Drugs

Warning on ‘Copycat’ Bausch Eye Drops

FDA has issued a warning on South Moon and Rebright or FivFivGo eye drops because of potential risks for eye infections. “These are copycat eye drop products that consumers can easily mistake for Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief,” the warning says.

FDA tested samples of South Moon and Rebright eye drops and Burkholderia cepacia complex, a group of bacteria that could result in an antibiotic-resistant infection, was detected. “While Rebright testing was negative for contamination, FDA recommends consumers not use this product,” the agency says.

FDA notes the copycat drops are unapproved drugs and should not be available for sale in the U.S. The warning includes photos comparing the similarity of copycats to the brand product.

“They claim to treat eye conditions such as glaucoma, which is treated with prescription drugs or surgery,” it says. “Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately. FDA recommends consumers properly discard the products.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome