NAION is a rare ischemic disease of the optic nerve that may cause sudden loss of vision in one eye. However, the US FDA only identifies "potential" risks, and it is most practical for drug users to first recognize the symptoms. (Preliminary summary: Research "Can slimming injections cure women's "unemployment problem"? The chance of dating new partners has also increased) (Background supplement: Bank of America BofA spends 250 million magnesium a year to help employees get slimming injections! CEO: It is better to invest even if you know people will run away) On November 9, the US FDA required all GLP-1 drugs (commonly known as "slimming injections" in Taiwan) to add warnings and precautions in the drug instructions NAION (Nonarteritic Anterior Ischemic Optic Neuropathy) risk, the drugs named include Ozempic, Wegovy, Mounjaro, and Zepbound, which are familiar to Taiwanese readers. How high are the risks? FDA 彙整 126 項隨機對照臨床試驗,每 10 萬人年(約等於 10 萬人用藥一年)有 6.4 例 NAION,對照組(安慰劑或非 GLP-1 的降血糖藥)則是 3.8 例。 But this group of proportions actually only comes from 15 cases, 10 in the medication group and 5 in the control group. The number of cases is very small. FDA 另外分析第二型糖尿病患者的真實世界用藥資料:跟使用 SGLT-2 抑制劑的人相比,風險沒有明顯差異;跟使用 DPP-4 抑制劑的人相比,風險高出約 4 成。 Animal data do not provide a mechanism for how GLP-1 drugs increase the risk of NAION. A spokesman for Eli Lilly told Reuters that the warning applies to all drugs with GLP-1 receptor agonism and that there are no findings specific to Eli Lilly's drugs; Novo Nordisk said that the available data are insufficient to prove a causal relationship. The European Medicines Agency's safety committee estimated last year that up to 1 in 10,000 people who had used semaglutide (the ingredient in Ozempic, Wegovy) for at least a year was affected, Reuters reported. What symptoms require medical attention? Symptoms listed by the FDA include: sudden, painless loss of vision in one eye, often noticed when you wake up; blind spots or narrowing of the visual field; colors that appear distorted; and blurred central vision. If any of these symptoms occur, contact your doctor immediately. People who have already experienced NAION should discuss with their doctor whether to continue using GLP-1 drugs. The FDA also lists several possible risk factors, including smoking, diabetes, high blood pressure, sleep apnea, anemia and kidney disease. These conditions are inherently common in people using GLP-1 drugs, so notified cases are difficult to interpret. NAION in one eye puts the other eye at increased risk. Will Taiwan follow suit? 食藥署藥品組簡任技正劉佳萍向自由時報表示,食藥署 2025 年 6 月針對 semaglutide 成分藥品發過風險溝通表,2026 年 6 月也已函請 semaglutide 藥商在仿單加刊 NAION 資訊。 This time, because the U.S. alert covers the entire class of GLP-1 drugs (including tirzepatide, an ingredient of Mengenex), the Food and Drug Administration will initiate an overall safety reassessment of this class of drugs and then take necessary risk management measures based on the results. The Food and Drug Administration pointed out that this year, the National Adverse Drug Reaction Reporting System received a total of 63 notifications of suspected use of GLP-1 drugs, of which 39 were used for weight loss. The reported symptoms included gastrointestinal diseases, hypoglycemia, nausea, vomiting, and injection site discomfort. In addition, the Food and Drug Administration also reminds that such drugs should be evaluated by a doctor and used according to the doctor's advice. Do not buy drugs from unknown or unapproved sources online. What does this warning mean? Label changes are required for the entire class of drugs, but the absolute risk of NAION remains low. Citi analyst Geoff Meacham told Reuters that the rarity of the disease, coupled with the drug's weight loss, blood sugar, cardiovascular, renal and sleep apnea benefits, the benefit-risk balance should still be favorable and prescriptions are unlikely to change drastically. For people who are taking medication, the key is to recognize the symptoms: if you wake up and find that you suddenly cannot see clearly in one eye, you should see a doctor immediately. Related reports Eli Lilly, the leading weight-loss drug, is said to be rushing into “psychedelic drugs”! The desire to acquire ATAI soared 66%. Why are hallucinogenic drugs suddenly in the market? Anthropic announced that it will “develop new drugs by itself”, but experts poured cold water: FDA certification will take at least 10 years. Why hasn’t AI developed a new drug that changes the world? Anthropic 執行長預言:不到十年,癌症、阿茲海默症等疾病將成為過去 Claude 自主設計蛋白質命中率達 35%,Anthropic 加速叩關新藥研發? 〈The US FDA requires slimming injections to be added to the potential risk of blindness, and the Food and Drug Administration initiates a re-evaluation〉 This article was first published in BlockTempo "Dongqu Dongzhi - the most influential blockchain news media".
U.S. FDA requires slimming injections to add potential risk of blindness, Food and Drug Administration initiates re-evaluation
NAION is a rare ischemic disease of the optic nerve that may cause sudden loss of vision in one eye. However, the U.S. FDA only identifies "potential" risks, and drug users must first […] The U.S. FDA requires slimming injections to add potential blindness risks, and the Food and Drug Administration initiates a re-evaluation> This article was first published in BlockTempo "Dong District Dongzhi - the most influential blockchain news media".

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