The Food and Drug Administration is warning several companies, including retail chains CVS and Walgreens, to stop selling unapproved and potentially dangerous eye drops. Products. The agency alleges that the companies committed a number of violations in the manufacture or marketing of these products. The FDA is also concerned about the addition of silver compounds in some products because silver can permanently turn people’s skin or eyes blue with long-term use.
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The FDA announced Tuesday that it is sending warning letters to eight different companies regarding their eye drop products. These companies include CVS Health and Walgreens Boots Alliance, Inc., both owners of retail pharmacy chains that sell branded versions of popular over-the-counter medications and health products. Other signposted companies, such as Similasan and Boirón, produce products commonly sold in retail pharmacies or online.
The FDA claims that the eye drop products sold by these companies are being marketed illegally. The labeling of these products often claims that they can treat or cure conditions such as conjunctivitis, cataracts, glaucoma, and others. As a general rule, however, anything sold in the United States that specifically claims to solve a medical problem must have been previously cleared, cleared, or approved by the FDA, and the agency states that these products do so Did not go through the process.
Some brands of eye drops were also allegedly manufactured in facilities that recently failed to meet standard manufacturing guidelines for product safety. and quality, including eye drops sold by CVS and Walgreens. The FDA goes on to say that these two brands of eye drops in particular contain silver, which appears to be used as a preservative. While silver can be used medicinally (often for its antimicrobial properties), the FDA is concerned that its use in eye drops could be dangerous. Long-term use of silver as a medicine is known to cause a condition called argyria, which can permanently turn our skin, internal organs, and soft tissues (including that of the eye) blue.
“The FDA is particularly concerned that these unapproved and illegally marketed eye medications pose an increased risk of harm to users because they are applied to the eyes by circumventing some of the body’s natural defenses,” the agency said in its announcement.
Many of the products mentioned by the FDA in these letters are also listed as homeopathic medicines. Homeopathy is a not-so-old form of alternative medicine that has no clear evidence of its effectiveness in treating medical problems. The agency cautions that people who use unapproved products such as these may delay or stop using products that have actually been shown to be safe and effective for their intended use.
The companies are expected to respond to the FDA within 15 days on how they will address their alleged violations. The agency has the option to take additional measures, including legal action, to seize or stop manufacturing these products. The FDA has also placed some of the companies on an import alert list, allowing the FDA to hold products shipped from abroad without inspecting them before they can be imported into the country.
“When we identify illegally marketed, unapproved drugs and drug quality deficiencies that pose potential risks, the FDA works to notify the companies involved of the violations,” said Jill Furman, director of the Evaluation Center’s Office of Compliance. and FDA Drug Research, in a statement. Continue to take the medications you need with confidence.”