor you closely for nerve problems, especially during the first three months of treatment.

You should know that nerve problems can occur at any time, even after you stop taking the medication. Let your healthcare provider know if you develop signs of neuropathy, such as numbness, tingling, or pain in the hands or feet. Your healthcare provider may recommend you temporarily or permanently stop taking the medicine.

  • Thalidomide can cause a sudden decrease in blood pressure (hypotension) and dizziness when you stand up after sitting or lying down. To help minimize this side effect, try to sit up for a few minutes before standing, so your body can get used to the change in position.
 
  • Thalidomide can decrease the amount of white blood cells in your body, which could increase your risk for infections. Your healthcare provider will monitor your white blood cell counts throughout treatment using a simple blood test. If your blood counts drop too low, you may need to temporarily stop taking the medication.
 
  • People taking this medicine for multiple myeloma may have an increased risk for developing a serious blood clot in the veins or lungs. Your healthcare provider may tell you to take certain other medicines, such as blood thinners, to help reduce your risk for blood clots. Contact your healthcare provider right away if you experience symptoms of a blood clot, such as:
 
    • Shortness of breath
    • Chest pain
    • Swelling of an arm or leg.
 
  • When taken by people who have human immunodeficiency virus (HIV), this medicine has been reported to increase the amount of the virus in the body. If you have HIV, your healthcare provider will likely monitor your viral load after your first and third months of treatment, and then every three months until you stop taking the medicine.
 
  • A slow heart rate (bradycardia) has been reported in people taking this medicine. Sometimes, the heart rate lowered so much that treatment was needed. Let your healthcare provider if you become dizzy or faint during treatment, as these can be signs of a low heart rate.
 
  • Thalidomide has been reported to cause serious skin rashes, including reactions known as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If you notice any skin rash while taking this medication, contact your healthcare provider right away, as these skin reactions can cause life-threatening complications.
 
  • There have been reports of seizures occurring in people taking thalidomide. It is unclear whether this medicine caused the seizures or if they were caused by something else. If you have a history of seizures, or are at risk for seizures, your healthcare provider may choose to monitor you closely.
 
  • Like other cancer medications, thalidomide can cause a condition known as tumor lysis syndrome. This condition occurs when the breakdown of dying cancer cells leads to metabolic and electrolyte problems, such as low calcium blood levels and high levels of potassium, phosphorus, and uric acid. Tumor lysis syndrome can cause kidney problems, seizures, and even death.
 
  • Some birth control options may be safer than others in certain women taking thalidomide. For example, intrauterine devices (IUDs) and implantable birth control may increase the risk for bleeding and infection in some women, while birth control that contains estrogen may increase the risk for blood clots. If you are a woman of childbearing potential, talk to your healthcare provider about the best birth control option for your individual situation during thalidomide treatment.
 
 
  • Because thalidomide passes through semen and sperm, men taking thalidomide should not donate sperm. Men who take this medication must also agree to use a condom during sex with females who are or may become pregnant.
 
  • It is unknown whether thalidomide passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Thalomid and Breastfeeding).
 
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