ST LOUIS (MD Consult) - On March 16, 2010, the US Food and Drug Administration (FDA) issued an alert to the public that it has ordered 2 companies, Glenmark Generics and Konec Inc, to stop marketing unapproved nitroglycerin tablets. The unapproved tablets (in 0.3-, 0.4-, and 0.6-mg strengths) have not been proved safe and effective, and the FDA has not reviewed the quality and labeling of these products. Nitroglycerin tablets are used to relieve chest pain and prevent myocardial infarction.
The unapproved products may differ from approved nitroglycerin products in some respects, such as formulation and labeling. The FDA states that it has seen significant quality and efficacy problems with some unapproved nitroglycerin products.
The FDA does not anticipate a supply problem for these products, as another manufacturer (Pfizer) markets FDA-approved sublingual nitroglycerin tablets in the same strengths. Pfizer has the ability to supply the entire market.
Consumers who are taking the unapproved products are being advised to continue taking their medications and to consult a health care professional for detailed guidance on treatment options. Health care practitioners and consumers can use Drugs@FDA, the National Drug Code (NDC) Directory, or the Orange Book (all available online) to determine whether a drug is FDA approved.
List of Approved Nitroglycerin Tablets (0.3, 0.4, and 0.6 mg)
|
Drug Product
|
Manufacturer
|
NDC #
|
|
Nitrostat 0.3 mg
|
Pfizer Pharmaceuticals
|
65427 - *417
|
|
Nitrostat 0.4 mg
|
Pfizer Pharmaceuticals
|
65427 - *418
|
|
Nitrostat 0.6 mg
|
Pfizer Pharmaceuticals
|
65427 - *419
|
List of Unapproved Nitroglycerin Tablets (0.3, 0.4, and 0.6 mg) Subject to Warning Letters
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Drug Product
|
Manufacturer
|
NDC #
|
|
Nitroglycerin Tablets, 0.3 mg
|
Glenmark Generics Inc
|
68462-*145
|
|
Nitroglycerin Tablets, 0.4 mg
|
Glenmark Generics Inc
|
68462-*146
|
|
Nitroglycerin Tablets, 0.6 mg
|
Glenmark Generics Inc
|
68462-*147
|
|
Nitroglycerin Tablets, 0.3 mg
|
Konec Inc
|
62515-*692
|
|
Nitroglycerin Tablets, 0.4 mg
|
Konec Inc
|
62515-*718
|
|
Nitroglycerin Tablets, 0.6 mg
|
Konec Inc
|
62515-*726
|
圣路易斯(MD Consult)——2010年3月16日，美国食品药品管理局(FDA)向公众发布了一项警告，内容为FDA已勒令Glenmark Generics和Konec Inc这两大公司停止销售未获准的硝酸甘油片。尚未证实未获准的片剂(规格有0.3mg、0.4mg及 0.6mg)对患者安全有效，FDA尚未对这些药品的质量和说明书进行审查。硝酸甘油片用于缓解胸痛及预防心肌梗死。
这类未获准的药品在剂型和说明书等一些方面与获准的硝酸甘油药品可能有所不同。FDA表示，现已发现某些未获准的硝酸甘油药品存在严重的质量和安全问题。
由于另一生产厂家——辉瑞——生产的同规格舌下硝酸甘油片已经通过FDA批准并上市，而该公司有能力满足整个市场对此药品的需求，故FDA预计这类药品的供应不会有问题。
对于服用这类未获准药品的消费者，FDA建议其继续服用并向医护人员就有关治疗选择的具体指导进行咨询。医护人员和消费者可通过应用Drugs@FDA、国家药品编码(NDC)目录或橙皮书(均可在线查到)确认药品是否获得FDA批准。
获准的硝酸甘油片(0.3、0.4及0.6 mg)一览表
|
药品及规格
|
生产厂家
|
NDC #
|
|
耐绞宁0.3 mg
|
辉瑞制药
|
65427 - *417
|
|
耐绞宁0.4 mg
|
辉瑞制药
|
65427 - *418
|
|
耐绞宁0.6 mg
|
辉瑞制药
|
65427 - *419
|
发出警告函的未获准的硝酸甘油片(0.3、0.4及0.6 mg)一览表
|
药品及规格
|
生产厂家
|
NDC #
|
|
硝酸甘油片, 0.3 mg
|
Glenmark Generics Inc
|
68462-*145
|
|
硝酸甘油片, 0.4 mg
|
Glenmark Generics Inc
|
68462-*146
|
|
硝酸甘油片, 0.6 mg
|
Glenmark Generics Inc
|
68462-*147
|
|
硝酸甘油片, 0.3 mg
|
Konec Inc
|
62515-*692
|
|
硝酸甘油片, 0.4 mg
|
Konec Inc
|
62515-*718
|
|
硝酸甘油片, 0.6 mg
|
Konec Inc
|
62515-*726
|
