|
Home > QR-E-Letter Archive > 10-27-2005
Issue No. 18 October 27, 2005
Welcome to the free Quick-Reference E-Letter from the publishers of The Complete Practitioner: Mental Health Applications. We hope you find the "Quick-Reference" items (below) interesting and helpful. (NOTE: We do not receive emails at the email address noted in the "From:" line of this email. To contact us, see the options toward the bottom of this page. Thank you.)
We will not disclose your email address to others. Among the reasons that you have received this e-letter are that you have requested it, and/or have subscribed to The Complete Practitioner (printed monthly), and/or you have expressed interest in The Complete Practitioner, and/or a colleague thought you would be interested in receiving this e-letter.
|
QUICK REFERENCE #28: What are the Food and Drug Administration's (FDA) “use-in-pregnancy” labeling categories for new drugs and biologic products?
“A”
Controlled studies show no risk. Adequate, well-controlled studies in pregnant women have failed to demonstrate risk to the fetus. Because studies cannot rule out the possibility of harm, however, the drug should be used in pregnancy only if clearly needed.
”B”
No evidence of risk in humans. Either animal findings show risk, but human findings do not, or if no adequate human studies have been done, animal findings are negative. Because studies cannot rule out the possibility of harm, however, the drug should be used in pregnancy only if clearly needed.
“C”
Risk cannot be ruled out. Human studies are lacking. Animal studies are lacking, or they have shown a fetal risk. However, potential benefits may outweigh the potential risk.
“D”
Positive evidence of risk. Investigational or postmarketing data show risk to the fetus. However, potential benefits may outweigh the potential risk.
“X”
Contraindicated in pregnancy. Studies in animals or humans, or investigational or postmarketing reports have shown fetal risk that clearly outweighs any possible benefit to the patient. The drug is contraindicated in women who are or may become pregnant.
The above information was compiled from 3 sources: (1) American Academy of Pediatrics Committee on Drugs. Use of psychoactive medication during pregnancy and possible effects on the fetus and newborn. Pediatrics, 105:880-887, 2000; (2) Concept paper on pregnancy labeling: Summary of comments from a public hearing and model pregnancy labeling based on recommendations. FDA, May 20, 1999; and (3) Physicians' Desk Reference 2004, 58th Edition. Medical Economics Company: Montvale, NJ, 2004.
NOTE: Over the past few years, the FDA has been reviewing its use-in-pregnancy labeling categories. Next week’s Quick Reference E-Letter will address criticisms of and recommendations pertaining to the categories.
(Note to The Complete Practitioner paid subscribers: You can access related content by conducting a search for "use-in-pregnancy labeling" in the Subscribers' Area of our Web site [http://www.completepractitioner.com].)
|
CONTINUING EDUCATION (CE) COURSES
For information about online Continuing Education courses that enable you to print out your CE certificate immediately after passing an exam, click here [http://tcpceu.com]. (CE courses are available for purchase.)
THE COMPLETE PRACTITIONER: MENTAL HEALTH APPLICATIONS
For information about our print publication (The Complete Practitioner: Mental Health Applications), click here [http://www.completepractitioner.com]. (Subscriptions to The Complete Practitioner: Mental Health Applications are available for purchase.)
TO SEND THIS E-LETTER TO A COLLEAGUE
To forward this e-letter to a colleague, click here [http://www.completepractitioner.com/cgi-bin/refer.cgi].
TO REGISTER TO RECEIVE THE QR-E-LETTER
If you received this e-letter from a colleague, you can register to regularly receive this free e-letter (approximately every two weeks). To register to regularly receive this e-letter, click here [http://www.completepractitioner.com/cgi-bin/register.cgi].
TO CHANGE THE E-MAIL ADDRESS TO WHICH YOU WANT THE QR-E-LETTER SENT
To provide us with your changed email address click here [http://www.completepractitioner.com/cgi-bin/change.cgi].
TO STOP RECEIVING THE QR-E-LETTER (ie, to UNREGISTER)
To stop receiving the QR-E-Letter send a blank email to: leave-eletter@completepractitioner.com.
The QR-E-Letter can receive email at eletter@completepractitioner.com. (We do not receive emails at the email address that appears in the "From:" line of this email. Thank you.)
|
IMPORTANT: Inclusion of content in this e-letter is for educational purposes only and does not indicate endorsement of any claims or recommendations made or implied by that content or by the content of any Web sites that are noted in or linked to this e-letter.
| |
We hope that you have enjoyed receiving this e-letter. Please note that a small portion of this e-letter contains advertising (as indicated, for example, by text stating that an item is available for purchase).
|
