The use of Avastin for eye disease can leave behind silicone “floaters” that look like air bubbles to the patient. Injections of Avastin can also cause serious infections or blindness.
Avastin Silicone Floaters and “Air Bubbles”
Avastin is not approved for eye diseases, so doctors must re-package Avastin into pre-filled syringes for eye injections. These syringes are not always safe for use in the eyes because they may be lubricated with silicone oil.
The problem is that silicone tends to migrate away from the syringe and mix into the liquid Avastin. Sometimes, silicone is injected into the patient’s eyes — leaving silicone “floaters” that look like air bubbles in the eye of the patient. These “floaters” can cause serious vision problems, including blindness.
What is Avastin?
Avastin is the brand name for the drug bevacizumab, created by Genentech, Inc. It was approved by the FDA in 2005 for first-line treatment of patients with malignant colorectal cancer. Since 2005, Avastin has gained approval for a wide variety of cancer: lung cancer (2006), breast cancer (2008), brain cancer (2009), and kidney cancer (2009).
How does Avastin Work?
Avastin is the first FDA-approved drug in new type of cancer medications. It works by preventing the formation of new blood vessels, in a process known as angiogenesis, and thereby inhibits the growth of cancerous tissue. Avastin has been shown to extend malignant colorectal cancer patients’ lives by about five months when given in combination with standard chemotherapy drugs.
FDA Warning for Avastin Eye Infections
In March 2013, the FDA and a compounding pharmacy issued a recall after contaminated lots of Avastin were linked to 5 cases of eye infections.
FDA Warning for Avastin and Blindness
In August 2011, the FDA issued another safety warning for Avastin after 12 people with eye diseases were blinded by doctors who injected their patients with small doses of Avastin. The FDA has not approved Avastin for the treatment of eye diseases.
Avastin Causing Blindness in “Off-Label” Use
Doctors commonly use Avastin for the treatment of age-related macular degeneration and other eye diseases. The reasoning is financially-motivated: one dose of Avastin costs roughly $50/injection. This is significantly cheaper than Lucentis, a similar drug created by Genentech, Inc. Lucentis has been approved for the treatment of eye diseases but costs $2000/injection.
Physicians believe that the reason Avastin is causing blindness is not because the drug is ineffective, but rather because the vials of Avastin must be repackaged into smaller doses for injection into the eye. The extra handling increases the risk of bacterial contamination.
FDA Safety Warnings for Avastin
On September 30, 2011, the FDA updated the safety label of Avastin because of the following serious risks associated with taking the medication:
- Ovarian Failure New cases of ovarian failure were identified in 34 percent (32/95) of women receiving Avastin compared with 2 percent (2/84) of women receiving chemotherapy alone.
- Venous Thrombolic Events (VTE) In a randomized study of 1,401 patients with metastatic colorectal cancer, the overall incidence of bleeding was 27.4 percent in the patients treated with bevacizumab compared with 20.9 percent in the patients treated with chemotherapy alone.
- Osteonecrosis of the jaw (ONJ) is a severe bone disease that occurs when a facial bone begins to starve from a permanent or temporary lack of blood. This side effect is probably related to the anti-angiogenic properties of Avastin.
Other safety warnings:
- September 27, 2006 – The FDA and Genentech, Inc. issued a safety warning after finding evidence of an increased risk of reversible posterior leukoencephalopathy syndrome (RPLS), a rare brain-capillary leak syndrome associated with hypertension, fluid retention, and cytoxic effects of immunosuppressive drugs on the vascular endothelium.
- August 12, 2004 — The FDA and Genentech issued a safety warning after finding an increased risk of serious arterial thrombolic events, including cerebrovascular accident, myocardial infarctions, transient ischemic attacks, angina, and fatal arterial thrombotic events. The risks of a serious arterial thrombotic event was approximately two-fold higher in patients taking Avastin, with an estimated overall rate of up to 5 percent.