Where is thalidomide approved

Trial patients reported mild side effects like muscle aches and sore a rms. Frances Oldham Kelsey, an FDA officer in the early s, found that there was not enough safety data on thalidomide as U. During the s,clinical trials could be conducted without FDA approval. Around the world, thousands of pregnant women who had taken the drug delivered infants without limbs or flipper-like arms and legs.

Some women in the U. The drug was withdrawn in the United Kingdom around Dec. Due to the work highlighted by Kelsey, President John F. The law also required testing on humans. The drug had unfortunately been given to around 20, Americans during the two clinical trials by Merrell, according to the New York Times and the Smithsonian Magazine here , here.

Kennedy in for her work in protecting the public from the drug. The drug amendments bill passed that year to change drug regulation here. In , the FDA approved thalidomide as a prescription drug for the treatment of myeloma and leprosy, with severe use warning labels for the drug here and here.

The FDA did not approve thalidomide for use in pregnant women in the s and s. The drug led to deaths and severe ailments in Europe and elsewhere. This article was produced by the Reuters Fact Check team.

Reuters Fact Check Updated. Ciba, a pharmaceutical company based in Switzerland, first synthesized thalidomide, a sedative similar to barbiturates and derived from glutamic acid, in Ciba said that it intended to use thalidomide as an anticonvulsive agent, but when the sedative did not show the desired effect on tested lab animals, Ciba stopped its thalidomide research.

Thalidomide became a popular sleeping pill in West Germany and was sold under the trade name Contergan. Combined with aspirin, thalidomide was used to treat everything from colds and coughs to asthma and nervousness. Some claimed that thalidomide could help treat loss of vision macular degeneration , diabetes, autoimmune diseases, and even some forms of cancer. Some recommended a liquid form of thalidomide to calm children. By the late s, thalidomide was marketed in forty-six countries with sales almost as high as those of aspirin.

Around this time research indicated that thalidomide relieved morning sickness in pregnant women. Some doctors recommended the off-label use of thalidomide to pregnant women, and soon this recommendation was generalized to pregnant women in forty-eight countries. In , a number of reports of nerve inflammation peripheral neuritis associated with long-term use of thalidomide surfaced in German medical journals.

In early , the pediatrician Widukind Lenz in Germany noticed thalidomide's teratogenic effects and later hypothesized that prenatal exposure to thalidomide caused severe malformations in newborns. Based on initial questionnaires sent to the parents of deformed infants and their physicians, Lenz noticed that approximately twenty percent of the mothers surveyed had taken thalidomide during pregnancy.

Lenz then asked all of the parents specifically about thalidomide, and half of them reported using the drug. Independent of Lenz's hypothesis, obstetrician William McBride , working in Australia, noticed severe birth defects in the babies whose mothers had taken thalidomide during gestation.

The most common birth defects included shortened, absent, or extra arms or legs dysmelia , incomplete development of extremities bone hypoplasticity , and a variety of ear, heart, and internal organ defects.

In McBride reported his findings to Distillers Company Limited laboratories, headquartered in Edinburgh, Scotland, the company that produced thalidomide for the UK. Within the few years after thalidomide was first marketed, greater than 10, babies worldwide were born with birth defects attributed to thalidomide. By March many countries had banned thalidomide.

In , the limited liability corporation Richardson-Merrell applied to the US FDA, headquartered in Maryland, for approval to sell Kevadon, the company's trade name for thalidomide. The company hoped to approve thalidomide as an over-the-counter drug and recommended it to treat a variety of ailments including alcoholism, anorexia, asthma, cancer, poor schoolwork, premature ejaculation, and tuberculosis.

Kelsey noticed reports of thalidomide's adverse effects in Germany. Because one of thalidomide's recommended uses was treating morning sickness, Kelsey requested more data from Richardson-Merrell to show that thalidomide was safe for use during pregnancy. At the same time that Kelsey requested more information, the Democratic Senator from Tenessee Estes Kefauver was independently conducting an investigation of the drug industry in the US.

As part of his investigation, Kefauver introduced a bill to enhance safety regulations of drugs. Kefauver learned about thalidomide's effects abroad through the work of Helen B. Women taking thalidomide are required to use two forms of birth control and regular pregnancy tests. Men are required to use contraception when taking thalidomide. People who are prescribed thalidomide undergo counselling and are talked through the risks.

This was not the end of the thalidomide story. Within three days the leprosy had gone and skin lesions healed. When the patient stopped taking the thalidomide the leprosy returned.

The drug seemed to be able to suppress the disease, although it was not a cure. And after more positive results, thalidomide was used as a treatment for leprosy in many countries.

More recently, it has been used successfully to control some AIDS-related conditions, and as a targeted cancer drug for treating cancers such as multiple myeloma. From mental health to epidemiology, discover the people and events who have shaped medicine as we know it today. Medicine: The Wellcome Galleries is the magnificent new home for the most significant medical collections in the world. Explore a variety of artefacts revealing the understanding and treatment of physical disability from the 16th century up to today.

Javascript is disabled. You are here: Home Objects and stories. Published: 11 December Story Content Introduction Thalidomide in the marketplace Thalidomide and pregnancy The thalidomide scandal The consequences of thalidomide Uses of thalidomide today Find out more. Thalidomide changed our relationship with new medicines for ever. Their advertisement claimed that Distaval can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child.