<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2323812187-430x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2323812187-430x241.jpg"/></p>
<p>美国食品药品监督管理局（FDA）已批准对辉瑞的避孕注射剂 Depo Provera 的标签进行更改，警告开处方者和患者该药物使用与脑膜瘤风险增加相关。图片来源：ShU studio via ShutterStock.com。</p>
<p>美国食品药品监督管理局（FDA）已批准对辉瑞的注射避孕药 Depo-Provera（醋酸美托洛尔）的标签进行更改，警告用户其脑膜瘤风险增加。</p>
<p>FDA 对 Depo-Provera 的打击正值辉瑞与 2000 多名女性之间的高度公开的法律斗争之中，这些女性目前正在起诉这家总部位于纽约的制药公司，因她们发展出她们认为是由避孕药引起的脑膜瘤。</p>
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<p>Depo-Provera 含有孕激素，这是一种合成的性激素孕酮。自 1990 年代初以来，它一直在 避孕市场 上销售，最近在《英国医学杂志》上发表的一项 研究 揭示了与该注射剂长期使用相关的颅内脑膜瘤风险增加。</p>
<p>2023 年 12 月的国家健康统计报告 估计，在 2015 年至 2019 年间，美国近 24.5% 的所有有性经验女性曾使用过 Depo-Provera。</p>
<p>脑膜瘤是生长在包裹大脑和脊髓的保护膜中的肿瘤。患有脑膜瘤的患者常常会经历头痛、癫痫发作、虚弱和麻木。尽管它们通常是良性的，但可能会对患者的生活质量产生重大影响。在某些情况下，它们也可能危及生命。</p>
<p>FDA 要求对 Depo-Provera 实施标签警告，标志着该机构在避孕药上的立场可能发生转变，因为它之前在 2024 年拒绝了辉瑞的标签更新申请。</p>
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<h2>FDA 的打击可能给辉瑞带来法律麻烦</h2>
<p>在辉瑞与 2000 多名原告之间的法律斗争中，对这家大型制药公司的指控主要集中在其未能警告医生和患者使用 Depo-Provera 与脑膜瘤风险相关。</p>
<p>辉瑞此前在法庭上辩称，FDA 禁止其在 Depo-Provera 上添加标签警告，因此促使公司请求驳回此类诉讼。</p>
<p>然而，Ben Martin，药物和医疗器械诉讼小组的创始人，Ben Martin Law Group，告诉《制药技术》杂志，这一辩护在法庭上可能不再成立。</p>
<p>马丁表示：“这种 ‘不可能’ 的优先权论点现在应该失败，因为警告不仅是可能的，而且 FDA 现在要求这样的警告。</p>
<p>“辉瑞几十年来一直知道 Depo-Provera 的使用与脑膜瘤的发展之间可能存在关联。”</p>
<p>在他看来，这家总部位于纽约的制药公司 “本可以并且应该进行研究以探索这一联系”，这将揭示使用 Depo-Provera 与不使用之间发展脑膜瘤的更大风险。</p>
<p>Aylstock Witkin Kreis &amp; Overholtz 的 Bryan Aylstock、Seeger Weiss 的 Christopher Seeger 和 Weitz &amp; Luxenberg 的 Ellen Relkin，作为 Depo-Provera 产品责任诉讼的共同首席律师，表达了这一观点，补充说辉瑞的不当行为导致 “女性因 Depo-Provera 引起的脑肿瘤而造成的持久神经损伤、视力丧失和死亡”。</p>
<p>“我们赞扬 FDA 最终要求这一标签更改，以更好地告知和保护女性，” 他们总结道。</p>
<h2>制药技术卓越奖 - 提名已关闭</h2>
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<p>Upperton Pharma Solutions 因其在 综合制造 方面的业务扩展而获得 2025 年制药技术卓越奖，正在迅速扩大其在英国的 GMP 和无菌制造能力。了解 Upperton 的综合 CDMO 模式如何帮助制药公司从早期开发转向临床和小众商业供应，减少交接并加快时间进度。</p>
<p>发现影响</p>

辉瑞

<p>美国食品药品监督管理局（FDA）已批准辉瑞的避孕注射剂 Depo-Provera 更改标签，以警告其增加脑膜瘤的风险。此决定是在超过 2000 起女性诉讼的背景下作出的，这些女性声称该避孕药导致了她们的脑膜瘤。FDA 之前在 2024 年拒绝辉瑞的标签更新申请的决定现已被推翻。法律专家表示，随着 FDA 现在要求发布警告，辉瑞的辩护可能会减弱</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2323812187-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2025/12/shutterstock_2323812187-430x241.jpg"/></p>
<p>The FDA has approved a label change to Pfizer’s contraceptive injection, Depo Provera, which will warn prescribers and patients of the increased risk of meningioma associated with the drug’s use. Image credit: ShU studio via ShutterStock.com.</p>
<div class="lb-trans"><p>美国食品药品监督管理局（FDA）已批准对辉瑞的避孕注射剂 Depo Provera 的标签进行更改，警告开处方者和患者该药物使用与脑膜瘤风险增加相关。图片来源：ShU studio via ShutterStock.com。</p>
</div><p>The US Food and Drug Administration (FDA) has approved a label change to Pfizer’s injectable contraceptive, Depo-Provera (medroxyprogesterone acetate), which will warn users of their increased risk of meningioma.</p>
<div class="lb-trans"><p>美国食品药品监督管理局（FDA）已批准对辉瑞的注射避孕药 Depo-Provera（醋酸美托洛尔）的标签进行更改，警告用户其脑膜瘤风险增加。</p>
</div><p>The FDA’s crackdown on Depo-Provera comes amid a highly publicised legal battle between Pfizer and more than 2,000 women, who are currently suing the New York-based pharma after they developed meningiomas they believe are caused by exposure to the contraceptive.</p>
<div class="lb-trans"><p>FDA 对 Depo-Provera 的打击正值辉瑞与 2000 多名女性之间的高度公开的法律斗争之中，这些女性目前正在起诉这家总部位于纽约的制药公司，因她们发展出她们认为是由避孕药引起的脑膜瘤。</p>
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</div><h4>LOA and PTSR Model - GSK-2256098 in Meningioma</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - GSK-2256098 在脑膜瘤中的应用</h4>
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</div><h4>LOA and PTSR Model - Pritumumab in Meningioma</h4>
<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Pritumumab 在脑膜瘤中的应用</h4>
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</div><p>Depo-Provera contains progestin, a synthetic form of the sex hormone progesterone. While it has been on the contraceptive market since the early 1990s, a recent study published in the <em>British Medical Journal</em> has uncovered the heightened risk of intracranial meningioma associated with the jab’s prolonged use.</p>
<div class="lb-trans"><p>Depo-Provera 含有孕激素，这是一种合成的性激素孕酮。自 1990 年代初以来，它一直在 避孕市场 上销售，最近在《英国医学杂志》上发表的一项 研究 揭示了与该注射剂长期使用相关的颅内脑膜瘤风险增加。</p>
</div><p>A December 2023 National Health Statistics Report estimates that nearly 24.5% of all sexually experienced women in the US have used Depo-Provera at some point between 2015 and 2019.</p>
<div class="lb-trans"><p>2023 年 12 月的国家健康统计报告 估计，在 2015 年至 2019 年间，美国近 24.5% 的所有有性经验女性曾使用过 Depo-Provera。</p>
</div><p>Meningiomas are tumours that grow in the protective membranes that coat the brain and spinal cord. Patients with meningiomas commonly experience headaches, seizures, weakness and numbness. Though they are typically benign, they can have a significant impact on a patient’s quality of life (QoL). In some cases, they are also life-threatening.</p>
<div class="lb-trans"><p>脑膜瘤是生长在包裹大脑和脊髓的保护膜中的肿瘤。患有脑膜瘤的患者常常会经历头痛、癫痫发作、虚弱和麻木。尽管它们通常是良性的，但可能会对患者的生活质量产生重大影响。在某些情况下，它们也可能危及生命。</p>
</div><p>The FDA’s call to enforce a label warning for Depo-Provera marks a potential turn in the agency’s stance on the contraceptive, as it previously rejected Pfizer’s label update application in 2024.</p>
<div class="lb-trans"><p>FDA 要求对 Depo-Provera 实施标签警告，标志着该机构在避孕药上的立场可能发生转变，因为它之前在 2024 年拒绝了辉瑞的标签更新申请。</p>
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<div class="lb-trans"><h1>美国关税正在变化 - 你会反应还是预见？</h1>
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</div><h2>FDA clampdown could spell legal trouble for Pfizer</h2>
<div class="lb-trans"><h2>FDA 的打击可能给辉瑞带来法律麻烦</h2>
</div><p>Throughout the legal battle between Pfizer and the 2,000-plus plaintiffs, claims against the big pharma have largely centred around its failure to warn doctors and patients of the risk of meningioma associated with Depo-Provera’s use.</p>
<div class="lb-trans"><p>在辉瑞与 2000 多名原告之间的法律斗争中，对这家大型制药公司的指控主要集中在其未能警告医生和患者使用 Depo-Provera 与脑膜瘤风险相关。</p>
</div><p>Pfizer has previously argued in court that the FDA had prohibited it from including a label warning on Depo-Provera, thus prompting the company to request the dismissal of such lawsuits.</p>
<div class="lb-trans"><p>辉瑞此前在法庭上辩称，FDA 禁止其在 Depo-Provera 上添加标签警告，因此促使公司请求驳回此类诉讼。</p>
</div><p>However, Ben Martin, founder of the drug and medical device litigation group, Ben Martin Law Group, told <em>Pharmaceutical Technology</em> that this defence may no longer hold up in court.</p>
<div class="lb-trans"><p>然而，Ben Martin，药物和医疗器械诉讼小组的创始人，Ben Martin Law Group，告诉《制药技术》杂志，这一辩护在法庭上可能不再成立。</p>
</div><p>Martin said: “This ‘impossibility’ pre-emption argument should now fail given that a warning was not only possible but that the FDA is now requiring such a warning.</p>
<div class="lb-trans"><p>马丁表示：“这种 ‘不可能’ 的优先权论点现在应该失败，因为警告不仅是可能的，而且 FDA 现在要求这样的警告。</p>
</div><p>“Pfizer has known for decades that there may be an association between the use of Depo-Provera and the development of meningiomas.”</p>
<div class="lb-trans"><p>“辉瑞几十年来一直知道 Depo-Provera 的使用与脑膜瘤的发展之间可能存在关联。”</p>
</div><p>In his eyes, the New York-based pharma “could and should have performed studies exploring this link”, which would have uncovered the greater risk of developing meningioma with the use of Depo-Provera versus not using it.</p>
<div class="lb-trans"><p>在他看来，这家总部位于纽约的制药公司 “本可以并且应该进行研究以探索这一联系”，这将揭示使用 Depo-Provera 与不使用之间发展脑膜瘤的更大风险。</p>
</div><p>Bryan Aylstock  of  Aylstock Witkin Kreis &amp; Overholtz, Christopher Seeger of Seeger Weiss, and Ellen Relkin of Weitz &amp; Luxenberg, co-lead counsel in the Depo-Provera Products Liability Litigation echoed this sentiment, adding that Pfizer’s misconduct has caused “lasting neurological damage, vision loss and death” in women who developed brain tumours caused by Depo-Provera.</p>
<div class="lb-trans"><p>Aylstock Witkin Kreis &amp; Overholtz 的 Bryan Aylstock、Seeger Weiss 的 Christopher Seeger 和 Weitz &amp; Luxenberg 的 Ellen Relkin，作为 Depo-Provera 产品责任诉讼的共同首席律师，表达了这一观点，补充说辉瑞的不当行为导致 “女性因 Depo-Provera 引起的脑肿瘤而造成的持久神经损伤、视力丧失和死亡”。</p>
</div><p>“We applaud the FDA in finally requiring this label change to better inform and protect women,” they concluded.</p>
<div class="lb-trans"><p>“我们赞扬 FDA 最终要求这一标签更改，以更好地告知和保护女性，” 他们总结道。</p>
</div><h2>Pharmaceutical Technology Excellence Awards - Nominations Closed</h2>
<div class="lb-trans"><h2>制药技术卓越奖 - 提名已关闭</h2>
</div><p>Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.</p>
<div class="lb-trans"><p>提名现已关闭，感谢所有参与的组织 - 你们的回应非常出色，展示了卓越的创新、领导力和影响力。</p>
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<div class="lb-trans"><p>Upperton Pharma Solutions 因其在 综合制造 方面的业务扩展而获得 2025 年制药技术卓越奖，正在迅速扩大其在英国的 GMP 和无菌制造能力。了解 Upperton 的综合 CDMO 模式如何帮助制药公司从早期开发转向临床和小众商业供应，减少交接并加快时间进度。</p>
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FDA approves meningioma label warning on Pfizer’s contraceptive injection

- FDA 批准了对 Pfizer 的避孕注射剂 Depo-Provera 的标签更改。  
- 新标签将警告用户增加 meningioma 风险，涉及超过 2000 名女性的诉讼。  
- 此次行动标志着 FDA 对该药物立场的潜在转变。

FDA 批准在辉瑞避孕注射剂上添加脑膜瘤警告标签