近日，FDA已批准所有缓释(ER)及长效(LA)阿片类镇痛药的标签变更，限制它们用于治疗严重疼痛患者。FDA称这次变更于去年9月份最初提出，旨在“遏制这些强效药物的误用、滥用、成瘾、过量及其所致死亡的危机。”
更新之后的标签规定，这些药物专门用于严重到需要每天、持续、长期阿片类药物治疗的疼痛，并且只能用于使用替代药物不能获得足够疼痛缓解的患者。目前，这些产品适用于治疗中至重度疼痛患者。此外，标签将包含一项黑框警告，提示孕妇怀孕期间长期使用这类药物与潜在新生儿阿片类戒断综合征有关。
2012年，FDA公布措施，旨在降低大约十几款ER与LA阿片类药物的误用和滥用。做出最新举措之前，美国疾病控制与预防中心于去年7月发布了一项报告，发现在1999年至2010年之间，与疼痛处方药有关的致命过量在男女患者中增加了几倍。
上个月，FDA行政长官Margaret Hamburg为FDA于2013年10月批准Zogenix公司疼痛药物Zohydro ER（ 重酒石酸氢可酮）进行了辩护，其间有来自不同组织对这款药物潜在滥用的担忧。
FDA approves labelling changes for extended-release, long-acting opioid analgesics
The FDA said it approved class-wide labelling changes for all extended-release (ER) and long-acting (LA) opioid analgesics to restrict their use to treat patients with severe pain. The agency has said the changes, which were initially proposed last September, are aimed at curbing "the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs."
The updated labelling will state that the drugs are meant for pain severe enough to require daily, continuous, long-term opioid treatment, and are only for patients unable to achieve adequate pain relief with alternative medicines. Currently the products are indicated to treat patients with moderate-to-severe pain. Further, the labels will include a boxed warning ab0ut the potential for neonatal opioid withdrawal syndrome associated with chronic maternal use of the drugs during pregnancy. The regulator had also said last year that companies which market ER and LA opioid analgesics would have to conduct additional studies to assess the known serious risks of misuse, abuse, hyperalgesia, addiction, overdose and death.
In 2012, the FDA unveiled measures designed to reduce the misuse and abuse of approximately one dozen ER and LA opioid drugs. The latest move follows a report issued last July by the US Centers for Disease Control and Prevention, which found that fatal overdoses 1inked to prescri-ption pain drugs increased several-fold among women and men between 1999 and 2010.
Last month, FDA Commissioner Margaret Hamburg defended the agency's October 2013 approval of Zogenix' pain drug Zohydro ER (hydrocodone bitartrate) amid concern from various groups ab0ut the product's potential for abuse. Earlier this month, Zogenix said a US district court ruling blocked a recent attempt by the governor of Massachusetts to ban Zohydro ER in the state.
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