Skip to 0 minutes and 6 seconds As we’ve seen from the previous section, doctors tend to be very concerned about women taking drugs during pregnancy. There’s very little information about efficacy and safety as pregnant women are not involved in drug trials. So online forums and social media can be very important as information sources. Here’s an example that was widely reported. An August 2015 Instagram post by Kim Kardashian. She used the post to promote a drug she had been taking to control her pregnancy-related sickness. Kardashian and the drug manufacturers were criticised by the US Food and Drug Administration. She was told to remove the post because it contravened regulations about the promotion of prescription medicines. In particular, it failed to mention risks associated with using the drug.
Skip to 1 minute and 3 seconds It’s worthwhile noting at this point that the USA is one of only two places in the world where promoting prescription medicines to the general public is permitted. The other is New Zealand. So what information should have been included? Well, the drug has known side effects including drowsiness, dizziness, headaches, constipation, heart problems, migraines, blurred vision, and nightmares. Also it’s not recommended for women who have certain medical conditions. It can cause problems in women who suffer from asthma, certain eye or stomach problems, or bladder-neck obstruction.
Skip to 1 minute and 44 seconds As we’ve seen, there’s a huge concern about the use of drugs in pregnancy. The reason for this, a drug called thalidomide that was marketed under a variety of brand names in the late 1950s and early ’60s. Thalidomide was originally developed by a German pharmaceutical company as a treatment for epilepsy, but early trials showed it wasn’t effective. However, it did work really well as a sleep medication.
Skip to 2 minutes and 13 seconds It had one special property: unlike many other sedatives, taking an overdose didn’t result in serious injury or death. Those who overdosed just slept longer. The promotional advertising of thalidomide concentrated heavily on its apparent safety. It was marketed as completely safe for both adults and children and could be used even during pregnancy. So it very quickly became a popular drug in around 50 countries. In Germany, it was reportedly promoted as being ‘safer than sugar drops’. Shortly after thalidomide became available, it was found to be highly effective in treating morning sickness. Although prescribing the drug for this purpose was never formally approved, taking thalidomide during pregnancy became common in many countries.
Skip to 3 minutes and 7 seconds A major exception was the USA, where the Food and Drug Administration didn’t give approval for the drug to be marketed. At the time, the USA was the only country which had a formal drug approval process that included full safety testing. In 1961, concerns about the safety of thalidomide were starting to be raised when mother’s had used thalidomide during pregnancy, babies were frequently born with phocomelia, meaning their limbs were absent, shortened, or not completely formed. They were also a range of other problems. Thalidomide was withdrawn everywhere by the end of the year. Unfortunately, by then more than 10,000 surviving children had been affected. And many more children had not survived.
Skip to 4 minutes and 1 second What became known as the thalidomide tragedy led to huge changes in the regulation and testing of drugs worldwide. Much tighter controls were introduced. Pharmaceutical companies standardised testing protocols and created clinical research departments. Drug development regulations now require an extensive testing process that takes around 8 to 12 years.
Skip to 4 minutes and 29 seconds Following the tragedy, worldwide surveillance measures were introduced to collect data on adverse effects for all marketed drugs. In Britain, reporting via the yellow card system commenced in 1964. Worldwide surveillance has led to the withdrawal of such drugs as the anti-inflammatory Vioxx and Avandia, a treatment for type 2 diabetes. Additionally, restrictions such as the black box warnings issued by the FDA in America have limited the use of other drugs. Although thalidomide continues to be banned for use during pregnancy, it is currently used to treat leprosy and multiple myeloma. Its use is controversial because in some countries it may not be possible to ensure that pregnant women don’t take the drug.
Case study: taking drugs in pregnancy
The impact of thalidomide.
Why is there such a huge concern around the use of drugs by pregnant women? In the late 1950s a drug called thalidomide was prescribed to pregnant women for the relief of severe morning sickness and many babies were born with phocomelia (absent, shortened or malformed limbs). More than 50 years later, the impact of this is still immense and has shaped doctors’ views and willingness to prescribe drugs in pregnancy.
© Archive footage licensed from British Pathé