The USFDA[1] has revealed that Global Pharma Healthcare recalls all the batches of artificial tears lubricant eye drops from the US market. These eye drops were distributed by EziCare, LLC, and Delsam Pharma to the consumers. The recent move was taken due to the possible contamination of these lots.
Global Pharma Healthcare recalls Artificial Tears Lubricant eye drops linked to vision loss in the US.
Livemint – 3 February 2023
Over 55 reports of adverse events have been reported with the use of these eye drops. These include eye infections, permanent loss of vision, and death due to bloodstream infection. The CDC[2] has also alerted the FDA to investigate the multi-state cluster of VIM[3] and GES[4] producing carbapenem-resistant Pseudomonas aeruginosa infections. These infections are likely associated with the use of artificial tears manufactured by the company.
Artificial Tears Lubricant eye drops are used as a protectant against irritation or to relieve dryness of the eyes. Global Pharma Healthcare has revealed that it has notified its distributors and is requesting the wholesalers, retailers, and customers to stop using the recalled product. It has also reiterated that customers using these eye drops should contact their physician if they have experienced any health problems. Read more: Which are the popular Medicines for the Eyes?
This Chennai-based pharma (Global Pharma Healthcare) firm produces and supplies various pharmaceutical products in several therapeutic forms. It delivers a wide range of markets like Southeast Asia, Central America, LATAM[5], CIS[6], and Africa.
Pharmexcil seeks an explanation from Global Pharma over the adverse effects of use of its eye drops
Pharmaceuticals Export Promotion Council -Pharmexcil[7] has sought a report from Global Pharma explaining the alleged adverse effects seen with the use of its eye drops. Per the USFDA[1], Global Pharma voluntarily recalls all the lots within the expiry of their Artificial Tear Lubricant eye drops due to possible contamination. This product was distributed by EziCare, LLC, and Delsam Pharma to consumers.
Over 55 reports of adverse events, including eye infections, permanent loss of vision, and one death, have been associated with the use of these eye drops. Pharmexcil has cited these alleged adverse events and asserted that this could have a huge impact on the trust of the international agencies in Indian pharma exports.
Global Pharma has been directed to provide the details of the licensees to whom it had submitted the proof of product and manufacturing license and product permissions. Furthermore, it has also been advised to investigate the reasons for the serious adverse events and update Pharmexcil within two days of receiving the latter’s email. Pharmexcil revealed that this would enable it to inform the Ministry (DoC) and take necessary action in the future.
Know more about the Abbreviations:
USFDA- United States Food and Drug Administration.
It is a federal agency of the United States Department of Health and Human Services. The USFDA protects the public health by ensuring the efficacy, safety, and security of medicines, biological products, and medical devices. It also ensures the safety of the food supply, cosmetics, and products that emit radiation. The US FDA is also responsible for speeding up innovations that make medicines and foods more effective and safer.
CDC- Centres for Disease Control and Prevention.
CDC stands for the Centers for Disease Control and Prevention. It is an agency within the United States Department of Health and Human Services. The CDC works to protect public health and safety by providing information to prevent and control diseases, injuries, and disabilities. The CDC also works to improve people’s health worldwide through research, disease surveillance, and health promotion. The CDC is the lead agency in the US government’s efforts to fight and prevent infectious diseases. It is charged with helping to protect the health of the American public. The CDC is one of the major operating components of the US Department of Health and Human Services, along with the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Agency for Healthcare Research and Quality.
VIM- Verona Integron-mediated Metallo-β-lactamase.
VIM-Verona Integron-mediated Metallo-β-lactamase (VIM-2) is a type of Metallo-β-lactamase enzyme. It is a bacterial enzyme capable of hydrolyzing various β-lactam antibiotics such as penicillin, cephalosporins, and carbapenems. The VIM-2 is produced by multiple Gram-negative bacteria, such as Pseudomonas aeruginosa, Acinetobacter baumannii, and Citrobacter freundii. VIM-2 is associated with the spread of antibiotic resistance in these bacteria and is a major cause of hospital-acquired infections. VIM-2 can make bacteria resistant to a wide range of antibiotics, making it difficult to treat these infections. Read about Cefixime- Drug Detail Profile
GES- Guiana-Extended Spectrum-β-Lactamase.
The GES (Guiana extended-spectrum β-lactamase) family is the most prevalent group of the less common ESBLs (Extended Spectrum-β-Lactamase).
ESBL is an Extended-spectrum β-lactamases (ESBL). These enzymes are responsible for resistance to certain antibiotics, including cephalosporins, commonly used to treat bacterial infections. ESBLs are found in Gram-negative bacteria, such as Escherichia coli, Klebsiella pneumonia, and Pseudomonas aeruginosa. They are responsible for developing multi-drug resistant strains.
ESBLs are a significant public health concern in the Guiana region. They are found in various clinical and environmental sources. As a result, the use of cephalosporins and other antibiotics may be less effective in treating infections caused by ESBL-producing bacteria. To reduce the spread of ESBLs, the region has adopted several strategies, such as improved hygiene and sanitation practices, better antibiotic stewardship, and increased surveillance of ESBL-producing bacteria. Know more Which are the popular antibiotics prescribed for infections?
LATAM-Latin America.
Latin American countries are taking steps to improve their healthcare systems. For example, Argentina, Chile, Colombia, and Mexico have all implemented healthcare reforms that have increased access to healthcare services. In addition, Brazil has implemented a program that provides free healthcare to low-income citizens. Ultimately, there is still much work to be done to improve healthcare in Latin America. With increased investments in healthcare infrastructure, reforms to improve access and quality of care, and improved public health measures, Latin American countries can work towards achieving better.
CIS- Commonwealth of Independent States.
The Commonwealth of Independent States (CIS) is an intergovernmental organization composed of nine member countries in Eurasia. It was founded in December 1991 by the leaders of Russia, Belarus, and Ukraine. It is intended to be a regional organization to promote economic, military, and political cooperation among its members. The nine members are Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, and Uzbekistan. The CIS is headquartered in Minsk, Belarus.
References:
- Official website of USFDA– United States Food and Drug Administration
- Official website of the CDC
- VIM- Tijet N, Macmullin G, Lastovetska O, Vermeiren C, Wenzel P, Stacey-Works T, Low DE, Patel SN, Melano RG. Verona integron-encoded metallo-β-lactamase 1 in Enterobacteria, Ontario, Canada. Emerg Infect Dis. 2013 Jul;19(7):1156-8. doi: 10.3201/eid1907.121294. PMID: 23763841; PMCID: PMC3713970.
- Commonwealth of Independent States- CIS Wikipedia
- list of countries in Latin America LATAM
- Castanheira, M., Simner, P. J., & Bradford, P. A. (2021). Extended-spectrum β-lactamases: An update on their characteristics, epidemiology, and detection. JAC-Antimicrobial Resistance, 3(3). https://doi.org/10.1093/jacamr/dlab092