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.

Melatonin is often opted to treat a bad night's sleep. But new research is raising an important question about what happens when the sleep supplement becomes a long-term habit.

A large preliminary study found that people with chronic insomnia who used melatonin for at least 12 months had a roughly 90% higher risk of developing heart failure over five years compared with similar people who did not use it.

The findings were presented at the American Heart Association's Scientific Sessions and are based on health-record data. Researchers have stressed that the study does not conclusively prove that melatonin causes heart failure.

About The Study

The researchers observed adults with insomnia and compared those who used melatonin for 12 months or more with those who didn't.

Over a period of five years, 4.6% of long-term melatonin users developed heart failure, compared to 2.7% of non-users. That translated into approximately a 90% higher risk.

Researchers found a similar association when they used a stricter definition of long-term use, looking at people who had filled at least two melatonin prescriptions at least 90 days apart. In that analysis, the risk was 82% higher.

So, it does not mean that 90 out of 100 people taking melatonin will develop heart failure. It means the relative risk was about 90% higher in the long-term melatonin group than in the comparison group.

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How Does Melatonin Help Sleep Better?

Melatonin is a hormone naturally produced by the body, mainly in response to darkness. It helps regulate the sleep-wake cycle, essentially telling the body that night time has arrived. Melatonin supplements are therefore used to help with sleep problems.

But chronic insomnia itself is not harmless. Poor sleep can be associated with high blood pressure, obesity, diabetes, and cardiovascular disease. And that creates a major problem in interpreting this study.

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Melatonin Or Insomnia: What Is Causing Heart Risk?

People taking melatonin long term may have more severe or persistent insomnia than people who do not take it. That underlying sleep disorder could itself contribute to cardiovascular problems.

There may also be other differences between the two groups that a medical-record study cannot completely account for. This is why the researchers have described the findings as preliminary and say more research is needed to understand whether melatonin itself has a harmful cardiovascular effect.

Talking about heart failure, it simply does not mean that the heart suddenly stops working. It means the heart has become unable to pump blood efficiently enough to meet the body's needs. People may develop symptoms like:

• Breathlessness, particularly when lying down or exercising
• Persistent tiredness
• Swelling of the legs, ankles or feet
• Rapid weight gain from fluid retention
• A persistent cough or congestion
• Reduced ability to exercise

Does This Mean You Should Stop Taking Melatonin?

The research is merely observational, so it cannot establish cause and effect. It also does not show that short-term melatonin use causes heart failure.

The American Heart Association described the findings as raising “new questions about the safety of taking melatonin for extended periods.”

If someone has been taking melatonin every night for months or years, particularly because of persistent insomnia, it may be worth discussing the underlying sleep problem with a doctor rather than simply continuing the supplement indefinitely.

Statins have long had the job of lowering LDL cholesterol and protecting the heart. But new a study has emerged stating that these medicines may have another significant benefit for the brain.

A 15-year Danish study involving more than 132,000 people with type 2 diabetes found that those who started taking statins earlier had a 15% lower risk of developing dementia compared with those who started treatment later. Even later, statin use was associated with a 10% lower risk.

The researchers suggest that the timing of treatment is key as prolonged exposure to high cholesterol and other cardiovascular risk factors could contribute to damage that accumulate over many years.

The findings, presented at the European Society of Cardiology Congress and published in The Lancet Regional Health – Europe, come as researchers are constantly exploring the connection between cholesterol, blood vessels, and brain health.

Connection Between Cholesterol And Brain

The brain is an enormous delivery network in which billions of cells depend on a constant supply of oxygen and nutrients delivered through tiny blood vessels.

High levels of LDL cholesterol can contribute to atherosclerosis, where fatty deposits build up inside arteries. Over time, this can damage blood vessels and restrict blood flow.

Damage to the brain's blood vessels can contribute to vascular cognitive impairment and vascular dementia, while strokes can also increase the risk of subsequent cognitive decline.

Also read: Hormone Replacement Therapy May Lower Dementia Risk In Women, Shows Study

Statins Were Not Proven To Prevent Dementia

This study merely observed the correlation between statins and dementia risk, meaning it did not establish a definite cause-and-effect relationship. People who start statins earlier may also differ from those who start later in other ways, including their overall management of diabetes and cardiovascular risk.

The researchers therefore say more work is needed to determine whether statins have a direct protective effect on the brain.

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Does Lower Cholesterol Mean Better Brain Health?

It is important to note the difference between treating unhealthy LDL cholesterol levels and assuming that everyone should aggressively lower cholesterol to prevent dementia. Statins remain as the medication to reduce cardiovascular risk.

Their potential brain benefits are an additional area of research. So, people must not blindly start popping statins to lower the risk of neurodegenerative diseases like dementia.

There is another reassuring point for people already taking statins. The concerns that these medicines may result in the increase of dementia risk have not been supported by the strongest available evidence.

A large review of randomised trials earlier this year found that most reported statin side effects were no more common than with placebo, including reported memory problems.

The most interesting takeaway may not be that “statins prevent dementia.” The evidence isn't strong enough to make that claim yet. It is that heart health and brain health are deeply intertwined.

Managing cholesterol, blood pressure, diabetes and other cardiovascular risk factors, along with regular physical activity and a healthy diet, may help protect the blood vessels that keep the brain functioning.

The Maharashtra Food and Drug Administration (FDA) has recently sparked headlines for bringing several known brands under its tight scrutiny. Cipla was one of them after the drug regulator cancelled one of its facility’s licenses over alleged violations associated with Reactin Plus tablets.

Soon after that, the Bombay High Court questioned the manner in which the action was taken, prompting the Maharashtra Food and Drug Administration (FDA) to withdraw its cancellation order.

The dispute has now become more about how far a regulator can go while enforcing drug safety rules, and whether due process was followed before cancelling the license.

Why Did Maharashtra FDA Cancel Cipla Facility’s License?

Maharashtra FDA recently conducted an inspection of Cipla Pharma & Life Sciences’ carrying and forwarding facility at Wadki in Pune.

During an inspection in June, FDA officials found that the packaging of Reactin Plus, a Schedule H prescription medicine, described it as an “analgesic and antipyretic”. The FDA said this amounted to unauthorised advertising of a prescription drug and violated provisions of the Drugs and Cosmetics Act and Rules.

The regulator seized Reactin Plus stock worth around Rs 11.19 lakh and instructed that the product be recalled.

But the FDA said the recall directions were not fully complied with. A subsequent inspection also found discrepancies between physical stock, computerised records and purchase and sales data.

Medicines were reportedly found stored directly on the floor, with inadequate proper storage arrangements. Deficiencies were also identified in the handling of expired medicines.

Based on these findings, the FDA cancelled the drug-sale licenses of the facility with effect from August 27.

Maharashtra FDA Commissioner Tukaram Mundhe said, “The Food and Drug Administration will not show any leniency regarding the safety of medicines and the health of citizens.”

He added, “Any entity within the pharmaceutical manufacturing and distribution system found violating regulations will face stringent legal action.”

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Why Did The Bombay High Court Step In?

Cipla challenged FDA's action before the Bombay High Court. On August 30, the court criticised the regulator's approach, describing it as “high-handed” and saying the FDA had gone “overboard”. The court also questioned whether the principles of natural justice had been followed.

During the hearing, the court asked, “Do you feel you are a Lord and you can do anything?”

The court's concern was not necessarily that the FDA should not regulate Cipla. Instead, it questioned the manner and procedure through which the license was cancelled.

Following the court's intervention, the Maharashtra FDA withdrew the cancellation order and said it would issue a fresh show-cause notice before passing an order.

So, the license has been restored for now, but that does not mean the underlying regulatory concerns have disappeared.

Also read: Everest Hing Sale Prohibited By FSSAI; 3 Other Masalas Flagged For Violations

What Does Cipla Say?

Cipla has maintained that the matter is under judicial consideration and therefore declined to comment in detail. The company said the FDA order relates to the operations of a C&F warehouse, rather than allegations concerning the medicine's safety or effectiveness.

According to mint, Cipla said, “Cipla has been a trusted healthcare organization for nine decades and continues to uphold the highest standards of quality, regulatory compliance, and patient safety.”

The company also clarified that the FDA order “does not allege any concerns relating to the safety, quality or efficacy of its products”.

Reactin Plus Is Safe

The FDA action focuses on violations related to labelling, recall compliance, storage, inventory records and distribution practices.

It did not establish that Reactin Plus was unsafe, ineffective, or contaminated. Cipla has specifically said the order did not concern the product's safety, quality, or efficacy.