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Avastin Associated With Life-threatening Side Effects

Avastin (bevacizumab) is a chemotherapy drug marketed by Genentech (a Roche company). It targets a protein found in many cancer cell types and halts cancer growth.

Avastin was approved by the FDA in 2004 and is usually given along with other chemotherapy drugs to treat different types of cancer, including:

  • non-small cell lung cancer
  • colon or rectal cancer
  • brain cancer
  • kidney cancer

In 2011, the FDA revoked the drug’s approval for treating metastatic breast cancer. The agency determined that the life-threatening risks associated with the drug did not justify its use in treatment.

  • The addition of Avastin to chemotherapy resulted in only a small delay in tumor growth (i.e., progression-free survival, PFS), and the average time it took for tumors to progress clinical trials was much shorter than had been expected based on the data from an earlier trial that led to accelerated approval.
  • The addition of Avastin to chemotherapy did not prolong the lives of women with breast cancer (i.e., overall survival, OS).

SIDE EFFECTS OF AVASTIN

Gastrointestinal (GI) perforation

  • GI perforation is the development of a hole in the stomach, small intestine, or large intestine.
  • Symptoms may include abdominal pain, nausea, vomiting, constipation, and fever.
  • Gastrointestinal Perforation: Occurs in up to 2.4% of Avastin-treated patients.
  • GI perforation can be fatal.

Perforations (holes in the body)

  • the nose (nasal septal perforation)
  • the stomach and intestines (gastrointestinal perforation and fistulas)

Incomplete Wound Healing

  • Treatment with Avastin can lead to slow or incomplete wound healing.
    • Ex: when a surgical incision has trouble healing or staying closed.
  • In some cases, this event resulted in fatality.

Fatal Bleeding

  • Treatment with Avastin can result in severe or fatal hemorrhage or hemoptysis.
  • This includes coughing up blood, bleeding in the stomach, vomiting blood, bleeding in the brain, nosebleeds, and vaginal bleeding, gastrointestinal bleeding, CNS hemorrhage, and vaginal bleeding.
  • These conditions often require blood transfusions.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

  • Development of a syndrome characterized by high blood pressure, headaches, confusion, seizures, visual loss, and evidence of swelling of the brain on brain (MRI) scans.

OTHER POSSIBLE SIDE EFFECTS

  • The formation of an abnormal passage from parts of the body to another part, sometimes fatal.
  • Stroke or heart problems, which can be fatal. Heart problems include blood clots, mini-stroke, heart attack, and chest pain.
  • Too much protein in the urine, which may lead to serious kidney problems.
  • Severe high blood pressure.
  • Nervous system and vision disturbances. Symptoms may include high blood pressure, headache, seizure, sluggishness, confusion, and blindness.
  • Infusion reactions. These may include high blood pressure or severe high blood pressure that may lead to stroke, difficulty breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headaches, tremors, and excessive sweating.

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