The sulfanilamide disaster of 1937, was a pivotal point in the regulation of medications by the FDA. For this discussion, research another example of a medication disaster and make an initial post explaining the event to your classmates. Be sure to mention if there were any of the following: lawsuits, deaths, fetal abnormalities, unusual marketing campaigns to sell the drug. Review the posts made by your classmates and reply to at least one addressing the following as appropriate: ways in which their event could have been avoided how the FDA should have handled the drug's availability on the market media responses to the medication incident follow up studies on individuals affected by the disaster.
Thallidomide disaster
Thallidomide disaster of 1962 is one of the dark page in the history of pharmaceutical research. It was marketed by German company Chemie Grunethal, primarily as a sedative or hypnotic to cure anxiety, insomnia and tension. It was marketed under trade name Contergan, and became an OTC drug soon and was marketed as safe even in pregnancies. The company advertised the drug as "Distaval (trade name of Thallidomide) can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child” .
Many pregnant ladies used it for morning sickness because of its antiemetic properties.
The drug came out with teratogenic deformities in the childrenborn after their mothers used it in pregnancy prior to third trimester. It led to the deaths of 2000 children and serious birth defects to nerves and limbs in more than 10000 children. The birth defects were moderate to severe in form.
The public protest made the drug to be taken off market by 1961. Media and public put pressure on the Government and the drug was taken back from the market. The criminal trial against the company started in 1968 for negligent homicide and injury. The trial ended in 1970 with no finding of guilt.
For the settlement, the company paid a special foundation 100 million DM and Government added 320 million DM to it. The victims were paid from this foundation, depending on the severity of disability occurred.
How this disaster could have avoided?
The proper studies were not done while patenting and testing. The studies of Thalidomide were done only on Rodents. Also the studies on pregnancy were not done in animals also.
The studies and more testing must have done before giving patent and introducing it to the market. Especially the effects of the drug in pregnancy have to be done.
Also the government should not have given the approval without proper testing.
The FDA has refused to give approval to market the drug, despite high pressure from the company side. But the drug was distributed for testing purposes and a total of 17 children with thalidomide induced malformations were born in US.
the US government has appreciated the FDA head for not approving the marketing of Thalidomide.
The sulfanilamide disaster of 1937, was a pivotal point in the regulation of medications by the...
The sulfanilamide disaster of 1937, was a pivotal point in the regulation of medications by the FDA. For this discussion, research another example of a medication disaster and make an initial post explaining the event to your classmates. Be sure to mention if there were any of the following: lawsuits, deaths, fetal abnormalities, unusual marketing campaigns to sell the drug. Review the posts made by your classmates and reply to at least one addressing the following as appropriate: ways in...
The sulfanilamide disaster of 1937, was a pivotal point in the regulation of medications by the FDA. For this discussion, research another example of a medication disaster and make an initial post explaining the event to your classmates. Be sure to mention if there were any of the following: lawsuits, deaths, fetal abnormalities, unusual marketing campaigns to sell the drug. Review the posts made by your classmates and reply to at least one addressing the following as appropriate: ways in...
Answer these questions about the article below. Ways in which their event could have been avoided? How the FDA should have handled the drug's availability on the market. Media responses to the medication incident. Follow up studies on individuals affected by the disaster. In 2001, the cholesterol medication Baycol (cerivastatin) that was manufactured by the German drug company Bayer and first released in the US in 1998, was recalled due to findings that it could cause a potentially fatal condition...