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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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Taiwan’s Food and Drug Administration (TFDA) has recalled of 87,360 tablets of a blood pressure medication after a specific batch failed a quality test. Health officials raised concerns, saying that the drug may not work as effectively as expected.
The recall involves Beniel F.C. Tablets 8 mg, manufactured by Synmosa Biopharma Corp. The affected batch is 2KA31, and the medicine contains benidipine hydrochloride, a drug used to treat high blood pressure.
The problem was first identified during a stability test of the drug, which found that the tablets failed to meet the required dissolution standards.
In simple terms, a dissolution test is conducted to check how a tablet breaks down and releases its active ingredient under controlled conditions.
This is an important test as a tablet has to release the medicine in the proper way for the body to absorb it and for the drug to produce its intended effect.
Also read: Blood Pressure, Heart Medicines May Boost Effectiveness Of Antidepressants, AIIMS Study Finds
Benidipine hydrochloride belongs to a group of drugs called calcium channel blockers. These medicines help lower blood pressure by relaxing and widening blood vessels. This enables the blood to flow more easily and reduces the pressure against artery walls.
That is why a problem affecting how a tablet dissolves can matter. If the active ingredient is not released into the body as expected, the medicine may not deliver its intended therapeutic effect.
Also read: Why Are More Women Under 35 Reporting Heart-Related Symptoms?
According to the TFDA, there is no immediate concern of medication shortage. Other batches of Beniel F.C. Tablets 8 mg are not affected, and the manufacturer has sufficient inventory.
Production of the drug will also not been stopped. Taiwan News reported that two other products containing the same active ingredient are also authorised for sale.
The manufacturer has been ordered to complete the recall by August 24 and submit an investigation report along with corrective and preventive measures for future production.
Patients should not stop their blood pressure medication on their own. The TFDA advised people who are concerned about their prescription to speak with their doctor about whether an alternative medicine is necessary.
The recall highlights an often overlooked part of medication safety: a medicine can contain the correct active ingredient but still fail a quality test if its physical properties affect how the drug is released. For now, the concern is focused on one specific batch, rather than the entire Beniel F.C. product line.
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The ongoing Ebola virus disease epidemic in the Democratic Republic of Congo (DRC) is moving faster than any previous outbreak, said WHO chief Dr Tedros Adhanom Ghebreyesus.
According to official data, confirmed cases have reached 4,449, with the death toll climbing to 2,061 across five provinces and 53 health zones in the country. However, the number of uncounted cases may be far higher than the reported figure.
“It is already the second-biggest Ebola epidemic on record, and it is moving faster than any previous Ebola outbreak. At its current pace, it is on track to eclipse the West African Ebola outbreak of 2014 to 2016,” Tedros said in a briefing.
The 2014-2016 outbreak reported at least 28,000 cases and took about eight months to reach 1,000 deaths.
Tedros noted that the current “outbreak had a big head start, it is still way ahead of us, and we are playing catch-up.”
He said this even as reports showed that the disease caused by the rare Bundibugyo virus had been circulating since February and went undetected for months. The WHO declared the outbreak on May 15.
Dr Abdirahman Mahamud, WHO’s director for health emergency alert and response operations, said the agency expects the outbreak to reach its peak within six months, AP News reported.
“But ... that’s the moderate scenario,” Mahamud said. “There is a one-case scenario where this outbreak may last nine months to 12 months.”
Also read: Ebola Death Toll Tops 2,000 In DRC: New Study Reveals Likely Source Of Bundibugyo Virus Outbreak
Tedros said about 90% of all cases and 80% of deaths are in the province of Ituri, with sustained transmission in the towns of Bunia, Rwampara, Nizi and Lita.
“Most concerningly, we see a high proportion of deaths in communities instead of treatment units, outside of known contact lists,” Tedros said.
“That tells us there are chains of transmission we don’t know about, and until we know about – and break – every chain of transmission, we will not stop the outbreak.”
Most transmission happens when people have late-stage disease and are not in treatment, or when their bodies are handled after death.
Early clinical care and safe and dignified burials are therefore critical for interrupting transmission. Both depend on the trust of affected communities, making community engagement and ownership essential.
“There is no other way,” Tedros said, adding that the response is now being scaled up, with the primary goal of interrupting transmission.
With partners, WHO is mapping and pooling resources to strengthen community-based surveillance, bring every suspected case into care and reach the 95% contact-tracing target needed to interrupt transmission. Currently, the rate is around 80%.
Read More: Ebola Outbreak: Officials To Probe Whether Bundibugyo Virus Is Mutating
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American drugmaker Eli Lilly has sued six companies in the US over the alleged illegal sale of its experimental weight-loss drug retatrutide.
In a statement, Lilly said that the lawsuits target US entities allegedly selling illegal retatrutide products, claiming that their products are for “research use only” while allegedly marketing them for human use. These include
“Retatrutide is being rigorously studied as part of a comprehensive clinical trial development program,” said David A. Hyman, Lilly’s chief medical officer.
“We take the responsibility of evaluating the safety and efficacy of our investigational medicines seriously. What is being sold on the black market is not a medicine – it is entirely unverified, unapproved and not worth the risk,” he added.
Lilly has filed lawsuits against:
Lilly said it has referred more than 200 individuals and entities to the US Food and Drug Administration (FDA), the US Department of Justice, state attorneys general, law enforcement agencies and professional licensing boards.
The company is also working with regulators, law enforcement and customs authorities worldwide to address the illegal market.
Lilly urged social media and e-commerce platforms, credit card companies, payment processors, and shipping and logistics companies used by sellers to help protect patients and tackle the illicit activity.
The drugmaker noted that it has reported more than 14,000 websites, advertisements, social media posts and product listings that allegedly market retatrutide unlawfully across more than 100 countries to internet service providers, social media platforms and e-commerce companies.
The US FDA has made clear that selling unapproved retatrutide directly to consumers is illegal. Retatrutide also cannot be lawfully compounded.
The FDA has warned that so-called “research-use only” products are of unknown quality and may pose risks to consumers’ health.
Black-market sellers and businesses posing as legitimate medical providers have openly marketed retatrutide as a weight-loss “hack.”
According to Lilly, such products are frequently made by unregulated foreign manufacturers. Regulators, customs agencies and law enforcement authorities worldwide have warned about these products and have taken actions including raiding clandestine manufacturing sites, seizing shipments and making arrests.
Retatrutide is one of Eli Lilly’s next-generation obesity treatments and is currently under development. Unlike Lilly’s currently approved GLP-1 drugs, retatrutide activates three hormone receptors: GLP-1, GIP and glucagon.
Researchers believe this triple-action approach could help people lose excess weight by reducing appetite while also increasing energy expenditure.
Retatrutide has attracted significant interest after late-stage clinical trials showed some of the highest weight-loss outcomes reported with an obesity medication. In Phase 3 studies, adults without diabetes who received the highest dose lost more than 28% of their body weight over 80 weeks.
Lilly plans to submit retatrutide for approval to the US FDA in the first quarter of 2027.
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