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.

At least 17 US states have reported cases of watery diarrhea, nausea and fatigue caused by the parasite Cyclospora cayetanensis.

According to the US Centers for Disease Control and Prevention (CDC), 145 people aged between five and 86 contracted the parasite between May 1 and June 16.

Twenty of those infected have been hospitalized. The infections have been reported across 17 states, with the highest number of cases recorded in New York.

"Local, state and federal (CDC, FDA) public health authorities are investigating several clusters of cases in more than one state. Investigations to identify potential sources are ongoing," the CDC said in its update on the outbreak.

Which States Are Reporting Cases?

New York has reported the highest number of cases, with between 31 and 80 infections, according to The Independent. Illinois and Texas have each reported between 11 and 30 cases. Other affected states include:

• Alaska
• Colorado
• Connecticut
• Florida
• Georgia
• Louisiana
• Massachusetts
• New Jersey
• North Carolina
• Ohio
• Pennsylvania
• Tennessee
• Virginia
• Wisconsin

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Cases Typically Rise During Summer

Cyclospora infections usually increase during the summer months, and the CDC considers May 1 through August 31 to be the peak cyclosporiasis season. No deaths have been reported in the current outbreak.

As of June 16, the CDC had also recorded 45 travel-related cases of cyclosporiasis among people who became ill after consuming contaminated food or water outside the United States.

Three of those patients were hospitalized, but no deaths have been reported.

Health officials believe the current outbreak is linked to contaminated food consumed within the United States. Most of the affected patients had not travelled outside the country before becoming ill.

The officials are still working to identify the specific food item responsible for the outbreak.

What is Cyclospora cayetanensis?

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Cyclospora cayetanensis is a parasite that leads to the illness Cyclosporiasis -- a form of food poisoning.

One can get a Cyclospora infection from contaminated food or water. It causes watery diarrhea and other intestinal symptoms.

A Cyclospora infection can be mild or very serious, and may last weeks or months. It is typically treated with antibiotics.

People with weakened immune systems, such as those with HIV/AIDS or cancer, are more at risk of severe disease.

Symptoms Of Cyclospora Infection

Symptoms of cyclosporiasis usually start within a week of exposure (eating or drinking contaminated food or water) and include:

• Watery or explosive diarrhea
• Loss of appetite
• Bloating and gas
• Fatigue (extreme tiredness)
• Low-grade fever
• Nausea
• Stomach cramps
• Vomiting

How Can You Prevent A Cyclospora Infection

While it is not yet fully understood how Cyclospora gets into food and water, individuals can prevent cyclosporiasis by not consuming food or water that may be contaminated with feces.

The US CDC advises people to take measures to prevent the foodborne illness such as:

• Wash your hands with soap and water before and after handling or preparing raw fruits and vegetables
• Wash all fruits and vegetables thoroughly under running water before eating, cutting, or cooking
• Fruits and vegetables that are labeled "prewashed" do not need to be washed again at home
• Scrub firm fruits and vegetables, such as melons and cucumbers, with a clean produce brush
• Cut away any damaged or bruised areas on fruits and vegetables before preparing and eating
• Refrigerate cut, peeled, or cooked fruits and vegetables as soon as possible (within two hours).

Even as Uganda works to contain what is already the third-largest Ebola outbreak on record, centred in neighbouring Democratic Republic of Congo (DRC), the country is now facing the risk of the Marburg virus, another deadly filovirus disease.

Media reports have indicated a possible Marburg virus case in Uganda, although the country has not yet publicly declared an outbreak.

Uganda Reports Case To WHO

Uganda, however, formally reported a case of Marburg virus disease to the World Health Organization (WHO) on June 30, according to a STAT News report.

On June 29, the US Embassy in the Ugandan capital, Kampala, also issued a health alert regarding a possible case of Marburg virus disease in the country.

"The US Embassy is aware there are reports of a potential case of Marburg Virus Disease, a viral hemorrhagic fever, in western Uganda," the embassy said in its advisory.

The alert was issued as a Level 4 travel advisory, warning Americans not to travel to Uganda.

Dual Threat May Complicate Response

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Uganda has extensive experience managing outbreaks of viral hemorrhagic fevers. The country last reported a Marburg virus outbreak in 2017, when there were four cases and three deaths.

However, responding to a potential Marburg outbreak while simultaneously battling Ebola could complicate public health efforts.

Both Ebola and Marburg virus disease are viral hemorrhagic fevers caused by closely related filoviruses. So far, Uganda has reported a total of 20 cases of the rare Bundibugyo species of Ebola, including two deaths. Of these, 15 cases were imported from the Democratic Republic of Congo.

What Is Marburg Virus?

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Marburg virus disease belongs to the same virus family as Ebola and has a case fatality rate that has varied widely across outbreaks.

The virus is primarily carried by fruit bats and can spread to humans through prolonged exposure to infected bats or contaminated environments. Once a person is infected, the virus spreads from person to person through direct contact with the blood, bodily fluids, or contaminated surfaces and materials used by infected individuals.

Common Signs And Symptoms

Marburg virus disease typically begins with a sudden onset of high fever, severe headache and muscle pain. Other common symptoms include diarrhea, vomiting, abdominal pain and weakness.

In severe cases, patients may develop internal and external bleeding, organ failure and shock, which can be fatal.

There is currently no approved specific treatment or vaccine for Marburg virus disease. However, supportive care significantly improves survival, and several vaccines, antiviral drugs and immune therapies are under development, according to the World Health Organization (WHO).

History Of Marburg Virus

According to the WHO, Marburg virus disease has killed between 24 per cent and 88 per cent of infected patients in previous outbreaks, depending on the virus strain and the quality of medical care available.

The virus was first identified in 1967 after simultaneous outbreaks occurred in Marburg and Frankfurt in Germany, and Belgrade in present-day Serbia. A total of 31 people were infected and seven died.

The outbreaks were traced to African green monkeys imported from Uganda for laboratory research. Fruit bats are now recognized as the natural reservoir of the virus, although other animals can also become infected.

Past outbreaks have been reported in countries including Angola, the Democratic Republic of Congo, Equatorial Guinea, Ghana, Kenya, South Africa, Uganda and Zimbabwe.

Outside Africa, only a handful of Marburg cases have been reported. Two fatal cases occurred in travelers who had visited bat-inhabited caves in Uganda—one in Europe and one in the United States.

The Indian Society of Anaesthesiologists (ISA) has issued an urgent advisory asking anaesthesiologists and hospitals across the country to immediately stop administering Hyperbaric Bupivacaine manufactured by Themis for spinal anaesthesia until further notice.

Why Has ISA Issued This Advisory?

Themis Hyperbaric Bupivacaine is commonly administered as a spinal anaesthesia. According to the ISA and the Anaesthesia Patient Safety Association (APSA), the anaesthesia resulted in several suspected adverse events.

These reports were significant enough to warrant an immediate nationwide safety alert, even though the exact cause and frequency of the adverse events have not been revealed yet.

However, according to Medical Dialogues, the Indian Society of Anaesthesiologists has suspected that the adverse incidents linked to Themis Hyperbaric Bupivacaine were reported at Apollo Hospitals and Yashoda Hospitals. They also said that Adverse Drug Reactions (ADRs) related to the drug have been reported, and an investigation is underway.

The associations also stressed that the advisory is strictly precautionary and does not imply that the drug is defective or that Themis is responsible for any negligence or unethical practices.

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What Does The Advisory Say?

Apart from stopping the administration of Themis Hyperbaric Bupivacaine, the advisory has also asked hospitals and healthcare facilities to:

• Identify, segregate, and isolate existing stock of Themis Hyperbaric Bupivacaine from clinical use.

• Switch to alternative approved brands of hyperbaric bupivacaine.

• Preserve details like batch number, manufacturing date, expiry date, and storage conditions.

• Report any suspected adverse events related to the drug to APSA and the relevant regulatory bodies.

Dr Sherry Mathews, President of the Hyderabad Metro City Branch of the Indian Society of Anaesthesiologists, said, “This is a precautionary advisory issued in the interest of patient safety. Reports of serious adverse events have been received from multiple hospitals, and until the investigation is completed, we have advised doctors to stop using the product.”

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A separate notice issued by the ISA's Hyderabad Metro City Branch directed consultants, resident doctors, anaesthesia technicians and operation theatre staff to immediately stop the use of Themis Bupivacaine for spinal anaesthesia.

It also said that no ampoules of the product should be used for neuraxial administration until an official clearance is issued. It added that any inadvertent use must be reported to the head of the department without fail.

The authorities are currently investigating these suspected adverse reactions, particularly their nature and association with the drug.

About Themis Hyperbaric Bupivacaine

Themis Hyperbaric Bupivacaine, marketed under brand names like Bupicain Heavy, is manufactured by Themis Medicare Limited, a 53-year-old Indian pharmaceutical company.

It contains Bupivacaine hydrochloride 0.5% (5 mg/mL), a local anaesthetic. It also contains Dextrose, which makes the solution hyperbaric (heavier than cerebrospinal fluid), which helps anaesthesiologists control how the anaesthetic spreads through the spinal canal.

Hyperbaric bupivacaine is commonly used for:

• Caesarean sections

• Orthopaedic surgeries involving limbs in the lower half

• Hip and knee surgeries

• Urological procedures

• Gynaecological surgeries

• Hernia surgeries

• Other surgeries below the umbilicus

Hyperbaric bupivacaine is widely trusted for spinal anaesthesia globally. Many pharmaceutical companies manufacture it. The concern raised by the Indian Society of Anaesthesiologists is not against the drug, but about one manufacturer's production.