Thalidomide, also known as α – N(phthalimido) glutarimide , was first developed in 1954 by a German pharmaceutical company called Grünenthal in Stolberg. In 1957, under the brand name Contergan , it was marketed as a sedative, tranquiliser and antiemetic that was found to be effective when prescribed to pregnant women to help combat the many symptoms associated with morning sickness.
Chemically similar to barbituates, the drug became a popular sedative and by the following year, although it was never approved by the Food and Drug Administration (FDA), it went into general use and was present in at least 46 countries under many different brand names.
Grünenthal allegedly claimed the drug was safe and harmless, however, by 1960, doctors were concerned about the possible side effects of Thalidomide as some patients had nerve damage in their limbs after long term use. In the early 1960’s the drug was found to be associated with birth defects, damaging the development of unborn babies, as it was not understood that these drug molecules could cross the placental wall, severely affecting the foetus.
In the late 1950s and early 1960s, the drug thalidomide affected over 10,000 babies and thousands of fetal deaths worldwide. The affected babies typically suffered from phocomelia, a failure of the limbs to develop. …show more content…
The tragedy revolving around Thalidomide helped change the way that drugs are developed and influence changes in the FDA. In October of 1962, the U.S Congress passed the Kefauver – Harris Amendments Act due to the effects regarding drug safety of Thalidomide. This act tightened up regulations advertising and production of drugs, under the Medicines Act 1968, requiring that manufactures prove they are both effective and safe before they are marketed, demonstrated by acceptable and controlled clinical investigations undertaken by qualified
Chemically similar to barbituates, the drug became a popular sedative and by the following year, although it was never approved by the Food and Drug Administration (FDA), it went into general use and was present in at least 46 countries under many different brand names.
Grünenthal allegedly claimed the drug was safe and harmless, however, by 1960, doctors were concerned about the possible side effects of Thalidomide as some patients had nerve damage in their limbs after long term use. In the early 1960’s the drug was found to be associated with birth defects, damaging the development of unborn babies, as it was not understood that these drug molecules could cross the placental wall, severely affecting the foetus.
In the late 1950s and early 1960s, the drug thalidomide affected over 10,000 babies and thousands of fetal deaths worldwide. The affected babies typically suffered from phocomelia, a failure of the limbs to develop. …show more content…
The tragedy revolving around Thalidomide helped change the way that drugs are developed and influence changes in the FDA. In October of 1962, the U.S Congress passed the Kefauver – Harris Amendments Act due to the effects regarding drug safety of Thalidomide. This act tightened up regulations advertising and production of drugs, under the Medicines Act 1968, requiring that manufactures prove they are both effective and safe before they are marketed, demonstrated by acceptable and controlled clinical investigations undertaken by qualified