Sickle Cell Information Center Guidelines

Edited by James Eckman, M.D. and Allan Platt, PA-C

Hydroxyurea Consent for Patients

Hydroxyurea is used to treat other sickness, but may increase fetal hemoglobin levels in your sickle blood cells. Fetal hemoglobin is the hemoglobin in babies before birth, it does not sickle and may prevent my sickle blood cells from sickling. It is thought that this will prevent pain episodes (crisis) and other sickling related problems hepatic sequestration, priapism and renal damage).

I understand that I will have to take the hydroxyurea and folic acid every day, unless otherwise instructed to stop by or other mid-level providers at the . I must also have my blood checked every two weeks initially after starting the hydroxyurea and at least monthly after my MTD (maximum tolerated dose) level is reached. The MTD is reached by adjusting the dose to highest level of medicine that will increase the fetal hemoglobin, but does not cause my blood counts to fall too low or cause other bad reactions.

Each visit will take about half an hour. At each visit a blood sample from a vein will be drawn with a needle and placed in a test tube to be evaluated for safe levels of treatment, and to determine if the medication dosage should be changed. These samples will also be checked to verify if medication appears to be taken.

Because it is also possible that treatment with hydroxyurea could be dangerous is I am infected with the HIV (AIDS) virus, my blood will be tested for the presence of HIV (AIDS) virus. I will be told the results of the test, and if it is positive, I will be given counseling and advice on how to get good treatment for the problem.

The risks of treatment have been explained to me and I understand that medicine can cause a sick stomach and vomiting, infection, bleeding, hair loss, fever, liver damage, kidney damage, and skin rash. These bad effects are rare, occurring in fewer than one in a hundred patients being treated, and usually disappear quickly if the drug is stopped or if the amount is reduced. There is a risk of also gaining a considerable amount of weight while taking the drug.

I understand that some believe that taking hydroxyurea over a long period of time may increase my chances of getting cancer. Studies in animals and man show that, if there is any increased change of getting cancer from taking this medication, this risk of cancer must be very low. No studies in humans have shown an increased risk of leukemia (blood cancer) when hydroxyurea is given to people with other types of blood cancer.

Hydroxyurea may damage an unborn baby. If I plan to get pregnant I cannot use hydroxyurea. If I agree to use it I must use birth control methods (birth control pills or diaphragm, for example) or I or my partner will have had an operation to prevent pregnancy like tubal ligations (tubes tied), the womb removed or a vasectomy. If I am not taking birth control precautions, and staff will help make provisions. I will be checked for pregnancy when I agree to take the medication. If I or my partner become pregnant during the time I am on hydroxyurea if I or my partner become pregnant. There may be bad effects from hydroxyurea on the baby if either the father or mother is taking the medicine. The same medical advice will be made to men as well as women. 

I understand that initially I will have blood samples drawn every two weeks to monitor the effects of the drug on blood counts, liver and kidney test as well as the level of fetal hemoglobin. The risk of drawing blood may include minimal pain, bruising, and infection at the site of blood drawing. All precautions will be taken to prevent these from occurring.

As with other therapies utilizing new treatments, there may be risks to using hydroxyurea that are not known at the present time. If any new bad effects are observed patients will be told as soon as possible and action taken to protect their safety.

The potential benefit of the medicine is that, if hydroxyurea caused an increase in the level fetal hemoglobin, it may decrease the pain due to crisis. Improvement may take several months after I am on the correct dosage of medicine. Also complications of sickle cell may decrease and health may improve secondary to hydroxyurea use (decrease transfusions and decrease episodes of chest syndromes).

If I start the hydroxyurea it is my own choice and the alternative to taking this medication is to continue my present treatment. If I stop, my care will continue as it has in the past prior to my taking the medication.

Emergency facilities will be available on a 24-hour basis for treating any problems that might arise from either blood drawing or treatment with hydroxyurea.

I understand that if I have any problems while on the medication, I should contact :

I will be provided a copy of this consent form to keep. If at any time I have any questions or concerns about my participation in this therapy, I will call about these issues. I also understand that I am free to discontinue the medication at any time. This decision will not affect subsequent medical treatment in any adverse way.

Date Participant's Signature

Witness

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Copyright © 1997 Sickle Cell Information Center
Last modified: March 07, 2002