The U.S. Food and Drug Administration (FDA) has given the go-ahead for the over-the-counter (OTC) sale of Voltaren Arthritis Pain, a topical gel for the temporary relief ofosteoarthritis pain。Since 2007, the medication has been available only by prescription.
“此药物现在现在为消费者提供了另一个OTC选项osteoarthritisin addition toibuprofen[advil]，萘普生[Aleve]，acetaminophen[Tylenol]，和capsaicin cream，“说Francis Luk, MD,a风湿病学者at Wake Forest Baptist Health in Winston-Salem, North Carolina.
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骨关节炎是可以导致的关节中的炎症，肿胀和温柔pain, stiffness, and difficulty moving. In the United States, about 30 million adults live with the condition, according to theCenters for Disease Control and Prevention。
Yili Huang, DO,the director of the疼痛管理在纽约困倦的Hollow的Northwell Health's Phelps医院的中心一直在为他的骨关节炎患者身份规定伏尔兰凝胶，并欢迎其OTC销售。
“The gel is generally effective in treating localized pain that is directly under the skin or in superficial joints [such as the ankle, knee, hands, wrist, and elbow],” says Dr. Huang.
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使疼痛缓解更容易获得
Theapprovalcomes as part of a process called anRX-to-OTC交换机，制造商（在这种情况下，制药公司glaxosmithkline.) must demonstrate that a drug is safe and effective for use in self-medication.
voltaren凝胶的OTC形式应该与处方版本一样有效，因为它与原始产品相同的实力和公式，根据Glaxosmithkline（GSK），唯一的公司赋予FDA祝福出售diclofenac gel作为OTC产品。
“批准更广泛的非前列药物通过增加消费者可以访问和使用的药物类型，否则批准公共卫生可以通过处方只能提供，否则这些毒品消费者可以访问和使用。”说Karen Mahoney, MD,,FDA毒品评估和研究中心的非前列药物办公室代理副主任a press release。
根据GSK的说法，该产品预计将在春季2020年春季商店购买。定价信息尚未提供，但制药公司表示将与市场上的其他OTC关节炎疼痛药物相媲美。
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The消费者医疗保健产品协会points out that in general, OTC medicines are more affordable that prescription drugs, saving the U.S. healthcare system $51.6 billion in drug costs every year. That translates to significant savings for the American consumer.
一种安全，低剂量的疼痛浮雕选择
As a 1 percent gel that can be applied directly to the skin, this nonsteroidal anti-inflammatory drug (NSAID) has a favorable safety profile when used as directed because it contains such a low amount of the active ingredient,双氯芬酸钠。像其他一样nsaids., Voltaren works by temporarily blocking the production of pain-signaling chemicals called前列腺素。
“凝胶可以是不忍受口腔非甾体抗炎症副作用的患者的更安全的选择，”黄说。“它似乎具有比其他已经过于反击的非甾体抗炎药，如萘普生或布洛芬的更好的安全性。“
Neha Shah，MD, a rheumatologist with Stanford Health Care in Palo Alto, California, adds that the gel may help individuals who are advised not to take oral NSAIDs.
“Patients withcontraindicationsto using oral NSAIDs — such as chronic or acute kidney disease, use of a blood thinner, or消化性溃疡疾病 - 可以用最小的风险使用局部药物，“她说。
虽然它被批准了treatment of pain from osteoarthritis据Shah博士称，伏特伦凝胶也可能暂时缓解类风湿性关节炎的疼痛。
“However, it is not a substitute for disease-modifying antirheumatic drugs,” she says. “It will not actuallytreat rheumatoid arthritis long term。“
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Gel Is an Alternative to Oral Diclofenac, a Pill
Shah强调，作为凝胶，与双氯芬酸的口腔形式相比，较小的产品被吸收到身体中（这是available only by prescription）。
“用厕所使用的药物的水平是你通过口服使用的一小部分，”她说。
In its oral form,diclofenac side effects可以包括胃问题如天然气，bloating, pain, cramping,便秘, bleeding, and diarrhea; headache andringing in the ears;和rash。药物可能会引发更严重的不良事件，例如低血压，血液疾病，肝损伤，以及充血性心力衰竭。
仍然，对于具有更深或更广泛炎症性的炎症疼痛的患者，可能不会对凝胶作出反应，并且对于那些没有反应过度反应的非甾体抗炎治疗的人来说，口服双氯芬酸可能有助于根据医生的方向使用。
仍然可以实现一些凝胶副作用
即使具有如此高的安全型材，伏特关节炎疼痛也不完全没有副作用。使用太多的太多可能导致皮疹，瘙痒，燃烧的感觉和与口腔双氯芬酸引起的灼热感。
TheFDA警告凝胶中的活性成分可能会引发严重的allergic reaction，特别是人们过敏aspirin。Liver damage may occur if this product is used more or longer than directed or in concert with other products containing diclofenac.
“That is why it is always important to consult with your healthcare provider on all medications that you are taking, even topical medications such as Voltaren,” says Huang.
The Gel Doesn’t Relieve Pain Right Away
voltaren关节炎疼痛is not for immediate relief — it may take up to a week to take effect. The FDA advises consumers to stop using the product and seek medical attention if their arthritis pain is not improved in seven days or they need to use the product for more than 21 days.
“一般来说，由于其对胃，肾脏和心脏的影响，我不建议延续任何非甾体抗炎，超过两周，”黄。
