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Re: Articles: Metformin, Preconception and Pregnancy From: Victoria (anonymous@obgyn.net) Thu, 12 Sep 2002 9:52:08 -0400 Messages sorted by: [ date ][ thread ][ subject ][ author ] Next message: Victoria: "Article on PCOS gene defects" Previous message: Sophie: "Re: Newbie" From: anonymous@obgyn.net (Sue) Actually, Pat, most of the research done with met and pg women has shown no harmful effects on the baby. >> I've found only one study done on humans - a Denmark study - that showed problems with Metformin compared to another drug. Almost all of the research to date (with the exception of Dr. Glueck) has been done in Europe on pg women who are also diabetic. Unbeknownst to many, the FDA often uses Europe as a guinea pig of sorts and studies the results from their drug trials, making note of the successes and failures. Once the FDA decides that it hasn't hurt anyone in European studies, they often change the classification of a medication or approve of its prior off-label use. >> I had a question on this from http://www.fda.gov/cder/about/faq/default.htm, #5 5. Does the FDA test drugs? FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of a drug's studies so that the Center can evaluate its data. The studies answer the question: "Does this drug work for the proposed use?" By analyzing the data, CDER reviewers assess the benefit-to-risk relationship and determine if the drug will be approved. Also 15. Is it legal for me to bring foreign-made medications into the United States, or have such products mailed to me? The United States Federal Food, Drug and Cosmetic Act prohibits the interstate shipment (which includes importation) of unapproved new drugs. Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs that have not received FDA approval. This indicates to me that the drug manufacturers have to apply first to get any drug labeling changed. At least that's my understanding. Has that changed? Victoria Next message: Victoria: "Article on PCOS gene defects" Previous message: Sophie: "Re: Newbie"

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