FDA Warns 8 Companies Over Marketing Unapproved Eye Drops That Could Cause Harm

FDA issued warning letters to 8 companies marketing unapproved ophthalmic drugs
Products claim to treat conditions like conjunctivitis, cataracts, and glaucoma without FDA approval
FDA concerned unapproved eye drops bypass body's defenses and pose harm
Some products contain silver that can permanently discolor eyes and skin
FDA asked companies to respond in 15 days on how they will correct violations

fda.gov

Relevant topic timeline:

8/23/2023

In a new warning, FDA urges people to stop using contaminated eyedrops

The FDA is warning people to stop using certain brands of eyedrops due to fungal and bacterial contamination, which can pose a risk to consumers and potentially lead to serious vision-threatening infections.

8/24/2023

FDA warns against using certain eye drops over microbial contamination

The US FDA has issued a warning against certain eye drops from Dr. Berne's and LightEyez due to microbial contamination, urging consumers to discard them to avoid potential vision-threatening infection.

8/24/2023

Ophthalmic Disease Therapeutics Market Set to Soar Past USD 53.8 Billion by 2030

The global Ophthalmic Disease Therapeutics Market is projected to reach USD 53.8 billion by 2030, with a CAGR of 6.10% in the forecast period, driven by factors such as the increasing prevalence of ophthalmic diseases and advancements in treatment options.

8/30/2023

US FDA declines to approve Outlook Therapeutics' eye disease drug

The U.S. Food and Drug Administration has declined to approve Outlook Therapeutics' experimental eye disease drug due to manufacturing issues observed during inspections, causing the company's shares to plummet by 78%.

9/12/2023

FDA Cracks Down on Retailers Selling Unapproved Eye Drops with Silver

The U.S. FDA has warned eight companies, including CVS Health Corp and Walgreens Boots Alliance, against manufacturing or marketing unapproved eye products that are illegally marketed to treat various eye conditions and pose increased risk, with some labeled as containing silver which can lead to permanent color changes in the eye.

9/12/2023

FDA Warns Retailers About Marketing Unapproved Eye Drops Containing Silver that Can Discolor Skin and Eyes

The FDA has warned CVS, Walgreens, and other companies for illegally marketing unapproved eye products, some of which contain silver and can cause the eye to permanently turn gray or blue-gray; multiple eye products have been recalled this year due to harm caused to people, including blindness and infections.

9/14/2023

FDA Recalls Raise Concerns Over Safety of Some Over-the-Counter Eye Care Products

Recent recalls and warnings regarding eye health products have raised concerns about their safety, with some products being illegally marketed and contaminated, leading eye experts to advise caution and consultation with a healthcare professional to ensure proper vetting and selection of eye drops and other eye care products.

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Posted 9/12/2023, 4:00:00 AM

FDA Warns 8 Companies Over Marketing Unapproved Eye Drops That Could Cause Harm

FDA issued warning letters to 8 companies marketing unapproved ophthalmic drugs
Products claim to treat conditions like conjunctivitis, cataracts, and glaucoma without FDA approval
FDA concerned unapproved eye drops bypass body's defenses and pose harm
Some products contain silver that can permanently discolor eyes and skin
FDA asked companies to respond in 15 days on how they will correct violations

fda.gov

Relevant topic timeline:

8/23/2023

In a new warning, FDA urges people to stop using contaminated eyedrops

8/24/2023

FDA warns against using certain eye drops over microbial contamination

8/24/2023

Ophthalmic Disease Therapeutics Market Set to Soar Past USD 53.8 Billion by 2030

8/30/2023

US FDA declines to approve Outlook Therapeutics' eye disease drug

9/12/2023

FDA Cracks Down on Retailers Selling Unapproved Eye Drops with Silver

9/12/2023

FDA Warns Retailers About Marketing Unapproved Eye Drops Containing Silver that Can Discolor Skin and Eyes

9/14/2023

FDA Recalls Raise Concerns Over Safety of Some Over-the-Counter Eye Care Products