The U.S. Food and Drug Administration has warned eight companies including CVS Health and Walgreens Boots Alliance, Inc. against manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.
The agency has issued warning letters as part of its ongoing effort to protect Americans from potentially harmful ophthalmic products.
Apart from CVS Health and Walgreens, the letters have been issued to Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics, Inc., OcluMed LLC, Similasan AG/Similasan USA, and TRP Co., Inc.
The unapproved eye products in question are illegally marketed to treat conditions such as conjunctivitis or pink eye, cataracts, glaucoma and others. Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility.
According to the agency, these illegally marketed, unapproved ophthalmic drug products are highly likely to cause harm to users as drugs applied to the eyes bypass some of the body’s natural defenses.
Among these affected eye products, some are labeled to contain silver, which may be characterized as silver sulfate, silver sulphate or argentum. The FDA noted that long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray, which is called “argyria.”
Further, with these unapproved drugs that claim to cure, treat or prevent serious conditions, consumers are likely to delay or stop medical treatments that have been found safe and effective through the FDA review process.
The agency’s investigation of eye products is ongoing, and it may take additional regulatory or enforcement actions, as warranted. Consumers currently using the affected eye products are urged to check with their health care professional, and to report any adverse reaction to FDA’s MedWatch program.
The companies are required to respond within 15 days of receipt of the letters with their planned measures to correct the violations. If failed, the FDA will pursue legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing an unapproved product.
The FDA also has placed some of these companies on import alert to help stop their products from entering the U.S.
Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, said, “When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations. We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern.”
In late August, the agency had issued warning letters to three infant formula manufacturers for violations of infant formula regulations.
In June, such letters were issued to 189 retailers against unauthorized sales of two of the most popular disposable e-cigarettes in the U.S., specifically Elf Bar and Esco Bars brand e-cigarettes.
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