The FDA announced yesterday that due to five cases of eye infections reported at one Georgia medical practice, a “compounding pharmacy” in Georgia has voluntarily recalled 79 lots of Avastin (bevacizumab) repackaged into small vials intended for retinal (eye) injections. Ophthalmologists sometimes use bevacizumab as an off-label treatment (not approved by the FDA) for “wet” macular degeneration.
No Avastin preparations for oncology practices were involved in the recall.
Clinical Specialties, the Georgia compounding pharmacy, said it distributes the bevacizumab-filled syringes to about a dozen physicians in Georgia, Louisiana, South Caroline and Indiana.
Just two days ago, the FDA announced that the New Jersey compounding pharmacy Med Prep Consulting was recalling all of its products after 5 bags of magnesium sulfate were found contaminated with mold. That recall also involved Avastin in prefilled syringes, as well as morphine and fentanyl products (but no other oncology drugs).
After a fungal meningitis outbreak last year killed dozens of people who were given a contaminated steroid from a Massachusetts compounding pharmacy, the FDA was criticized for inadequate regulation of compounding pharmacies that produce or repackage drugs on an industrial scale. Legislators, advocates, and regulatory staff are working on solutions for heightened monitoring.
What Patients Need to Know
Fight Colorectal Cancer monitors FDA recall announcements for recalls which might affect–or raise concerns for–colorectal cancer patients. More information is available directly from the sources listed with each update. In this case, oncology patients are not affected by recalls of Avastin repackaged for eye injections.
Sources: “Clinical Specialties Issues Voluntary Nationwide Recall of Avastin Unit Dose Syringes due to Potential Serious Eye Infection,” FDA press release, March 18 2013 ; “Compounding Pharmacy Crackdown Continues With Avastin Recall,”March 19 2013 Medscape Oncology News ; “Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination,” March 17 2013 FDA press release.