Latest news with #CenterforDrugEvaluationandResearch
CNBC
13-05-2025
- Health
- CNBC
FDA moves to take prescription fluoride drops and tablets for kids off the market
The Food and Drug Administration on Tuesday announced it will begin the process of pulling prescription fluoride drops and tablets for children off the market. The supplements are usually given to kids at high risk for cavities. The federal government and some state legislatures are increasingly drawing attention to what they claim are the risks associated with fluoride, a mineral that's been used for decades in community water systems, toothpastes and mouth rinses to prevent tooth decay. Dentists fiercely contest that the harms of fluoride outweigh the benefits. FDA Commissioner Dr. Marty Makary said in a news release that he's instructing the agency's Center for Drug Evaluation and Research "to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area." The news release suggested that ingested fluoride can alter a child's gut microbiome and cause weight gain, thyroid disorders and "possibly decreased IQ." "The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene," Makary said. The FDA said the evaluation should be completed by Oct. 31. The new action goes after tablets and drops that contain fluoride. According to the American Dental Association, pediatric dentists can prescribe fluoride supplements to kids living in areas with low fluoride levels in drinking water. Dr. Meg Lochary, a pediatric dentist in Union County, North Carolina, said she's been prescribing more of the drops and tablets since county commissioners voted to stop adding fluoride to its water supply last year. "This is really going to hamper our goal of providing kids with fluoride," Lochary said. "It's ridiculous, and it takes away the choice of parents to allow their children to have better dental health. It doesn't make scientific sense." "Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers," the news release said. Health Secretary Robert F. Kennedy Jr. has previously referred to fluoride as "industrial waste" on the social media platform X and said on MSNBC that the faster the mineral goes away, the better. "Ending the use of ingestible fluoride is long overdue," Kennedy said in Tuesday's announcement. Utah and Florida recently banned the addition of fluoride to public water systems.
Yahoo
13-05-2025
- Health
- Yahoo
Fluoride drops and tablets for kids should be taken off the market, FDA says
The Food and Drug Administration on Tuesday announced it will begin the process of pulling prescription fluoride drops and tablets for children off the market. The supplements are usually given to kids at high risk for cavities. The federal government and some state legislatures are increasingly drawing attention to what they claim are the risks associated with fluoride, a mineral that's been used for decades in community water systems, toothpastes and mouth rinses to prevent tooth decay. Dentists fiercely contest that the harms of fluoride outweigh the benefits. FDA Commissioner Dr. Marty Makary said in a news release that he's instructing the agency's Center for Drug Evaluation and Research 'to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area.' The news release suggested that ingested fluoride can alter a child's gut microbiome and cause weight gain, thyroid disorders and 'possibly decreased IQ.' 'The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene,' Makary said. The FDA said the evaluation should be completed by Oct. 31. The new action goes after tablets and drops that contain fluoride. According to the American Dental Association, pediatric dentists can prescribe fluoride supplements to kids living in areas with low fluoride levels in drinking water. Dr. Meg Lochary, a pediatric dentist in Union County, North Carolina, said she's been prescribing more of the drops and tablets since county commissioners voted to stop adding fluoride to its water supply last year. 'This is really going to hamper our goal of providing kids with fluoride,' Lochary said. 'It's ridiculous, and it takes away the choice of parents to allow their children to have better dental health. It doesn't make scientific sense.' 'Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers,' the news release said. Health Secretary Robert F. Kennedy Jr. has previously referred to fluoride as 'industrial waste' on the social media platform X and said on MSNBC that the faster the mineral goes away, the better. 'Ending the use of ingestible fluoride is long overdue,' Kennedy said in Tuesday's announcement. Utah and Florida recently banned the addition of fluoride to public water systems. This article was originally published on
NBC News
13-05-2025
- Health
- NBC News
FDA moves to take prescription fluoride drops and tablets for kids off the market
The Food and Drug Administration on Tuesday announced it will begin the process of pulling prescription fluoride drops and tabletsfor children off the market. The supplements are usually given to kids at high risk for cavities. The federal government and some state legislatures are increasingly drawing attention to what they claim are the risks associated with fluoride, a mineral that's been used for decades in community water systems, toothpastes and mouth rinses to prevent tooth decay. Dentists fiercely contest that the harms of fluoride outweigh the benefits. FDA commissioner Dr. Marty Makary said in a press release that he's instructing the agency's Center for Drug Evaluation and Research 'to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area.' The press release suggested that ingested fluoride can alter a child's gut microbiome and cause weight gain, thyroid disorders and 'possibly decreased IQ.' 'The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene,' Makary said. The FDA said the evaluation should be completed by October 31. The new action goes after tablets and drops that contain fluoride. According to the American Dental Association, pediatric dentists can prescribe fluoride supplements to kids living in areas with low fluoride levels in drinking water. Dr. Meg Lochary, a pediatric dentist in Union County, North Carolina, said she's been prescribing more of the drops and tablets since county commissioners voted to stop adding fluoride to its water supply last year. 'This is really going to hamper our goal of providing kids with fluoride,' Lochary said. 'It's ridiculous, and it takes away the choice of parents to allow their children to have better dental health. It doesn't make scientific sense.' 'Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers,' the press release said. Health and human services secretary Robert F. Kennedy Jr has previously referred to fluoride as 'industrial waste' on the social media platform X and said on MSNBC that the faster the mineral goes away, the better. 'Ending the use of ingestible fluoride is long overdue,' Kennedy said in Tuesday's announcement.
Miami Herald
07-05-2025
- Business
- Miami Herald
Jaguar Health Provides Overview of 2025 Crofelemer-Related Catalysts
Press Releases Jaguar Health Provides Overview of 2025 Crofelemer-Related Catalysts Crofelemer is the only oral drug approved by the FDA's Center for Drug Evaluation and Research under Botanical Guidance Click here to access replay of company's April 30, 2025 investor webcast Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today provided an overview of expected Q2 - Q4 2025 catalysts related to potential follow-on indications for crofelemer, the company's novel plant-based prescription drug approved by the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER). "As discussed during Jaguar's investor webcast last week, 2025 is a year of catalysts for crofelemer in both of our major development programs - our rare disease intestinal failure program and our cancer therapy-related diarrhea program," said Lisa Conte, Jaguar's Founder and CEO. "As a reminder, crofelemer is the only oral drug approved under the FDA's Botanical Guidance. It is not a biologic product. Click here to access the replay of our April 30, 2025 investor webcast." Rare Disease Intestinal Failure Program Initial proof-of-concept (POC) results were issued last week for the ongoing investigator-initiated trial (IIT) of a novel liquid formulation of crofelemer in Abu Dhabi in the United Arab Emirates in pediatric patients with intestinal failure due to the rare orphan diseases microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF). The initial POC results, presented April 26, 2025 at the Annual ELITE PED-GI Congress, show crofelemer reduced the required total parenteral nutrition (TPN) and/or supplementary intravenous fluids, collectively referred to as parenteral support, in patients with intestinal failure due to MVID and SBS-IF by up to 27% and 12.5% respectively Crofelemer also reduced stool volume output, frequency of watery stools, and increased urine output - indicating improved nutrient oral absorption Based on these initial findings, crofelemer's novel antisecretory mechanism of action appears to have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in this patient population The observed TPN reduction is particularly compelling for MVID, an ultrarare pediatric disease characterized by severe diarrhea and malabsorption that requires intensive parenteral support for nutritional and fluid management and for which no approved drug treatments exist, or any potential approach to reduce TPN This initial proof-of-concept data in MVID supports crofelemer's potential inclusion in the European Medicines Agency's (EMA) PRIME program for expediated and assisted regulatory approval in the EU as well as in the FDA's Breakthrough Therapy program for expedited regulatory approval in the US Jaguar, through Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics, is currently supporting three POC IITs, and conducting two placebo-controlled Phase 2 studies, for crofelemer for MVID and/or SBS-IF patients in the US, EU, and/or Middle East/North Africa regions Additional POC results from IITs in MVID and/or SBS-IF are expected throughout 2025 Cancer Therapy-Related Diarrhea (CTD) Program As announced, the FDA granted Napo a Type C Meeting in Q2 2025 to discuss the responder analysis results in the prespecified subgroup of patients with breast cancer in Napo's recently conducted Phase 3 OnTarget trial. Patients with breast cancer accounted for 183 of the 287 participants in this unprecedented prophylactic clinical trial of crofelemer for diarrhea in adults with solid tumors receiving targeted therapy with or without standard chemotherapy. While the initial top line results from the OnTarget study showed that this multicenter, double-blind, placebo-controlled pivotal trial did not meet its primary endpoint for the prespecified analysis of all tumor types, the subgroup analysis in adult breast cancer patients indicates that crofelemer achieved significant results in this subgroup. The company's goal for the meeting is to discuss the most efficient potential pathway to make crofelemer available to adult breast cancer patients for CTD. The results in breast cancer patients were the subject of a poster presentation on December 11, 2024, at the San Antonio Breast Cancer Symposium, and additional significant results in adult breast cancer patients from the OnTarget study have been accepted for presentation as an oral rapid e-poster at the Multinational Association of Supportive Care in Cancer (MASCC) Annual Meeting in June 2025 in Seattle, Washington. About Crofelemer Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health, visit Napo Pharmaceuticals, visit Napo Therapeutics, visit Magdalena Biosciences, visit Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that crofelemer's mechanism of action may have the potential to provide a novel therapeutic option to reduce TPN and associated complications, including liver, renal, and cognitive deficits, as well as infections from IV infusion, in pediatric MVID and SBS-IF patients, Jaguar's expectation that POC data in MVID may support crofelemer's potential inclusion in the EMA's PRIME program for expediated and assisted regulatory approval and in the FDA's Breakthrough Therapy program for expedited regulatory approval in the US, Jaguar's expectation that additional POC results from IITs will be available throughout 2025, Jaguar's expectation that Napo will meet with the FDA in Q2 2025 and discuss the most efficient potential pathway to make crofelemer available to adult breast cancer patients for CTD, and Jaguar's expectation that additional significant results in adult breast cancer patients from the OnTarget study will be presented at the 2025 MASCC Annual Meeting. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. CONTACT: hello@ Jaguar-JAGX SOURCE: Jaguar Health, Inc.
Bloomberg
26-04-2025
- Health
- Bloomberg
How the FDA Helped Ignite, and Then Worsened, the Opioid Crisis
An investigation into the agency's repeated violations of its own rules to approve addictive drugs—and its ongoing failure to rein in the public-health crisis. By On a sunny May afternoon 14 years ago, a group of doctors from across the country gathered in a windowless conference room at the US Food and Drug Administration's main campus in White Oak, Maryland, with an urgent message: Prescription opioids were not just addictive, they were also ineffective in treating chronic pain. The physicians, all pain and addiction experts, told Janet Woodcock, then director of the FDA's Center for Drug Evaluation and Research (CDER), that pharmaceutical companies had lied when they claimed opioids harmed only abusers seeking to get high. The drugs could be valuable tools for relieving acute, short-term pain, the doctors allowed. But they accused the FDA of acting rashly, starting with the 1995 approval of Purdue Pharma 's OxyContin label, which helped expand opioid use to millions of new patients, including people with long-term conditions such as arthritis and back pain.
