Question

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

Answer 1

THE THALIDOMIDE MEDICATION DISASTER - 1960

Thalidomide disaster is one of the darkest episodes in pharmaceutical research history. It was first entered into the German market (1957) with a caption "completely safe for everyone (including mother and child) and even during pregnancy". This new drug also reduced the morning sickness in pregnant mothers (purposes other than those for which the drug was approved) so its market value has raised rapidly and by 1960 this medication was marketed in more or equal to 46 countries and thus this tragedy happened as an side effects.

Thalidomide was marketed in US where sleeplessness was more common and was marketed along with tranquilizers and sleeping pills. At this period of time one out of seven Americans took them regularly. This was the only non-barbiturate sedative known at the time among Americans. Followed by this massive medication tragedy or as an after effect, the tragedy give raise to rigorous drug approval and monitoring systems called Food and Drug Administration (FDA) as a regulatory body to monitor the toxicity, safety and efficacy of medications in US.

WHAT HAPPENS? After the practice of prescribing medications for off-label purposes (sleeping pills to reduce morning sickness ) in pregnant mothers resulted in severe birth defects in the babies called PHOCOMELIA ( shortened, absent or flipper-like limbs). Following this, a German newspaper had found out 161 newborn babies with the same birth defects and halted circulation of medications and banned in those countries (46 countries) where it was previously sold after 2 years of incidence.

WHAT WAS THE REASON?

There were two main reasons why this incident occurred?

1. During this era, clinical trials were not required any FDA approval. Without any prior approval, this medication have distributed to over 20,000 patients across the nation ( approximately 3500 women of child bearing age and 200 whom were pregnant).

2.After marketing this medication, many medical professionals participated in the post-surveillance trials but failed to track their patients which was the another cause.

IN WHAT WAYS WOULD IT HAVE BEEN AVOIDED?

1. There are 2 methods in the development of a medication or vaccines. They are a) Pre-clinical testing ( laboratory and animal testing) and b) Clinical testing (human testing). These testings are done to find out the safe and effectiveness and also to identify its distribution in the body. It usually takes an average of 15 years to bring a drug to the public to use. So it is important to have a testing on a new drug before it is marketed.

2. If the regulatory body (FDA) have overlooked the trials before and during the process of product development and these incidence would have been reduced.

3. They should have tested the medications for toxicology, safety and efficacy before marketing the product.

4. Post- marketing surveillance ( begins after product approval by FDA) could have been made more effective to avoid this serious incidence on newborn babies.