Wednesday Nov 19, 2008 (foodconsumer.org) -- Use of cancer drug Avastin as part of chemotherapy raises the risk of blood clots in the veins by 30 percent, according to a new study published in the Journal of the American Medical Association.

The study analyzed 15 clinical trial of nearly 8,000 patients found Avastin, marketed by Roche and Genentech raises the risk of a blood clot in the veins from 10 percent of patients to 13 percent.

This means that 10 percent of patients who use other chemotherapy drugs alone will experience blood clots in the veins compared to 13 percent of those who used Avastin along with other chemo drugs.

Avastin a so-called angiogenesis inhibitor works to block vascular endothelial growth factor or VEGF, which helps tumors grow a blood supply.   Blood clotting is not a risk newly found. The Avastin label already acknowledges the risk.

For more information on Avastin, read on.

Patient Information Sheet: Bevacizumab (marketed as Avastin)

This is a summary of the most important information about Avastin. For details, talk to your healthcare professional.

What is Avastin used for?

Avastin is used in combination with:

    * intravenous 5-FU based combination chemotherapy regimens as the first-treatment or second-treatment for patients with metastatic colon cancer (cancer of the colon or rectum that has spread to other areas of the body).

    * carboplatin and paclitaxel for first‑ treatment of patients with unresectable (unable to remove by operation), locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.

Avastin will not cure colorectal cancer or lung cancer.   Overall, patients given Avastin plus chemotherapy for treatment of either colon cancer or lung cancer that has spread live longer than those who receive only chemotherapy.

Special Warning(s) with Avastin:    

    * Avastin may cause gastrointestinal perforation (holes in the stomach, intestines or colon) requiring surgery to repair.

    * Avastin may impair wound healing or cause wounds to open up.   Avastin should not be started for at least 28 days following major surgery and full wound healing, and should be stopped before a scheduled surgery.  

    * Mild bleeding (such as nosebleeds) is common in patients who receive Avastin.   Serious bleeding from the lungs or digestive system, requiring blood transfusions, occur in less than 5% of patients receiving Avastin.   When very severe, patients have died from blood loss.

    * Avastin may cause a severe increase in blood pressure so patients receiving Avastin should have their blood pressure checked regularly.

    * Avastin may cause proteinuria (protein in the urine, a sign of kidney damage).

    * Avastin may cause blood clots.   The chances of blood clots are highest in patients who are elderly.

    * Avastin may cause congestive heart failure (failure of the heart to pump blood well) especially when given with chemotherapy that is known to damage the heart (such as doxorubicin).

General Precautions with Avastin:

    * Avastin should be used with caution in patients who are allergic to Avastin or to any of the ingredients in Avastin.

    * Avastin may cause severe infusion reactions such as trouble breathing. This usually happens during the first dose, so patients should receive treatment in a doctor’s office or clinic.

What should I tell my healthcare provider?

Tell your healthcare provider if you:

    * have or had liver or kidney problems

    * have high blood pressure

    * have congestive heart failure or other heart problems

    * are pregnant, are trying to become pregnant, or are breast-feeding

    * have recently had surgery or are planning to have surgery

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.   Some medicines may affect how Avastin works or Avastin may affect how your other medicines work.

What are some possible side effects of Avastin? (This list is NOT a complete list of side effects reported with Avastin.   Your healthcare provider can discuss with you a more complete list of side effects.)

Serious side effects include of Avastin treatment include:

    * gastrointestinal perforation

    * impaired wound healing

    * severe bleeding

    * a dangerously high increase in blood pressure

    * kidney damage

    * blood clots

    * congestive heart failure

More common side effects of Avastin treatment include:

    * tiredness and weakness

    * stomach pain

    * headache

    * high blood pressure

    * diarrhea

    * nausea and vomiting

    * loss of appetite

    * mouth sores

    * constipation

    * lung infections

    * nose bleeds

    * shortness of breath

    * decreased white blood cells

    * skin peeling

    * protein in the urine

For more detailed information about Avastin (bevacizumab), ask your healthcare provider.

Cited from FDA