Featured Research

from universities, journals, and other organizations

Preventing Fetal Exposure To Popular Acne Drug

Date:
October 14, 2005
Source:
John Wiley & Sons, Inc.
Summary:
Isotretinoin (also known as Accutane) is a drug used to treat severe acne, but it can cause birth defects when taken by pregnant women. A study published in Birth Defects Research (Part A): Clinical and Molecular Teratology surveyed pregnant women who contacted a birth defect information service seeking information on the effects of isotretinoin. The purpose of the survey was to determine how the drug was dispensed in women who subsequently became pregnant and to identify possible reasons for failure in preventing conception.

Isotretinoin (also known as Accutane) is a drug used to treat severeacne, but it can cause birth defects when taken by pregnant women.Because of these risks, the U.S. Food and Drug Administration and RochePharmaceuticals (Accutane's manufacturer) developed a voluntarypregnancy prevention program (PPP) in 1988 to try and preventconception in women taking the drug. This program was replaced in theU.S. in 2002 with the System to Manage Accutane Related Teratogenicity(SMART), a program that placed more emphasis on pregnancy testing andcontraception.

A study published online October 14, 2005 in Birth Defects Research (Part A): Clinical and Molecular Teratology (www.interscience.wiley.com/journal/bdr)surveyed pregnant women who contacted a birth defect informationservice seeking information on the effects of isotretinoin. The purposeof the survey was to determine how the drug was dispensed in women whosubsequently became pregnant and to identify possible reasons forfailure in preventing conception.

Led by Julia Robertson of the Birth Defects and GeneticsProgram at the Utah Department of Health in Salt Lake City, researcherssurveyed 34 women who had called a member service of the Organizationof Teratology Information Services (OTIS) between April 2002 andSeptember 2004 because they had become pregnant while takingisotretinoin. "The results of the OTIS survey show that the majority ofwomen who participated were treated for less severe disease than isrecommended in the SMART program," the researchers state. A total of 24percent of the women reported receiving contraception counseling whiletaking the drug. In addition, the results showed that healthcareprofessionals and their patients failed to comply with a number of keySMART and/or PPP requirements. According to these requirements, womenmust have two negative pregnancy tests before receiving a prescription,yet 76 percent of the women in the study said they did not have asecond pregnancy test during menstruation. When asked about the SMARTrequirement of receiving a pregnancy test each month before refilling aprescription, 35 percent of the women surveyed said they did not havemonthly pregnancy tests during the therapy. SMART also requires womento use two forms of birth control simultaneously while takingisotretinoin, yet only 62 percent of the women reported using birthcontrol and only 29 percent of these women reported using two forms ofcontraception. In addition, only 53 percent of the women reportedsigning the informed consent required by SMART prior to taking thedrug.

The authors point out that the study's strengths include usingcounselors with extensive experience in communicating with women abouttheir reproductive concerns and the fact that most initial interviewswere completed within 3 months of exposure, before fetal outcome wasknown. They acknowledge that the study's limitations include the smallnumber of women surveyed and the fact that responses are based onpatient self-reporting and may be subject to recall error."Nonetheless, women were surveyed prior to the outcome of thepregnancy, so we believe the responses provided in this report can beuseful in elucidating important factors that hinder the success ofpregnancy prevention programs," the authors state.

Last year, the FDA began examining ways of designing a newpregnancy program with stricter requirements to preventisotretinoin-related birth defects and in August 2005 the new plan,called iPLEDGE, was announced. Beginning December 31, 2005, theregulations will require doctors and patients to register in anelectronic database before the drug can be dispensed. The plan alsoincludes the two pregnancy tests, two birth control methods, and othersafeguards previously recommended by SMART.

###

Article: "A Survey of Pregnant Women Using Isotretinoin," JuliaRobertson, Janine E. Polifka, Marina Avner, Christina Chambers, GeorgeDelevan, Gideon Koren, Sharon Voyer Lavigne, Lynn P. Martinez, RichardK. Miller, John C. Carey, Birth Defects Research (Part A): Clinical andMolecular Teratology; Published Online: October 14, 2005 (DOI:10.1002/bdra.20197).


Story Source:

The above story is based on materials provided by John Wiley & Sons, Inc.. Note: Materials may be edited for content and length.


Cite This Page:

John Wiley & Sons, Inc.. "Preventing Fetal Exposure To Popular Acne Drug." ScienceDaily. ScienceDaily, 14 October 2005. <www.sciencedaily.com/releases/2005/10/051014072017.htm>.
John Wiley & Sons, Inc.. (2005, October 14). Preventing Fetal Exposure To Popular Acne Drug. ScienceDaily. Retrieved September 3, 2014 from www.sciencedaily.com/releases/2005/10/051014072017.htm
John Wiley & Sons, Inc.. "Preventing Fetal Exposure To Popular Acne Drug." ScienceDaily. www.sciencedaily.com/releases/2005/10/051014072017.htm (accessed September 3, 2014).

Share This



More Health & Medicine News

Wednesday, September 3, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Snack Attack: Study Says Action Movies Make You Snack More

Snack Attack: Study Says Action Movies Make You Snack More

Newsy (Sep. 2, 2014) You're more likely to gain weight while watching action flicks than you are watching other types of programming, says a new study published in JAMA. Video provided by Newsy
Powered by NewsLook.com
U.N. Says Ebola Travel Restrictions Will Cause Food Shortage

U.N. Says Ebola Travel Restrictions Will Cause Food Shortage

Newsy (Sep. 2, 2014) The U.N. says the problem is two-fold — quarantine zones and travel restrictions are limiting the movement of both people and food. Video provided by Newsy
Powered by NewsLook.com
Doctors Fear They're Losing Battle Against Ebola

Doctors Fear They're Losing Battle Against Ebola

AP (Sep. 2, 2014) As a third American missionary is confirmed to have contracted Ebola in Liberia, doctors on the ground in West Africa fear they're losing the battle against the outbreak. (Sept. 2) Video provided by AP
Powered by NewsLook.com
Tech Giants Bet on 3D Headsets for Gaming, Healthcare

Tech Giants Bet on 3D Headsets for Gaming, Healthcare

AFP (Sep. 2, 2014) When Facebook acquired the virtual reality hardware developer Oculus VR in March for $2 billion, CEO Mark Zuckerberg hailed the firm's technology as "a new communication platform." Duration: 02:24 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins