The US Food and Drug Administration has approved TNKase or Tenecteplase, which is a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.

Ischemic strokes happen when a blood clot blocks a blood vessel in your brain. It can cause permanent brain damage and death. If enough brain cells die, you can also lose the abilities or body functions those cells control. They are also the most common types of stroke, with 80% of all strokes being ischemic strokes.

How is TNKase administered?

It is delivered as a single five-second intravenous bolus, which is faster than the standard of care Activase or alteplase, which is administered as an intravenous bolus followed by a 60-minute infusion. The manufacturer of TNKase, Genetech said a new 25-mg vial configuration will also be available in the coming months.

How Was TNKase approved?

The approval came at the backdrop of a study that compared TNKase to Activase in patients with acute ischemic stroke. These patients also presented with a disabling neurological deficit. Results show that TNKase was comparable to Activase in terms of efficacy and safety.

How Common Are These Strokes?

In the United States it self, it affects more than 795,000 people each year and is the leading cause of long-term disability. It is also the fifth leading cause of death. Since brain damage can happen if this progresses rapidly, one needs an immediate, fast-acting medical care.

TNKase thus provide a faster and simpler administration which can be critical for anyone. The chief medical officer and head of global product development at Genetech, Levi Garraway, MD., PhD., said, "Today's approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients."

What Are The Symptoms Of Ischemic Strokes?

Some of the most common symptoms include weakness or paralysis on one side of your face and body. You may also feel trouble speaking or have loss of speech, also known as aphasia. You may faced slurred or garbled speaking, also known as dysarthria. Other symptoms include loss of muscle control on one side of your face, or sudden worsening or loss of your senses, including vision, hearing, smell, taste, and touch.

Other symptoms include:

• Loss of coordination or clumsiness
• Blurry vision or double vision
• Dizziness or vertigo
• Nausea and vomiting
• Neck stiffness
• Mood swings or sudden personality changes
• Confusion or agitation
• Seizures
• Memory loss (amnesia)
• Headaches which are sudden and severe
• Passing out or fainting
• Coma

Are There Any Warning Signs?

While these are symptoms one has who is prone to this condition. However, often, many may confuse it with other illnesses. It is best to keep an eye out for warning signs. These could be looking out for yourself or your loved one. Note if there is a sudden loss of balance. Look out for sudden vision loss or changes in one or both eyes. Look for a droop on one or both sides of your face, especially when you smile. Raise both arms and see if one arm sags or drops in a way it usually does not. Note for your speech. Are you as fluent? Are you have trouble speaking? If you see any of such signs, start tracking it and talk to your healthcare provider.

France just raised its bird flu alert to "high" nationwide. Not just France, but Germany too raised alarm over bird flu, and have linked the risk to poultry farms as "high" as cases continue to rise across Europe.

The French agriculture ministry said that poultry farms are now required to keep their birds indoors and that authorities must aim "to strengthen surveillance and prevention measures" against the virus.

Reuters reported that "This decree was issued following evidence of infection among migratory wild birds in Europe, including France, and the confirmation of several outbreaks in poultry farms. So far, two bird flu outbreaks have been detected on poultry farms and three backyard flocks, the ministry said in the decree. A first case had ben detected in mid-October at a pheasant and partridge breeding farm in northern farm."

In Germany too, authorities have raised the risk level after several people came into contact with infected birds and other animals. This has raised the risk of the virus, and the fact that it could mutate and spread much more easily among people. This has also caused a concern among global health experts.

Other European countries which have also taken steps to address bird flu include the Dutch agriculture ministry that detected an outbreak on poultry farm, and lead to the culling 71,000 birds and also ordered to keep birds indoors.

In recent years, tens of millions of birds have been culled in Europe to prevent the virus from spreading. “The risk to human health in the EU/EEA is currently considered very low,” the European Centre for Disease Prevention and Control (ECDC) said in a press release.

What Is Bird Flu?

Avian influenza, or bird flu, is a virus that affects birds, especially chickens, ducks, and wild waterfowl. This can spread fast through bird droppings, feathers, and contaminated surfaces. Since it spreads fast, so it can easily sneak into poultry farms, where thousands of birds live close together, and could give the virus the perfect chance to multiply and mutate.

Can Humans Get Bird Flu?

While humans can get bird flu, the cases are rare. However, when it happens, it usually happens to those who work at poultry farms, or live near to them. Those who handle birds on a day to day basis, like market sellers, or vets are also at a higher risk.

However, one of the bird flu strains, the H5N1 is very dangerous and it can cause serious illness in humans if it jumps species. A few signs and symptoms which resemble those of regular flu initially, high fever, cough, sore throat, can sometimes turn extremely severe, leading to pneumonia or breathing problems, which can also be fatal. However, human-to-human spread is extremely uncommon, and health experts say there’s no need for panic.

For this year's Delhi, the Supreme Court had lifted the blanket ban on bursting firecrackers, and allowed the citizens to burst green crackers, which emit 30 to 40% less harmful gases. The court also set a time limit between 8pm to 10pm, however, as reports show, Delhiites, very well burst crackers post the 10pm limit. As a result, Delhi pollution shot up 100 times the World Health Organization (WHO) limits, showed the data by Delhi Pollution Control Committee (DPCC).

For instance, On Monday 10am, in Nehru Vihar, the level of PM 2.5 was at 1,753 micrograms per meter, which is 116.8 times the WHO permission limit of 15 micrograms per cubic meter for a 24-hour period.

Also Read: Severe AQI In Delhi: Why Early Morning Walks Can Be Dangerous For Senior Citizens

In Patparganj area of Delhi, at 4am on Tuesday, the PM 2.5 was recorded at 1,144.8 micrograms per cubic meter, which is 76 times the WHO limit. Similarly, Ashok Vihar reported 1,353 micrograms per cubic meter at 12am on Tuesday, which is over 90 times the WHO limit.

In such a case, how can someone protect themselves? While pollution has crossed the safe limit, lives haven't stopped, people are still going out for work, and what's important is to wear protective gears to limit exposure to harmful gases in the pollution.

Surgical Mask Or N-95: Which One To Choose?

The answer to this is to wear masks. Now the question that arises is which one? Should we wear a surgical one, that comes in 3-ply protection, or should we go for an N-95 mask?

Dr Sandeep Nayar, Principal Director and HOD of Chest & Respiratory Diseases at BLK-Max Super Speciality Hospital says that N-95 should be considered. He says that normal surgical masks do not prevent you from getting exposed to smaller pollutants including PM 2.5 particles, which could directly enter your airways and may diffuse into the blood and affect all organs of your body.

What Is A Surgical Mask?

As per the US Food and Drug Administration (USFDA), a surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and the nose of the wearer and potential contaminants in the immediate environment. However, the FDA, notes, that they do not filter or block very small particles in the air.

A surgical mask has a different kind of thickness, and it enables the wearer to be protected from contacts with liquid. It also effects how easily you can breathe. If worn properly, it can block large-particle droplets, splashes, sprays, or splatter that could contains germs via viruses or bacteria from reaching your mouth and nose. The main function of a surgical mask is to reduce exposer of saliva and respiratory secretions to others.

What Is An N-95 Respirator?

It is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles, notes the FDA. This is what makes it fit for use during high levels of pollution.

The edges of N-95 are designed to form a seal around the nose and mouth. Some models even have exhalation valves that can make breathing out easier and help reduce the heat build-up.

As per a 2021 study published in the Indian Journal of Radiology and Imaging, the N-95 mask could block "at least 95% of very small test particles". There are various kinds of such masks, called the filtering facepiece respirators or FFRs with various numerical designation like N-95, N-99, N-100, P-95, P-99, P-100, R-95, R-99, and R-100, where the number shows the filter's minimum filtration efficiency. The letters also hold a meaning, for instance the 'N' is for not resistant to oil, 'R' is for somewhat resistant to oil, and 'P' denotes strongly resistant to oil.

Kenvue, the American company behind Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label reflecting research about a possible link between its use during pregnancy and autism or ADHD diagnoses in children.

The company emphasizes that acetaminophen, the generic name for Tylenol, also called paracetamol is “one of the most studied medicines in history” and argues that adopting the proposed label warning would be arbitrary, capricious, and unlawful.

Tylenol generates roughly $1 billion annually for Kenvue and remains the company’s top-selling brand, according to Morningstar. The current label advises pregnant or breastfeeding individuals to “ask a health professional before use.”

Kenvue: Push for Label Change Sparks Attention

The call for a label change gained attention after former President Donald Trump held a news conference last month, telling pregnant women in pain to try to “tough it out” instead of taking Tylenol, even though acetaminophen is widely considered the safest over-the-counter pain reliever during pregnancy.

Trump claimed, without evidence, that taking Tylenol during pregnancy is linked to a “very increased risk of autism.” “Fight like hell not to take it,” he urged.

Most pregnant people use acetaminophen at some point, studies show. Other common pain or fever treatments, such as ibuprofen or regular-dose aspirin, can increase the risk of serious complications during pregnancy. Untreated pain or fever can also be dangerous, possibly leading to miscarriage, birth defects, or high blood pressure.

Kenvue And Tylenol: FDA and Public Health Actions

Beginning the process to change acetaminophen labels was one of several steps the Trump administration planned. HHS Secretary Robert F. Kennedy Jr. said his agency would also launch a public service campaign about the issue.

The FDA sent a letter to physicians noting that the decision to take Tylenol “still belongs with parents,” while also warning that its use during pregnancy may carry an “increased risk of neurological conditions such as autism and ADHD in children.”

However, the letter stressed that “a causal relationship has not been established” and that studies examining a potential link are “contradictory,” as per CNN.

Citizen Petition Filed

The Informed Consent Action Network, an anti-vaccine nonprofit closely tied to Kennedy, filed a citizen petition with the FDA on the same day as Trump’s news conference. Citizen petitions allow individuals, industry groups, or consumer organizations to request FDA action on specific issues.

The petition claimed that, because of “urgent public health implications,” the FDA should add a warning to acetaminophen labels stating that “studies show that frequent use of this product during pregnancy may increase your child’s risk of neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder.”

Kenvue Responds

On Friday, Kenvue formally asked the FDA to deny the petition, saying that the proposed label changes are unsupported by scientific evidence and would represent a departure from the FDA’s longstanding position on acetaminophen during pregnancy. The company said it had met with Kennedy in early September after he suggested a link between acetaminophen use during pregnancy and autism, and Kenvue informed him there was no such connection.

FDA Guidance and Global Response

The FDA website on acetaminophen has not been updated to reflect the Trump administration’s views. The last update, in August, states, “to date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.” Acetaminophen has been studied for decades, and according to the American College of Obstetricians & Gynecologists, no reputable study has concluded that its use in any trimester causes neurodevelopmental disorders in children.

Following Trump’s news conference, medicine regulatory agencies in the European Union, United Kingdom, and Canada quickly released statements confirming that acetaminophen remains safe for pregnant individuals.