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<p>美國食品藥品監督管理局（FDA）已批准對輝瑞的避孕注射劑 Depo Provera 的標籤進行更改，警告開處方者和患者該藥物使用與腦膜瘤風險增加相關。圖片來源：ShU studio via ShutterStock.com。</p>
<p>美國食品藥品監督管理局（FDA）已批准對輝瑞的注射避孕藥 Depo-Provera（醋酸美託洛爾）的標籤進行更改，警告用户其腦膜瘤風險增加。</p>
<p>FDA 對 Depo-Provera 的打擊正值輝瑞與 2000 多名女性之間的高度公開的法律鬥爭之中，這些女性目前正在起訴這家總部位於紐約的製藥公司，因她們發展出她們認為是由避孕藥引起的腦膜瘤。</p>
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<p>Depo-Provera 含有孕激素，這是一種合成的性激素孕酮。自 1990 年代初以來，它一直在 避孕市場 上銷售，最近在《英國醫學雜誌》上發表的一項 研究 揭示了與該注射劑長期使用相關的顱內腦膜瘤風險增加。</p>
<p>2023 年 12 月的國家健康統計報告 估計，在 2015 年至 2019 年間，美國近 24.5% 的所有有性經驗女性曾使用過 Depo-Provera。</p>
<p>腦膜瘤是生長在包裹大腦和脊髓的保護膜中的腫瘤。患有腦膜瘤的患者常常會經歷頭痛、癲癇發作、虛弱和麻木。儘管它們通常是良性的，但可能會對患者的生活質量產生重大影響。在某些情況下，它們也可能危及生命。</p>
<p>FDA 要求對 Depo-Provera 實施標籤警告，標誌着該機構在避孕藥上的立場可能發生轉變，因為它之前在 2024 年拒絕了輝瑞的標籤更新申請。</p>
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<h2>FDA 的打擊可能給輝瑞帶來法律麻煩</h2>
<p>在輝瑞與 2000 多名原告之間的法律鬥爭中，對這家大型製藥公司的指控主要集中在其未能警告醫生和患者使用 Depo-Provera 與腦膜瘤風險相關。</p>
<p>輝瑞此前在法庭上辯稱，FDA 禁止其在 Depo-Provera 上添加標籤警告，因此促使公司請求駁回此類訴訟。</p>
<p>然而，Ben Martin，藥物和醫療器械訴訟小組的創始人，Ben Martin Law Group，告訴《製藥技術》雜誌，這一辯護在法庭上可能不再成立。</p>
<p>馬丁表示：“這種 ‘不可能’ 的優先權論點現在應該失敗，因為警告不僅是可能的，而且 FDA 現在要求這樣的警告。</p>
<p>“輝瑞幾十年來一直知道 Depo-Provera 的使用與腦膜瘤的發展之間可能存在關聯。”</p>
<p>在他看來，這家總部位於紐約的製藥公司 “本可以並且應該進行研究以探索這一聯繫”，這將揭示使用 Depo-Provera 與不使用之間發展腦膜瘤的更大風險。</p>
<p>Aylstock Witkin Kreis &amp; Overholtz 的 Bryan Aylstock、Seeger Weiss 的 Christopher Seeger 和 Weitz &amp; Luxenberg 的 Ellen Relkin，作為 Depo-Provera 產品責任訴訟的共同首席律師，表達了這一觀點，補充説輝瑞的不當行為導致 “女性因 Depo-Provera 引起的腦腫瘤而造成的持久神經損傷、視力喪失和死亡”。</p>
<p>“我們讚揚 FDA 最終要求這一標籤更改，以更好地告知和保護女性，” 他們總結道。</p>
<h2>製藥技術卓越獎 - 提名已關閉</h2>
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輝瑞

<p>美國食品藥品監督管理局（FDA）已批准輝瑞的避孕注射劑 Depo-Provera 更改標籤，以警告其增加腦膜瘤的風險。此決定是在超過 2000 起女性訴訟的背景下作出的，這些女性聲稱該避孕藥導致了她們的腦膜瘤。FDA 之前在 2024 年拒絕輝瑞的標籤更新申請的決定現已被推翻。法律專家表示，隨着 FDA 現在要求發佈警告，輝瑞的辯護可能會減弱</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>美國食品藥品監督管理局（FDA）已批准對輝瑞的避孕注射劑 Depo Provera 的標籤進行更改，警告開處方者和患者該藥物使用與腦膜瘤風險增加相關。圖片來源：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>美國食品藥品監督管理局（FDA）已批准對輝瑞的注射避孕藥 Depo-Provera（醋酸美託洛爾）的標籤進行更改，警告用户其腦膜瘤風險增加。</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 對 Depo-Provera 的打擊正值輝瑞與 2000 多名女性之間的高度公開的法律鬥爭之中，這些女性目前正在起訴這家總部位於紐約的製藥公司，因她們發展出她們認為是由避孕藥引起的腦膜瘤。</p>
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</div><h4>LOA and PTSR Model - GSK-2256098 in Meningioma</h4>
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<div class="lb-trans"><h4>LOA 和 PTSR 模型 - Pritumumab 在腦膜瘤中的應用</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，這是一種合成的性激素孕酮。自 1990 年代初以來，它一直在 避孕市場 上銷售，最近在《英國醫學雜誌》上發表的一項 研究 揭示了與該注射劑長期使用相關的顱內腦膜瘤風險增加。</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 月的國家健康統計報告 估計，在 2015 年至 2019 年間，美國近 24.5% 的所有有性經驗女性曾使用過 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>腦膜瘤是生長在包裹大腦和脊髓的保護膜中的腫瘤。患有腦膜瘤的患者常常會經歷頭痛、癲癇發作、虛弱和麻木。儘管它們通常是良性的，但可能會對患者的生活質量產生重大影響。在某些情況下，它們也可能危及生命。</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 要求對 Depo-Provera 實施標籤警告，標誌着該機構在避孕藥上的立場可能發生轉變，因為它之前在 2024 年拒絕了輝瑞的標籤更新申請。</p>
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<div class="lb-trans"><h1>美國關税正在變化 - 你會反應還是預見？</h1>
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</div><h2>FDA clampdown could spell legal trouble for Pfizer</h2>
<div class="lb-trans"><h2>FDA 的打擊可能給輝瑞帶來法律麻煩</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>在輝瑞與 2000 多名原告之間的法律鬥爭中，對這家大型製藥公司的指控主要集中在其未能警告醫生和患者使用 Depo-Provera 與腦膜瘤風險相關。</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>輝瑞此前在法庭上辯稱，FDA 禁止其在 Depo-Provera 上添加標籤警告，因此促使公司請求駁回此類訴訟。</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，藥物和醫療器械訴訟小組的創始人，Ben Martin Law Group，告訴《製藥技術》雜誌，這一辯護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>馬丁表示：“這種 ‘不可能’ 的優先權論點現在應該失敗，因為警告不僅是可能的，而且 FDA 現在要求這樣的警告。</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>“輝瑞幾十年來一直知道 Depo-Provera 的使用與腦膜瘤的發展之間可能存在關聯。”</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>在他看來，這家總部位於紐約的製藥公司 “本可以並且應該進行研究以探索這一聯繫”，這將揭示使用 Depo-Provera 與不使用之間發展腦膜瘤的更大風險。</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，作為 Depo-Provera 產品責任訴訟的共同首席律師，表達了這一觀點，補充説輝瑞的不當行為導致 “女性因 Depo-Provera 引起的腦腫瘤而造成的持久神經損傷、視力喪失和死亡”。</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>“我們讚揚 FDA 最終要求這一標籤更改，以更好地告知和保護女性，” 他們總結道。</p>
</div><h2>Pharmaceutical Technology Excellence Awards - Nominations Closed</h2>
<div class="lb-trans"><h2>製藥技術卓越獎 - 提名已關閉</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>提名現已關閉，感謝所有參與的組織 - 你們的回應非常出色，展示了卓越的創新、領導力和影響力。</p>
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<div class="lb-trans"><p>Upperton Pharma Solutions 因其在 綜合製造 方面的業務擴展而獲得 2025 年製藥技術卓越獎，正在迅速擴大其在英國的 GMP 和無菌製造能力。瞭解 Upperton 的綜合 CDMO 模式如何幫助製藥公司從早期開發轉向臨牀和小眾商業供應，減少交接並加快時間進度。</p>
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FDA approves meningioma label warning on Pfizer’s contraceptive injection

- FDA 批准了對 Pfizer 的避孕注射劑 Depo-Provera 的標籤更改。  
- 新標籤將警告用户增加 meningioma 風險，涉及超過 2000 名女性的訴訟。  
- 此次行動標誌着 FDA 對該藥物立場的潛在轉變。

FDA 批准在輝瑞避孕注射劑上添加腦膜瘤警告標籤