Compounding pharmacy issues voluntary nationwide recall due to sterility issues
By Jennifer A. Webb
Washington, DC-The manufacturer of a cancer drug commonly used to treat wet age-related macular degeneration (AMD) is renewing its warning against its off-label use in the eye. This action was prompted after a Georgia compounding pharmacy began recalling all lots of the single-use syringes it prepared for ophthalmologists.
Genentech, which makes bevacizumab (Avastin, Genentech/Roche), reminded ophthalmologists that only its FDA-approved ranibizumab (Lucentis) is approved for use in the eye.
“We do not support or promote the off-label intravitreal use of [bevacizumab] for disorders of the eye. [Bevacizumab] is not manufactured or approved for use in the eye,” said Genentech spokesman Terry Hurley in an e-mail response to Ophthalmology Times’ request for comment.
“The practice of compounding medicines in the pharmacy may introduce the potential for error due to improper or inadequate handling procedures, which may lead to microbial or particulate contamination, or incorrect dosing calculations,” Hurley said.
The FDA announced March 18 that Clinical Specialties, of Martinez, GA, was recalling 79 lots of bevacizumab (unit dose syringes that were linked to five cases of endophthalmitis reported to the Centers for Disease Control and Prevention. Two days later, the FDA said the compounding pharmacy had expanded its recall to include all lots of all sterile products distributed nationwide after it was unable to confirm their sterility.
The individual, single-use syringes were prepared from a larger vial of bevacizumab for off-label injection into the eye to treat wet AMD. The lots were distributed between Dec. 18, 2012, and March 19, to ophthalmology practices in Georgia, Indiana, Louisiana, and South Carolina.
On March 20, the FDA announced that Clinical Specialties was recalling all lots of its repackaged products in the interest of its patients, even though there had been no evidence of contamination with sterile products other than the specified bevacizumab lots. The additional lots, which included such eye preparations as latanoprost 0.025% eye drops, mitomycin solutions, ophthalmic dilation gel, and vancomycin, were distributed nationwide between Oct. 19, 2012, and March 19.
Healthcare providers were instructed to immediately stop using products distributed by Clinical Specialties and return them to the company.
Clinical Specialties’ representatives did not return calls seeking comment.
Many retina specialists rely on bevacizumab because it can be administered at a fraction of the cost of ranibizumab, and the two drugs have similar efficacy in treating wet AMD. But because bevacizumab is only available in larger quantities, specialists rely on compounding pharmacies to prepare single-unit syringes.
“When intravitreal [bevacizumab] is used in everyday practice, a single-use vial for intravenous infusion must be compounded into several smaller doses for use, thus making it possible that multiple eyes are treated from a single vial intended for a single patient for intravenous use,” Hurley said. “The compounding of [bevacizumab] into smaller doses for injection into the eye brings with it further uncertainty due to the risk of potential contamination and infection, inflammation.”
He reiterated Genentech’s position that ophthalmologists prescribe ranibizumab.
“We specifically designed [ranibizumab] for use in the eye and to clear quickly from the bloodstream to minimize side effects,” Hurley said. “[Ranibizumab] is approved for use in the eye by health authorities worldwide. [Ranibizumab] also has a well-characterized safety profile, following more than 6 years of real-world use and [more than] 1 million patient-treatment years of exposure.”
Consumers or health-care providers with questions regarding this recall may contact Clinical Specialties by phone at 866/880-1915 or e-mail at email@example.com Monday through Friday between the hours of 10 a.m. to 5 p.m. EDT. Patients who have received any product distributed by Clinical Specialties Compounding and have concerns should contact their health-care provider.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. For additional information, visit http://www.fda.gov/Safety/Recalls/ucm344786.htm.