The Food & Drug Administration (“FDA”) oversees the regulation and safety of prescription drugs, over-the-counter drugs, and medical devices. It also oversees the regulation and safety of many food items and cosmetic products. Below are recent notifications by the FDA concerning the safety of drugs and medical devices:
Eye Drops
The FDA issued a warning for certain over the counter eye drops after it found bacterial contamination in the products’ manufacturing facility. The contaminated products may cause eye infection that can lead to vision loss.
Brands subject to the warning include CVS Health, Leader, Rugby, Rite Aid, Target Up&Up, Equate, and Velocity Pharma. The same facility manufactured all of the products. The 26 products are sold nationwide in stores including CVS, Rite Aid, Walmart, and Target. No recall has been issued for any of the eye drops. However, the FDA recommends that the manufacturers recall all of the products. A complete list of products can be found here.
The Safety Alert follows an FDA warning a few months ago urging consumers to stop using two eye drop products manufactured by Dr. Berne’s and LightEyez. Dr. Berne’s products were found to contain a fungus that could lead to eye infections. Likewise, LightEyez eye drops were contaminated with drug resistant bacteria. The same drug resistant bacteria was previously found in other brands of artificial tears and eye drops. Sadly, 81 people died from bacterial infections associated with the products.
Essure
Essure is a permanent birth control device for women. The device is implanted into the fallopian tubes. Tissue grows around the device to block the fallopian tubes, thereby preventing conception.
Unfortunately, numerous women reported adverse events related to the implant. Injuries include abdominal pain, abdominal bleeding, organ perforation, metal poisoning, and accidental pregnancy. Subsequently, the manufacturer, Bayer, stopped selling Essure in 2018.
In response, the FDA implemented a post market surveillance study to learn more about the long-term effects of Essure. The FDA recently published interim results of the study since it has been in place three years. Predictably, the study confirms the severe injuries women implanted with the device have reported for years.
If you or a loved one has been injured by the aforementioned products, contact the FDA. You may also want to consult an attorney.
