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The pregnancy catagories as previously described on this page will be obsolete after June 30, 2015. The FDA has released the Final Rule on the changes, officially listed in the federal registry on 12/4/2015.
From the page:
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the “Pregnancy,” “Labor and delivery,” and “Nursing mothers” subsections of the “Use in Specific Populations” section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the “Labor and delivery” subsection because information about labor and delivery is included in the “Pregnancy” subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.
I will leave the updating of the page to others, but this is important to document correctly.
Garylian ( talk) 15:48, 5 December 2014 (UTC)
The actual definitions of the pregnancy categories are copied verbatim from the FDA regulations (which are in the public domain).
Reference to some of the history:
I'm planning on creating the following table (and a similar one for the Austrialian system) in the next day or so. Any comments? While I'm at it, I'll probably add a list of common drugs, and which pregnancy category they go in in the various classification systems. Any help in the non- FDA systems would be appreciated. Ksheka 18:19, May 12, 2004 (UTC)
The passage reading "A shortcoming of the FDA definitions of the pregnancy categories is that the FDA requires an unrealistic amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A" doesn't seem to be fully neutral in tone. Perhaps you could consider some alternate language?
Plaid
03:22, 22 May 2006 (UTC)
References
The spellings "fetus" and "foetus" are both used in this article. Only one spelling should be used for consistency within the article.
Perhaps "foetus" should be used instead of "fetus" for the Australian ADEC table, seeing as though this would actually be the spelling used in the official classification.
Australian categorisation wouldn't use American spelling. —Preceding
unsigned comment added by
121.219.26.202 (
talk)
12:18, 15 April 2008 (UTC)
As defined in this article, Pregnancy Category C indicates "Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans." However, a current link from the FDA defines Pregnancy Category C indicates that animal studies may not have been conducted. (See
http://www.fda.gov/cder/handbook/categc.htm). I was unable to find online access to the original 1980 federal register article. Should the definition be updated to reflect the current information on the FDA site?
Jmccauley36 (
talk)
15:38, 1 June 2008 (UTC)
Links to pregnancy category are enabled in Template:drugbox, but relevant wikipedia cataloging has not been implemented. This makes it difficult for readers to search here for drugs by pregnancy category. Could someone here lend a hand in implementing some sort of category scheme? -- Una Smith ( talk) 00:13, 1 January 2008 (UTC)
According to Gluck JC and Gluck PA (Am J Obstet Gynecol. 2005 Feb;192(2):369-80) theophylline should be rated PRC B. Is there an official FDA statement? —Preceding unsigned comment added by 88.66.51.155 ( talk) 13:50, 19 January 2008 (UTC)
Is this article written in a neutral point of view? It outlines American and Australian pregnancy drug systems, with no reference to the systems used anywhere else in the world. As far as I know, us here in Britain use the same system as America (ABCDX) but I'm not sure if they're exactly the same. Surely this should be clarified though? -- Ged3000 ( talk) 19:03, 21 May 2008 (UTC)
Under "Categorization of selected agents" there is no US "A" mark. Are there no drugs in group A in the US? 212.29.231.179 ( talk) 14:14, 18 March 2012 (UTC)
![]() | This article is rated Start-class on Wikipedia's
content assessment scale. It is of interest to the following WikiProjects: | |||||||||||||||||||||||||||||||||
|
The pregnancy catagories as previously described on this page will be obsolete after June 30, 2015. The FDA has released the Final Rule on the changes, officially listed in the federal registry on 12/4/2015.
From the page:
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the “Pregnancy,” “Labor and delivery,” and “Nursing mothers” subsections of the “Use in Specific Populations” section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the “Labor and delivery” subsection because information about labor and delivery is included in the “Pregnancy” subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.
I will leave the updating of the page to others, but this is important to document correctly.
Garylian ( talk) 15:48, 5 December 2014 (UTC)
The actual definitions of the pregnancy categories are copied verbatim from the FDA regulations (which are in the public domain).
Reference to some of the history:
I'm planning on creating the following table (and a similar one for the Austrialian system) in the next day or so. Any comments? While I'm at it, I'll probably add a list of common drugs, and which pregnancy category they go in in the various classification systems. Any help in the non- FDA systems would be appreciated. Ksheka 18:19, May 12, 2004 (UTC)
The passage reading "A shortcoming of the FDA definitions of the pregnancy categories is that the FDA requires an unrealistic amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A" doesn't seem to be fully neutral in tone. Perhaps you could consider some alternate language?
Plaid
03:22, 22 May 2006 (UTC)
References
The spellings "fetus" and "foetus" are both used in this article. Only one spelling should be used for consistency within the article.
Perhaps "foetus" should be used instead of "fetus" for the Australian ADEC table, seeing as though this would actually be the spelling used in the official classification.
Australian categorisation wouldn't use American spelling. —Preceding
unsigned comment added by
121.219.26.202 (
talk)
12:18, 15 April 2008 (UTC)
As defined in this article, Pregnancy Category C indicates "Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans." However, a current link from the FDA defines Pregnancy Category C indicates that animal studies may not have been conducted. (See
http://www.fda.gov/cder/handbook/categc.htm). I was unable to find online access to the original 1980 federal register article. Should the definition be updated to reflect the current information on the FDA site?
Jmccauley36 (
talk)
15:38, 1 June 2008 (UTC)
Links to pregnancy category are enabled in Template:drugbox, but relevant wikipedia cataloging has not been implemented. This makes it difficult for readers to search here for drugs by pregnancy category. Could someone here lend a hand in implementing some sort of category scheme? -- Una Smith ( talk) 00:13, 1 January 2008 (UTC)
According to Gluck JC and Gluck PA (Am J Obstet Gynecol. 2005 Feb;192(2):369-80) theophylline should be rated PRC B. Is there an official FDA statement? —Preceding unsigned comment added by 88.66.51.155 ( talk) 13:50, 19 January 2008 (UTC)
Is this article written in a neutral point of view? It outlines American and Australian pregnancy drug systems, with no reference to the systems used anywhere else in the world. As far as I know, us here in Britain use the same system as America (ABCDX) but I'm not sure if they're exactly the same. Surely this should be clarified though? -- Ged3000 ( talk) 19:03, 21 May 2008 (UTC)
Under "Categorization of selected agents" there is no US "A" mark. Are there no drugs in group A in the US? 212.29.231.179 ( talk) 14:14, 18 March 2012 (UTC)