Top 5 Drug Disaster’s You Should Know About
A drug disaster is the ill or hazardous effects caused by a drug after it reaches the market for patients. Many times a drug has to be recalled or banned due to certain extremely harmful undesirable effects.
Technically, a drug is a chemical substance that is used for the treatment, prevention, mitigation, cure of any disease condition in humans or animals. The new drugs receive extensive scrutiny before Food and Drug Administration (FDA) approval. FDA, established in 1906, is responsible for protecting and promoting public health through the control and supervision of drug products.
The drug may have beneficial as well as harmful effects on the body. That’s why clinical trials are done in order to evaluate the safety, efficacy, and toxicity of a drug substance. But the long-term safety and effectiveness can be assured once the drug is marketed, the study is called “Post-marketing surveillance”.
Here’ the list of Top 5 Drug Disasters You Need to Know About.
|Sulfanilamide Use||As a first-aid treatment to reduce infection rates, for treatment of vaginal yeast infections.|
|Manufacturer||S.E. Massengill Company|
|Affected Population||Deaths of more than 100 People in the US|
Sulfanilamide Drug Disaster:
In 1937, this drug was responsible for the deaths of more than 100 people in the US. The medicine that killed people was Elixir Sulfanilamide. Sulfanilamide, a drug used to treat streptococcal infections and had been used safely for some time in tablet and powder form.
Due to the demand for its liquid dosage form, Company’s chemist researched and experimented with the drug and found that sulfanilamide would dissolve in diethylene glycol. The company tested the mixture for organoleptic characteristics. When found satisfactory, they immediately distributed the formulation throughout the country.
The Elixir Sulfanilamide had not been tested for any kind of toxicity. At that time the food and drugs law did not require that safety studies be done on new drugs. Diethylene glycol, a chemical normally used as antifreeze, is a deadly poison, which in turn made Elixir Sulfanilamide toxic and deadly.
4. Diethylstilbesterol (DES)
|Diethylstilbesterol (DES) Class||Synthetic estrogen|
|Diethylstilbesterol (DES) Use||Initially to pregnant women to prevent miscarriages (1938-1971), and later as an emergency contraceptive pill and to treat breast cancer.|
|Exposed Population||5 to 10 Million Population|
Diethylstilbesterol (DES) Drug Disaster
Diethylstilbestrol (DES) is a hormone artificially created in the late 1930s. From 1938 to 1971, Doctors prescribed it to help some pregnant women who had miscarriages.
Diethylstilbesterol (DES) in Preganancy
However after 1953 to 2000s, several research studies found that DES did not actually prevent miscarriages, instead, the drug was responsible for causing cancer in women who administered it and also to the daughter/sons of a mother who administered DES when pregnant. The Drug has an increased risk of development of breast cancer, and which may extend to their daughters and granddaughters as well.
3. Rofecoxib (Vioxx)
|Rofecoxib Class||Nonsteroidal Anti-Inflammatory Drug (NSAID)|
|Rofecoxib Use||Rofecoxib is a selective COX-2 inhibitor used in patients with osteoarthritis, rheumatoid arthritis, dysmenorrhea, and acute pain.|
|Manufacturer||Merck & Co.|
|Year of Withdrawal||2004|
|Rofecoxib Side Effects||According to FDA, An estimated 88,000-140,000 cases of serious coronary heart disease probably occurred in the United States.|
Rofecoxib (Vioxx) Drug Disaster
FDA originally approved Vioxx in May 1999. The safety data included approximately 5000 patients on Rofecoxib (Vioxx) and did not show any risk of heart attack or stroke. Merck then began to conduct long-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.
In September 2004, Merck withdrew Rofecoxib from the market because of concerns about an increased risk of heart attack and stroke associated with long-term, high-dosage use. Rofecoxib was one of the most widely used drugs ever to be withdrawn from the market.
|Class||It is an amphetamine derivative and a sympathomimetic stimulant with appetite-suppressant properties.|
|Year of Withdrawal||1997|
|Reason of Withdrawal||The occurrence of significant valvular disease associated with the use of this drug is reported to be as high as 23%.|
Fenfluramine/Phentermine Drug Disaster
The combination fenfluramine/phentermine, usually called fen-phen, was an anti-obesity treatment that utilized two anorectics. Fenfluramine is a selective serotonin reuptake inhibitor (SSRI). It causes the feeling of fullness and reduced appetite.
After incidents of valvular heart disease and pulmonary hypertension, primarily in women who had been undergoing treatment with fen-phen or (dex)fenfluramine, the FDA requested its withdrawal from the market in September 1997.
In addition to valvular heart disease, these drugs are also been responsible for causing pulmonary hypertension. The increasing number of these unwanted incidents eventually led to its withdrawal and legal damages of over $13 billion.
|Thalidomide Class||Immunomodulatory drug|
|Thalidomide Use||As sedative or hypnotic, thalidomide also claimed to cure anxiety, insomnia, gastritis, and tension. Then, it was used against nausea and to alleviate morning sickness in pregnant women.|
|Affected Population||50 Countries and around 100,000 babies were affected by Thalidomide.|
Thalidomide Drug Disaster
Thalidomide is a drug that was used as a sedative and treatment for morning sickness in pregnant women in the late 50s and early 60s. What then followed was the biggest drug disaster ever, where over 10,000 children were born with a range of severe and debilitating malformations.
Thalidomide was responsible for causing a range of disabilities in babies including shortening and absence of limbs, malformation of hands and digits, damage to ears and eyes, sensory impairment, facial disfigurement/palsy, and damage to the brain, internal organs, and skeletal structure.
Australian obstetrician Dr. William McBride found that the drug can also be used for morning sickness. He started recommending this off-label use of Thalidomide to his pregnant patients. However, the drug interfered with the babies’ normal development, causing many of them to be born with phocomelia, resulting in shortened, absent, or flipper-like limbs.
Thalidomide is used today for the treatment of myeloma and also for the treatment of Hansen’s disease (once known as leprosy).
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