Daily Bulletin


The Conversation

  • Written by The Conversation Contributor
image

The thalidomide tragedy of the late 1950s and early 1960s left more than 10,000 offspring of women exposed to the drug in early first trimester with irreversible congenital defects ranging from limb deformities (phocomelia) to facial malformations. It was also implicated in thousands of spontaneous abortions.

This taught us important lessons about how drugs can impact on fetal organ development.

However, the thalidomide tragedy changed how medicines are viewed during pregnancy – not only by pregnant women, but also the wider community.

Why do women take medicines during pregnancy?

An analysis of nearly 5,000 pregnancy-related questions from Australian consumers shows women are concerned about safe drug use in pregnancy. They are also likely to overestimate the risks.

Despite their fears, pregnant women commonly need to use medication during the nine months of gestation. A recent study found 81.2% of women in Europe, North America, South America and Australia reported using at least one prescribed or over-the-counter medication during pregnancy.

This should not be surprising. If planning a pregnancy, women should already be taking folate supplements (to reduce the risk of neural tube defects) and iodine supplements (to support the fetus' developing brain and nervous system).

They may need to continue taking medication for any underlying medical condition, or require therapy for a pregnancy-associated medical condition, such as morning sickness.

They are also likely to require symptom relief for an episodic illness such as headache or pain.

Excluding pregnant women from drug trials

For more than half a century, health professionals were taught that pregnant women were “vulnerable” participants of research who, for ethical reasons, should either be excluded from drug trials or be required to use contraception while taking part.

But excluding pregnant women from clinical trials has made them “therapeutic orphans”, forced to use medication “off-label”. This means the drug hasn’t been tested for safety and efficacy in pregnancy and regulators haven’t officially approved this use.

We have therefore done little to prevent another thalidomide tragedy.

Attitudes are, however, changing. In November 2015, the American College of Obstetricians and Gynecologists (ACOG) radically updated its 2007 position statement on research involving women. The college called for “evidence-based consideration of pregnancy exposures in research rather than broad exclusion of all pregnant women”.

The statement acknowledges that pregnant women are complex, rather than vulnerable, participants who can make autonomous decisions about whether to participate in research.

The college concludes that although there is concern that including pregnant women in drug trials could cause harm to the fetus, excluding these women from research can also lead to harm:

The pursuit of zero fetal risk is not attainable and will come at a real risk to maternal health, and potentially to the health of a wider population of fetuses, outside the research setting.

Overestimating the risks

Medication-induced birth defects tend to be overestimated by the public. This prompts some women to stop taking medication for ongoing health conditions when they become pregnant.

However, failing to treat conditions such as epilepsy or depression can be a greater risk to both mother and fetus. All couples have a 3-5% “background risk” of having a baby with a major birth defect. Untreated maternal disease, such as epilepsy or depression, can actually increase this background risk.

Some drugs have been unfairly crucified in response to the thalidomide saga. It took a meta-analysis of 170,000 safe exposures to the morning sickness drug Bendectin (a combination of doxylamine-dicyclomine and vitamin B6), before the product was finally reintroduced, with US Food and Drug Administration (FDA) approval, in 2013.

Bendectin was originally marketed in the mid-1950s for nausea and vomiting of pregnancy, but was voluntarily withdrawn in 1983 as the manufacturer found the cost of defending the drug prohibitive.

What should you do?

Some medications must be absolutely avoided during pregnancy. This includes thalidomide, vitamin A derivatives, certain anticancer and immune-modifying medicines, high doses of alcohol, the epilepsy drug phenytoin, the anticoagulant warfarin, the mood stabilisers valproate and lithium (to treat bipolar disorder).

For other drugs, the first step is to decide if the medicine is needed or not. If it is, look for a Category A medicine on the Australian Categorisation System for Prescribing Medicines in Pregnancy, or your national classification system. Category A means large numbers of women have taken the drug without adverse affects to them or their unborn babies.

By reading the packaging, labels and information that come with a medicine, and asking questions of your health providers, you can get the right advice to use medication safely in pregnancy.

This is part of The Conversation’s series on thalidomide. Read the other instalments here.

Authors: The Conversation Contributor

Read more http://theconversation.com/thalidomide-taught-us-to-use-medications-with-care-during-pregnancy-not-to-stop-using-them-51862

Writers Wanted

Planning a road trip in a pandemic? 11 tips for before you leave, on the road and when you arrive

arrow_forward

Biden's cabinet picks are globally respected, but one obstacle remains for the US to 'lead the world' again

arrow_forward

The Conversation
INTERWEBS DIGITAL AGENCY

Politics

Prime Minister Interview with Ben Fordham, 2GB

BEN FORDHAM: Scott Morrison, good morning to you.    PRIME MINISTER: Good morning, Ben. How are you?    FORDHAM: Good. How many days have you got to go?   PRIME MINISTER: I've got another we...

Scott Morrison - avatar Scott Morrison

Prime Minister Interview with Kieran Gilbert, Sky News

KIERAN GILBERT: Kieran Gilbert here with you and the Prime Minister joins me. Prime Minister, thanks so much for your time.  PRIME MINISTER: G'day Kieran.  GILBERT: An assumption a vaccine is ...

Daily Bulletin - avatar Daily Bulletin

Did BLM Really Change the US Police Work?

The Black Lives Matter (BLM) movement has proven that the power of the state rests in the hands of the people it governs. Following the death of 46-year-old black American George Floyd in a case of ...

a Guest Writer - avatar a Guest Writer

Business News

Nisbets’ Collab with The Lobby is Showing the Sexy Side of Hospitality Supply

Hospitality supply services might not immediately make you think ‘sexy’. But when a barkeep in a moodily lit bar holds up the perfectly formed juniper gin balloon or catches the light in the edg...

The Atticism - avatar The Atticism

Buy Instagram Followers And Likes Now

Do you like to buy followers on Instagram? Just give a simple Google search on the internet, and there will be an abounding of seeking outcomes full of businesses offering such services. But, th...

News Co - avatar News Co

Cybersecurity data means nothing to business leaders without context

Top business leaders are starting to realise the widespread impact a cyberattack can have on a business. Unfortunately, according to a study by Forrester Consulting commissioned by Tenable, some...

Scott McKinnel, ANZ Country Manager, Tenable - avatar Scott McKinnel, ANZ Country Manager, Tenable



News Co Media Group

Content & Technology Connecting Global Audiences

More Information - Less Opinion