This eyedrop has caused 4 deaths and 14 blindness
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This eyedrop has caused 4 deaths and 14 blindness
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News on May 19, according to the latest news from the US Centers for Disease Control and Prevention, an incident in the US where eye drops were contaminated with highly drug-resistant bacteria has now resulted in 4 deaths and 14 blindness.
The eye drops, traded under the trade name ‘EzriCare’, are manufactured in India by Global Pharma Healthcare Limited.
Recall!
The CDC said on its website that 81 patients from 18 states had been confirmed to be infected with a rare strain of drug-resistant bacteria called Pseudomonas aeruginosa. This is an increase of 13 patients since the agency updated its data in March.
The statistics from the US Centers for Disease Control and Prevention show that as of March 14 this year, 16 states have reported a total of 68 cases of infection, of which 3 died, 4 had their eyes removed, and 8 were visually impaired.
The company is recalling large quantities of unexpired EzriCare artificial tears and another product, the FDA said.
The U.S. Centers for Disease Control and Prevention had previously issued a health alert that said the infections spanned multiple states. These infections include some bacterial infections found in the blood, urine and lungs.
These eye drops are artificial tears used to lubricate the eyeball. According to experts, the eyes are connected to the nasal cavity through the tear duct, and bacteria can enter the nasal cavity from the eyes, and then enter other tissues or parts of the body such as blood.
The infection is caused by a bacterium called Pseudomonas aeruginosa. Experts say the infection is particularly worrisome because the bacteria causing it are resistant to standard antibiotics.
The U.S. Food and Drug Administration stated that India’s Global Pharmaceutical Healthcare Co., Ltd., which produces eye drops, has irregular production problems, including insufficient microbiological testing measures and packaging that does not meet hygienic requirements.
The Food and Drug Administration has issued a warning to the company, prohibiting the eye drops from entering the US market. The FDA issued the same warning for another eye drop made by the company.
Do not use eye drops indiscriminately
Eye drops, eye ointments, eye gels and other topical eye medicines can be divided into three categories according to their ingredients: anti-infection, anti-inflammatory and artificial tears.
Among them, anti-infection eye drugs include anti-bacterial, anti-viral, etc., while anti-inflammatory eye drugs include hormones and non-steroidal drugs.
Steroidal anti-inflammatory eye drops can quickly reduce inflammation, but long-term use can easily induce glaucoma, cataracts, etc., while non-steroidal anti-inflammatory eye drops are often used to control mild inflammation with relatively few side effects.
In fact, even eye drops produced normally should not be used indiscriminately, or cause infection. Doctor’s reminder: The shelf life written on the eye drops generally refers to the storage time in the unopened state, and the eye drops after opening are recommended to be used up within one month.
Previous News on April 05, 2023
3 dead and 8 blind! American Indian eye drops factory cannot guarantee product sterility
Eye drops produced by an American brand in India have caused three deaths and eight blindness in U.S.
The Food and Drug Administration (FDA) issued a preliminary investigation report stating that the manufacturing plant in India cannot guarantee a sterile production environment.
The recalled Delsam Pharma eye ointment was ordered to be withdrawn due to Pseudomonas aeruginosa contamination.
From the end of February to the beginning of March, the U.S. government sent personnel to inspect the factory of Global Pharma Healthcare in Tamil Nadu, southern India, and found more than a dozen problems in the eye drops manufacturing and testing process.
The biggest problem is It is impossible to guarantee the sterility of the product, especially the batch of products manufactured between December 2020 and April 2022 and shipped back to the United States for sale.
The eye drops were commissioned by two major brands, EzriCare and Delsam Pharma. Due to the contamination of Pseudomonas aeruginosa, there have been 68 cases of infection in the United States, resulting in three deaths, eight blindness, and four eyeball removals. To save lives, all these batches have been recovered at present.
The reason why this wave of infections is particularly worrying is that Pseudomonas aeruginosa is extremely resistant to antibiotics, which cannot be dealt with by general antibiotics.
On February 3, the United States announced the recall of defective products, and health inspectors arrived at the Indian factory on February 20 for inspection. This is the first time that Food and Drug Administration personnel have visited the factory for inspection.
Food and Drug Administration spokesman Jeremy Khan said that the preliminary report indicated that the pharmaceutical company “may have violated the regulations of the Food and Drug Administration” and that a warning letter will be sent to the manufacturer after a formal report is released. He called on consumers to stop using the eye drops produced by the factory because it “may be harmful to health”.
During the on-site inspection of the Indian factory of a global pharmaceutical company, officials of the Food and Drug Administration found that the floor, walls, and ceiling of the factory were “difficult to clean”. Some medicine bottles can’t be completely sealed, and only rely on human eyes to check for leaks.
The Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) investigated and found that the EzriCare eye drops used by infected patients contained the disease strain. Food and Drug Administration officials are also checking unopened eye drops for bacteria.
This eyedrop has caused 4 deaths and 14 blindness
(source:internet, reference only)
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