Headaches are a common symptom of a stressful lifestyle, your body not feeling well and other issues. While headaches can be dealt with easily, migraines are not so easy to handle. Migraines are a type of headache that feels like severe throbbing and pulsing sensation, almost like you are hearing your own heartbeat in your brain, usually on one side of the brain. Many people believe that migraines are not that big of a deal because you just have to deal with the pain, but that is not all migraine is, some people find it very difficult to do their daily tasks as they experience dizzying spells, nausea and extreme sensitivity to light and sound! These attacks can last hours and make it difficult for people to go about their daily lives as well. While there are medications available for migraine patients, these medications need time to take effect, so you may be in a lot of pain, but there are not many quick reliefs you can have in place other than learning the symptoms of a migraine attack and taking medication before it happens. But a new approval by the FDA may change this!

The U.S. Food and Drug Administration (FDA) has approved Symbravo, a new medicine to treat acute migraine attacks in adults. This means adults can now use Symbravo to get relief from their migraine symptoms. The FDA's decision was based on the results of three big studies, called Phase 3 trials. These trials involved over 21,000 migraine attacks, so the FDA has a lot of information about how well Symbravo works and how safe it is. The FDA only approves medicines that have been shown to be both safe and effective through a thorough testing process.

Importance of New Treatment Option

"Migraine attacks can happen suddenly and really mess up people's lives. It's estimated that over 39 million people in the U.S. alone get migraines," said Herriot Tabuteau, M.D., CEO of Axsome Therapeutics told US News. This shows how common migraines are and how important it is to have good treatments. "Symbravo gives patients and doctors a new option that can quickly stop a migraine attack, keep it away, and let people get back to their normal activities, all with just one dose." Having a medicine that can give fast and long-lasting relief from migraine pain is a big deal for millions of people. This new treatment is a real step forward in how we treat migraines.

Symbravo Trial Results, How Was It Approved

The trials took place in 3 steps, the Momentum trial study focused on people whose migraines had moderate to severe pain. The results showed that a lot more people taking Symbravo felt pain-free two hours after taking the medicine compared to those who took a placebo which is a dummy pill. Even better, many people felt relief for up to 24 and even 48 hours after just one dose. This long-lasting relief is really important for people with migraines because it means they can get back to their normal lives without worrying about the pain coming back. The study also looked at how many people were free from their worst symptom, like sensitivity to light or sound, or nausea. Symbravo worked better than the placebo in this area too.

While the intercept trial looked at people who took Symbravo when their migraine pain was still mild. Even when the pain was just starting, Symbravo was effective. The results were similar to the MOMENTUM trial, with many people getting pain relief and relief from their worst symptoms. Treating migraines early is often better because it can stop the pain from getting really bad.

And lastly the Movement trial which was to see how safe the medication is when people take it regularly. This study followed 706 people who had at least two migraines a month. The most common side effects people experienced were sleepiness and dizziness. While these side effects are important to know about, the study showed that Symbravo is generally safe for people to use on a regular basis.

Commonly known as the ‘morning-after pill’, emergency contraceptive pills will soon be sold with prominent warnings on packs.

The Union Health Ministry has proposed bringing levonorgestrel 0.75 mg and 1.5 mg emergency contraceptive tablets under Schedule K of the Drugs Rules, 1945, with mandatory warnings on their packaging and package inserts. The draft notification was issued on September 3 and is currently open to public objections and suggestions.

The proposed warnings are intended to make it clear that the pills are meant only for emergency contraception and that they are not a regular contraceptive method.

They will also indicate that they are not abortion pills and do not protect against HIV or other sexually transmitted infections. They would also warn that frequent use can lead to side effects and advise women seeking regular contraception to consult a healthcare professional.

What Do Emergency Pills Actually Do?

Levonorgestrel is a synthetic version of the hormone progesterone. When taken as emergency contraception, it primarily works by delaying or preventing ovulation, meaning it can prevent an egg from being released when sperm are present.

It is intended to be taken after unprotected sex or contraceptive failure, such as a broken condom. The World Health Organization recommends levonorgestrel emergency contraception as a single 1.5 mg dose, or 0.75 mg in two doses 12 hours apart. It works best when taken as soon as possible and can be used within 120 hours of unprotected intercourse.

Crucially, it does not terminate an established pregnancy. That is why it should not be confused with medication used for medical abortion.

Also read: Exclusive With Leading HIV Expert: What's Driving Rising HIV Cases Among India's Youth And How To Prevent It

Emergency Pills Cannot Protect Against STIs

One of the proposed warnings is meant to addresses a common misconception about emergency contraceptive pills prevents pregnancy, not sexually transmitted infections.

It is important to under stand that levonorgestrel does not protect against HIV, syphilis, gonorrhoea, chlamydia or other STIs. Sexually transmitted infections can be prevented by barrier methods like condoms, when used correctly.

The proposed Indian warning specifically states that emergency contraceptive pills “do not offer any protection against HIV or any sexually transmitted infections.”

Also read: 5 Reasons To Get Regular STI Testing If You’re 'Sexually Active'

Reason Behind The Move

The move follows recommendations from the Drugs Technical Advisory Board (DTAB) after an expert review of contraceptive use in India.

Minutes of the 67th Drugs Consultative Committee meeting recorded recommendations for the package warnings stating that levonorgestrel emergency contraceptives should not be used more than twice a month, that they do not protect against HIV or STIs, and that alternative contraception should be considered with a registered medical practitioner.

The latest draft notification also states that frequent use “may lead to side effects” and encourages women to seek medical advice. However, this does not mean emergency contraception is considered inherently unsafe.

The WHO says side effects like nausea, vomiting, fatigue and temporary menstrual changes are generally mild and can be resolved without treatment. It also states that emergency contraceptive pills do not cause any harm to fertility.

The concern is instead about using an emergency method as a substitute for regular contraception. Repeated use can lead to menstrual irregularities and side effects.

The proposal would place levonorgestrel 0.75 mg and 1.5 mg tablets under Schedule K, while retaining their availability without a prescription. The draft is therefore not supposed to make morning-after pills prescription-only.

India’s campaign to eliminate iodine deficiency has made a substantial progress. A recent Lancet Regional Health – Southeast Asia study has found that cases of goitre among school-going children have reduced significantly.

But the research has also highlighted that another thyroid concerns have surfaced among Indian children simultaneously. They include thyroid autoimmunity and thyroid dysfunction.

The nationwide study, conducted across eight centres, examined 8,903 school children between the ages of 10 to 18 years.

Researchers examined goitre, thyroid function, thyroid antibodies and iodine status as part of the ICMR-SALT-T 1 study.

Goitre Cases Have Gone Down After Decades Of Iodised Salt

India introduced universal salt iodisation in 1986 to tackle iodine deficiency, a major cause of goitre and other disorders that affect growth and brain development.

The new study found that 10.3% of children had goitre, a substantial decline from 23.5% in 2003 and 17.6% in 2012. Nearly 99% of the detected goitre cases were classified as grade 1.

The findings reflect the fact that India’s iodisation programme has helped extensively in eliminating iodine deficiency.

More than 90% of surveyed households reported using iodised salt, while 89% of 1,615 tested salt samples contained more than 15 parts per million of iodine.

The median urinary iodine concentration was 133.2 micrograms per litre, indicating adequate iodine nutrition at the population level.

India’s National Iodine Deficiency Disorders Control Programme continues to target household use of adequately iodised salt and regular monitoring of iodine levels.

Also read: Ashwagandha Gummies Linked To Liver Failure, Brain Damage In UK Woman: What Is The Risk With The Herb?

But Thyroid Autoimmunity Is Rising

Despite adequate iodine nutrition, 10.4% of the 5,726 children tested for thyroid antibodies were positive for anti-thyroid peroxidase, or anti-TPO, antibodies.

These antibodies are produced when the immune system mistakenly targets the thyroid. Their presence can be a marker of thyroid autoimmunity and may be associated with conditions like Hashimoto’s thyroiditis. But antibody positivity alone does not mean a child has thyroid disease.

Girls were about twice as likely as boys to test positive for anti-TPO antibodies. Children with goitre were also more likely to have the antibodies.

The study also found hypothyroidism in 13% of the 5,512 children for whom thyroid-function data were available.

In this condition, thyroid-stimulating hormone is elevated but thyroid hormone levels can remain within the normal range. Anti-TPO positivity was independently linked with a higher likelihood of hypothyroidism.

Also read: The Growing Burden of Autoimmune Disorders: Can Ayurveda Offer a Holistic Solution?

Does Iodised Salt Cause Autoimmunity?

Researchers note that previous studies conducted after the introduction of universal salt iodisation had raised questions about iodine excess and thyroid autoimmunity.

Excess iodine can affect thyroid function and has been proposed as one possible contributor to autoimmune thyroid disease.

But it is important to note that thyroid autoimmunity has multiple possible influences, including genetic, environmental, nutritional and lifestyle factors.

The new Indian study is cross-sectional, which means it captures thyroid and iodine status at one point in time. It therefore cannot determine whether iodine exposure caused the antibody findings.

The findings do not undermine the public-health value of salt iodisation. Instead, they suggest that India’s priorities may now need to include continued monitoring of iodine intake alongside thyroid function and autoimmunity.

After US President Donald Trump’s executive order to split MMR into three shots came out in August, he put forth a proposal recently for some childhood vaccines to be divided into five doses.

Trump recently said his administration plans to push vaccine makers to split some childhood vaccines into five separate shots, believing and claiming that giving smaller amounts at longer intervals could lead to a significant reduction in autism.

Trump made the claims on September 18 but did not specify which vaccines he wants divided into five doses, nor did he provide scientific evidence linking vaccination schedules to autism. He said the doses would be given at six-month intervals.

The proposal follows an executive order Trump signed in August, directing changes to federal childhood vaccine recommendations, including separating the combined measles, mumps and rubella (MMR) vaccine into three individual shots and administering them at separate visits.

What Is Trump’s Proposal?

Also read: Trump Nominates Dr Nicole Saphier As Third Surgeon General Pick

On Friday, the President Trump said that his administration is planning to recommend that certain childhood immunizations should be separated into five shots, each with a “small amount of the vaccine.” He added that these doses would each be given six months apart.

“Instead of a child going in and having a tremendous amount of different vaccines pumped into a big proportion of the body … we’re going to recommend that they do five doses marked one, two, three, four, five and that they be given in six-month intervals, so that a small amount of the vaccine gets pumped into the body,” Trump said.

He also said he expects that this could lead to a “massive reduction in autism.” However, it remains unclear which childhood vaccines would be affected or how such a five-dose schedule would be implemented.

HHS Secretary Robert F. Kennedy Jr., who was standing by Trump as he announced the vaccine changes, received a standing ovation Thursday at the conference of the anti-vaccine advocacy group Children’s Health Defense.

He praised Trump’s embrace of vaccine skeptics, stating, “You have a strong and steadfast friend at the White House” and said that he would “stay in this fight.”

Vaccine formulations and dosing schedules are established through clinical research and regulatory review. So, Trump’s proposal to divide an existing dose has sparked reactions.

No Evidence That Vaccines Cause Autism

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Decades of research have not established that childhood vaccines cause autism. The CDC's current vaccine-safety information says multiple studies have found no link between MMR vaccination and autism.

In August, Trump signed an executive order to change the federal government’s approach toward childhood vaccines, insisting that infants should receive fewer immunizations over a longer period.

He advised that the measles-mumps-rubella (MMR) vaccine be separated into three individual shots, despite little to no scientific evidence. Research also proves that there is no published scientific evidence showing a benefit from separating the combined MMR vaccine into three individual shots.

However, the CDC's current website reflects the Trump administration's position, stating it has not definitively ruled out every possible relationship between infant vaccines and autism. It also says that HHS is funding further research into biological mechanisms.

The strongest available evidence for MMR specifically continues to show no association with autism, according to the CDC's cited evidence reviews.

Would Splitting Vaccines Make Them Safer?

There is currently no evidence that splitting combination vaccines into smaller doses prevents autism. The CDC also says there is no published scientific evidence that separating MMR vaccine into individual measles, mumps and rubella vaccines provides a safety benefit.

Experts have also questioned the idea that simply dividing a vaccine dose would change its safety profile.

José Romero, a former senior CDC official, told The Washington Post that vaccines are formulated in a way, so the total dose produces the intended immune response.

Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia told CNN that Trump’s plan would render vaccines ineffective and wouldn’t make them safer necessarily.

Offit said, “When you create a vaccine, you do a dose response curve, and you’re trying to give the least amount of vaccine that induces an immune response that’s protective. So, you don’t want to give too much, where you know you don’t need all that, and you don’t want to give too little, where it’s you know sub-immunogenic.”

He added, “What he’s suggesting would not work. He’s basically saying he wants to give vaccines in a manner in which they wouldn’t be protective.”