The U.S. Food and Drug Administration (FDA) has made a much-needed change in labelling requirements for prescription drugs. It is called the Pregnancy and Lactation Labelling Rule (PLLR), and it changes both the format and the content required on prescription labels regarding the safety and risks of taking a drug during pregnancy and while breast feeding as well as any effect on fertility in both women and men.
The Old System
The old system used letter categories A through D and X for the risk level during pregnancy, labor and delivery, and lactation. Medications in category A were the least risky, with the risk increasing through D, and X signifying that the drug was completely unacceptable during pregnancy and lactation.
It did not give doctors or patients much information to work with when making difficult decisions about the risks versus benefits of a drug. It left mothers and their doctors in a position where women often went without the medications that they desperately needed, to be on the safe side, even if not taking the drug would also put the baby in danger.
The New System
The new labelling system is supposed to provide more information, so that doctors and other healthcare practitioners can make better choices when recommending a drug and give their patients more detailed information so that patients are able to make informed choices about their healthcare.
There will be three categories:
- Pregnancy (including labor and delivery) – will include the risk summary, clinical considerations, and data, as well as information on the pregnancy exposure registry for the drug when there is one.
- Lactation – addresses breastfeeding safety including the amount of the drug that will wind up in breast milk and potential effects on the breastfed baby.
- Females and Males of Reproductive Potential – will include information about the need for pregnancy testing and contraception recommendations if the drug should never be used during pregnancy, and information about infertility as it relates to the drug.
Implementation
The new rule will go into effect on June 30, 2015, but drugs that are already on the market will not have to comply immediately. Any medication submitted for FDA approval after the rule goes into effect will have to comply with PLLR when it hits the market. Drugs that were approved on or after June 30, 2001 will be phased in over time, so it could be a while before we see the full benefits of PLLR
Also, keep in mind that it only applies to prescription medications. Over-the-counter (OTC) drugs are not affected by the new rule, so their labels are unlikely to change.
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