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
Thalidomide tragedy was a milestone in the regulation of medications by FDA. Thalidomide which was sold under the brand name immunoprin was an immunomodulatory drug. It also had tranquilizer like effects. In 1957, it got approval as an over the counter drug in Germany.it was used as a sleeping pill by many. By 1960 the drug was approved and released in 46 countries. It was found that the drug alleviated the symptoms of morning sickness. So it was widely used in pregnant patients. By 1961, Dr. William McBride, Australian obstetrician came with finding that the babies born to patients who used thalidomide were affected by phocomelia ( shortening or absence of limbs). Following this research by 1962 the drug was banned in many of the countries.
FDA Inspector of United states, Frances Keley was appreciated for the drug disapproval in 1957 itself. She reported that the data of drug safety and effectiveness was insufficient and lacks in fact whether it crosses the placenta.
Later kefauver-harris Drug amendment act was passed in 1962 which tightened the restrictions for approval of drugs. Despite of the side effects of thalidomide it is now used as a treatment for Hansen's disease(leprosy) and as a chemotherapeutic agent for patients with multiple myeloma. The dispensing of the drug is now regulated by STEPS( System for thalidomide education and prescribing safety). All the patients receiving thalidomide will be educated about the adverse effects of the drug under this programme. The many more adverse effects are been researched and tracked currently.
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...