Of the many things FDA approved and banned, the latest on the list is Journavx, a new type of painkiller that does not carry the risk of addiction or overdose associated with opioid medications. This is the first new class of pain medicine approved by the FDA in more than 20 years.

Jacqueline Corrigan-Curay, the acting director of the FDA's Center for Drug Evaluation and Research in a statement said, "Today’s approval is an important public health milestone in acute pain management. A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”

Why Is The Approval Important?

This approval is considered a major breakthrough in treating acute pain without the need for opioid medication as reliance on such medications could lead to addiction. As per the Centers for Disease Control and Prevention (CDC) data, more than 81,000 people in 2023 died in overdoses which involved opioids.

What Are Opioids?

Opioids are used to treat pain, cough, and diarrhea. They can be used to treat pain from an injury, illness or surgery. As per National Institute on Drug Abuse (NIDA), opioids are a class of natural, semi-synthetic, and synthetic drugs. Natural opioids include morphine, codeine, opium and thebaine, semi-synthetic opioids include heroin, oxycodone, hydrocodone, and oxymorphone, whereas synthetic opioids include fentanyl. NIDA also mentions that it can be highly addictive, if misused and can cause breathing difficulties, and overdose could also lead to death. These medications can also cause tolerance, physical dependence and opioid use disorders.

As per the World Health Organization (WHO), the term "opioids" includes compounds that are extracted from the poppy plant as well as semisynthetic and synthetic compounds with similar properties that can interact with opioid receptors in the brain. WHO also notes that in 2019, about 600,000 deaths were causes worldwide due to drug abuse, among them, 80% of the deaths were related to opioids, whereas 25% were caused by opioid overdose.

What happens when you overdose on opioids:

• Pinpoint pupils
• Unconsciousness
• Difficulties with breathing

Journavx and how it works

As per FDA, Journvax "reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain." It is different from opioids, as they bind to the receptors in the brain that receive nerve signals from the body.

The newly approved medicine also showed a "statistically significant superior reduction in pain" when compared to a placebo in two randomized trials, said FDA. However, it did not outperform a common opioid-acetaminophen combination pill.

However, the advantage of the newly approved drug is not its efficacy but the side effect profile, which also includes the absence of addiction potential. The medicine will cost $15.50 per pill, which is more expensive than comparable opioids.

Does it have any adverse reaction?

As per FDA, the common adverse reactions in the study for Journavx, the participants experienced itching, muscle spasms, increased blood level of creatine phosphokinase and rash.

In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved the use of the SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for patients with severe aortic stenosis who show no symptoms. This is the first-ever approval of TAVR therapy for asymptomatic patients, marking a significant shift in how this life-threatening condition may be treated going forward.

What Is Severe Aortic Stenosis?

Aortic stenosis is a narrowing of the aortic valve opening, which restricts blood flow from the heart to the rest of the body. In severe cases, the heart must work harder to pump blood, which can eventually lead to heart failure. While some patients experience chest pain, breathlessness, or fainting, others show no outward symptoms despite the seriousness of the condition.

The danger lies in the unpredictability—many asymptomatic patients may suddenly deteriorate, experiencing life-threatening events without warning. Until now, clinical guidelines advised “watchful waiting” for these patients, meaning treatment was delayed until symptoms appeared.

What Is TAVR and the SAPIEN 3 Platform?

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure that replaces the narrowed aortic valve without the need for open-heart surgery. The SAPIEN 3 is a next-generation TAVR device developed by Edwards Lifesciences. It is inserted via a catheter, usually through the femoral artery in the leg, and guided to the heart, where it expands and takes over the function of the diseased valve.

SAPIEN 3 is already widely used in patients with symptomatic severe aortic stenosis. With this new FDA approval, its use extends to a new, broader population of asymptomatic patients.

What Prompted the FDA Approval?

The decision was largely based on findings from the EARLY TAVR trial, a randomized clinical study that enrolled over 900 patients with severe aortic stenosis who had no symptoms. Participants were divided into two groups: one received TAVR using the SAPIEN 3 valve, while the other was monitored with watchful waiting.

After a median follow-up of 3.8 years, the trial found that:

• 26.8% of patients in the TAVR group experienced death, stroke, or unplanned cardiovascular hospitalization.

• In contrast, 45.3% of patients in the watchful waiting group faced such outcomes.

• These significant differences show that even patients without symptoms can benefit from early intervention, reducing the risk of sudden health events and hospitalizations.

What This Approval Means

The FDA’s approval of the SAPIEN 3 platform for asymptomatic severe aortic stenosis patients could lead to changes in clinical guidelines, encouraging earlier evaluation and treatment.

“There is an urgent need to change practice and TAVR guidelines,” said Dr. Philippe Genereux of Morristown Medical Center, who was involved in the EARLY TAVR trial. He emphasized that patients who seem stable can become symptomatic without warning, and early TAVR offers an opportunity to improve outcomes and ease the burden on the health care system.

Poultry-related outbreak has been on going in the US, especially with the ever on going bird flu. Recently, yet another outbreak has been associated with backyard poultry which has sickened at least seven people in six states. This is the new salmonella outbreak. The health officials have confirmed its news this Monday.

As per the Centers for Disease Control and Prevention (CDC), two cases were identified in Missouri, and one each in Florida, Illinois, South Dakota, Utah and Wisconsin.

The CDC noted that most people started falling sick in February and March of this year. All of them had the same strain of salmonella, which is a version that has been traced to hatcheries in the past. The health officials confirmed that investigation with regards to this recent outbreak is on going.

What Is Salmonella?

As per the US Food and Drugs Administration (FDA), Salmonella are a group of bacteria that can cause gastrointestinal illness and fever called salmonellosis. It can be spread by food handlers who do not wash their hands and/or the surfaces and tools they use between food preparation steps. It can also happen when people consume uncooked and raw food. Salmonella can also spread from animal to people.

FDA notes that people who have direct contact with certain animals, including poultry and reptiles can spread the bacteria from the animal to food if hand washing hygiene is not practiced.

Pets too could spread the bacteria within the home environment if they eat food contaminated with Salmonella.

Is It Caused Only By Poultry?

Salmonella bacteria leads to infections in around 1.35 people in the United States, every year. However, the source does not always remain poultry. As per the CDC website Salmonella outbreaks previously have been linked with cucumbers, pet bearded dragons or gecko, eggs, small turtles, poultry, charcuterie meat, cantaloupes, diced onions, cookie dough, and flour.

Backyard Poultry As A Source

The biggest concern with backyard poultry is that even if the chickens look clean and healthy, they could still carry salmonella bacteria. A backyard poultry associated outbreak which ended last year caused 470 cases, which were spread across 48 states and including one death.

What Are The Symptoms Like?

FDA notes that most people infected with Salmonella will begin to develop symptoms 12 to 72 hours of the infection, which lasts for about four to seven days. Most people recover without treatment.

Most people experience these following symptoms:

• Diarrhea
• Fever
• Abdominal Cramps

In severe cases of salmonella, you may experience:

• High fever
• Aches
• Headaches
• Lethargy
• A rash
• Blood in urine and stool

As per the CDC, each year, around 450 people diet in the United States due to acute salmonellosis.

Who Are At More Risk?

Children who are younger than five and the elderly, and people with weakened immune system could be more at risk to have severe salmonellosis infections.

What Can You Do To Be Safe?

• Clean and sanitize all surfaces and items that may have come into contact with contaminated food. This includes the inside walls and shelves of your refrigerator, cutting boards, countertops, and utensils. Use a solution of one tablespoon of chlorine bleach mixed with one gallon of hot water. Wipe dry with a clean, unused cloth or paper towel.

• Also clean and disinfect any surfaces used to store or serve potentially contaminated products.

• After cleaning and sanitizing, wash your hands thoroughly with warm water and soap.

• Children, older adults, pregnant women, and individuals with weakened immune systems should avoid eating raw sprouts of any kind.

• Pet owners should be especially careful to prevent cross-contamination. Wash your pet’s food dishes right after each use, and avoid letting high-risk individuals (like children or the elderly) handle pet food or come into contact with animals that may have eaten contaminated food.

• Consumers may also voluntarily report complaints, illnesses, or serious allergic reactions related to any food product.

United States is experiencing its deadliest flu season for children in 15 years, according to a federal report released Friday. The Centers for Disease Control and Prevention (CDC) has reported 216 pediatric deaths so far this flu season—surpassing last year's 207 fatalities and marking the highest number since the 2009-2010 H1N1 pandemic.

The season is not yet over, making this already grim milestone even more concerning. In fact, the final death toll for the 2023-2024 flu season won’t be confirmed until later this year. "This number that we have now is almost certainly an undercount,” said Dr. Sean O’Leary of the American Academy of Paediatrics. “When the season is declared over, and they compile all the data, it’s almost certain to go up.”

O’Leary, who is also a pediatric infectious diseases specialist at the University of Colorado, pointed to declining flu vaccination rates among children as a key factor in this season’s severity. Over the past five years, the flu vaccination rate for children in the U.S. has dropped from about 64 per cent to just 49 per cent.

While flu vaccines do not always prevent infection, they are highly effective at reducing hospitalisations and deaths. "Flu vaccinations may not prevent people from coming down with symptoms, but research shows they are highly effective at preventing hospitalisations and deaths," O’Leary said.

This flu season has proven severe not only for children but for the general population as well. CDC estimates indicate at least 47 million illnesses, 610,000 hospitalisations, and 26,000 deaths so far. Among 5,200 adults hospitalised with the flu, 95 per cent had at least one pre-existing condition. In contrast, among 2,000 hospitalised children with more detailed health data, only about 53 per cent had underlying health issues such as asthma or obesity.

The CDC report did not include information on how many of the children who died had received the flu vaccine. Additionally, the agency did not provide a spokesperson to discuss the current season’s trends.

There is, however, a positive sign: flu activity has been declining since February. Last week, all 50 states reported low or minimal flu activity. The season also saw an unusual mix of circulating strains, with both H1N1 and H3N2 Type A viruses contributing significantly to infections. Earlier CDC data suggested that the flu vaccines offered this season were relatively effective in preventing hospitalisations and deaths.

The CDC continues to advise that everyone aged 6 months and older receive an annual flu vaccine.

The broader decline in childhood vaccinations is being fueled by online misinformation and the politicisation of vaccines, especially since the COVID-19 pandemic. Robert F. Kennedy Jr., who recently assumed the role of U.S. health secretary, has echoed antivaccine rhetoric, further influencing public opinion.

According to O’Leary, other factors may also be impacting flu vaccination rates. Pediatric clinics are often short-staffed and no longer holding as many after-hours vaccination events. Additionally, while more Americans are getting vaccinated at pharmacies, some drugstores do not offer flu shots for children.

"My hope is that this season will be a bit of a wake-up call for folks—that we actually do need to vaccinate our kids against influenza," O’Leary said.