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Eye Drop Manufacturer Recalls Artificial Tears After CDC Warning

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Eye Drop Manufacturer Recalls Artificial Tears After CDC Warning


The manufacturer behind the eye drops that made headlines for possibly killing one user and leaving others blind has officially issued a recall.

Global Pharma Healthcare is recalling its Artificial Tears Lubricant Eye Drops distributed via EzriCare and Delsam Pharma, according to the U.S. Food and Drug Administration (FDA). 

The FDA said the company decided to pull out the product due to possible contamination with the antibiotic-resistant Pseudomonas aeruginosa

“Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness,” read the risk statement published by the agency. 

Global Pharma has requested wholesalers, retailers and customers who have the product to stop its sale, distribution and use. 

Consumers are strongly advised to contact their physician or healthcare provider if they have experienced problems while or after using the over-the-counter eye drops. 

Adverse reactions or quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program online or by fax. 

The recall was issued Thursday, weeks after the Centers for Disease Control and Prevention (CDC) published a warning about the Artificial Tears possibly causing a bacterial infection that’s resistant to multiple antibiotics. 

The public health agency identified 56 isolates from 50 case patients from 11 states between May 17, 2022, and Jan. 19, 2023. Among the reported cases, one died due to a bloodstream infection, while three others became blind in one eye after an ocular infection. 

The other patients investigated by the CDC got hospitalized due to respiratory infections or urinary tract infections. 

At the time, the CDC already urged consumers to “immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete.”

New Jersey-based EzriCare addressed the issue via an online statement, saying it “immediately took action to stop any further distribution or sale of EzriCare Artificial Tears” after learning about CDC’s investigation. 

“To the greatest extent possible, we have been contacting customers to advise them against continued use of the product,” the company added. 

Though commonly found in soil and water, P. aeruginosa is also spread in healthcare settings. The bacterium is known to constantly find ways to develop antibiotic resistance, making it difficult to treat. 

In 2017, the U.S. documented around 2,700 deaths due to multidrug-resistant P. aeruginosa.





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More Mpox Cases Reported In New York, Other States Amid Possible Resurgence

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How To Protect Yourself Against Monkeypox Amid Global Outbreak


More cases of mpox infection have been reported recently, with the U.S. Centers for Disease Control and Prevention (CDC) updating its tally to include 21 more from different locations in the country.

The latest CDC update released Thursday showed that Illinois had recorded nine new cases. On the other hand, New York and Maryland reported three each. Meanwhile, Alabama, Arizona, Florida, Louisiana, Texas, Utah and Virginia had one new case each.

The CDC’s U.S. map and case count also showed that the total number of cases reported in the country since data became available was 30,422. The total number of deaths due to the virus was 42.

Earlier this month, the World Health Organization (WHO) declared the mpox outbreak officially over after recording an almost 90% decline in global cases in the past three months.

However, around the same time, local health officials sounded the alarm over an mpox outbreak in the Chicago area. Between April 17 and May 5, the area reported 12 confirmed and one probable case of mpox infection. All of them were men, and most of them had been vaccinated.

The outbreak prompted the CDC to issue a public health warning about a possible resurgence of mpox in the country this summer, especially when many people gather for festivals and other events.

The CDC also recommended the JYNNEOS vaccine for smallpox and mpox – formerly monkeypox. Though most of the new cases were reported among vaccinated individuals, the agency stressed the importance of getting the shots.

“Getting vaccinated is still very important. No vaccine is 100% effective, and infections after vaccination are possible, but they may be milder and less likely to result in hospitalization,” the CDC stated.

The U.S. still averages less than three cases reported per day, far smaller than the hundreds reported last summer, according to CBS News.

But Dr. Christopher Braden, the head of the CDC’s mpox response, told clinicians in a recent call that things could change very quickly in the coming months.

“The risk of near-term clusters and outbreaks is substantial, and the outbreaks could be large, especially in the warmer months, with planned gatherings that may have the potential for skin-to-skin contact and increased sexual activity,” Braden was quoted as saying by the outlet.

Published by Medicaldaily.com



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COVID-19 Vaccine Fall Overhaul: What You Need To Know

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The COVID-19 pandemic may be a thing of the past now, but the risk of catching the viral disease remains. And so, pharmaceutical companies are still hard at work in delivering vaccine and booster supplies wherever needed.

In the U.S., regulators have already settled on a new strategy for vaccination that would require yearly updated shots, similar to how the flu shot is rolled out every fall season, according to Science.

The U.S. Food and Drug Administration advisers are reportedly convening on June 15 to discuss the next iteration of the COVID-19 vaccine and which strains of the virus it should target. From there, the agency would then greenlight a version that pharmaceutical companies will mass-produce ahead of its fall release.

Earlier this week, Pfizer and Moderna relayed their plan via CNBC to make new versions of their vaccines that would aim to provide broader and longer-lasting immunity against SARS-CoV-2 infection instead of the regularly updated boosters.

The new versions would be ideal in the post-pandemic era since they would simplify how people coexist and deal with the risk of catching the virus annually. The yearly dose pattern works well for the flu, so companies want to do the same with their COVID-19 vaccines.

Interestingly, instead of getting two separate shots each fall season — one for the flu and the other for COVID-19, Pfizer and Moderna plan to release vaccines with a dual purpose. Not only would they be capable of protecting against COVID-19, but they could also target other respiratory diseases, such as the flu.

Both Pfizer and Moderna are working on new vaccines that target both COVID-19 and the flu. Pfizer is also developing another shot that targets both COVID-19 and RSV. However, these dual-purpose vaccines are unlikely to become available until 2024 to 2025.

For this fall season, the goal is to kickstart the planned annual COVID-19 vaccines. This way, people, especially the immunocompromised, won’t have to worry about getting jabbed every three months or so.

Last week, the World Health Organization (WHO) issued a statement on the antigen composition of the COVID-19 vaccines, saying pharmaceutical companies should design updates that no longer target the original strain of SARS-CoV-2 since it is no longer circulating in humans.

In the same breath, the organization shared that its advisory group recommended having a single-strain fall vaccine for the XBB.1 lineage, which is currently dominating across continents. However, the WHO maintained that it’s open to other formulations as long as they enhance mucosal immunity for improved protection against COVID-19 in the post-pandemic era.

Published by Medicaldaily.com



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Those Who Skipped Updated Booster Have ‘Little’ Protection Against COVID-19: Report

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The hesitancy to get the updated COVID-19 booster has put many adults in the U.S. in danger of catching the viral disease.

The latest Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC) pointed out the “relatively little” protection vaccinated adults have after skipping the bivalent booster shots.

According to the CDC, the bivalent mRNA vaccine boosters from Pfizer and Moderna provide protection against COVID-19. However, the durability of such protection was unknown, so it determined the estimated durability of the boosters in preventing COVID-associated hospitalization and critical illness.

The public health agency found that the bivalent booster vaccine effectiveness against COVID-associated hospitalization dropped from 62% at 7-59 days postvaccination to 24% at 120-179 days in adults aged 18 and above without immunocompromising conditions. This is compared to unvaccinated adults.

Among immunocompromised adults, booster vaccine effectiveness was observed against COVID-associated outcomes, including intensive care unit admission or death.

“Adults should stay up to date with recommended COVID-19 vaccines. Optional additional bivalent vaccine doses are available for older adults and persons with immunocompromising conditions,” the CDC wrote.

“Results of this analysis indicate that these adults might have relatively little remaining protection against COVID-19-associated hospitalization compared with unvaccinated persons, although might have more remaining protection against critical illness,” the agency added.

When the bivalent booster shots rolled out last September, experts were hoping for a better uptake than just 20% of U.S. adults as of May 10, according to U.S. News & World Report.

Last month, the Food and Drug Administration (FDA) authorized additional booster shots for people deemed vulnerable to severe COVID-19 illness, including those aged 65 and above and the immunocompromised.

Federal officials are reportedly considering a fall booster campaign to drive more adults to get the updated mRNA vaccine boosters.

Published by Medicaldaily.com



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