What is Gleevec?

Gleevec (imatinib mesylate) is a prescription medicine used to treat certain types of cancer -- including Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumors (GIST). Gleevec works by preventing and stopping the growth of cancer cells.

CML is a disease in which the body makes too many abnormal white blood cells, making a person become sick more often, and feel weak and tired. Gleevec helps the body stop making these abnormal white blood cells.

GIST is a group of cancer cells that start growing in the wall of the stomach, intestines, or rectum. Gleevec also helps the body stop making these abnormal cells.

Gleevec is manufactured by Novartis Pharmaceuticals Corporation, and was approved by the U.S. Food and Drug Administration (FDA) in 2001.

Gleevec and the Risk of Heart Failure

Recent studies have suggested that Gleevec can cause heart problems for patients taking the drug to treat CML. In its August 2006 publication, Nature Medicine reported a study of ten CML patients who were treated with Gleevec and developed congestive heart failure after one to fourteen months.

On the other hand, studies have shown that Gleevec keeps between 80% and 90% of CML patients cancer free for at least five years. Because the overall survival rate of most CML patients treated with Gleevec is extremely high, and because the cancer relapse rate (as well as the number of reported heart failures) is low, many say that the benefits of Gleevec outweigh its risks.

Who Should Not Use Gleevec?

Women should avoid becoming pregnant while being treated with Gleevec.

Gleevec can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. To reduce the risk of infection or bleeding, you can take the following precautions:

• Avoid people with infections. Tell your healthcare professional immediately if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your healthcare professional immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Talk to your healthcare professional about other ways you can clean your teeth and gums and before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

What Should I Tell My Healthcare Professional?

You should tell your healthcare professional if you:

• have or have had any unusual or allergic reaction to Gleevec (imatinib), or if you are allergic to any other substances (foods, preservatives, or dyes).

• are pregnant, may become pregnant, or a breast-feeding. Although Gleevec has not been studied in pregnant women, animal studies have shown that Gleevec causes birth defects and other problems with pregnancy. It is unknown whether Gleevec passes into human breast milk. Gleevec use is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

• have anemia, platelet problems, or white blood cell problems.

• have chickenpox (including recent exposure) or herpes zoster (shingles).

• have liver disease.

• have an infection.

• plan to have any immunizations (vaccinations) after you stop Gleevec treatment. Gleevec can lower your body's resistance and you may get the very infection the immunization is meant to prevent. People in your household should not take oral polio vaccine while you are taking Gleevec, and you should avoid persons who have taken an oral polio vaccine. Contact can increase your chances of contracting the polio virus.

Gleevec Side Effects

Common side effects associated with Gleevec use include:

• Nausea
• Vomiting
• Fluid retention
• Muscle cramps
• Skin rash
• Diarrhea
• Heartburn
• Headache

Serious side effects of Gleevec use are uncommon, but include:

• Severe fluid retention (edema)
• Liver problems
• Potential for bleeding (hemorrhage), especially in the elderly

Tell your healthcare professional if you experience swelling or weight gain from water retention.

Are There Any Interactions With Drugs or Foods?

Gleevec and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take - including prescription and non-prescription medicines.

Tell your healthcare professional if you take any of the following medications that may increase the amount of Gleevec in your blood:

• Ketoconazole
• Itraconazole
• Erythromycin
• Clarithromycin

Tell your healthcare professional if you take any of the following medications that may decrease the amount of Gleevec in your blood:

• Dexamethasone
• Phenytoin
• Carbamazepine
• Rifampicin
• Phenobarbital
• St. John's Wort

Grapefruit, grapefruit juice, or grapefruit-containing food or vitamins may increase the amount of Gleevec in your body, and therefore increase the chance of side effects.

Gleevec - Getting Legal Help

While most medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."

If you or a loved one have experienced any dangerous symptoms or unusual medical conditions while taking Gleevec, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Gleevec use.

• Go here to learn more about an attorney's role in a pharmaceutical liability case.
• To find an experienced attorney, use the "Find a Lawyer" tool on the left side of this page, or click here.