Opportunistic etiological agents causing lung infections: emerging need to transform lung-targeted delivery
FDA Warns Against 2 More Eyedrop Products Due To Contamination : NPR
Enlarge this imagePseudomonas aeruginosa bacteria as seen under a microscope. The Centers for Disease Control and Prevention says 68 people have become infected with a drug-resistant strain of the bacteria, with many infections linked to the use of contaminated eye drops. Janice Haney Carr/AP hide caption
toggle caption Janice Haney Carr/APPseudomonas aeruginosa bacteria as seen under a microscope. The Centers for Disease Control and Prevention says 68 people have become infected with a drug-resistant strain of the bacteria, with many infections linked to the use of contaminated eye drops.
Janice Haney Carr/APThe FDA has issued a warning for consumers to stop purchasing and using two eyedrop products — Dr. Berne's MSM Drops 5% Solution and LightEyez MSM Eye Drops Eye Repair — due to bacterial and fungal contamination.
The LightEyez product was contaminated with the drug-resistant bacteria Pseudomanas aeruginosa, Mycobacterium, Mycolicibacterium and Methylorubrum. The Dr. Berne's product was contaminated with Exophiala fungi.
Both products list their active ingredient as methylsulfonylmethane (MSM), which is not found in any legally marketed eye drugs in the U.S.
Neither of the products have caused adverse effects in consumers yet, the FDA said.
Sponsor MessageThis warning comes after the U.S. Centers for Disease Control and Prevention reported an outbreak of Pseudomonas aeruginosa found in a handful of other brands of artificial tears or eyedrop products.
The bacteria strain had been found in 81 people — four of whom had died from infections, according to specimens collected between May 2022 and April 2023, according to the CDC's update this past May.
Over 10 different brands of ophthalmic drugs were involved in these cases, the CDC said. But the most common was Ezri Care Artificial Tears, which the Food and Drug Administration warned consumers to stop purchasing in February.
The CDC confirmed a matching strain of Pseudomonas aeruginosa in opened bottles of the product and says it will test unopened bottles to test whether contamination occurred during manufacturing.
Health 2 more eyedrop brands are recalled due to risks of injury and vision problemsAccording to the FDA, Ezricare's parent company, an India-based pharmaceutical provider named Global Pharma Healthcare, had failed to provide appropriate microbial testing of its over-the-counter eye product. The same was true of another of the company's products, Delsam Pharma Artificial Eye Ointment, which the company voluntarily recalled shortly after.
The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.
Global Pharma did not immediately respond to NPR's request for comment.
Two additional companies, Apotex Corp. And Pharmedica USA, recalled eyedrop products in February, though products from those companies had not been linked to infections at the time.
Health Manufacturer recalls eyedrops after possible link to bacterial infectionsPer the CDC's update in May, infections had been identified in 18 states: California, Colorado, Connecticut, Delaware, Florida, Illinois, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Washington and Wisconsin.
Common symptoms of the bacterial infection include discharge from the eye, redness of the eye or eyelid, blurry vision, a sensitivity to light and eye pain.
In the most extreme cases, the infection can spread to other parts of the body, including the bloodstream. Four people have died due to infections, the CDC said. At least 14 others have experienced vision loss and four have undergone enucleation — the surgical removal of the eyeball.
Infections are generally treated with antibiotics, but the bacteria are becoming increasingly resistant to multiple drugs. The CDC does not recommend patients undergo testing for infection unless they have symptoms.
In 2017, a drug-resistant strain of the bacteria was believed to have caused an estimated 32,600 infections among hospitalized patients in the U.S., continuing a downward trend from 46,000 in 2012, the CDC said in an informational tip sheet.
The FDA Issues Warning For Eyedrop Products Due To Infection Risk : NPR
Enlarge this imageThe FDA warned consumers to stop using eyedrop products from six different brands on Wednesday after agency investigators found bacteria contamination at a manufacturing site. Manuel Balce Ceneta/AP hide caption
toggle caption Manuel Balce Ceneta/APThe FDA warned consumers to stop using eyedrop products from six different brands on Wednesday after agency investigators found bacteria contamination at a manufacturing site.
Manuel Balce Ceneta/APU.S. Health officials are warning consumers to stop using more than two dozen over-the-counter eye drop products due to the potential risk of eye infection that could lead to vision loss.
The Food and Drug Administration on Friday issued the alert for 26 products from the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up and Velocity Pharma.
The federal regulatory agency said it recommended the manufacturers to recall of the subject products on Wednesday, after FDA investigators found bacterial contamination in critical drug production areas of a manufacturing facility.
Sponsor MessageCVS, Rite Aid and Target are removing the products in store and online, according to the FDA. Products branded as Leader, Rugby and Velocity may still be available but should not be purchased, said the agency. None of the products have caused adverse effects in consumers yet, they added.
It's the FDA's latest statements in a series of warnings against using eyedrop products linked to potential contamination. Two months ago, the FDA urged consumers to stop using two eyedrop products due to bacterial and fungal contamination. At the time, the drug-resistant bacteria Pseudomanas aeruginosa, Mycobacterium, Mycolicibacterium and Methylorubrum was found in LightEyez MSM Eye Drops Eye Repair product; Dr. Berne's MSM Drops 5% Solution was contaminated with Exophiala fungi.
In February, the Centers for Disease Control and Prevention reported an outbreak of Pseudomonas aeruginosa tied to the contamination of other brands of artificial tears and eyedrops.
As NPR previously reported, the bacteria strain was found in 81 people, four of whom had died from infections, the CDC said in May.
Over 10 different brands were linked to the infections, the most common being Ezri Care Artificial Tears from India-based Global Pharma Healthcare. The FDA said Global Pharma's microbial testing of its eye product was inadequate and that the pharmaceutical provider failed to use adequate, tamper-resistant packaging and distributed the drugs without proper preservatives.
Two additional companies recalled eyedrop products in February, although those products were not linked to the infections at the time.
In its Friday notice, the FDA did not specify the bacteria strain that was found at the manufacturing site.
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