The drug ‘Thalidomide’ was introduced in Europe in the
late 1950s to relieve morning sickness during
pregnancy. Evidence slowly emerged that it was
teratogenic, causing malformations of the foetus.
Children were born with greatly shortened and distorted
limbs.
The thalidomide molecule is chiral. One enantiomer is
teratogenic; the other alleviates morning sickness and is
not teratogenic. The drug sold in Europe was a racemic
mixture.
US MOTHERS GIVE THANKS TO KELSEY’S
Frances Kelsey was a pharmacologist who stopped the drug being used in the USA and
as the human disaster unfolded she saved US mothers for the horrific birth defects
witnessed in Europe.
Question – Find out what the words chiral, enantiomer,
teratogenic and racemic means.
Birth-Defect Drug Is Back
Thalidomide wins guarded approval for leprosy
Thalidomide, the morning-sickness drug that became infamous for causing severe birth
defects a generation ago, won FDA approval yesterday for treating leprosy patients.
The FDA said its approval came with "unprecedented" restrictions. Doctors and
pharmacies who prescribe the drug must register with its maker, Celgene Corp., and
women must use at least two forms of birth control. Male patients have to use a condom
during sex even though there's no evidence that birth defects come from sperm.
"This oversight program is designed to help insure a zero-tolerance policy for
thalidomide exposure during pregnancy," the agency's announcement said.
Thalidomide was introduced in Europe in the late 1950s, first as a sedative and then as
a remedy for morning sickness. But by 1961, scientists tied the drug to as many as
8,000 babies born with defective limbs or no limbs at all. It was quickly taken off the
market in most countries, and the name of the drug became a buzzword for science
gone awry.
But in recent years, researchers found that thalidomide can help some very sick people,
including those with leprosy (also known as Hansen's disease) and HIV.
"We know a lot more about this drug than we did back then," said Dr. David Stirling,
executive vice president for pharmaceutical research and development for Celgene. "It
has more and more clinical benefit. The risk-benefit ratio is important, so we are only
considering it for life-threatening situations."
Another condition of approval is that patients clearly know that they're taking
thalidomide. The name of the drug must appear prominently next to the brand name. It
will be marketed under the name Thalomid.
Today's approval restricts the use of the drug to treating erytema nodosum leprosum
(ENL), a complication of leprosy. The inflammatory condition causes painful skin sores
that, left untreated, could be fatal. The drug makes the lesions disappear quickly,
Stirling said.
Stirling said several thousand people in this country, mostly immigrants, suffer from
leprosy.
Women cannot be pregnant in order to receive the drug. If they do become pregnant,
they must stop using it immediately. Men are being warned to practice safe sex, too,
even though it's never shown up in semen -- but "it's tough to prove a negative," Stirling
said.
Clinical trials have shown thalidomide can reverse the "body-wasting" process that
AIDS patients suffer from, and Celgene hopes to receive approval for that purpose
sometime next year.