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The CDC says the tainted eye drops were linked to an outbreak of the bacteria Pseudomonas aeruginosa, which is deadly in hospitals and other health care settings. The bacteria has killed three people and caused 68 infections in 16 states. Eight patients have lost vision and four had to have their eyeballs surgically removed.
Pseudomonas aeruginosa is a type of bacteria that can cause infections in many parts of the body, including the lungs and bloodstream. It is especially dangerous for people with weakened immune systems or who are in hospitals or nursing homes. This bacteria often spreads through contaminated equipment or hands. It can also infect wounds, which makes it especially dangerous for people who are on ventilators or have catheters. It is commonly found in water, soil, and human waste. It can also spread through public hot tubs, Jacuzzis, and pools. Symptoms of an infection can include yellow, green, or clear discharge from the eye or a feeling that something is in your eye. Generally, the symptoms of an infection are mild but can become serious and even life-threatening in some cases.
An outbreak of Pseudomonas involving two types of eye drops has been linked to three deaths and vision loss in at least four patients. The infections were caused by a drug-resistant strain of the bacteria that has never been seen in the United States. The strain was resistant to the antibiotic carbapenems, typically used as a last resort for severe infections.
The outbreak has been linked to the over-the-counter product EzriCare and the prescription brand Delsam Pharma’s Artificial Tears, both manufactured by Global Pharma Healthcare. As of March 14, more than 55 patients had been infected in 16 states, most linked to four healthcare facilities. Three of those died, and eight had to have their eyeballs surgically removed. The CDC warned that more people were likely to develop an infection.
Infections linked to the eye drops have been reported in California, Colorado, Connecticut, Florida, Illinois, New Jersey, New Mexico, New York, Nevada, Texas, Utah, and Washington. The CDC is testing opened bottles of eye drops to determine whether they contain the bacteria and is investigating how it got into the products. Earlier this month, the company that manufactures both brands issued a voluntary recall.
The maker of a popular brand of eye drops has recalled the product after it was linked to an outbreak of drug-resistant bacteria that killed one person and caused severe infections in others. The Food and Drug Administration and the Centers for Disease Control and Prevention are advising people to stop using EzriCare Artificial Tears Lubricant Eye Drops. The bacterial infection, called Pseudomonas aeruginosa, can cause infections in the blood, lungs, and other areas of the body. It is particularly difficult to treat because the bacteria often develop resistance to antibiotics.
Pseudomonas bacterium is usually found in soil and water but can also live in hospitals and other healthcare settings. It can infect people who have weakened immune systems or are suffering from other health problems, such as diabetes or heart failure. The bacteria can lead to a variety of symptoms, including fever, chills, cough, sweating, light-headedness, and difficulty breathing. In addition, it can also lead to infections in the genital area and urinary tract.
Eye infections that are caused by the bacterium can cause permanent vision loss, hospitalization, and even death in some cases. The CDC has identified more than 80 infections in patients across the country. These infections have been linked to a rare strain of drug-resistant bacteria called Pseudomonas, which had never been seen in the US before.
Earlier this week, a Florida woman sued the manufacturer of the eyedrops, saying that they led to an infection that forced doctors to remove her eye. Her lawyer said the manufacturer did not use enough preservatives in the product, making it more likely to contain toxins that can cause an infection.
The FDA has urged consumers to stop using the product and asked distributors to halt sales and retailers to pull it from shelves. The FDA also recommends that anyone who has used the product immediately contact their doctor. Over-the-counter drugs are not regulated as closely as prescription medications, but they should still be safe to use if taken as directed. In this case, the manufacturer did not follow the recommended storage instructions for the medication.
Earlier this year, the Centers for Disease Control and Prevention (CDC) warned people to stop using over-the-counter eye drops made in India by EzriCare and Delsam Pharma because they may be contaminated with a highly drug-resistant bacteria. The bacteria, Pseudomonas aeruginosa, has caused infections in more than 68 people across 16 states, including three deaths and eight cases of permanent loss of vision. Some patients have even had their eyeballs surgically removed.
In February, the manufacturer of the drops, Global Pharma Healthcare, issued a recall for all lots of its EzriCare and Delsam brands of “Artificial Tears Lubricant Eye Drops.” A CDC statement cited “adverse reactions including eye infections, permanent loss of vision, and one death with a bloodstream infection” as reason to call back the product.
The FDA has expanded the recall to include another over-the-counter product made by the same company, Delsam Pharma’s Artificial Eye Ointment cream. The agency is warning consumers not to use the product and has placed an import alert so additional shipments from the company are blocked from entering the country.
A Florida woman is suing the company after she suffered an infection that required doctors to remove her eye. She claims that her health problems were caused by the lack of preservatives in the medication. She is also seeking damages for her loss of income.
The CDC’s latest tally of infections linked to the EzriCare and Delsam drops is 68, with four of those patients having their eyeballs surgically removed. The company that produces the drops, Global Pharma Healthcare, has been hit with a series of citations by the FDA and has been ordered to improve its manufacturing processes.
Despite the warning from the FDA and CDC, many Americans have continued to use the products. A lawyer for a Florida woman who sued the company last week told CBS News that there are likely more victims who have yet to come forward. She says that the ointment is often used by patients with chronic illnesses or conditions, like diabetes and rheumatoid arthritis, which make them more susceptible to serious complications from infection.
Global Pharma Healthcare
The manufacturer of a popular brand of eye drops linked to an outbreak of drug-resistant bacteria has been ordered to stop production at its factory in Tamil Nadu. The company, Global Pharma Healthcare, has been asked to halt production of its entire ophthalmic range after a joint team of Central Drug Standards Control Organization (CDSCO) and State Drug Controller officials inspected its facility on Friday. The inspection followed an FDA ban on the firm’s ophthalmic products after it was found to have contaminated a lot of its EzriCare artificial tears with the dangerous bacteria. The drops were linked to a multistate outbreak that has affected dozens of people and caused three deaths, reports the Centers for Disease Control and Prevention.
The contamination was due to a strain of Pseudomonas aeruginosa, a dangerous and often antibiotic-resistant bacteria that is usually found in hospitals and other medical settings. It can cause severe infections throughout the body, especially in patients who are immunocompromised. Pseudomonas aeruginosa is often spread when patients infected with the bacteria touch common items or each other, and it can also be spread by healthcare workers.
According to a report in Business Standard, the team of drug inspectors found a number of issues at Global Pharma’s plant, including dirty equipment and clothing, missing safety controls, and improper sterilization processes. The inspection, which took place from February 20 through March 2, was the first time the company had been visited by FDA inspectors.
Infections from contaminated eye drops are typically mild and resolve on their own, but more serious infections can lead to vision loss or even blindness. Patients who experience vision loss or other symptoms associated with the bacterial infection should see their doctor right away. Over-the-counter medications aren’t as closely regulated as prescription drugs, so they can be more susceptible to bacterial contamination.
Ed Lott, Ph.D., M.B.A.
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