Avastin is a drug approved by the U.S. Food and Drug Administration for the treatment of cancer. However, healthcare professionals also use Avastin off-label to treat an eye disease known as wet AMD (age-related macular degeneration). Off-label use refers to an FDA-approved drug being prescribed to treat a condition other than the one for which it was approved. Recently, off-label use of Avastin has come under scrutiny after numerous patients in the Miami area developed serious eye infections from this dangerous drug. Patients at three Miami-area clinics suffered from Streptococcus endophthalmitis following Avastin injections. When a defective drug like Avastin harms patients, an experienced drug attorney can protect their rights.
The Streptococcus endophthalmitis outbreak in the Miami area was traced to a single pharmacy in Hollywood, Fla., which repackaged Avastin from 4 mL single-use vials into 1 mL single-use syringes. The FDA reported in August that there were 12 confirmed cases where patients who used the syringes developed an endophthalmitis infection. All of the affected patients had vision problems before using Avastin, but the infection caused some to lose all remaining vision. Eye infections associated with off-label Avastin use have also been reported in Nashville and Los Angeles.
In September, the U.S. Department of Veterans Affairs (VA) announced its suspension of off-label Avastin use pending an investigation into the reports of serious eye infections and blindness. Avastin gained popularity as a wet AMD treatment because it costs as little as $50 per injection, compared to $2,000 per injection of Lucentis, a drug approved by the FDA specifically for the treatment of wet AMD.
Although the Roche Group’s Genetech unit, which manufactures Avastin, has not issued a drug recall, the company reportedly opposes off-label use of the cancer drug. Genetech recommends Lucentis for the treatment of wet AMD, another of its products. Some reports speculate whether Genetech opposes treating wet AMD with Avastin simply because substituting Avastin for the more expensive Lucentis cuts into the company’s profits.
Doctors in the United States are allowed to use an FDA-approved drug to treat any condition, not just the one for which the drug was approved. Healthcare providers routinely use drugs in this off-label fashion to treat a variety of illnesses. The risk of harmful side effects or medication errors may be higher with off-label drug use, because while permitted, off-label use is not regulated in the United States, and research into off-label uses for a particular drug may be limited.
All drugs come with risks, and patients should be aware of possible side effects whether they are prescribed a drug off-label or for its intended use. If you or a loved one has been harmed by a recalled drug, a medication like Avastin that was prescribed for an off-label purpose, or any prescription or over-the-counter medicine, contact a qualified drug lawyer today to discuss your case and learn about your legal rights.