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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Delhi HC Allows HPV Vaccine Drive To Continue Due To No 'Immediate Safety Risk'

Updated Jul 30, 2026 | 01:00 PM IST

SummaryThe Delhi High Court has refused to put a stay on Centre's HPV vaccination drive for adolescent girls amid safety concerns.
Delhi HC Allows HPV Vaccine Drive To Continue Due To No 'Immediate Safety Risk'

Credit: AI

The Delhi High Court has refused to stay the Centre's ongoing Human Papillomavirus (HPV) vaccination programme for adolescent girls. The court said that there is no evidence of "immediate harm" from the vaccine.

It also said that the concerning questions around its rollout, safety and scientific backing remain open for judicial scrutiny.

Delhi High Court Refuses To Stay HPV Vaccination Drive

A public interest litigation (PIL) was filed by gynaecologist Dr. Sujata Mittal and health entrepreneur Jitendra Chouksey, who challenged the nationwide rollout of Merck's Gardasil vaccine.

The plea states that the vaccination programme violates the constitutional rights of adolescent girls, including their rights to bodily autonomy, informed parental consent and personal liberty under Articles 19 and 21 of the Constitution of India. It also raises concerns over long-term safety, efficacy, and post-vaccination monitoring.

A Division Bench comprising Chief Justice D.K. Upadhyaya and Justice Tejas Karia rejected the plea for an interim stay.

The Bench observed, "There may not be long-term benefit (of HPV vaccination) but there is no immediate harm."

It added that the safety concerns related to the vaccine would be examined during the course of the proceedings.

Also read: Delhi High Court Questions Govt, ICMR Over HPV Vaccine Rollout, Issues Notice

Centre Defends HPV Vaccination Programme

Representing the Centre, Additional Solicitor General Chetan Sharma told Delhi HC that over 55 crore people worldwide have received HPV vaccines across nearly 160 countries.

He also informed the Bench that more than 55 lakh doses have been administered in India so far and only around 120 recipients reported minor side effects like nausea or headache.

"The government is taking appropriate and adequate measures while administering the vaccination," Sharma said, arguing that there was no scientific basis to drop the programme.

The High Court directed the Centre, the Indian Council of Medical Research (ICMR), the Central Drugs Standard Control Organisation (CDSCO) and the National Immunization Technical Advisory Group (NITAG) to file detailed replies explaining the scientific and regulatory justification for introducing the vaccine.

Also read: India Vaccinates Over 5.2 Million Girls Against HPV To Fight Cervical Cancer

What Does The Petition Allege?

Apart from arguing that the programme violates the bodily autonomy of adolescent girls, the petition also alleged that the vaccinations are being administered through schools and public health systems without adequate informed parental consent.

It also states that frontline health workers have been assigned with enrolment targets. This directly creates pressure on the workers who compel these girls to receive the vaccine.

The plea also includes cases of reported adverse events after vaccine administration, including that of a 14-year-old girl from Tamil Nadu.

Also read: Cervical Cancer Cases In India Drop 37% Over A Decade, Highlighting Impact Of Screening & HPV Vaccination

About The Case

The case was first heard by the Delhi High Court on July 22, when the Bench described the issue as "extremely important" and sought the Centre's response.

During the latest hearing, the court declined to halt the programme but clarified that its order should not be considered as the final endorsement of the vaccine rollout.

The court will continue hearing arguments on the programme's scientific basis, efficacy, informed consent process, and adverse event reporting.

HPV is one of the most common sexually transmitted viruses and persistent infection with high-risk strains, particularly HPV-16 and HPV-18, and is responsible for nearly all cases of cervical cancer.

Vaccination before exposure to the virus is considered one of the most effective ways to prevent cervical cancer and many other HPV-related cancers.

India launched its HPV vaccination campaign in February 2026, offering a free single-dose quadrivalent HPV vaccine to eligible 14-year-old girls as part of its cervical cancer prevention strategy.

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Adult Kidney Transplant Recipients Who Took COVID-19 Drug Remdesivir At Lower Risk Of Transplant Failure

Updated Jul 30, 2026 | 09:00 AM IST

SummaryA new study says COVID-19 antiviral drug remdesivir has been proven to be an effective medication for adults who have undergone kidney transplant.
Early Remdesivir May Improve Long-Term Outcomes in Kidney Transplant Patients With COVID-19: Study

Credit: AI

COVID-19 antiviral drug remdesivir can help kidney transplant patients in more than one ways. Apart from keeping them free from COVID-19 infection, the drug could also help lower the risk of losing the transplanted kidney and reduce future heart-related complications.

The findings, published in JAMA Network Open, come from one of the largest studies to examine the long-term effects of remdesivir in adult kidney transplant recipients.

The subsection of patients that remains especially vulnerable to severe COVID-19 because of lifelong immune-suppressing medications.

What Did The Study Find?

Researchers from Johns Hopkins Medicine studied data from 432 adult kidney transplant recipients diagnosed with COVID-19 between March 2020 and January 2024.

Of these, 177 patients received remdesivir within a week of diagnosis for at least three consecutive days, while 255 did not receive the antiviral.

Patients treated with other COVID-19 therapies, such as monoclonal antibodies or alternative antivirals, were excluded.

After adjusting for factors including age, underlying illnesses, transplant timing, vaccination status and disease severity, researchers found that patients who received early remdesivir had a 47% lower risk of all-cause graft loss, over the following year.

Graft loss refers to transplant failure or death. They also had a 42% lower risk of cardiovascular events, including heart attack, stroke or cardiac-related death.

“These findings suggest that timely antiviral treatment may have benefits beyond the acute phase of COVID-19 in this population,” said Dr. Nitipong Permpalung, senior author of the study and associate director of the Johns Hopkins Transplant Research Center.

“We hope these findings will help reduce hesitations that physicians may have with considering providing remdesivir, when clinically appropriate, to adult kidney transplant recipients,” he added.

Also read: Dr Anthony Fauci's Personal Journals Reignites Debate On COVID-19 Origin; Says He Overshadowed President Trump

Kidney Transplant Recipients Are At Higher Risk

Patients who have undergone kidney transplants take immunosuppressive medicines to prevent organ rejection. While these drugs protect the transplanted kidney, they also weaken the body’s ability to fight infections, making COVID-19 more severe and increasing the risk of serious complications.

In the study, nearly 95% of participants had high blood pressure, 46% had diabetes, and one in five required supplemental oxygen when diagnosed with COVID-19.

More than half also temporarily stopped one of their immunosuppressive medications during infection.

Also read: Can Long COVID Be Prevented Before It Starts? Study Suggests Early Paxlovid May Help

What Does This Mean?

Although the initial results are encouraging, researchers stressed that the study was observational rather than a randomised clinical trial.

That means it shows a strong association but cannot definitively prove that remdesivir alone caused the improved outcomes.

“I do think that the findings suggest the potential benefits of treating COVID-19 early may extend beyond the short-term benefits that the early clinical trials have shown,” Dr. Permpalung said in an interview with The American Journal of Managed Care.

He also said that that larger and more diverse studies are needed to understand why early treatment appears to protect transplanted kidneys and whether similar benefits extend to recipients of other transplanted organs such as the heart, lungs and liver.

The findings could help guide treatment for transplant specialists, particularly because kidney transplant recipients are often excluded from large clinical trials.

If confirmed in future studies, early antiviral treatment with remdesivir may become an important strategy not only for reducing severe COVID-19 but also for protecting transplanted organs and lowering long-term cardiovascular risks in such patients.

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Why The FDA Recalled Nearly 12 Million Over-The-Counter Cooling Eye Drops Across The United States

Updated Jul 30, 2026 | 07:00 AM IST

SummaryThe US FDA recently issued a class II recall of millions of bottles of commonly used eye drops that are available over the counter.
Why The FDA Recalled Nearly 12 Million Cooling Eye Drops Across The United States

Credit: AI

Millions of bottles of over-the-counter cooling eye drops have been recalled across the United States after the US Food and Drug Administration (FDA) raised concerns that the products may not be sterile. Sterility issues raises the risk of eye infections significantly.

The FDA has classified the recall as a Class II recall. An FDA Class II recall for a product refers to the public health action that may cause temporary health problems, where the chance of serious harm is remote.

This recall covers nearly 12 million bottles of eight Rohto cooling eye drop products. The agency said the recall was initiated on July 14, due to a “lack of assurance of sterility” in the affected products.

The eye drops were manufactured in Vietnam and distributed nationwide by The Mentholatum Company.

Which Products Are Affected In The Recall?

The recent FDA recall includes several popular Rohto products, including:

  1. Rohto All-in-One
  2. Rohto Max Strength
  3. Rohto Cool Relief
  4. Rohto Dry Aid
  5. Rohto Digi Eye
  6. Rohto Optic Glow
  7. Twin-pack versions of some of these products

The food and drugs regulatory body has warned consumers to stop using the recalled eye drops immediately and check the FDA’s recall notice for affected lot numbers and expiration dates.

Also read: FDA Recalls Popular Thyroid Medication: What Levothyroxine Users Need to Know

Is Sterility A Serious Concern?

Unlike tablets or capsules, eye drops are applied directly onto the eye. The process has limited natural protection against harmful microorganisms.

When sterility cannot always be guaranteed, bacteria or fungi may contaminate the solution easily.

Using contaminated eye drops significantly increases the risk of eye irritation, painful infections, damage to the corneas and, in extreme cases, vision loss.

Although the FDA has not disclosed any confirmed adverse effects linked to this recall, it said the products were withdrawn from the market as a precaution because ophthalmic products must strictly remain sterile throughout their shelf life.

The agency classified the recall as Class II, meaning exposure could cause temporary or reversible health effects, while serious harm is mostly unlikely.

Also read: US FDA Approves New Blood Test To Screen For Colorectal Cancer

Commenting on previous FDA recalls, Dr Gary Novack, clinical professor in the Department of Ophthalmology and Vision Science at UC Davis, said, “For eye drops, that means strict sterility, ensuring products are free from microorganisms like bacteria.”

He also said that manufacturing facilities must maintain contamination-free conditions because medicines used in the eye bypass many of the body’s natural defence mechanisms.

Dr Jeffrey H. Ma, ophthalmologist at the UC Davis Eye Center, also advised patients not to use recalled products: “Drops that are not on the recall list should be safe to use. If you have any of the drops on the list, you should immediately throw them away.”

What Should You Do If You Have The Recalled Products?

Health authorities recommend that people:

  • Stop using any recalled Rohto eye drops immediately.
  • Check product lot numbers and expiry dates against the FDA recall list.
  • Contact a healthcare provider if they experience eye pain, redness, blurred vision, discharge or persistent irritation after using the recalled products.
  • Return or safely dispose of affected products according to the manufacturer’s instructions.

The latest recall comes after multiple eye drop recalls in recent years linked to manufacturing and sterility issues, highlighting growing scrutiny of ophthalmic products.

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