FDA Reveals New Drug Labeling for Pregnant Women

Many pregnant women suffer from chronic conditions, such as diabetes, high blood pressure, or asthma and they have to take medication, such as Metformin, Sectral, and Alvesco, on a regular basis. They may also develop new conditions during pregnancy, such as gestational diabetes, an infection, or morning sickness. In addition, the dosage of medications they took previously might change as their body changes during pregnancy. There are so many factors involved that it can be very intimidating for a woman to know what medication she can and cannot safely take.

Previous FDA Drug Labeling System

Up until now, the FDA has used an outdate letter system to label prescription drugs for pregnant and breastfeeding women. The letters used in this system include A, B, C, D, and X, and according to CTV News, even the FDA admits that the system is highly misleading. The letters stand for the following:

  • A – Poses no risk to the fetus
  • B – Poses no risk to animals or no risk to humans even if there has been an adverse reaction in animals
  • C – Inconclusive data
  • D, X – Poses a risk to the fetus

However, when it comes to these ratings, there may not necessarily be less of a risk to the fetus with a level A or B drug than with a C drug. It might just be that the C drug has been studied in greater depth and more is known about it.

New FDA Drug Labelling System

The new drug labeling system will begin in the summer of 2015 and will be used immediately on all newly approved drugs. Drugs that have previously been approved will have their labelling changed over the next three to five years. The new system will not show detailed information on the pill bottles, but this information will be included on the official drug labelling that doctors are required to read before prescribing medication. It will also come as a package insert when a patient picks up medication from the pharmacy.

The information included in the new drug labelling system will contain a section that provides detailed information regarding what is and is not known about the safety of using the drug during pregnancy or while breastfeeding. News moms need says this includes details regarding the methods used to obtain the safety information and whether it was obtained studying humans or animals. The March of Dimes is also highly supportive of the new drug labeling system for pregnant women.

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New Drug Labeling for Pregnant and Breastfeeding Women

Due Diligence

The new FDA rules do not take effect until next year, which means you still have to do your due diligence with regards to the current labelling system. Of course, that due diligence will still be required after the rules change; it just might be a little easier to gather information. Always consult your doctor if you are pregnant (or think you might be) or nursing. He or she is your first line of defense against medications that could harm your baby.

When you do need to take medication during pregnancy, while nursing, or at any other time, you will want to save as much money as possible. To save between 50%-90% on the cost of all your prescription medications, please visit eDrugSearch.com, where we have been working with trusted licensed online pharmacies for over seven years.

About Cary Byrd

eDrugSearch founder, Cary Byrd, has been called an “e-health innovator” by MarketIntellNow, interviewed by top pharmaceutical industry journalists, invited to Matthew Holt’s Health 2.0 Conference and a Consumer Report's health summit, and highlighted on numerous health blogs.

FDA Reveals New Drug Labeling for Pregnant Women

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