The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.
Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chickenpox — the varicella-zoster virus. Anyone who once had chickenpox is at risk of shingles since the virus may become reactivated years after the initial infection.  PHN is a condition affecting nerve fibers and the skin that can cause excruciating pain for weeks, months or even years. About 10 to 15 percent of patients who have shingles experience PHN and the complication is even more common in elderly patients.
Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review . It was approved on Nov. 16.
“This new product can provide effective pain relief for patients who suffer from PHN,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug uation and Research.
 The most frequently reported adverse drug reactions included pain, swelling, itching, redness, and bumps at the application site.
Qutenza must be applied to the skin by a health care professional since placement of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief such as ice or use of opioid pain relievers. The patient must also be monitored for at least one hour since there is a risk of a significant rise in blood pressure following patch placement.
 The patch is manufactured by Lohmann Therapie-Systems AD of Andernach, Germany and distributed by NeurogesX Inc. of San Mateo, Calif.
美国食品药品管理局（FDA）近日已批准德国LohmannTherapie-Systems公司的Qutenza（辣椒碱）8%贴剂上市。这种外用皮肤贴剂可用于缓解疱疹后神经痛（PHN）——一种带状疱疹发病后的常见严重并发症。
    带状疱疹会使患者皮肤上出现大量红疹或水疱。与水痘相同，带状疱疹也是由水痘-带状疱疹病毒引起的。这种病毒可能会在初次感染的数年后再次活化，因此曾患水痘的人群更易出现带状疱疹症状。PHN会对神经纤维和皮肤产生影响，从而引起长达数周、数月甚至数年的剧烈疼痛。大约10%～15%的带状疱疹患者都曾遭受过PHN，这种并发症在老年患者中尤为常见。
    Qutenza中含有辣椒碱（一种存在于辣椒中的成分）。虽然目前市场上已有含低浓度辣椒碱的OTC产品用于治疗PHN，但Qutenza是首个经FDA批准的，含有高浓度合成纯辣椒碱的处方药。
     该药品常见的不良反应包括疼痛、肿胀、瘙痒、发红、用药部位出现肿块等。