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.

India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), has approved Wegovy (semaglutide injection 2.4 mg) for the treatment of adults with fatty liver disease, Novo Nordisk announced today.

According to the company, Wegovy is the first and only GLP-1 receptor agonist (GLP-1 RA) approved globally and in India for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, alongside a reduced-calorie diet and increased physical activity.

"People with MASH face a higher risk of serious liver complications and heart-related disease. This approval is an important milestone, giving doctors and patients a new treatment option while also helping address obesity and related heart and metabolic diseases," said Vikrant Shrotriya, Managing Director, Novo Nordisk India.

Clinical Trial Findings

The approval is based on findings from the ESSENCE clinical trial, which showed that:

• 63% of patients treated with Wegovy experienced resolution of steatohepatitis, an advanced form of fatty liver disease.
• 37% showed improvement in liver fibrosis.
• 33% achieved both resolution of steatohepatitis and improvement in liver fibrosis.

Who Should Take Wegovy?

Semaglutide injection (Wegovy) is indicated, alongside a reduced-calorie diet and increased physical activity, for:

• Chronic weight management in adults with a BMI of 30 kg/m² or higher, or 27 kg/m² or higher with at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidaemia.
• Chronic weight management in adolescents aged 12 years and older with obesity and a body weight above 60 kg.
• Reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack, or non-fatal stroke) in adults with established cardiovascular disease who are overweight or have obesity.
• Treatment of noncirrhotic MASH with moderate to advanced liver fibrosis (F2-F3) in adults.

What Is MASH?

Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease caused by excess fat accumulation in the liver, leading to chronic inflammation and liver damage.

According to Novo Nordisk, two in three Indians have fatty liver disease. The condition is often called a "silent disease" because many people do not develop symptoms until liver damage has become advanced. If left untreated, MASH can progress to severe liver complications.

"MASH is becoming more common in India as lifestyles change. In many people, early MASH has no obvious symptoms, so the condition may not be diagnosed until liver damage is more advanced," said Dr. Dharmesh Kapoor, Senior Consultant Hepatologist, Hyderabad.

He stressed the importance of early screening, particularly for people with obesity, type 2 diabetes, or other metabolic conditions.

"Wegovy has demonstrated benefits in reducing liver inflammation and fibrosis while also supporting weight management and blood sugar control, both of which are linked to MASH progression," Dr. Kapoor added.

Novo Nordisk said innovator semaglutide is backed by more than 50 clinical trials, 49 million patient-years of exposure, and extensive real-world evidence.

The medicine, manufactured using recombinant DNA (rDNA) technology, has been approved in 75 countries, including by the Drugs Controller General of India (DCGI), the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

Planning an overseas holiday this summer? The UK government is urging British travellers to be aware of the dangers of methanol poisoning.

The warning comes after reports of British nationals becoming seriously ill or dying after unknowingly consuming alcohol tainted with methanol in popular tourist destinations.

The UK government has now added warnings about methanol poisoning to its travel advice for 29 destinations, including popular holiday hotspots such as Indonesia, Laos and Vietnam.

"We are working to raise awareness of the warning signs of methanol poisoning and urge anyone who suspects they may have been exposed to seek immediate medical attention, helping British nationals stay safe overseas," said Minister for Consular Hamish Falconer MP.

He urged travelers to check the latest travel advice before departure and act immediately if they suspect methanol poisoning.

UK Launches 'Know the Signs' Campaign

Also read: Cyclospora Parasite: CDC, FDA Trace Outbreak In 5 States To Taco Bell Lettuce Supplier

As part of its 'Know the Signs' campaign, the Foreign, Commonwealth & Development Office (FCDO) has released new videos featuring the families and friends of British nationals who died after unknowingly drinking methanol-contaminated alcohol overseas.

The campaign includes first-hand testimonies from survivors and bereaved families to raise awareness of the warning signs and encourage travelers to seek urgent medical help if methanol poisoning is suspected.

"No one expects a holiday to end in tragedy, yet methanol poisoning can have devastating—and sometimes fatal—consequences. The courage of survivors and bereaved families in sharing their experiences will help raise awareness and could save lives," Falconer added.

What Is Methanol?

Methanol is a highly toxic industrial alcohol that can sometimes be present in counterfeit, illegally produced or contaminated alcoholic drinks.

As little as 30 ml—about one shot—can be fatal for an adult, while even smaller amounts can cause permanent blindness, brain damage and other life-threatening complications.

One of the biggest dangers is that there is no reliable way to tell whether alcohol has been contaminated. Symptoms often do not appear until 12 to 24 hours after drinking, delaying life-saving treatment.

Know the Warning Signs

Read More: Botulism Cases Surge in UK: MHRA Issues Botox Safety Warning Over Rare Life-Threatening Side Effect

Early symptoms of methanol poisoning may resemble ordinary alcohol intoxication or a hangover, making it easy to miss.

Warning signs include:

• Nausea and vomiting
• Dizziness
• Confusion
• Severe headache
• Blurred or disturbed vision
• Difficulty breathing

Vision problems and breathlessness typically develop 12 to 48 hours after consuming contaminated alcohol.

Anyone experiencing these symptoms after drinking alcohol abroad should seek emergency medical attention immediately, as early treatment can be life-saving.

How to Reduce Your Risk

The UK government advises travellers to:

• Buy alcohol only from reputable bars, restaurants, hotels and licensed retailers.
• Choose sealed bottles or cans whenever possible.
• Avoid homemade, bootleg or street-sold alcohol.
• Do not accept free shots or cocktails from unknown sources.
• Be cautious of unusually cheap or heavily discounted alcoholic drinks claiming to be premium brands.
• Take extra care with spirit-based drinks served as shots, cocktails, buckets or "on the rocks."
• Check the latest travel advice before travelling.

The US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have traced an ongoing Cyclospora outbreak in at least five states to shredded iceberg lettuce supplied to select Taco Bell restaurants.

The agencies have advised consumers: "Do not eat shredded iceberg lettuce from Taco Bell locations in Indiana, Kentucky, Michigan, Ohio, and West Virginia."

The FDA identified Taylor Farms as the supplier of the shredded iceberg lettuce served at the affected Taco Bell locations, where it is linked to illnesses in more than 1,644 people.

Taylor Farms is one of the world's largest producers of fresh salads and ready-to-eat foods, with production facilities across the US, Canada, Mexico, and Western Europe.

The FDA is working with the company to determine whether the contaminated lettuce was distributed to other businesses. Taco Bell has voluntarily removed the affected ingredients from the impacted restaurants.

The Cyclospora outbreak has been reported in more than 30 states. The CDC said this investigation is separate from other Cyclospora outbreaks currently being monitored nationwide.

Also read: H5N1 Bird Flu Reaches New Zealand; 12 Human Infections Reported Worldwide

Michigan Worst Affected

Michigan has reported the highest number of cases, with state officials identifying leafy lettuce as the leading suspected source after interviewing more than 1,000 patients.

As of July 16, the state had reported more than 4,300 cases and at least 100 hospitalizations linked to the outbreak.

More Than 5,100 Cases Under Review

According to the CDC, 1,645 confirmed US cases have been reported since May 1, while more than 5,100 cases are under review to determine whether the infections were acquired domestically.

No deaths have been reported, although officials warned that confirmed case numbers could continue to increase through the end of August.

Taco Bell Responds

Earlier this week, Taco Bell said it has voluntarily and temporarily removed limited fresh ingredients from select restaurants as a precaution.

Notices posted at some Detroit-area Taco Bell restaurants last week informed customers that the chain was temporarily unable to serve lettuce, cilantro, onions, pico de gallo, and guacamole due to a nationwide recall, according to media reports.

The company said it will continue to monitor the situation and follow guidance from public health authorities.

"The health and safety of our guests is our top priority," Taco Bell said in a statement.

How to Reduce Your Risk

Health officials recommend:

• Avoid eating shredded iceberg lettuce from affected Taco Bell locations.
• Wash all fresh fruits and vegetables thoroughly under clean running water, even if they are labeled pre-washed.
• Follow safe food-handling practices.
• Stay updated on food recalls and outbreak alerts.
• Contact a healthcare provider if symptoms develop.

Experts also recommend choosing whole heads of lettuce instead of bagged greens. Remove the outer leaves, wash the inner leaves thoroughly under running water, and cook produce whenever possible, as heat is the most effective way to kill Cyclospora.

Symptoms of Cyclospora Infection

Cyclospora cayetanensis is a microscopic parasite that causes cyclosporiasis, a foodborne intestinal illness. People become infected after consuming contaminated food or water.

Symptoms usually begin about one week after exposure, although they can appear anywhere from two days to more than two weeks later. Common symptoms include:

• Prolonged watery diarrhea
• Loss of appetite
• Weight loss
• Stomach cramps
• Bloating
• Nausea
• Fatigue

The CDC also advises people with persistent diarrheal illness to specifically request testing for Cyclospora, as routine stool tests do not always screen for the parasite.