When you’re looking to take some medication, all you want is some relief from whatever unpleasant symptoms you are experiencing. Or perhaps you are taking medication for a long term condition, to prevent any further complications.
When you’re pregnant though, it’s not just you that you’ve got to worry about. You need to be sure that any prescription medicines you take won’t have any adverse effect on your baby’s development or health – so how can you tell? Labels have come under fire for being confusing, so there are big changes on the horizon. Designed to make medication labels more user friendly, the FDA’s revamp is promising to make expectant mum’s lives easier, so we’re going to tell you all you need to know.
The current guidelines
Currently, the guidelines on prescription medication labels are confusing at best. The letters A, B, C, D and X are used as scale of how risky the drug would be to take, but even the FDA admits that it’s a hugely flawed and confusing system. Instead of this, it’s going to be a case of providing parents with detailed information on any risks that taking the drugs may cause – so that they can then read them and make an informed choice rather than relying on a scale.
The new rules
So what information will these new labels provide? Well, there are three separate subsections that will be covered: the drug’s potential effects on pregnancy, lactation and lastly, males and females of reproductive potential. Additionally, the pregnancy and lactation subsections will also include three subheadings: risk summary, clinical considerations and data.
Providing so much detailed information can seem like a lot to take in, so the use of subsections means that patients can access the information that they want quickly. For example, the information dealing with pregnancy wouldn’t be as relevant for a mum who has just given birth, so having a subsection dedicated to lactation means that she can find out what she needs to without having to read through lots of other information first.
How will this affect patients right now?
So what does this mean for current drugs on the market? Well, these new regulations aren’t due to come into effect until the 30th of June, 2015 – and that’s just for new drugs that are being released. For drugs that are already available on prescription, there will be more of a gradual change from the old labels to the new ones.
Of course, all of this information won’t fir onto the small labels stuck to the outside of boxes and bottles – so it will be included in the package inserts that are included with the medication. Of course, if these changes are successful then it means that this system could be rolled out across all drugs, not just ones that are prescribed by a doctor.
Over the counter medicines are taken by many pregnant women, so if they had access to this kind of information with every purchase they make, it could revolutionise pregnancy healthcare. We may not be at that stage yet but these new regulations are a very, very promising start.
Tammy Wiltshire is the Marketing Director for Essex based label designer and manufacturers – Labelnet.
