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INFORMED CONSENT FOR THE USE OF PURINETHOL
(6 MERCAPTOPURINE) OR IMURAN (AZATHIOPRINE)
Your physician has prescribed you a medication called 6-Mercaptoprine (6MP, Purinethol) or Imuran (Azathioprine). The purpose is to control inflammatory bowel disease (IBS), i.e Crohn’s disease, uncreative colitis, or liver inflammation. This medication is prescribed: 1. To reduce or eliminate the use of Prednisone. (Predisone is a steroid which has several potential long-term side effects). 2. To keep the disease under control over an extended period of time. 3. To treat complications of Crohn’s disease (fisrula, drainage, etc.).
Reason for Informed Consent
6MP or Azathioprine has been used for more than 30 years by thousands of patients.
These medicines have been used in very careful conducted studies. These medications are
not FDA approved because the pharmaceutical companies have chosen to apply to the
FDA for approval, since these medicines are already available and on the market for
other disease and conditions. These drugs have been used for cancer treatment, to prevent
injection for organ transplants and for other immune disorders for many years.
Another reason is to inform you of the complications, which may occur.
Complications

1. Pancreatitis. (Inflammation of the pancreas). The pancreas is responsible for
producing digestive enzymes and insulin. When pancreatitis develops, usually this causes pain in the upper abdomen that radiates to the back. This may be associated with nausea and vomiting. Pancreatitis caused by these medications usually occurs within several weeks of starting the medication. It occurs in about 3% of patients. If pancreatitis should develop, 6-MP or Imuran is stopped and the pancreatitis resolves without complications. 2. Bone Marrow Suppressions. These Medications can cause reduction in cell
counts, most commonly the white blood cell count. This could predispose to serious infection. For these reasons, while on 6-MP or Imuran, the blood counts need to be monitored on a regular basis. Usually this is preformed more frequently as the medication is being started. In patients who do not comply with having their blood work checked, as recommended, Prescription refills are not granted. 3. Other Possible Symptoms. Joint and muscle pain, skin rash and nausea are
occasionally noted. These Symptoms often will improve with time and/or reducing the dose. 4. Elevation of Liver Tests. Rarely a drug-induced hepatitis can occur. Reducing
the dose, or stopping the drug results in complete resolution. There have not been cases of chronic liver disease caused by these medications. 5. Infections. These medicines do modulate the immune system and may predispose
to a variety of bacterial and viral infections. 6. Possibility of Malignancy. These medications do modulate the immune system
and could theoretically pre-dispose to malignancy. There have been rare cases of cancer in reported in patients with chronic inflammatory bowel disease who have been on these medications, but it has not been proven that these medications do contribute to the development of malignancy. Malignancy has been reported with these and similar medications when used in other settings, such as organ transplant, but these patients take these along with other medications in higher dose. 7. Use in Pregnancy. These medications have been felt to be reasonably safe to
continue during pregnancy. The risk/benefit should be discussed with your physicians (including obstetrician), if you intend to become pregnant.
I _______________________________ UNDERSTAND THE REASON FOR THE
USE OF 6MP/ASATHIOPRINE AND UNDERSTAND THE RISKS AND SIDE
EFFECTS, AS OUTLINED ABOVE. ALL OF THE QUESTIONS REQARDING
THIS MEDICATION HAVE BEEN ANSWERED TO MY SATISFACTION AND I
AGREE TO PROCEED WITH THE TREATMENT.

Signature of Patient:_________________________________ Date:________________

Source: http://springfieldgastro.com/uploads/2/8/0/6/2806297/consent_for_the_use_of_purinethol.pdf

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