The US Centers for Disease Control and Prevention (CDC) has advised an immediate halt in the use of Indian-manufactured eye drops EzriCare Artificial Tears, as the agency is investigating an outbreak of a bacterial infection in connection with this drug.
As per a warning issued, the CDC has identified at least 55 people in 12 states in the US with Pseudomonas aeruginosa, a type of bacteria resistant to most antibiotics.
The eye drops are manufactured by Chennai-based Global Pharma Healthcare. It is distributed in the US by EzriCare, LLC and Delsam Pharma.
This artificial tear lubricant eye drop is not sold or used in India, according to several doctors South First reached out to.
What is the infection?
Pseudomonas aeruginosa is a bacteria that can cause infections in the blood, lungs, and several other parts of the body.
The strain of bacteria that is being reported after the use of EzriCare Artificial Tears was earlier not identified in the US.
The bacteria is said to be resistant to a class of antibiotics called carbapenems, which is generally considered the medication of choice when treatment using all other medications fail.
What the CDC said
The CDC, in its warning, on Tuesday, 31 January, said that this particular bacterial strain was found in 55 people in 12 states of the US.
The infection had led to the death of one person, permanent vision loss in five, and 11 reported eye infections and some of them even had to be hospitalised.
The CDC put out an official health advisory on 1 February, stating, “…CDC laboratory testing identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers, collected from two states. Patients and healthcare providers should immediately discontinue using EzriCare Artificial Tears, pending additional guidance from the CDC and the Food and Drug Administration (FDA).”
The CDC also advised patients who used this artificial tears eye drops to monitor for signs and symptoms of infection.
It additionally advised healthcare providers treating patients for keratitis or endophthalmitis to ask if they have used EzriCare Artificial Tears.
If patients report use of this product, then doctors should consider performing cultures and antimicrobial susceptibility testing to help guide therapy, the CDC statement said.
However, it also said that the CDC does not recommend testing patients who have used this product and who are not experiencing any signs or symptoms of the infection.
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Symptoms to look out for
According to the CDC, these are possible signs to look out for if one has used EzriCare Artificial Tears.
Any signs of eye infection like:
- Discharge from the eye
- Eye pain or discomfort
- Redness of the eye or eyelid
- Feeling of something in the eye
- Increased sensitivity to light
- Blurry vision
Statement from Global Pharma Healthcare
Meanwhile, Global Pharma Healthcare, the Chennai-based manufacturer of artificial tears (carboxymethylcellulose sodium) lubricant eye drops, has voluntarily recalled all lots of its artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma nationwide.
“The product was distributed nationwide in the USA over the internet. The drops are distributed by EzriCare and Delsam Pharma,” it stated.
Meanwhile, EzriCare, in its statement on Wednesday, stated that, “It had no role in the formulation, packaging, delivery system or actual manufacturing of the product.”
The company stated that it only designed the label and was involved in the marketing of the product.
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What’s the situation in India?
Renowned ophthalmologist in Hyderabad, Dr Ravi Prasad Challa, said that this artificial tear lubricant eye drop is not used in India.
“We do not prescribe this particular tear lubricant. It is not available for sale in India either,” he noted.
Another doctor from Bengaluru’s Karnataka Institute of Diabetology, Dr Dinesh, corroborated Dr Challa. “I have not prescribed this drug, neither is it available for use in India.”
The manufacturers of the eye drops are based in Chennai and the products sent to the US have been recalled once the issue was brought to their notice.
Systems are in place
As it is yet not clear at which stage any contamination could have happened with the medicine, doctors also caution against tarring all manufacturers with the same brush.
“Indian pharma companies have a high amount of diligence in manufacturing. There is oversight from the government and also a number of them look at voluntary accreditation. The company affected by the recall is an export-oriented company, their products are not used in institutions here,” Dr. Kaushik Murali, president, medical administration, quality and education, Sankara Eye Foundation India, told South First.
Noting that there is not much information on how the contamination occurred, he said it was a “very rare occurrence where the asepsis was impacted” during production or the seal of the product was breached.
“We are seeing reports of the ‘preservative free’ nature of the drug being a cause. It is important to not brush all medications with a single stroke as these have other stabilisers, etc, to maintain the efficacy of the formulation.”
“As with the automotive and other industries, it may be time for Indian pharma to come together to share best practices and establish peer oversight to ensure that the credibility built over the years is maintained,” he added.