美国食品及药物管理局FDA日前批准了Striant睾酮口腔贴剂可以用于缓解包括性腺功能减退的男性睾酮缺乏症。该贴剂是由Columbia　Laboratories公司研制生产的，大小如同一片阿司匹林，可快速黏附在牙龈与上唇交接处，能够在12小时内向口腔黏膜缓慢释出睾酮。

　由于无需经由消化道而直接进入上腔静脉，故睾酮的效应相应增强，可以作为睾酮皮肤贴剂、局部乳膏或注射剂之外的另一种选择。根据专家介绍，Striant含有30mg睾酮，每天早、晚各贴一片即可使体内的睾酮含量保持正常而稳定

FDA变更Striant, Naprosyn, EC-Naprosyn, Anaprox, Anaprox DS, AndroGel的安全性标示

 Feb. 9, 2005 - 美国食品药物管理局(FDA)在去年12月核准了几项药物的安全标示，包括男性患者疑似或确定患有乳癌及前列腺癌，不得使用睪酮素口颊锭系统；Naproxen (悬浮液、锭剂、肠衣缓释锭)及naproxin sodium (锭剂、双效锭)，可能会导致类过敏反应；睪酮凝胶在乾燥时会燃烧，可能造成危害；上述的安全标示改变案，乃针对保健专业人员所发布。
　　
 睪酮素口颊锭系统(Striant)不得使用在男性的乳癌或前列腺癌患者身上
 11月3日，FDA核准了睪酮素口颊锭系统(Striant 口腔黏膜黏著剂，Columbia Laboratories, Inc製造)的安全标示变更，男性不论疑似或确定患有乳癌及前列腺癌，都不得使用Striant。
　　
 FDA表示，老年患者、临床及人种族群上显示，有前列腺炎倾向的患者，在使用睪酮素替换疗法前，必须要先作异状评估；正在接受睪酮素治疗的患者，应该持续以生殖腺治疗準则进行监控。
 睪酮素口颊锭系统为一睪酮素替换疗法，适应症为先天及后天的内生睪酮素缺乏症。
　　
  Naproxen及Naproxen Sodium (Naprosyn, EC-Naprosyn, Anaprox, Anaprox DS)可能会导致类过敏反应
  在11月10日，FDA核准了naproxen的安全标示变更案，剂型包含悬浮液及锭剂(Naproxyn)，缓释型肠衣锭(EC-Naprosyn)，及naproxen sodium的普通及双效锭(Anaprox, Anaprox；皆由Roche Palo Alto製造)；FDA对这些药物提出使用上的警告及禁忌。
　　
  患者若会因阿斯匹灵或其他非类固醇抗炎药物(NSAIDs)而引发气喘、鼻炎及鼻息肉(阿斯匹灵三徵)等潜在致命症状，不得使用naproxen及naproxen sodium；FDA强调，这些复合性症状一般会发生在气喘患者身上，这些患者会有鼻炎的症状，但不见得会有鼻息肉的现象；或者，在服用阿斯匹灵或其他NSAIDs药物后，引发致命性的气管痉挛现象。
　　
　FDA警告，不论患者是否使用过NSAIDs药物，naproxen都可能会导致类过敏反应；因此在治疗之前应该要对患者详加询问，确定没有气喘、鼻息肉、蕁麻疹或低血压等类似NSAIDs副作用；如果发现所述的现象之一，应立即停止治疗。
　　
　此外，严重肾臟病患者，不建议使用naproxen治疗；在无法避免使用naproxen的情况下，肾功能应该详加监控。
　　
　如同其他的NSAID类药物，怀孕后期应该避免使用naproxen，因为动脉导管可能会在不成熟情况下关闭。
　　
　Naproxen及naproxen sodium的适应症，为风湿性关节炎、骨关节炎、僵直性脊椎炎及青少年关节炎等。
　　
　除了naproxen缓释锭以外，Naproxen及naproxen sodium的适用症状，为肌腱炎、滑液囊炎、急性痛风及月经不顺等。
　　
　注意！睪酮素凝胶1%(AndroGel)乾燥时会燃烧
　11月19日，FDA核准了睪酮素凝胶1%(AndroGel，Solvay Pharmaceutical製造)的安全标示变更案，该药物为以乙醇作为基剂的凝胶，具有燃烧性，患者应该远离火源。
　　
　睪酮素凝胶1%为一睪酮素置换疗法，适应症为先天及后天的内生睪酮素缺乏症。

 
FDA Safety Labeling Changes: Striant, Naprosyn, EC-Naprosyn, Anaprox, Anaprox DS, AndroGel

Feb. 9, 2005 — The U.S. Food and Drug Administration (FDA) approvedinNovember, 2004 revisions to safety labeling to advise healthcare professionals of the following changes: use of a testosterone buccal system is contraindicated in men with breast cancer or known/suspected prostate cancer; use of naproxen (suspension, tablets and enteric-coated delayed-release tablets) and naproxen sodium (tablets and double-strength tablets) may cause anaphylactoid reactions; testosterone gel is flammable and may pose a hazard when wet.

Testosterone Buccal System (Striant) Not for Use in Men With Breast or Prostate Cancer

On Nov. 3, the FDA approved revisions to the safety labeling for a testosterone buccal system (Striant mucoadhesive, made by Columbia Laboratories, Inc.), advising that its use is contraindicated in men with carcinoma of the breast or known/suspected carcinoma of the prostate.

The FDA recommends that geriatric patients and other patients with clinical or demographic characteristics that are linked to an increased risk of prostate cancer be evaluated for the presence of malignancy prior to initiation of testosterone replacement therapy. Surveillance for prostate cancer in men receiving testosterone therapy should be consistent with current guidelines for eugonadal men.

The testosterone buccal system is indicated for replacement therapy in males for congenital and acquired conditions associated with a deficiency or absence of endogenous testosterone.

Naproxen and Naproxen Sodium (Naprosyn, EC-Naprosyn, Anaprox, Anaprox DS) May Cause Anaphylactoid Reactions

On Nov. 10, the FDA approved revisions to the safety labeling for naproxen suspension/tablets (Naprosyn) and enteric-coated delayed-release tablets (EC-Naprosyn), and naproxen sodium regular and double-strength tablets (Anaprox, Anaprox DS; all made by Roche Palo Alto, LLC, a division of Hoffman-LaRoche, Inc.), to advise of contraindications and warnings associated with their use.

Use of naproxen and naproxen sodium is contraindicated in patients for whom aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)/analgesics induce the potentially fatal syndrome of asthma, rhinitis, and nasal polyps (aspirin triad). The FDA notes that this symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.

The FDA warns that naproxen and other NSAIDs may cause anaphylactoid reactions even in patients with no known prior exposure to the products. Patients should therefore be carefully questioned prior to therapy initiation, with an emphasis on symptoms of asthma, nasal polyps, urticaria, and hypotension associated with past NSAID use. Therapy should be discontinued if these symptoms occur.

Naproxen therapy is not recommended in patients with advanced kidney disease. If treatment with naproxen or other NSAIDs is required, kidney function should be closely monitored.

As with other NSAIDs, naproxen use should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosis.

Naproxen and naproxen sodium are indicated for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and juvenile arthritis.

Naproxen and naproxen sodium, with the exception of naproxen delayed-release tablets, are indicated for the relief of signs and symptoms of tendonitis, bursitis, acute gout, pain, and primary dysmenorrhea.

Testosterone Gel 1% (AndroGel) Flammable When Wet, Caution Advised

On Nov. 19, the FDA approved revisions to the safety labeling for testosterone gel, 1% (AndroGel, made by Solvay Pharmaceuticals, Inc.), to warn patients of the flammability of the alcohol-based gel. Patients should avoid fire, flames, or smoking until the gel has dried.

Testosterone gel 1% is indicated for replacement therapy in males for congenital and acquired conditions associated with a deficiency or absence of endogenous testosterone.

Reviewed by Gary D. Vogin, MD