The Union Health Ministry implemented a ban on 156 "irrational" FDC medicines, effective immediately. These medicines, including widely used antibiotics, painkillers, and multivitamins, were commonly used to treat fever, cough, and infections. The ban was imposed due to the associated health risks and lack of therapeutic justification for the ingredients in these FDCs.

What are FDC medicines?

FDCs or fixed-dosed combinations, also known as "cocktail drugs," are medications that combine multiple drugs in a single pill. They are designed to treat multiple symptoms or conditions simultaneously. While they offer convenience, they can pose significant risks. These risks include the possibility of overdose, adverse interactions between the drugs, and the development of antibiotic resistance. Additionally, many FDC medicines lack sufficient scientific evidence to support their safety and efficacy.

Expert opinions on FDC medicines

Experts have raised concerns about the use of FDC medicines. They believe that many of these combinations lack sufficient scientific evidence to support their safety and effectiveness. Additionally, the combination of multiple drugs in a single pill can increase the risk of adverse side effects and interactions with other medications.

Experts have also found that FDC medicines may not be as effective as individual drugs in treating certain conditions. It is important to note that safer and more effective alternatives are available for most of the medical conditions that FDC medicines were used to treat. One particular concern is the inclusion of antibiotics in some FDCs. Overuse of antibiotics can contribute to the development of antibiotic resistance, a major public health threat.

The risks of FDC medicines

The use of FDC medicines can lead to adverse effects, including serious ones. Additionally, safer alternatives, tested in clinical trials, are available to treat the same medical conditions. Experts recommend prescribing drugs individually based on a patient's clinical symptoms rather than combining them in FDCs.

The ban on irrational FDC medicines by the Union Health Ministry can be seen as a positive step towards promoting rational drug use and protecting public health. The goal is to eliminate unnecessary and potentially harmful drug combinations. This is a step forward in reducing the risks associated with medication and ensure safer and more effective treatment options for patients.

A popular over-the-counter eye drop has been recalled across the US over concerns that the product may not be sterile, raising the risk of contamination and potential eye infections.

Prestige Brands Holdings has voluntarily recalled 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief, according to the FDA. The recall includes a specific lot of the product.

The recall is particularly important because eye drops are applied directly to the eyes, which means contaminated products can bypass some of the body's natural protective barriers.

Which Clear Eyes Eye Drops Are Recalled?

Consumers who have been using this brand's eye drop must check for the following details:

• Product: Clear Eyes Maximum Itchy Eye Relief
• Bottle size: 15 mL (0.5 fl oz)
• Lot: 2552A
• Expiration date: September 30, 2027
• NDC: 67172-999-01
• UPC: 6 78112 65920 3
• Quantity recalled: 39,060 bottles

The company initiated the voluntary recall on July 29, 2026, and the FDA classified it as a Class II recall on August 14.

A Class II recall means exposure to the affected product could cause medically reversible health consequences, although the likelihood of serious harm is considered remote.

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Why Is Contamination In Eye Drops A Serious Concern?

Eye drops are different from other medicines as they are intended to be strictly sterile at all times. The FDA notes that ophthalmic medicines pose a heightened risk because they could bypass some of the body's natural defences.

Contaminated eye drops can introduce microorganisms directly onto the eye and potentially cause infection.

Depending on the type and severity of contamination, an eye infection can cause symptoms ranging from redness and irritation to pain, discharge, vision changes and, in severe cases, serious damage to the eye. This is why sterility is a major safety requirement for ophthalmic products.

This particular recall is based on a potential contamination and lack of assurance of sterility. It does not mean that every bottle is contaminated or that everyone who used the product will develop an infection.

The FDA has not indicated that every user of the recalled product will experience adverse effects. However, consumers who have a recalled bottle should stop using it rather than taking the risk.

Also read: After FDA Crackdowns, Karnataka Launches QR Code To Report Food & Drug Safety Violations Instantly

What Should You Do If You Have The Recalled Eye Drops?

If you have the recalled bottle of eye drops, check the lot number and expiration date on the packaging. If your bottle matches the recalled product, stop using it.

Consumers should also follow the recall instructions for returning or disposing of the product and can contact a healthcare professional.

The FDA also advises people to stop using eye drops and seek medical advice if they develop eye pain, discharge, changes in vision or significant discomfort.

One Of Many Eye-Drop Recalls

The latest recall comes amid a broader series of eye-drop safety concerns in the US. In recent months, other eye-drop products have also been recalled over sterility concerns and potential contamination. For example, nearly 12 million cartons of certain Rohto Cooling Eye Drops were recalled in July because sterility could not be assured.

The FDA says it continues to monitor ophthalmic products through sampling and testing, because contaminated eye drops have previously been linked to infections and serious eye complications.

A US woman undergoing routine knee surgery at a Nashville hospital was left paralyzed following a medical mistake in which potassium was reportedly given instead of the intended anesthetic.

Speaking to the media, her daughter-in-law said that while the 72-year-old’s knee replacement went well, potassium administered during spinal anesthesia instead of bupivacaine has left her paralyzed.

“The joint replacement went wonderfully. Her knee is great. The rest of her is not,” daughter-in-law Kristina Dorton was quoted as saying by WSMV.com.

What Went Wrong During the Knee Surgery?

On August 14, her mother-in-law went in for a routine knee replacement at Ascension Saint Thomas Hospital Midtown. Everything appeared normal for the healthy 72-year-old until the surgical team realized that she had been given the wrong medicine during spinal anesthesia.

“It was supposed to be the anesthetic. It was supposed to be Bupivacaine, and it was potassium, and we don’t know what quantity,” Dorton said.

According to Dorton, when her mother-in-law woke up from surgery, she was sent to the intensive care unit. While the knee replacement was successful, her family is worried that she may never be able to feel her knee or any part of her lower body again.

“Currently, she has zero feeling, movement, or response to pain from her breastbone down. We don’t know what recovery looks like or if there is recovery,” Dorton said.

Four Patients Reportedly Impacted

According to media reports, the woman was not the only patient affected. An investigation found that as many as four patients were impacted by similar “events” involving the administration of the wrong medication at Ascension Saint Thomas Hospital Midtown.

“Our hearts are with the four patients and their families impacted by this event. On behalf of our leadership and care teams, I am deeply sorry for the harm caused to our patients,” Dr. Shubhada Jagasia, president and CEO of Ascension Saint Thomas Hospital’s Midtown, said in a statement.

However, hospital officials did not confirm whether the other patients also received potassium instead of the intended anesthetic, stating that they would not provide specific clinical details to protect patients’ privacy.

While Jagasia said the hospital is ensuring that affected patients have access to the resources and ongoing care they need, Dorton said treatment aimed at reversing her mother-in-law’s paralysis has not worked.

“This is life-changing. You don’t come out of this without some type of life-altering, catastrophic deficit,” Dorton said.

“We just are hoping that publicizing this gets some sort of genius somewhere that knows what to do… Time is of the essence here for recovery,” Dorton added.

When Can Potassium Turn Dangerous?

Potassium is an essential mineral that helps the body function. While it plays important roles in blood pressure regulation, bone health and kidney function, having too much potassium in the blood can lead to serious and potentially life-threatening problems.

Too much potassium in the blood is known as hyperkalemia. Severe hyperkalemia can affect the heart’s electrical activity and cause dangerous abnormal heart rhythms or cardiac arrest.

Potassium is also not used as an anesthetic agent. During medical care, potassium levels must be carefully managed because changes in this electrolyte can significantly affect heart and muscle function.

A personalized mRNA cancer vaccine developed by pharma giants Moderna and Merck has shown promise for patients with melanoma, a potentially deadly form of skin cancer, in a late-stage trial.

The vaccine, called intismeran autogene, or mRNA-4157/V940, is custom-made for each patient using the unique genetic blueprint of their tumor.

The Phase 3 results build on earlier Phase 2b findings and showed that the combination of intismeran and Keytruda reduced the risk of cancer recurrence or death by 49% and reduced the risk of distant cancer spread or death by 59% up to five years.

“These Phase 3 findings represent a pivotal moment for the field of cancer research. For many years, the idea of creating an mRNA treatment designed specifically for an individual patient's cancer was aspirational. We are now helping turn that vision into a reality,” said Stéphane Bancel, CEO of Moderna.

Trial Shows Longer Cancer-Free Survival

The Phase 3 INTerpath-001 trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS).

Intismeran autogene in combination with Keytruda demonstrated statistically significant and clinically meaningful improvements in RFS and DMFS compared with Keytruda alone.

The findings were seen in patients with stage IIB, IIC, III, or IV cutaneous melanoma who had undergone complete surgical removal of their cancer and had not previously received systemic therapy.

The companies, however, aim to continue evaluation of other key secondary endpoints, including overall survival.

What Is Intismeran Autogene?

Intismeran autogene is an experimental "neoantigen therapy" that uses specific mutations in a patient’s tumor to train the immune system to recognize and fight cancer cells.

The treatment is designed using a patient’s tumor sample to identify the unique mutational signature, or “fingerprint,” of their cancer and generate an anti-tumor immune response.

Each therapy contains synthetic mRNA coding for up to 34 neoantigens and is tailored to the unique biology of an individual patient’s tumor.

After administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, helping generate specific T-cell responses against cancer cells.

How Was the Phase 3 Trial Conducted?

• 1,137 patients with high-risk, resected stage IIB-IV melanoma took part in the trial.
• Participants were randomly assigned 2:1 to receive either:
• Intismeran autogene + Keytruda
• Keytruda alone
• Intismeran was given every three weeks for up to nine doses.
• Keytruda was given every six weeks for up to nine cycles, for about one year.
• The trial assessed the safety and effectiveness of the combination compared with Keytruda alone.

Were There Any Safety Concerns?

The safety profiles of intismeran autogene and Keytruda in the trial were consistent with those observed in previously reported studies of the combination. No new safety signals were observed.

“Intismeran in combination with pembrolizumab has the potential to establish a new treatment paradigm in the adjuvant melanoma setting, helping patients remain cancer-free for longer,” said Professor Georgina Long, the study’s principal investigator and medical director of Melanoma Institute Australia.

Long said the results “represent a landmark moment for adjuvant melanoma treatment.”