{"id":33700,"date":"2014-12-04T14:32:54","date_gmt":"2014-12-04T06:32:54","guid":{"rendered":"https:\/\/canadianinquirer.net\/v1\/?p=33700"},"modified":"2014-12-04T14:01:03","modified_gmt":"2014-12-04T06:01:03","slug":"fda-women-to-get-more-information-about-which-prescription-drugs-are-safe-to-use-in-pregnancy","status":"publish","type":"post","link":"https:\/\/canadianinquirer.net\/v1\/2014\/12\/04\/fda-women-to-get-more-information-about-which-prescription-drugs-are-safe-to-use-in-pregnancy\/","title":{"rendered":"FDA: Women to get more information about which prescription drugs are safe to use in pregnancy"},"content":{"rendered":"

\"shutterstock_18257989\"<\/a><\/p>\n

WASHINGTON\u2014Pregnant women are about to get easier-to-understand information on how safe their medicine is for baby.<\/p>\n

The Food and Drug Administration is revamping how lists any risk, scrapping a system that confused both doctor and patient in favour of spelling out what\u2019s known and what\u2019s not on the multi-page labeling inserts that come with prescription drugs.<\/p>\n

\u201cMore information about drugs will be provided than ever before,\u201d Dr. Sandra Kweder of FDA\u2019s Center for Drug Evaluation and Research, said Wednesday.<\/p>\n

There are more than 6 million pregnancies in the U.S. every year, and FDA says women take an average of three to five prescription drugs during pregnancy. They may have a pregnancy-related infection or morning sickness. Or they may have an ongoing condition\u2014asthma, diabetes, epilepsy or depression\u2014that could dangerously worsen if they avoided treatment because of drug concerns.<\/p>\n

Few medications have been fully studied to answer those questions, or even tell if the woman\u2019s changing body requires a different dose. What information is available is hard to tease out. The FDA has long used a letter system\u2014A, B, C, D and X\u2014to convey risk, but admits that\u2019s hugely misleading. A \u201cB\u201d drug might not really be safer than a \u201cC\u201d drug that just hasn\u2019t been properly studied in people to tell.<\/p>\n

Starting next summer, FDA said the official labeling for new prescription drugs will have a clearly designated section for what\u2019s known about safe use during pregnancy and breastfeeding. Older drugs will phase in the new labels over the next three to five years.<\/p>\n

The information won\u2019t be on small pill bottles. It\u2019s required to be on the official drug labeling that doctors are supposed to read when deciding to prescribe, information that often is passed to consumers as package inserts at the pharmacy.<\/p>\n

Nor does the new rule apply to over-the-counter medications.<\/p>\n

Still, \u201cthis is a huge step forward,\u201d said Dr. Christina Chambers of the University of California, San Diego, who works with the MotherToBaby hotline that counsels worried callers about medications during pregnancy.<\/p>\n

Under the new rule, the information \u201cencompasses the larger picture of the safety data in the context of treatment, or lack of treatment,\u201d she said.<\/p>\n

Some medications do come with a lot of pregnancy information. Diclegis, for example, is the only drug to win FDA approval specifically to treat morning sickness. Doctors\u2019 groups and the government recommend a flu shot for pregnant women, to protect themselves and because the baby is born with some of mom\u2019s protection.<\/p>\n

Other drugs are known to pose particular birth-defect risks. For example, the FDA requires versions of the acne drug isotretinoin, first marketed as Accutane, to be sold under special tight controls.<\/p>\n

But many fall somewhere in the middle. Maybe they have risks only in the first trimester, when organs are forming. Or there simply may not be enough research to know.<\/p>\n

Consider urinary tract infections, common during pregnancy. Some antibiotics are safe throughout pregnancy but require a dose change; others are supposed to be avoided in certain trimesters, noted Dr. Siobhan Dolan, an adviser to the March of Dimes, which for years has urged the FDA\u2019s label move.<\/p>\n

Another example: Pregnant women often are given old blood pressure medications even though new ones may work better, because the pregnancy impact of the newer brands hasn\u2019t yet been studied, Dolan added.<\/p>\n

The new labeling is supposed to offer details that Dolan said could help doctors and women weigh the known pros and cons with the unanswered questions. It must be clear if safety information comes from scientific studies of people, or only is predicted based on animal research. Registries that are collecting information on how pregnant women fare must be listed.<\/p>\n

One section will provide information about how much of the drug collects in breast milk, and any effects on the baby.<\/p>\n

A final subsection will say if the drug may impact future fertility when used by women or men of reproductive age.<\/p>\n

If the drug hasn\u2019t been studied for reproductive safety, the labeling must say so. While FDA isn\u2019t forcing companies to do new pregnancy studies, Kweder said the changes will pressure them to add the most up-to-date information that\u2019s available.<\/p>\n

Easier-to-read information is only a first step, cautioned Cynthia Pellegrini of the March of Dimes\u2014because many drugs won\u2019t have much pregnancy information to list.<\/p>\n

\u201cThis format will make even more clear how critical the need is for more human pregnancy data for all medications likely to be used by women of reproductive age,\u201d agreed California\u2019s Chambers.<\/p>\n

Online<\/h6>\n

FDA: http:\/\/www.fda.gov<\/a><\/p>\n

MotherToBaby: http:\/\/www.mothertobaby.org<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

WASHINGTON\u2014Pregnant women are about to get easier-to-understand information on how safe their medicine is for baby. The Food and Drug …<\/p>\n","protected":false},"author":44,"featured_media":33701,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[37],"tags":[],"class_list":["post-33700","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","mauthors-lauran-neergaard","mauthors-the-associated-press"],"_links":{"self":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/33700","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/users\/44"}],"replies":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/comments?post=33700"}],"version-history":[{"count":0,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/33700\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/media\/33701"}],"wp:attachment":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/media?parent=33700"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/categories?post=33700"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/tags?post=33700"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}