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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.
"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.
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.
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A widely sold nasal spray is being pulled from shelves across the United States after tests revealed mold and microbial contamination, prompting officials to urge consumers to stop using it right away.
MediNatura New Mexico issued a voluntary recall of ReBoost Nasal Spray on Wednesday, the US Food and Drug Administration said in a public notice. The action follows findings that one specific lot of the product contained yeast and mold, along with unsafe levels of microbial contamination.
Laboratory testing also identified the presence of Achromobacter, a type of bacteria that can cause infections, particularly in people with weakened immune systems. The FDA has advised customers to immediately discontinue use of the affected nasal spray.
MediNatura New Mexico Inc. has voluntarily recalled its ReBoost Nasal Spray after the product was found to contain yeast, mold, and microbial contamination. One of the organisms identified was the bacteria Achromobacter, detected at levels higher than safety limits, according to the US Food and Drug Administration.
The FDA warned that use of the spray could result in severe health effects, particularly for people with weakened immune systems. The agency noted a real risk of serious and potentially life-threatening infections in this group.
The Hawaii State Department of Health, which also issued a recall notice, listed symptoms that may be linked to the contaminated spray. These include fever, sinus swelling, headaches, facial pain or pressure, and numbness in the face.
Consumers who notice any of these symptoms after using the product have been advised to contact a doctor or healthcare provider.
As of December 10, MediNatura said it had not received any reports of health problems related to the recalled nasal spray. This information was confirmed by both the FDA and the Hawaii health department.
As per NBC, the nasal spray company was contacted for comment but did not receive a response by the time of publication.
ReBoost Nasal Spray is a homeopathic product that contains echinacea and other natural ingredients. The company markets it as a remedy for nasal congestion and related symptoms.
The recall applies to sprays packaged in a white and yellow box containing a 20 mL bottle. The affected lot number is 224268, with an expiration date of December 2027. The product carries NDC number 62795-4005-9 and UPC 787647101863.
The FDA has urged customers to stop using the nasal spray right away. Those who bought it directly from MediNatura can request a refund by emailing recall@medinatura.com. Consumers who purchased it through other retailers should return it to the place of purchase.
The product was sold both online and in physical stores across the United States.
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Danish drugmaker Novo Nordisk has officially introduced its widely known diabetes medication Ozempic in India, pricing the starter dose of 0.25 mg at ₹2,200 per week. According to a Reuters report, the injectable medicine will be available in three strengths in the country: 0.25 mg, 0.5 mg and 1 mg.
Ozempic is a once-weekly injectable prescribed for people living with type 2 diabetes.
The weekly injection received approval from the US Food and Drug Administration in 2017 for treating type 2 diabetes. Since then, it has grown into a global blockbuster and is also commonly prescribed off-label for weight loss because of its appetite-suppressing effects.
The lowest strength will cost ₹2,200 per week. Prices for the higher doses have also been announced, as per the Reuters report.
Here are the details:
India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), approved Ozempic, also known as semaglutide, in October this year for adults with type 2 diabetes.
As per the US FDA, Ozempic is prescribed along with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. It is also indicated to reduce the risk of major cardiovascular events in adults with type 2 diabetes who already have heart disease.
As per NDTV Profit, currently, Wegovy is priced at Rs 2,712 per week for the 0.25 mg dose, while the 0.5 mg dose costs Rs 3,462 weekly. The 1 mg dose is also priced at Rs 3,462 per week, and the 1.7 mg dose is available at Rs 4,100 per week. Mounjaro (tirzepatide), a combination therapy of GLP-1 receptor agonist and GIP that helps improve blood sugar control in adults with type 2 diabetes when paired with a healthy diet and regular exercise, is priced at Rs 13,500 per month for the 2.5 mg dose.
Ozempic mimics the action of a naturally occurring hormone called GLP-1. Here’s how it supports weight loss, as outlined in an earlier HT report.
As previously reported by Mayo Clinic, some potential side-effects of Ozempic include:
This article is intended for informational purposes only and should not be taken as a replacement for professional medical advice.
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Anti-pollution measures under GRAP-3 came into force in Delhi on Saturday as air quality slipped into the “severe” bracket. By noon, the national capital reported an Air Quality Index of 405, according to figures released by the Central Pollution Control Board (CPCB). Earlier in the day, Delhi’s AQI hovered close to 390 during the morning hours.
Each winter, Delhi and the surrounding NCR (National Capital Region) bring in curbs under the Graded Response Action Plan, which divides air quality into four levels: Stage 1 (Poor, AQI 201–300), Stage 2 (Very Poor, AQI 301–400), Stage 3 (Severe, AQI 401–450) and Stage 4 (Severe Plus, AQI above 450).
Under GRAP-3, non-essential construction and demolition activities have been halted, along with stone crushing and mining operations. The measures also include restrictions on older diesel goods vehicles within Delhi. Schools up to Class 5 are required to move to a hybrid learning model, while offices across Delhi-NCR may function with only 50 per cent staff strength, as per Press Information Bureau.
Hazardous AQI levels have become a recurring feature across several parts of Delhi during the winter months. Quoting environmental experts, an IANS report linked the sharp decline in air quality to a mix of stagnant wind conditions, vehicle emissions, industrial pollution and seasonal factors such as crop residue burning in neighbouring states.
The biggest shift under the updated GRAP framework is that stricter steps will now come into force earlier, instead of waiting for air quality to deteriorate further.
As per Press Information Bureau, under the revised system, measures that were earlier reserved for Stage 4 will now apply at Stage 3 itself. This means that once the AQI reaches the 301–400 range, public, municipal and private offices will function with only 50 percent staff. Central government offices will also move to work-from-home at this stage, rather than waiting for the AQI to cross 450.
In the same way, actions that earlier fell under Stage 3 have now been pushed to Stage 2. As a result, staggered timings for government offices will begin as soon as the AQI enters the 201–300 category.
Stage 2 measures have also been advanced to Stage 1. This brings uninterrupted power supply arrangements into effect earlier, at an AQI level of 101–200, to reduce the need for diesel generator use and limit additional emissions.
In response to the worsening situation, the Delhi government confirmed that the Commission for Air Quality Management (CAQM) has activated all measures under Stage III of GRAP, which falls under the “Severe” air quality category with AQI levels between 401 and 450, across the entire NCR.
These Stage 3 curbs will apply in addition to the existing Stage I and Stage II measures. Authorities, including NCR Pollution Control Boards, have been instructed to step up enforcement to prevent further deterioration of air quality across the region.
Even as Stage III of the Graded Response Action Plan comes into force, certain essential activities and services will continue to operate to minimise disruption to daily life.
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