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.

In a world first, an experimental treatment has been administered to a 26-year-old woman, the daughter of American hedge fund manager Bill Ackman, in which mitochondria from her leg were injected into her eyes.

While the treatment did not restore vision, it produced a temporary return of the pupils’ response to light, offering a potentially important finding, according to scientists from the Icahn School of Medicine at Mount Sinai in a paper published as a preprint on Research Square.

The eye study, posted as a preprint on August 10, has not yet undergone peer review. The treatment remains highly experimental and involved only one patient.

“It was my daughter. Mitochondria has amazing potential,” Ackman said in a post on X, adding that the family had seen a sustained benefit from the initial injection, although it was weaker than the immediate response.

Brain Hemorrhage Left Her Unable To See

In February this year, Ackman’s daughter Lucy collapsed in her Brooklyn apartment after suffering a brain hemorrhage, leaving her unable to move, speak or see, the billionaire said in a post on X.

While doctors performed emergency surgery, the injury damaged her optic nerve and left her unable to see. Her pupils also stopped responding to light.

Despite the progress in other areas, Lucy’s vision has remained severely affected.

After receiving emergency approval from the US Food and Drug Administration, doctors at Mount Sinai extracted mitochondria — the energy-producing structures inside cells — from Lucy’s leg muscle and injected them into the fluid of both eyes, according to Nature.

“Over the last six months, she has recovered her cognition – she understands everything including her circumstance – is able to walk a hundred or more steps at a time with assistance, is making progress with sounds, vowels and consonants and the beginnings of speech, but she remains unable to see,” Ackman said.

Mitochondrial Transplant Showed Temporary Visual Response

The researchers reported that Lucy, who had optic nerve damage in both eyes for three months, received one mitochondrial injection in each eye, 24 hours apart.

Importantly, neither eye developed inflammation. Within days of the injections, her pupils began responding to light again — something that had not happened in 45 tests over the previous 71 days.

She also reported seeing shapes and shadows through her left eye.

However, the response faded after about four weeks, and the treatment did not restore normal vision.

“We are working on a method to inject her eyes with more frequency,” Ackman wrote on X.

When Can Mitochondrial Transplants Help?

According to the researchers, mitochondrial transplantation involves delivering healthy, functioning mitochondria into tissue where the mitochondria have been damaged.

The approach has been studied in the human heart and brain, but had not previously been used in the eye.

"To our knowledge, this is the first administration of isolated mitochondria to the human eye. The procedure was performed to the filed specification in both eyes," the researchers said in the paper.

Retinal ganglion cells, which are involved in transmitting visual information from the eye to the brain, depend heavily on mitochondria to produce energy. In studies involving rodents, mitochondria injected into the vitreous — the gel-like substance inside the eye — have been taken up by these cells and improved their survival after optic nerve injury.

In Lucy’s case, the injection of her own mitochondria into the eyes was reported to be safe and was associated with the temporary return of pupillary responses to light. However, it did not restore normal vision, and the visual response faded after about four weeks.

Because the report involves only one patient and has not yet undergone peer review, much more research is needed to determine whether mitochondrial transplantation could eventually become a treatment for optic nerve damage or other forms of vision loss.

The US Food and Drug Administration has approved a new breast cancer treatment that aims to act on signs of treatment resistance before the cancer starts progressing.

The US FDA has granted accelerated approval to Etcamah (camizestrant), in combination with a CDK4/6 inhibitor, for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer whose tumours develop an ESR1 mutation while being treated with an aromatase inhibitor and a CDK4/6 inhibitor.

All About The New Breast Cancer Treatment

The new approach uses a blood test to detect circulating tumour DNA (ctDNA) carrying an ESR1 mutation. If the mutation is detected, doctors can switch treatment to camizestrant rather than waiting for visible disease progression on scans.

The FDA described this as its first cancer therapy approval guided by detection of a resistance mutation in circulating tumour DNA before imaging shows progression of the disease.

Also read: Have Dense Breasts? What Women Should Know About Their Breast Cancer Risk

What Did The Clinical Trial Find?

The approval was based on results from the Phase III SERENA-6 trial, which included 315 patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer.

All participants were receiving an aromatase inhibitor plus a CDK4/6 inhibitor as their initial endocrine based treatment and had no evidence of disease progression when an ESR1 mutation was detected through blood testing.

Patients were randomly assigned to either switch to camizestrant while continuing their CDK4/6 inhibitor or continue their existing aromatase inhibitor with the CDK4/6 inhibitor.

Survival period without progression was 16 months with camizestrant compared with 9.2 months with standard treatment. The risk of disease progression or death was reduced by 56% with the camizestrant combination.

Also read: Alcohol-Linked Cancer Deaths Doubled In US: Colorectal Leads In Men, Breast Leads In Women

Importance Of ESR1 Mutations

ESR1 mutations are one way hormone receptor-positive breast cancers can adapt to treatment. According to the FDA, fewer than 5% of patients have an ESR1 mutation when HR-positive metastatic breast cancer is first diagnosed. After disease progression on an aromatase inhibitor, however, the mutation is found in nearly 40% of patients.

This means that detecting the mutation earlier could potentially give doctors a chance to change treatment while the cancer is still controlled.

Dr Kevin Kalinsky, an investigator on SERENA-6, said, "The approach allows doctors to change treatment at an earlier opportunity ahead of disease progression rather than waiting until the cancer becomes harder to treat."

Risks And Limitations

The FDA approval is accelerated, meaning continued approval may depend on confirmatory studies that will verify clinical benefit.

The regulator specifically noted that it has not yet been established whether intervening when an ESR1 mutation is detected, before radiographic progression, ultimately translates into a meaningful overall survival benefit.

The FDA has simultaneously approved the Guardant360 CDx blood test as a companion diagnostic to identify patients whose tumours carry the relevant ESR1 mutations.

The significance of the approval therefore goes beyond a new drug. It represents a shift toward using molecular clues in the bloodstream to detect treatment resistance and change therapy before cancer progression becomes visible on a scan.

Illegal horse trade across the US-Mexico border are raising fresh concerns among US officials and ranchers as the country tries to contain the spread of New World screwworm, a flesh-eating parasite that can cause severe and possibly fatal wounds in animals.

According to Reuters, horses and other animals are continuing to cross the border outside regulated channels, bypassing veterinary inspections designed to detect diseases and parasites.

There is no confirmed link between individual smuggled horses and specific screwworm cases, but experts warn that uncontrolled animal movement creates a gap.

What Is New World Screwworm?

Unlike ordinary maggots that generally feed on dead tissue, screwworm larvae feed on living tissue, creating wounds that can become severe as more larvae develop. The parasite can infest cattle, horses, pets and wildlife and, more rarely, humans. An untreated infestation can cause serious tissue damage and death.

The US had previously eradicated the parasite through a decades-long campaign involving the release of sterilised male flies. But New World screwworm has been moving northward through Mexico and is now threatening US livestock again.

Also read: Wegovy & Zepbound Are Not Approved By US FDA For Children Under 12: So Why Are Prescriptions Rising?

Smuggled Horses Are A Concern

Animals entering the US through legal channels undergo veterinary checks and must meet health requirements. Smuggled animals can bypass those safeguards.

Reuters reported that authorities in Presidio County, Texas, have intercepted more than 50 smuggled horses over two years. Some were reportedly moved through remote areas along the Texas-Mexico border, making them difficult to monitor.

That matters because an infected animal can potentially carry screwworm larvae or adult flies into new areas.

USDA officials have described animal trafficking as a biosecurity concern. However, authorities have not established that illegally transported horses are responsible for particular screwworm infections in the US.

Also read: Psychedelic Compound Found In 'Magic Mushrooms' May Help Prevent Painful Chemotherapy Side Effects, Study Finds

Why Is The US Worried About Screwworm Again?

The parasite was previously eliminated from the US, making its recent return a major agricultural concern.

The USDA says New World screwworm is a devastating pest capable of causing serious, often deadly damage to livestock. It can also affect pets, wildlife and, in rare circumstances, people.

The economic consequences include potential damage from a major Texas outbreak at up to $1.8 billion, reflecting losses to livestock and related industries.

The threat comes as the US is also navigating the difficult balance between controlling screwworm and maintaining livestock trade with Mexico.

In August, the US began a phased reopening of Mexican cattle imports after a more than year-long suspension linked to the screwworm threat. Mexico has simultaneously been releasing sterile flies and other containment efforts along its northern border.

How Is The US Trying To Stop It?

One of the main tools is the sterile insect technique. Large numbers of male screwworm flies are sterilised and released into affected areas. When they mate with wild females, they produce no viable offspring, helping reduce the population.

As of September 4, the agency said the current risk to animals and people in the US remained very low, and stressed that screwworm is not a food-safety issue. But illegal animal trade complicates those efforts.