Talk:Pregnancy category

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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.

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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:

  • Sannerstedt R, Lundborg P, Danielsson BR, Kihlstrom I, Alvan G, Prame B, Ridley E. "Drugs during pregnancy: an issue of risk classification and information to prescribers." Drug Saf. 1996 Feb;14(2):69-77.
  • Food and Drug Administration. Federal Register 1980;44:37434-67

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)

Nevermind. I'll put it in now, and discussion can be based on how it looks. :-) Ksheka 21:57, 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)

re-worded this. The american system is not simply negative. All this is is a characteristic not a shortcoming. Just look at Thalidomide. --Ccosta 02:42, 13 June 2006 (UTC)

References

inconsistency

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)

Pregnancy category in drugbox template

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)

Discussion here. --Una Smith (talk) 17:03, 1 January 2008 (UTC)

Pregnancy category for theophylline

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)

Neutral Point of View?

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)

Wrong to assert a NPOV issue - but rather country-centric issue vs globalisation.
There is no standard pregnancy classification system used in UK. The British National Formulary's Appendix 4:Pregnancy has no fixed categories. Indeed appendix intro states "It should be noted that the BNF provides independant advice and may not always agree with the product literature". The BNF will state the trimester of risk and does tend to use a series of set phrases:
  • "Manufacturer advises avoid (toxicity in animal studies)"
  • "Manufacturer advises use only if potential benefit outweighs risk - no information available"
  • "Teratogenic"
  • "No eveidence of teratogenicity; embryotoxicity in animal studies with high doses"
  • "Benefit of prophylaxis and treatment in malaria outweighs risk"
  • "Avoid-..."
but also a host of other phrases or modified forms of the above. It is because the US & Australian regulators do apply a simple classification that the {{Drugbox}} allows for such information. That said, I agree some comment should be made whether these 2 systems are the only two worldwide or just the only 2 that editors have bothered to add to this article :-) David Ruben Talk 19:28, 21 May 2008 (UTC)

"Categorization of selected agents"

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)

There are several, but not a huge many examples of Cat A in the US. I believe that doxylamine and mag sulfate are category A in the US... --98.70.44.88 (talk) 19:54, 11 June 2013 (UTC)