US FDA eliminates risk evaluation, mitigation strategies for CAR-T cancer therapies
Bengaluru: The U.S. Food and Drug Administration said on Friday it had eliminated
risk evaluation and mitigation strategies
(REMS), a safety program to protect patients from risky drugs, for currently approved CAR-T cell immunotherapies.
REMS is required by the FDA to ensure a drug's benefits outweigh its risks by managing serious safety concerns.
The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed warnings for cytokine release syndrome and neurological toxicities, and medication guides.
The cancer therapies include Bristol-Myers Squibb's Breyanzi and its partnered therapy Abecma with 2seventy bio , Johnson & Johnson's unit Janssen and Legend Biotech's Carvykti, Novartis AG's Kymriah, and Gilead Sciences' unit Kite's Tecartus and Yescarta.
Bristol-Myers Squibb and Gilead Sciences did not immediately respond to Reuters' requests for comment.
These are gene therapies that are currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma, the health regulator said.
CAR-T treatment generally involves extracting disease-fighting white blood cells known as T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body.
In January 2024, the FDA
asked several drugmakers
to add a serious warning on the label of their cancer therapies that use CAR-T technology after reports of T-cell malignancies and adverse events identified since approval.
The FDA earlier said the risk of T-cell malignancies including leukemia and lymphoma applies to all therapies in the class and can lead to hospitalization and death.
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First Post
4 hours ago
- First Post
Shefali Jariwala Passes Away: Did self-medication, anti-aging drugs and Glutathione play a role in her cardiac arrest?
The actress passed away due to low BP as per a statement by a police official. Jariwala was taking antiaging treatment that could have caused her untimely demise read more Actress Shefali Jariwala died recently at the age of 42. At first, it was reported she died of cardiac arrest. Then, her cause of death was 'reserved' by the police as the investigation was on. And now, as the investigation has deepened, an official has broken silence on what actually transpired. What did the official say about the actress? The officer was quoted saying, 'As a part of this procedure, the doctors said they suspected the cause of death to be a dip in her BP.' STORY CONTINUES BELOW THIS AD 'The statements of all family members and her husband, Parag Tyagi, were recorded, and they have no complaints. No foul play has been observed,' the officer added. Shefali's anti-aging treatment The actress' long-time doctor has issued a statement speaking to ABP news and revealed she had no serious medical condition and was undergoing anti-ageing treatment for the last five-six years. The doctor revealed Jariwala didn't have any serious heart condition either and always made sure to stay fit and healthy. Earlier statement by the police official A police official said, 'The autopsy has been done, but the opinion on the cause of death has been reserved. Based on preliminary information, it appears to be a natural death, and there was no foul play.' Reports also say that the actress was undergoing anti-ageing treatment, which involved the use of Vitamin C and a drug called Glutathione. What is the Glutathione drug Glutathione is involved in tissue building and repair, making chemicals and proteins needed in the body, and in immune system function. People take glutathione for aging, alcohol use disorder, liver disease, heart disease, and many other conditions, but there is no good scientific evidence to support these uses. STORY CONTINUES BELOW THIS AD Medical experts break silence 'These drugs may have US, CDSO approvals for other conditions,' as per Dr. Rishi Parashar. He added that the supplement market is unregulated as they don't know what's in them. These dugs are used to reduce wrinkles. But at least 22 women had harmful reactions in the U.S. Parashar added that too many unverified medical clinics in India are mushrooming. Dr. Anup Dhir said Glutathione is not FDA approved and can have harmful side-effects. He also said that the dosage must be as per the body weight. Netizens debate on social media Intrusive approach is not good, what was the reality behind this the only god knows👏👏 Can't just survive in inj have to eat basic unprocessed food Anti-aging lete lete early death hi aa gyi😢😮
NDTV
4 hours ago
- NDTV
Can Anti-Ageing Drugs Cause Cardiac Arrest? Doctors Explain Shefali Jariwala Death
On June 27, 2025, when news of the tragic and sudden death of actress Shefali Jariwala broke, it left everyone in shock. The 42-year-old actress, who rose to fame with the iconic remix of the Kaanta Laga song that every Y2K person knows about, died suddenly from a possible cardiac arrest, leading to various speculation about the cause of her death. One such cause, according to sources, points to the use of so-called age-defying anti-ageing treatments, which might come with hidden, and sometimes fatal, cardiovascular risks. The Toxic Cocktail Of Anti-Ageing Treatments And Fasting Reports suggest that Shefali, who had a history of epilepsy, might have received a cosmetic anti-ageing injection containing Glutathione and Vitamin C on empty stomach, which was potentially followed by a sudden drop in blood pressure leading to cardiac arrest. While the exact cause of death is under investigation, and a post-mortem report is awaited, medical experts across India are cautioning against the use of unregulated anti-ageing therapies. Dr Anesh Jain, Consultant Cardiologist at Ruby Hall Clinic, Pune, explains to NDTV, "Although glutathione and Vitamin C are widely used in skin treatments, introducing such compounds in a dehydrated or fasted state can place unnecessary stress on the cardiovascular system. In rare cases, this can result in a dangerous drop in blood pressure, possibly leading to cardiac arrest." He adds, "There is no formal category of 'anti-ageing' drugs approved by the FDA (US Food and Drug Administration). Most of these treatments are off-label, experimental, or cosmetic in nature - and lack proper long-term cardiovascular safety data." A quick research showed that the FDA has explicitly warned against the use of glutathione powder intended for dietary supplements to compound sterile injectable drugs due to safety concerns, including reports of adverse events linked to endotoxin contamination in compounded glutathione injections. Moreover, injectable glutathione is also not FDA-approved for skin lightening. In fact, there are no published clinical trials or official guidelines supporting the safety or efficacy of injectable glutathione for skin whitening. Rather, the FDA has highlighted risks such as toxic effects on the liver, kidneys, and nervous system, and potential severe reactions like Stevens-Johnson Syndrome. Injectable Vitamin C products are also not FDA-approved for skin lightening. In 2019, the FDA requested all companies to stop distributing unapproved versions of ascorbic acid (Vitamin C) injection. In India, the Central Drugs Standard Control Organisation (CDSCO) have approved glutathione and Vitamin C injections but only for specific medical indications, not for cosmetic or skin whitening purposes. The Problem With Anti-Ageing Treatments Experts suggest that while glutathione and Vitamin C are not known to directly affect the heart, their impact when used without proper medical context - such as being taken intravenously on an empty stomach or alongside other drugs - can trigger a dangerous cascade, potentially including hypotension and cardiac arrest. And this is not just about glutathione or Vitamin C. It's about a range of anti-ageing drugs. Dr Srinivas Kudva, Interventional Cardiologist at Lilavati Hospital, explains that anti-ageing drugs have gained immense popularity in recent years, driven by a global interest in longevity and the prevention of age-related decline. "These therapies target various biological mechanisms, ranging from hormone modulation (eg, testosterone, growth hormone) to cellular metabolism and mitochondrial function (eg, NAD+ boosters, mTOR inhibitors). While many are designed to enhance cellular resilience and slow biological ageing, their effects on cardiovascular health are not uniformly positive and remain under active investigation," he adds. He explains that these hormonal agents can significantly influence cardiovascular dynamics. "Elevated testosterone or growth hormone levels may increase red blood cell production, elevate blood pressure, and alter lipid metabolism, all of which can contribute to a higher risk of arrhythmias, arterial stiffness, or thrombotic events. Even newer compounds like NAD+ precursors, though marketed for their regenerative properties, may accelerate metabolic activity and place excess strain on the heart, especially in individuals with pre-existing cardiovascular vulnerabilities," Dr Kudva says. Women's Hearts At Greater Risk Both globally and in India, cardiovascular disease (CVD) is now the leading cause of death in women - surpassing even breast cancer. Dr Ashish Agarwal, Director Of Cardiology At Aakash Healthcare, points out, "CVDs are often overlooked in women. In fact, heart attacks and cardiac arrests kill 10 times more women than breast cancer. One in five Indian women aged 15-49 has untreated hypertension. Early screening is crucial." Adding to this, Dr Subrat Akhoury, Chairman of the Cath Lab and Head of Unit-I at Asian Hospital, says, "Women's heart attack symptoms are frequently misdiagnosed. Nausea, fatigue, shortness of breath - these can be mistaken for other issues. Plaque builds up differently in women's arteries, making diagnosis tricky. Emotional stress and depression - which are more common in women - can also raise cardiac risk." He added a stark warning, "It's crucial that patients understand the heart is especially vulnerable to untested hormone-altering anti-ageing drugs. Cardiac arrest can be the first and final symptom." Low Blood Pressure: A Silent Trigger One of the potential complications in Shefali's case could have been a sudden drop in blood pressure - a known trigger for cardiac arrest. Dr Abhijit Khadtare, Cardiologist At Ruby Hall Clinic, Pune, explains, "Severe hypotension, or a sudden and steep drop in blood pressure, is a medical emergency. It can deprive vital organs of oxygen, leading to shock - a life-threatening condition." He elaborated that causes of sudden hypotension include: Severe dehydration or blood loss Septic shock from infections Anaphylactic reactions Heart attack or failure "Symptoms like confusion, fainting, rapid weak pulse and cold, sweaty skin should never be ignored. Immediate medical attention is vital to prevent fatal outcomes," Dr Khadtare says. The Need For Supervision According to police sources, Shefali had been taking heavy doses of anti-ageing, multivitamin, and skin whitening medications for many years without any doctor's supervision, indicating this could be a case of self-medication. The Amboli police found a large number of medicines in Shefali's room - in the fridge, drawer, and on the table - including anti-ageing medication like glutathione. Shefali started taking medicines on her own about eight years ago after consulting a doctor once, and continued this without regular monitoring by any current doctor, said sources. Dr Praveen Gupta, Chairman of Marengo Asia International Institute of Neuro and Spine and Chief Clinical Strategy for the North India region, warned against the growing trend of self-medication with anti-ageing treatments. "People assume 'natural' or 'anti-ageing' means safe. That's simply not true. Many of these drugs interact with existing medications for blood pressure or diabetes. In older adults, this can be especially dangerous," he says. He stressed that these substances are often sold online, bypassing regulations and quality checks. "We need to treat anti-ageing interventions like any other medical procedure - only under professional guidance. Without proper screening, these so-called youth elixirs can pose serious risks," Dr Gupta concludes. Actress-model Shefali Jariwala's death puts the spotlight back on the rise of self-medication and anti-ageing treatments, with devastating consequences.
Indian Express
11 hours ago
- Indian Express
Shefali Jariwala sudden death: Why anti-ageing medication, IV glutathione and Botox use should be under the scanner
What triggered sudden cardiac arrest in actor-performer Shefali Jariwala is the question that's on everybody's mind, especially after police found evidence of self-medication. Among the things bandied about in media reports are that she took anti-ageing pills and relied on skin improvement treatments like glutathione. Generally, most reports argue that she had built a drug dependency, and on a day she was fasting, she had reacted to something that may have sent her body into allergic shock, causing sudden death. But is that the real story? The real story that nobody wants to talk about is the pressure that social media exerts on prioritising agelessness, the extent of obsession that drives people to resort to all sorts of bio hacks being peddled online instead of going to a doctor, a greedy and unregulated supplement industry which peddles 'safe' ways to stop the wrinkles and an appearance-conscious world which imposes new standards of acceptance every day. We spoke with experts to find out why anti-ageing procedures go wrong. This comprises drugs or combinations of drugs and compounds which slow down there are concentrated supplements like those of the flavonoid quercetin — one of the most abundant polyphenols found in fruits, vegetables, nuts, wine, and black tea — curcumin, NR (Nicotinamide Riboside, a form of vitamin B3), NMN (Nicotinamide Mononucleotide, a compound broken down from Vitamin B3), and even repurposed concoctions made from drugs meant for other diseases. 'The problem with repurposed drugs is that they may have US FDA (Food and Drug Administration) and even CDSCO (Central Drugs Standard Control Organisation) approvals for a certain disease. But then their components are played around with by certain supplement makers claiming anti-ageing properties,' says Dr Rishi Parashar, Chairman, Dermatology, Sir Gangaram Hospital, Delhi. 'Besides, the so-called herbal supplements market is unregulated and we do not know what is being put into them or whether they are within safe limits. Also, many anti-ageing medications that are in clinical trials have not yielded any significant positive results. Most of these trials are animal studies and the results may be completely different in human trials. The efficacy of anti-ageing compounds, as being touted now, will take years to show results. Till then, what you read on social media is nothing short of quackery,' he adds. What about Botox injections going bad? Over the last 20 years, Dr Parashar has been administering Botox injections and fillers for anti-ageing. Derived from a bacterium called clostridium botulinum, its toxin paralyses and relaxes facial muscles and hence reduces wrinkles. 'The jab has been proven to be safe except for complications in very rare cases, most of which got resolved too. The only thing required is that they be administered by a registered dermatologist in a medical facility that meets stringent hygiene and safety standards. Some injectable treatments include prescription medication and so should only be administered by a qualified nurse or doctor, following an initial consultation,' insists Dr Parashar. Suspicions around Botox gained momentum in April 2024 when the US Centre for Disease Control and Prevention (CDC) released an alert warning that 22 women between 25 and 59 had 'harmful reactions' to counterfeit or mishandled Botox. Eleven people were hospitalised, and six were treated with an antitoxin because of concerns around botulism – a condition where the toxin spreads beyond the local site and attacks the central nervous system causing muscle paralysis, difficulty breathing and even death. Symptoms included blurry and double vision, drooping eyelids, difficulty swallowing, slurred speech, difficulty breathing, fatigue, and weakness. 'It was proven that all the women received injections from unlicensed or untrained people in places that were not healthcare centres. We have many such neighbourhood clinics mushrooming in India,' says Dr Parashar. Botox procedures are allowed only in certain parts of the face. If you apply the same routine elsewhere on your face or any other body part where it is not meant to, there will be adverse reactions. What's the truth about glutathione? Another compound that's much misunderstood is the antioxidant glutathione, often used for skin lightening because it manages to suppress the levels of melanin that regulates skin pigmentation. Hence its popularity in skin creams, serums and lotions, all meant for topical application. 'But the real risk is in the use of IV (intravenous) glutathione, which many Bollywood celebrities are endorsing too. The US Food and Drug Administration (FDA) does not approve its use for cosmetic skin lightening. It is not available with long-term safety data, and potential side effects include allergic reactions, low blood pressure, kidney injury and interference with the body's natural antioxidant balance. Various global health authorities even warn against its use for vanity purposes,' says cosmetic surgeon Dr Anup Dhir. The Central Drugs Standard Control Organisation (CDSCO) has not approved glutathione for skin lightening though it's widely used off-label for that purpose. 'It is actually authorised for intravenous use in conditions like alcoholic fatty liver, fibrosis, cirrhosis, and alcoholic hepatitis and sometimes to neutralise the toxicity from chemotherapy,' says Dr Dhir. Yet skin clinics administer glutathione injections, often alongside Vitamin C, for skin lightening. 'Research on the cosmetic effects of all IV infusions is limited. While some anecdotal evidence suggests positive results, these are often based on individual experiences rather than studies. Besides, how much of it is being absorbed by the body to make a remarkable skin tone difference is a matter of debate,' says Dr Dhir, who never advises this injection. IV products should only be given by a healthcare provider, not by a salon hand. 'That's why you see so many cases of skin eruptions and damage. A very important part of a glutathione injection is dosage, which needs to be calibrated and administered as per body weight. The recommended daily dose of glutathione for adults ranges from 500-2,000 mg per day when taken orally, or 10-20 mg/kg body weight when administered intravenously for disease supportive therapies. Who knows how much is being given for the skin?' asks Dr Dhir. Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B when a non-medical practitioner administers this treatment in a non-sterile facility. Do not buy online Dr Parashar argues for strict monitoring of online sales of such products. 'Users buy them on the basis of the label's declared promises as a safe beauty product. The platform aggregator is least concerned about the concentration of their ingredients or their side effects. Users go to the local skin clinic and get them administered. They wouldn't even know that they would have to seek prompt medical attention if something goes awry,' he warns.
