Recalled Artificial Tears Eye Drops Linked to Deadly Infections were Never Tested by FDA: Bloomberg Reports

Many over-the-counter products in the U.S., like the recently recalled Artificial Tears eye drops, are allowed to be sold to consumers on a sort of “honor system”, according to the report.

Federal regulators announced an Artificial Tears eye drops recall earlier this year, after reports surfaced involving dozens of severe eye infections caused by bacterial contamination, including cases that resulted in eyeball removals, blindness and fatal infections. However, a recent report highlights how the imported eye drops were allowed into the country without any testing or inspection.

The recalled Artificial Tears eye drops have been found to contain Carbapenem-Resistant Pseudomonas Aeruginosa (CRPA), which is bacteria that may result in infections resulting in mild to severe health consequences, including fever, chills, body aches, light-headedness, rapid pulse, heavy breathing, nausea and vomiting, diarrhea, and decreased urination.

The strain of Pseudomonas aeruginosa linked to recalled Artificial Tears eye drops poses a major health risk due to its antibiotic resistance and capability of mutating quickly. In severe cases, Pseudomonas aeruginosa may cause endophthalmitis, which is a rare but serious infection of the eyeball that can cause inflammation and destruction of the tissue throughout the eye, resulting in irreversible blindness.

While the manufacturers now face a growing number of Artificial Tears recall lawsuits being pursued by individuals left with devastating injuries, the federal regulatory system is also coming under scrutiny, and questions are being asked about how contaminated eye drops were able to be so widely distributed and sold in the U.S. before the problems were discovered.

Last week, a comprehensive investigative report was published by Bloomberg News (subscription required), highlighting how the U.S. Food and Drug Administration never tested the products and never inspected the overseas manufacturing facility where the eye drops were made.

Over-the-Counter Drugs Allowed into U.S. on “Honor System”

According to Bloomberg, under current regulations, many over-the-counter products sold to U.S. consumers do not require manufacturers to provide evidence establishing that they are safe or effective. In addition, manufacturers are not always required to undergo FDA inspections of their production facilities or packaging plants before they can be widely distributed to Americans.

All a company has to do is tell the FDA that it is using the approved ingredients and following good manufacturing practices. The agency does not check to see if the manufacturer’s claims are true until there is a problem, relying on a form of honor system.

In the case of Artificial Tears eye drop recall, two U.S. businessmen, neither of whom had ever sold a drug product before, hired Global Pharma Healthcare Pvt, Ltd. in Chennai, India to manufacture the eye drops, selling them under the separate Ezricare and Delsam Pharma labels. However, Global Pharma had no experience ever exporting a drug to the U.S., particularly one which had to be sterile, meaning it had never had to meet FDA standards with any of its previous products.

Despite that, the FDA allowed the product to be shipped to the U.S. and sold in pharmacies nationwide, as well as through Amazon.com and other on-line retailers.

The report highlights major failings of the FDA’s “honor system”, suggesting that the agency should have noticed the inexperience of the manufacturers involved, and the fact that the eye drops were being marketed as “preservative free,” which meant they lacked certain ingredients that are used to prevent the growth of bacterial contaminants.

FDA officials say they are trying to improve their automated systems to monitor and screen products. However, the generic drug market is growing too rapidly for the agency to keep up, Bloomberg News reported. Such improvements may require significant increases in funding, restructuring, and staff, experts say.

Artificial Tears Eye Drops Lawsuits

The U.S. Centers for Disease Control and Prevention (CDC) has been tracking infections linked to recalled Artificial Tears eye drops, indicating in May that the agency was aware of at least 81 infections in 18 different states.

In addition to four deaths linked to severe infections caused by the eye drops, the CDC indicates a number of other cases involved hospitalization or individuals who suffered vision loss, with at least another four cases resulting in the need for surgical eye removal.

As the number of reported eye drops infections continue to rise, a series of lawsuits have been filed against the manufacturers, claiming they failed to perform proper microbial testing, allowing the products to be sold directly to consumers containing Pseudomonas aeruginosa.

Lawyers are actively investigating potential eye drop infection lawsuits against the manufacturers and distributors of EzriCare and Delsam Pharma’s eye drops for multiple injuries and side effects caused by the contamination, including;

• Eye Infection
• Partial Blindness
• Permanent Blindness
• Bloodstream Infection
• Other injuries caused by the eye drops