乙型肝炎药物Viread的不良反应增加了肺炎

StephenW

Pneumonia added to adverse reactions of hepatitis B drug Viread

    By Lee Hye-seon
    Approval 2017.11.28 16:07
   
The government has received reports of adverse drug reactions, including pneumonia, ALT (alanine aminotransferase) and AST (aspartate aminotransferase) elevations, in 746 patients who took tenofovir disoproxil-based drugs to treat hepatitis B and HIV, in postmarketing surveillance (PMS).

Through PMS, the regulators monitor the safety of a new drug after the market release.

The Ministry of Food and Drug Safety said it would collect the related drugmakers’ opinions by Dec. 18 and reflect the PMS results on the drug approval conditions.

According to the six-year PMS for a re-evaluation of tenofovir disoproxil-based drugs, the medicines had 11.66 percent incidence rate of adverse events, or 87 patients out of 746 reporting 225 cases of adverse drug reactions, regardless of causal relationship. Among them, four rare cases (0.1-1 percent) occurred as serious adverse drug reactions that could not rule out a causal relationship. The four are pneumonia, ALT and AST elevations, and osteoporosis.

Unpredicted adverse reactions that could not rule out a causal relationship included 22 reports (0.1-1 percent), such as indigestion, gastroesophageal reflux, uneasiness in the abdomen, chronic gastritis, uneasiness in the solar plexus, dry mouth, pneumonia, weight loss, urine reduction, hair loss, rash, sleep disorder, and osteoporosis.

Severe adverse reactions regardless of a causal relationship amounted to 50 cases, including indigestion, constipation, gastroesophageal reflux, vomit, hydrops abdominis, abdominal inflation, urinary tract infection, shingles, asthenia, and arthralgia.

Thirty-two drugs manufactured by 30 drugmakers will face a change in approval conditions. They include Gilead’s Viread and Stribild, Janssen Korea’s Complera, and incrementally modified medicines and generic drugs referencing Viread for which local drugmakers had received the license.

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<© Korea Biomedical Review, All rights reserved.>

StephenW

乙型肝炎药物Viread的不良反应增加了肺炎

    Lee Hye-seon
    批准2017.11.28 16:07
   
在上市后监测（PMS）中，746例使用替诺福韦二吡呋酯为基础的药物治疗乙型肝炎和艾滋病病毒的患者中，政府收到了药物不良反应报告，包括肺炎，ALT（丙氨酸转氨酶）和AST（天冬氨酸转氨酶）升高。

通过PMS，监管机构在市场发布后监控新药的安全性。

食品药品安全部表示，将在12月18日前收集相关制药商的意见，并反映药品管理体系对药品批准情况的结果。

根据以替诺福韦酯为基础的六年药物重新评估的药物，药物不良事件发生率为11.66％，在746例报告的225例药物不良反应中有87例不论因果关系。其中，4例罕见病例（0.1-1％）发生严重不良反应，不能排除因果关系。四种是肺炎，ALT和AST升高，以及骨质疏松症。

不能排除因果关系的不良反应包括消化不良，胃食管反流，腹部不适，慢性胃炎，太阳神经丛不适，口干，肺炎，体重减轻等22个报道（0.1-1％尿量减少，脱发，皮疹，睡眠障碍和骨质疏松症。

严重不良反应不论因果关系达50例，包括消化不良，便秘，胃食管反流，呕吐，腹水，腹胀，尿路感染，带状疱疹，虚弱，关节痛等。

由30位制药商制造的32种药物将面临审批条件的变化。它们包括Gilead的Viread和Stribild，Janssen Korea的Complera，以及涉及Viread的渐进式改良药物和非专利药物，当地制药商已经获得许可证。

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<©韩国生物医学评论，保留所有权利>

newchinabok

吃药，反正浑身都不舒服，不舒服也凑合着过

Espoir

是时候快速推进TAF上市啦

newchinabok

回复 Espoir 的帖子

国家对TAF的思路和替诺福韦一样，慢慢体会

windu

如果恩替卡韦不耐药，taf意义何在？

Hepbest

回复 windu 的帖子

恩替卡韦不能持续让病毒不可测吧——有很多战友有这个问题