FDA Approves TNKase To Treat Ischemic Strokes In Adults

Updated Mar 7, 2025 | 08:52 AM IST

SummaryIt 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.
Ischemic Stroke

Credits: Canva

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.

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Trump Administration Asks SC To Restrict Gender-Affirming Care In Prisons: What Happens If Treatment Stops

Updated Sep 29, 2026 | 07:43 AM IST

SummaryTrump Administration seeks to restrict gender-affirming care for transgender inmates in US prisons. This includes surgeries, hormone therapies and other social accommodations.
Trump Administration Wants To Restrict Gender-Affirming Care For Transgender Inmates: What Happens If Treatment Stops

Credit: AI

The Trump administration has asked the US Supreme Court to allow federal prisons to restrict gender-affirming medical care for transgender inmates. This has escalated a legal battle over what healthcare transgender inmates in federal custody are entitled to receive.

The Justice Department filed an emergency request on September 28, asking the court to lift a lower-court order that currently prevents the Bureau of Prisons from enforcing its restrictions.

The case concerns a policy introduced by the Bureau of Prisons in February 2026. Under the policy, federal prisons would stop providing surgeries and hormone therapy for transgender inmates and would also remove certain cosmetic accommodations like wigs and other clothing-related provisions. Mental health and psychiatric care would remain available.

Here's a wider look at its implications on prison healthcare for transgenders.

Why Is The Policy Being Challenged?

Also read: Why Is The Trump Administration Stopping Obamacare Health Plans For 760,000 Enrollees?

Three transgender inmates in federal prisons in New Jersey, Florida and Minnesota filed a class-action lawsuit challenging the restrictions.

A federal judge, Royce Lamberth, ordered the government to continue providing gender-affirming medical care like hormone therapy to affected inmates. He found that the Bureau of Prisons was likely to have acted unlawfully.

The US Court of Appeals for the District of Columbia Circuit declined to lift that order on September 18, leaving the restrictions blocked while the legal challenge continues.

The administration has now taken the dispute to the Supreme Court, asking the justices to allow the restrictions to be enforced while the wider case proceeds.

The administration argues that an executive order required the Bureau of Prisons to revise its medical care policies so that federal funds aren’t spent “for the purpose of conforming an inmate’s appearance to that of the opposite sex." It also argues that security and prison-management concerns support the policy.

The government is seeking permission to enforce the policy before the courts reach a final decision on whether the restrictions themselves are lawful. It says that the Bureau of Prisons had “determined that sex-trait-modification surgeries, hormone interventions in general, and social accommodations could no longer be justified as treatment for gender dysphoria.”

What Do The Inmates Say?

Also read: Trump Proposes A New Board That Could Have Veto Power Over 48 Billion NIH Budget & Prevent 'Woke' Research

Attorneys representing the transgender inmates argue that withholding medically necessary treatment because a person is transgender could violate their constitutional rights. They have also raised the Eighth Amendment, which prohibits cruel and unusual punishment. Their argument is that prison officials have a constitutional obligation to provide necessary medical care for serious health conditions and that gender dysphoria can require personalised treatment.

The legal dispute therefore involves two questions: whether the Bureau of Prisons can change its medical policy in this way, and whether denying gender-affirming treatment to transgender inmates can amount to unconstitutional refusal of medical care.

What Is Gender Dysphoria?

Gender dysphoria is a clinical diagnosis that identifies significant emotional distress that someone experiences when their gender identity and their sex assigned at birth do not match.

Treatment for gender dysphoria can vary from person to person. Depending on an individual's circumstances and clinical assessment, gender-affirming care may include mental health support, hormone therapy or surgery.

Having gender dysphoria does not automatically mean that every person diagnosed with it will receive every form of gender-affirming treatment.

How Does This Affect Healthcare For Transgender Inmates?

Inmates cannot simply choose another doctor if a certain kind of treatment is restricted. Medical treatments are largely controlled by the correctional authorities. The Bureau of Prisons previously allowed inmates with gender dysphoria to receive gender-affirming treatment when clinicians determined that it was medically appropriate. The new policy would make that approach invalid.

The Bureau said in 2025 that it was providing hormone therapy to more than 600 inmates, highlighting the number of people affected.

The case could ultimately affect other areas besides federal prisons, as it challenges medical necessity, prison healthcare and transgender rights directly before the nation's highest court.

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US FDA Recalls India-Made BP Drug For The Second Time In 3 Months: Here's Why

Updated Sep 29, 2026 | 06:37 AM IST

SummaryA blood pressure medication manufactured in India has been recalled by the US FDA for the second time in three months due to the same quality issue.
US FDA Recalls India-Made BP Drug For The Second Time In 3 Months: Here's Why

Credit: AI

A blood pressure medicine manufactured in India has been recalled in the US for the second time in three months after a few batches failed a test designed to ensure that the drug dissolves properly in the body.

The medicine is chlorthalidone 25 mg, a commonly used diuretic, or 'water pill', manufactured by Inventia Healthcare Limited in India. The latest recall involves more than 13,500 bottles, while the earlier recall included 11,460 bottles. Both recalls have been classified by the US Food and Drug Administration (FDA) as Class II recalls.

India-Made BP Drug Recalled In The US For The Second Time

The US Food and Drug Administration recalled chlorthalidone due to “failed dissolution specifications.” It means that when the tablet is swallowed, its active ingredient needs to dissolve at the right rate so the body can absorb the medicine.

If a tablet does not dissolve properly in the body, less of the active ingredient may become available for absorption, making the medicine less effective that it should be.

For someone taking chlorthalidone to control high blood pressure, inadequate drug absorption could mean that blood pressure is not controlled as effectively as intended. The FDA has not reported contamination or a toxic ingredient as the reason for this particular recall.

Also read: Chlorthalidone Recall: FDA Flags Second India-Made Blood Pressure Drug

Why Was The Drug Recalled Again?

The first recall was made by Inventia Healthcare on June 5, 2026, involving 11,460 bottles. A second, separate recall was initiated on September 3, involving another 13,567 bottles. The FDA classified this second recall as Class II on September 17. Together, the two recalls affect more than 25,000 bottles of the medication.

The second recall has raised eyebrows as both issues were linked to the same type of manufacturing quality problem, which is failure to meet dissolution specifications.

The earlier recall involved batches RISA24001 and RISB24002. The latest recall involves 25 mg chlorthalidone tablets. Patients must check their medicine packaging for:

  • Manufacturer: Inventia Healthcare Limited
  • Strength: Chlorthalidone 25 mg
  • Batch: RISA24002
  • Expiry: April 2027
  • NDC: 64980-599-01

Also read: Thyroid Medicine Recall Gets US FDA’s Highest Risk Rating: What To Know

More About Chlorthalidone & Class II Recall

Chlorthalidone is a diuretic used to treat high blood pressure. It works mainly by helping the kidneys remove excess sodium and water from the body. This reduces the amount of fluid circulating through the blood vessels and helps lower blood pressure.

Keeping blood pressure under control is essential as untreated hypertension increases the risk of heart attack, stroke, heart failure and kidney disease.

A Class II recall does not mean the medicine will cause serious harm in everyone who takes it. The FDA defines Class II recalls in which the affected product could cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

In this case, the concern is primarily that the affected tablets may not work as intended because of inadequate dissolution.

What Should Patients Who Take This Medicine Do?

Patients should not stop the medication abruptly without speaking to a doctor or pharmacist. The FDA advises that people generally should not stop a recalled medicine without medical guidance, as suddenly stopping treatment for high blood pressure could be risky.

If you take chlorthalidone, check the batch number on your bottle and contact your pharmacist or healthcare provider if it matches one of the recalled ones.

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IARC Says Low-Dose CT Can Cut Lung Cancer Deaths: AIIMS Expert Explains Why India Needs Its Own Screening Evidence

Updated Sep 28, 2026 | 10:07 PM IST

SummaryIn the US, LDCT was linked to a 16% lower risk of lung cancer death at 7 years, while a European trial found lower mortality among men screened with LDCT at 10 years. Dr Abhishek Shankar said India needs its own screening evidence and access to screening and follow-up care for high-risk people.
IARC Says Low-Dose CT Can Cut Lung Cancer Deaths: AIIMS Expert Explains Why India Needs Its Own Screening Evidence

Credit: iStock

Low-dose CT (LDCT) screening of people at high risk based on age and smoking history can reduce lung cancer deaths and advanced-stage disease, according to an International Agency for Research on Cancer (IARC) working group.

Speaking to HealthandMe, Dr Abhishek Shankar of AIIMS New Delhi, the only Indian author among the 23 experts from 17 countries involved in the IARC review, said India needs to generate its own screening evidence.

The review was published in The New England Journal of Medicine as part of IARC WHO Handbook 21.

India Should Not Wait For A Perfect Model

Dr Shankar, a lung cancer specialist, said India needs to generate its own screening evidence while ensuring high-risk people have access to screening and follow-up care.

“India should not wait for a perfect screening model and there is a need to generate Indian evidence while ensuring that those at highest risk have access to lung cancer screening and care pathways for screen positive cases,” he said.

Dr Shankar is leading the Indian Lung Screening Trial (ILST), which is assessing risk-based lung cancer screening across 10 centers in India.

Also read: Never Smoked, Still Got Lung Cancer? Rare Gene Mutation Linked To Over 60x Risk

Who Should Undergo LDCT Screening?

The evidence mainly covers people aged 50 to 80 with a substantial smoking history, typically 20–30 pack-years or more. Studies involving former smokers generally included those who had quit within the previous 10–15 years.

In India, people aged 50 to 80 who have smoked at least 20 pack-years and are current smokers or quit within the past 15 years can contact ILST about screening under the trial.

“High-risk smokers should be encouraged to participate in organized screening rather than opportunistic CT scanning, with appropriate nodule management, follow-up and smoking-cessation support,” Dr Shankar said.

What Did The Trials Show?

Read More: World Lung Day: Dry Cough, Breathlessness May Not Always Be Asthma — Could It Be ILD?

In the US National Lung Screening Trial, LDCT was linked to a 16% lower relative risk of lung cancer death at seven years compared with chest X-rays. The European NELSON trial also found lower lung cancer mortality among men screened with LDCT at 10 years.

IARC classified LDCT as Group A, indicating established evidence that it reduces lung cancer mortality and stage III or IV disease. Chest X-rays, with or without sputum examination, were classified as Group C, as a mortality benefit could not be established.

What Are The Risks Of LDCT Screening?

LDCT is not meant for everyone. Across studies, false-positive rates ranged from 1% to 42%. Among those with false-positive results, 5% to 32% underwent an invasive procedure, with complications reported in 10% to 22% of those procedures.

The review also estimated that 3% to 26% of lung cancers detected in randomized trials could represent over-diagnosis.

The IARC group stressed that screening requires more than CT scans, including risk assessment, nodule management, follow-up, smoking-cessation support and adequate healthcare capacity.

“India has an opportunity to build an equitable, affordable, locally relevant lung cancer screening pathway and ILST can provide the evidence needed to guide that future,” Dr Shankar said.

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