Dozens of batches of the Roche drug Avastin are being recalled after being linked to at least five cases of inner eye infection.
A safety alert posted today by the U.S. Food and Drug Administration says the recall is being conducted voluntarily by Clinical Specialties, the drug’s Martinez, GA compounding pharmacy.
Avastin is widely used by ophthalmologists to treat macular degeneration, a common vision disorder among senior citizens. Physicians typically administer the drug during surgery or in a medical office. It is packaged in sterile syringes.
Beginning in December 2012, the syringes were distributed to doctors in Georgia, Louisiana, South Carolina, and Indiana.
The infections leading to the current recall were identified and reported by physicians who had used the drug on patients.
Avastin was originally approved as a cancer drug. It’s use for macular degeneration was an off-label use, not approved by the FDA. According to a report in the Washington Post today, Avastin is structurally similar to Lucentis, another drug made by Swiss drug maker Roche. Lucentis is approved to treat macular degeneration – but at a much higher cost. Repackaged injections of Avastin only cost about $50, compared with $1050 for Lucentis. Compounding pharmacies have been repackaging Avastin for years in small vials for use by eye doctors.
Roche apparently discouraged the off-label use of Avastin, according to the Washington Post report. That same report notes however, that the American Academy of Ophthalmologists claims there is no detectable difference in outcomes for patients between the two drugs.
What to do
Clinical Specialties recommends that doctors who have the product, stop using it immediately. And consumers who may have questions are asked to call Clinical Specialties directly. The phone number is 866.880.1915. Consumers can also contact the company through email at the following address: firstname.lastname@example.org
Any patients who have experienced problems that could be related to this product should also contact their physician. Patients can also report adverse reactions or quality problems resulting from the product to the FDA through its MedWatch Adverse Event Reporting program – www.fda.gov/medwatch/report.htm
A March 18th press release issued by Clinical Specialties, provides the lot numbers of all the batches of Avastin covered by the recall.