#black-box-warnings

#black-box-warnings

Aidan O'Brien faces a series of allegations including that he failed to provide good clinical care to 10 patients between 2011 and 2019.

A report last year found unnecessary surgeries were carried out, cancers were missed and poor standards of care were delivered at the University Hospital of North Durham and Darlington Memorial Hospital. CDDTF said it wanted to support the patients it had let down, including by offering access to psychological support, and to ensure they knew how to make a claim or raise concerns with police.

According to the patent, a specific crystalline form of the drug known as polymorph C may be more effective than other versions because it is absorbed more efficiently by the body. The patent also notes that laboratory studies showed the drug reduced tumor growth and helped mice with brain tumors live longer, prompting early clinical trials to test whether the treatment is safe and effective in humans.

Emma Dyer remembers the moment she clicked "buy now" on a set of weightloss jabs she found online. She had no medical consultation, no ID checks, and no questions about her history of anorexia and bulimia. "It was just so easy - too easy," she says. "They never asked for my medical history or what medication I was taking. It was like buying groceries."

A blood pressure medication has been recalled after a mix-up that may have led to some bottles containing the wrong drug. According to Health Canada, Marcan Pharmaceuticals Inc. has recalled two lots of MAR-Amlodipine 5 milligram tablets, which are used to treat high blood pressure and chest pain. That's because some bottles may instead contain 2.5 milligram tablets of midodrine, a medication used to treat low blood pressure.

Guy's and St Thomas' NHS Foundation Trust said that the videos, found on social media platforms like Facebook and TikTok, "falsely claim a number of our clinicians are using and endorsing these products". The videos, which show doctors applying weight loss patches to their bodies and losing weight over a period of time, appear to be AI-generated, the Trust said, and do not show doctors who work there.

As AI becomes integrated into daily life and personal decision making, it is unsurprising that many people are consulting AI for assistance with depression, anxiety, and other mental health concerns. Mental health chatbots, self-help applications, and large language models can provide immediate responses, emotional validation, and structured coping strategies.

The U.S. Food and Drug Administration is reportedly mulling whether more prescription drugs should be sold over the counter (OTC) at pharmacies. In an interview on Wednesday, FDA commissioner Martin Makary told CNBC that everything should be over the counter except drugs that are deemed unsafe or addictive or that require clinical monitoring. Makary said the agency is reviewing how it decides which drugs can be sold with or without a prescription from a health care practitioner.

When generic drug manufacturers have issues like contamination, it is difficult for those who take the medications to know if they are affected. There is no standardized way to look up the data for where the pills in your bottle came from. ProPublica made an app that makes the lookup more straightforward. Even though generic drugs make up 90% of prescriptions dispensed in the U.S., the FDA only provides piecemeal information about them.

When she was 16, Bethan James told her YouTube channel that by 2026 she hoped to have a partner, an enjoyable job and maybe even children. Bethan would have been 27 now - but her dreams were taken when she died aged 21 from a combination of sepsis, pneumonia and Crohn's disease. Bethan's sepsis wasn't spotted early enough and life-saving care was delayed.

As Theresa Defino recently reported, HHS OCR will prioritize risk assessments and expand its investigations into risk management in 2026. Alisa Chestler and Layna Cook Rush of Baker Donelson have summarized some recent recommendations from HHS OCR's January 2026 Cybersecurity Newsletter that regulated entities may want to pay increased attention to at this point: Patching Is a Required Risk Management Activity Legacy Systems and Unpatchable Vulnerabilities Are Not Excuses Unnecessary Software and Default Accounts Create Hidden Risk

Ashfiat Alharamain Energy Support, a product sold as a honey-based, male sexual enhancement supplement, was voluntarily recalled by its manufacturer because the product contains undeclared Tadalafil, an ingredient in FDA-approved products for treatment of male erectile dysfunction, the agency said in a statement. The recall was initiated after a previous notification from the FDA of sample results that showed the presence of the prescription-only substance.

Google disabled specific queries, such as "what is the normal range for liver blood tests," after experts contacted by The Guardian flagged the results as dangerous. The report also highlighted a critical error regarding pancreatic cancer: The AI suggested patients avoid high-fat foods, a recommendation that contradicts standard medical guidance to maintain weight and could jeopardize patient health. Despite these findings, Google only deactivated the summaries for the liver test queries, leaving other potentially harmful answers accessible.

But these studies typically require large numbers of patients, huge amounts of data, and thorough follow-ups, none of which comes easy or free. The upshot is fewer investigations into scenarios that are clinically important but unlikely to yield a profit for the firms funding them. Accordingly, researchers have been developing an option that uses real-world data from insurers to save patients from falling through the cracks.

We provide thought partnership. When a company is developing a drug, there's a lot of work involved, such as understanding the science, designing a study and generating good data. We come in and explain what the standard of care looks like today for their patient population, and what we think it will look like in five to eight years or whenever they plan to launch their therapy.