Granules recalling 33,000 bottles of hypertension drug in U.S.
It is a voluntary, firm-initiated recall on account of failed dissolution specifications. The product failed to meet dissolution acceptance criteria in the stability studies at the 6th month, the U.S. Food and Drug Administration (U.S. FDA) said in its latest enforcement report.
Granules Pharmaceuticals Inc is recalling 27,648 100-count bottles and 5,376 500-count bottles of the drug manufactured by Granules India, Hyderabad.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Hindu
2 days ago
- The Hindu
Precigen shares jump after U.S. FDA approves first therapy for rare respiratory disease
Precigen's immunotherapy for a rare respiratory disease has become the first treatment to win U.S. regulatory approval for the condition, which typically requires frequent surgeries, sending the company's shares soaring 83% on Friday. The U.S. Food and Drug Administration has approved the therapy, Papzimeos, to treat adults with recurrent respiratory papillomatosis (RRP) — a condition that causes growth of benign tumors in the respiratory tract due to human papillomavirus (HPV) infection. A distinguishing aspect of RRP is the tendency for the tumors to return even after removing them through surgical procedures. The disease can be fatal as there is no cure. The FDA approval was based on an early-to-mid-stage study data that showed 51% of patients required no surgeries in the 12 months after the treatment. "Randomised trials are not always needed to approve medical products and this approval is proof of that philosophy," said Vinay Prasad, who recently returned to the FDA to oversee vaccine, gene therapy and blood product regulation. Papzimeos is designed to stimulate an immune response against cells infected with HPV types 6 and 11 — the strains that cause the disease. H.C. Wainwright analysts estimate peak sales of the drug to reach $1.1 billion in 2033. "We may finally be able to say no more surgery," said Kim McClellan, president of the Recurrent Respiratory Papillomatosis Foundation. McClellan herself was diagnosed with RRP at the age of five and has since then had more than 250 surgeries. Precigen estimates about 27,000 adult RRP patients in the U.S. It did not immediately respond to a Reuters request for comment on the treatment's pricing. Simon Best, associate professor of Otolaryngology at Johns Hopkins Hospital, said patients were eagerly awaiting a new treatment. "There's nothing more frustrating than doing a surgery and then having the patient come back six months later."
Time of India
12-08-2025
- Time of India
60-year-old man turns to ChatGPT for diet tips, ends up with a rare 19th-century illness
From Kitchen Swap to Psychiatric Ward You Might Also Like: Asked ChatGPT for motivation, but this user discovered a whole new use for AI instead Bromism: A Disease From Another Era The AI Factor Recovery and Reflection OpenAI Tightens Mental Health Guardrails on ChatGPT What began as a simple health experiment for a 60-year-old man looking to cut down on table salt spiralled into a three-week hospital stay, hallucinations, and a diagnosis of bromism — a condition so rare today it is more likely to be found in Victorian medical textbooks than in modern to a case report published on 5 August 2025 in the Annals of Internal Medicine , the man had turned to ChatGPT for advice on replacing sodium chloride in his diet. The AI chatbot reportedly suggested sodium bromide — a chemical more commonly associated with swimming pool maintenance than seasoning man, who had no prior psychiatric or major medical history, followed the AI's recommendation for three months, sourcing sodium bromide online. His aim was to remove chloride entirely from his meals, inspired by past studies he had read on sodium intake and health he arrived at the emergency department, he complained that his neighbour was poisoning him. Lab results revealed abnormal electrolyte levels, including hyperchloremia and a negative anion gap, prompting doctors to suspect the next 24 hours, his condition worsened — paranoia intensified, hallucinations became both visual and auditory, and he required an involuntary psychiatric hold. Physicians later learned he had also been experiencing fatigue, insomnia, facial acne, subtle ataxia, and excessive thirst, all consistent with bromide was once common in the late 1800s and early 1900s when bromide salts were prescribed for ailments ranging from headaches to anxiety. At its peak, it accounted for up to 8% of psychiatric hospital admissions. The U.S. Food and Drug Administration phased out bromide in ingestible products between 1975 and 1989, making modern cases builds up in the body over time, leading to neurological, psychiatric, and dermatological symptoms. In this case, the patient's bromide levels were a staggering 1700 mg/L — more than 200 times the upper limit of the reference Annals of Internal Medicine report notes that when researchers attempted similar queries on ChatGPT 3.5, the chatbot also suggested bromide as a chloride substitute. While it did mention that context mattered, it did not issue a clear toxicity warning or ask why the user was seeking this information — a step most healthcare professionals would consider authors warn that while AI tools like ChatGPT can be valuable for disseminating health knowledge, they can also produce decontextualised or unsafe advice. 'AI systems can generate scientific inaccuracies, lack the ability to critically discuss results, and ultimately fuel the spread of misinformation,' the case report aggressive intravenous fluid therapy and electrolyte correction, the man's mental state and lab results gradually returned to normal. He was discharged after three weeks, off antipsychotic medication, and stable at a follow-up two weeks case serves as a cautionary tale in the age of AI-assisted self-care: not all answers generated by chatbots are safe, and replacing table salt with pool chemicals is never a good light of growing concerns over the emotional and safety risks of relying on AI for personal wellbeing, OpenAI has announced new measures to limit how ChatGPT responds to mental health-related queries. In a blog post on August 4, the company said it is implementing stricter safeguards to ensure the chatbot is not used as a therapist, emotional support system, or life decision follows scrutiny over instances where earlier versions of the GPT-4o model became 'too agreeable,' offering validation rather than safe or helpful guidance. According to USA Today, OpenAI acknowledged rare but serious cases in which the chatbot failed to recognise signs of emotional distress or delusional updated system will now prompt users to take breaks, avoid giving advice on high-stakes personal decisions, and provide evidence-based resources instead of emotional counselling. The move also comes after research cited by The Independent revealed that AI can misinterpret or mishandle crisis situations, underscoring its inability to truly understand emotional nuance.
The Hindu
11-08-2025
- The Hindu
Zydus gets U.S. FDA nod for Diltiazem Hydrochloride tablets
Generic drugmaker Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for Diltiazem Hydrochloride tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. A generic of Cardizem Tablets, the drug is indicated for management of chronic stable angina and angina due to coronary artery spasm. Diltiazem Hydrochloride tablets had annual sales of $13.9 million in the U.S., Zydus said, citing IQVIA MAT June 2025 numbers. The approved drug will be produced at its plant in Baddi, Himachal Pradesh, the company said. Belonging to a class of drugs called calcium-channel blockers, Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle, it said. Zydus Lifesciences shares closed 2.18% higher at ₹955.90 apiece on the BSE.
