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巴基斯坦劣质药致大量死亡进展,值得制药界反思

时间: 2012-05-21 21:54:22 作者: 来源: 字号:
药品单硝酸异山梨酯中混入超剂量乙胺嘧啶,引发严重不良反应。。

乙胺嘧啶(息疟定) Pyrimethamine (Daraprine)
剂量与用法  病因性预防:口服每周25mg/次;或50mg/次,2周服1次。防复发治疗:口服每日50mg/次,连服2日。
副作用与不良反应  副作用:

  1 长期较大量口服可致叶酸缺乏而影响消化道粘膜及骨髓等细胞的增殖功能,引起恶心、呕吐、腹痛及腹泻,较严重者出现巨幼细胞性贫血或白细胞减少。长期用药应定期检查血象。

  2 本品可透过血胎屏障并可进入乳汁,引进胎儿畸形和干扰叶酸代谢,孕妇和哺乳妇女禁用。

  3 急性中毒,往往因误服(特别注意小儿误服)或超剂量,可引起惊厥、抽搐,甚至死亡。

  不良反应:

  口服一般抗疟治疗量的毒性很低,应用安全。长期大量应用会出现叶酸缺乏症状,如恶心、呕吐、腹痛、腹泻等,偶可出现巨幼细胞性贫血、白细胞缺乏症等。应定期检查血象,及早停药,可自行恢复。给予甲酰四氢叶酸钙可改善骨髓造血功能。本品味带香甜,曾有儿童误作糖果大量服食(1次顿服50mg~100mg)引起急性中毒,表现为恶心、呕吐、胃部烧灼感、头晕,重者出现惊厥、昏迷甚至死亡。可按一般急性中毒常规处理,并用巴比妥类控制惊厥。

An official told reporters outside the factory that the team had visited the place on directives from higher authorities in view of reports that a product (generic name isosorbide 5-mononitrate) of the company contained anti-malaria ingredients.

It was also astonishing for them that each of the 30 cardiac patients had consumed 20mg of Isotab twice a day along with other medicines, including Alfagril and Aspirin. As the 20mg Isotab was carrying 50mg Pyrimethamine, the combination of the other two drugs acted as ‘fuel to fire’.

“The approved doze of Pyrimethamine is 25mg once a week. If the contaminated products contain approximately 50mg per tablet then this would be very significant, particularly as the contaminated products would have been taken at least once a day, i.e. a minimum overdose of 14-fold over time.

“Section 4.9 of the Pyrimethamine SmPC clearly lists bone marrow toxicity as the main feature of chronic overdose, as does the National Poison Information Service (NPIS) Toxbase database.” The report said chronic Pyrimethamine toxicity would be consistent with the bone marrow toxicity seen.

详见:
Tests in UK identify drug which caused havoc in Lahore
http://www.dawn.com/2012/02/02/pharmaceutical-firm-in-karachi-sealed-tests-in-uk-identify-drug-which-caused-havoc-in-lahore.html




药不是普通商品,所以当一瓶500ml输液的价格不抵一瓶农夫山矿泉水价格时,我们的生命安全还有保障吗?这是值得我们深思并要解决的问题。




出事公司:Efroze, a Pakistani pharmaceutical manufacturer
http://www.efroze.com/Products/TherapeuticClass.aspx
出事批次:Batch J093; 出事药品:单硝酸异山梨酯片Isotab 20mg tablets(Isosorbide-5-mononitrate)
The U.S. Embassy in Islamabad has advised its employees that any person taking Isotab 20mg tablets made by Efroze Batch J093 should immediately stop doing so and see their health care provider.
http://www.hthtravelinsurance.com/health_sec_news/article_template.cfm?p_fn=ne_news_79259.html




继续关注:
PIC(Pakistan Institute of Cardiology) 只有105万片Isotab tablets (batch J092 and 095,Efroze )发放记录,而出事的从病人手里获得的batch J093批Isotab tablets 在 PIC没有任何记录。

病人手中的batch J093批Isotab tablets 不是来源于PIC?
还是PIC删除了batch J093批Isotab tablets 相关信息?

PIC sweeps Isotab record under carpet
http://dunyanews.tv/index.php?key=Q2F0SUQ9MiNOaWQ9NjM3NjE=




Three more local and foreign laboratories have declared the Isotab-20 drug substandard with adulteration of pyrimethamine.

The reports were issued by the Drug Testing Laboratory, the government of Punjab; the Federal Drug Testing Laboratory and the Interek Expert Services, Switzerland.

Earlier, the Isotab drug was declared spurious in a report issued by the Medicines and Healthcare products Regulatory Agency (MHRA), London.

According to a source, the DTL, Punjab, and the Federal Drug Testing Laboratory have traced 53mg and 56mg pyrimethamine, respectively, while Intertek Expert Services, Switzerland, declared it hazardous for human life.

http://www.dawn.com/2012/02/04/three-more-labs-declare-isotab-spurious.html




上海华联事业,教训足够深刻。
但是,国人好像还没有认识到。




医改绝不是一味药品降价,而是要努力建立客观、法制、科学的环境。




基本清晰了:
1、其他四种药没有问题。four drugs — Cardiovestin (辛伐他汀)20mg of Mega Pharma, Corcont (氨氯地平)5mg of Swiss Pharma, Zafnol (阿替洛尔)50mg of Zafa Pharma and Solprin(阿司匹林) 300mg of Pharma Wise
2、确定只有J093的Isotab(单硝酸异山梨酯)有问题。Isotab J093, J094, J095, j097 and J098.All the samples of the drug were found up to the laid down standard except for J093  2    1 2 下一页 尾页
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