The subject under discussion could be traced to the Disease Control and Prevention (CDC) website. The CDC is a highly reputable research institution based in the USA. A point made about medications used in pregnancy is most revealing because many people may not know this.
It notes that little is known about the effects of taking most medications during pregnancy because pregnant women are often not included in studies to determine safety of new medications before they get to the market. Less than 10% of medications approved by the U.S. Food & Drug Administration (FDA) since 1980 have enough information to determine the risk for birth defects.
It goes on to state that because studies are conducted after medications reach the market, it is known that taking certain medications during pregnancy can cause serious birth defects. The effects of Thalidomide and Isotretinon on pregnancy are well known.
While some medications are known to be harmful when taken during pregnancy, the safety or risk of most medications are not known.
The effects of medications on pregnancy depend on among others how much medications taken (dose), when during the pregnancy the medication is taken, other health conditions a woman might have and other medications a woman takes.
It is important to inform your health care provider about all medications (including herbals) you are taking or planning to take to prevent any untoward effects on the unborn child.
The CDC also notes the list of medications posted by several internet websites on safe medications during pregnancy but adds that many of such information are not proven. It therefore cautions people not to use such information without first discussing with their health care provider.
There are situations where the pregnant woman may already be on some medications for certain conditions, like high blood pressure, diabetes, epilepsy, or depression. It is important to discuss these with your health care provider as soon as pregnancy sets in so as to review the medications in light of the pregnancy.
The USA FDA has a number of resource tools to assist persons to make informed choices about the safe use of medications during pregnancy. It advises one to ask questions, read the label on all medicines, report any problems associated with the medication, and sign up for the pregnancy registry. We may not be able to apply all of these in Ghana but we can apply the first one by discussing prior, current, future medications use with our health care provider.
A number of concerns on prescriptions and Over-The-Counter (OTC) pain medicines used in pregnancy compelled the US FDA to review the available studies on such preparations. I was particularly struck by its outcomes. The FDA evaluated research studies published in the medical literature and determined they are too limited to make any recommendations based on the studies at this time.
In the light of this uncertainty the FDA cautions the use of pain medicines during pregnancy and urges all pregnant women to always discuss all medicines with their health care provider before using them.
It notes that severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother. Medicines including Nonsteroidal Anti-inflammatory Drugs (NSAIDs), Opioids, and Acetaminophen can help treat severe and persistent pain. It was however important to carefully weigh the benefits and risks of using prescriptions and OTC pain medicines during pregnancy.
The published studies reviewed by the FDA reported on the potential risks associated with the following three types of pain medicines used during pregnancy:
l Prescription of NSAIDs and the risk of miscarriage in the first half of pregnancy. Examples of prescription of NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Celecoxib.
l Opioids, which are available only by prescription, and the risk of birth defects of the brain, spine, or spinal cord in babies born to women who took these products during the first trimester of pregnancy. Examples of Opioids include Oxycodone, Hydrocodone, Hydromorphone, Morphine, and Codeine.
l Acetaminophen in both OTC and prescription products and the risk of attention deficit hyperactivity disorder (ADHD) in children born to women who took this medicine at any time during pregnancy. Acetaminophen is a common pain reducer and fever reducer found in hundreds of medicines including those used for colds, flu, allergies, and sleep.
The FDA found all of the studies reviewed to have potential limitations in their designs; sometimes the accumulated studies on a topic contained conflicting results that prevented the FDA from drawing reliable conclusions. As a result, the recommendations on how pain medicines are used during pregnancy will remain the same at this time, that is, seeking the advice of your health provider before usage.
It is important to stress that safety data on medications is dynamic. For example, the current Drug Lens of country’s FDA has important information on Domperidone.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that Domperidone is associated with a small increased risk of serious cardiac side effects.
Consequently, the indication is now restricted to the relief of nausea and vomiting and the dosage and duration of use have been reduced. It is no longer recommended for the treatment of bloating and heartburn.
The PRAC recommended that Domperidone should only be used for the management of symptoms of nausea and vomiting for not more than one week.
It is contraindicated in patients with conditions where cardiac conduction is, or could be impaired, or patients with underlying cardiac diseases such as congestive heart failure, or patients receiving other medications known to prolong QT interval or potent CYP34A inhibitors, or patients with severe hepatic impairment.
The British National Formulary has an interesting introduction to the section on prescribing in pregnancy. It notes that medicines can have harmful effects on the embryo or foetus at any time during pregnancy.
It is important to bear this in mind when prescribing for a woman of childbearing age or for men trying to father a child. A male client was surprised to learn that while on Griseofulvin, he should avoid fathering a child and for at least six months after taking the drug.
By Edward O. Amporful