Michael H. Bereston, Inc.

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FDA rules and resources to help expectant mothers

Expectant mothers and fathers-to-be may find themselves simultaneously eager, nervous, excited and maybe a little scared. It is not unusual to see them portrayed in movies and sitcoms with stacks of books on their nightstands, constantly preoccupied with doing the right things and avoiding the wrong in order to ensure their baby grows and develops in a way they would consider healthy, strong and happy. Despite their best efforts, parents-to-be may find it difficult to navigate the labeling on their prescription drugs. In order to prevent harm to the developing child and the mother, they need to have sufficient information and counsel regarding drug information.

In an effort to clarify and make more meaningful the labeling on prescription drugs, including antibodies and vaccines, the Food and Drug Administration published a new rule in 2014, which went into effect in 2015. According to the FDA, the new prescription drug labeling rule is designed to assist medical professionals to provide better counseling to women during pregnancy and lactation, especially with regard to weighing risks and benefits.

Pregnant women are also able to contribute anecdotal information about their use of certain medications while pregnant and read about the experiences of others. The FDA has also compiled a list of registries provided by sponsors and investigators for the purpose of using and sharing information and experiences. Using this tool, women can search for a registry by either medical condition or by medicine name. The results indicate the name of the registry, contact information, and whether the status of the registry is ongoing or closed. While the FDA disclaims responsibility for the content of registries and does not provide any endorsement, the registries may be helpful for pregnant women seeking additional guidance about their medications or hoping to share their experiences.

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Office Location

Michael H. Bereston, Inc.
138 Main Street, Suite 200
P.O. Box 2990
Annapolis, MD 21401

Maryland: 410-793-4554
Toll Free: 866-517-4037
Baltimore/Annapolis: 410-269-5011
DC: 202-628-2226
Fax: 410-269-5022

Annapolis Medical Malpractice Office

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