Thalidome Approved to treat Leprosy
Washington- Thalidome, a drug whose name for decades has been synonymous with
the nightmarish birth defects and death, has won approval Thursday to treat a
painful symptom of leprosy.
In licensing the notorious drug for that narrow purpose, the FDA imposed
unprecedented restrictions on its use to prevent a recurrence of the medical
crisis that gripped the world in the early 60's.
While fewer than 100 people in the US suffer from the condition for which the
drug was approved, doctors are now free to prescribe it for other purposes.
The FDA acknowledges that many more Americans will use thalidomide than just
leprosy patients. It is legal for US doctors to prescribe drugs in any way
they see fit, & thalidomide is being researched against AIDS-related ulcers
and wasting, brain tumors and such autoimmune diseases as lupus and rheumatoid
arthritis.
Officials said they are taking extraordinary steps to protect the public
because of thalidomide's unique status in US history.
Once prescribed by many doctors to treat morning sickness, thalidomide caused
more than 10,000 birth defects and an unknown number of miscarriages worldwide
before being withdrawn in 1962. Although never approved in the US, nearly two
dozen American children were born with the characteristic missing or misshapen
limbs associated with the drug's use after its US manufacturer supplied
samples to 1,200 doctors.
Like the explosion of the atomic bomb, thalidomide altered the way people
thought about technology in post war America. But the tragedy also led to
laws that strengthened the FDA and helped establish the regulatory framework
considered by many nations to be the world's gold standard.
The return of thalidomide was greeted Thursday with grim resignation by those
who work to prevent birth defects. "We'd prefer not to have the drug out
there," said David Johnston, the medical director of the March of Dimes. But
both Johnston's organization and the Thalidomide Victims Ass. of Canada have
cautiously endorsed the approval.
The FDA is requiring doctors who prescribe the drug and pharmacies that sell
it to register with the agency and undergo specific training on how to warn
patients about the drug's dangers. Female patients won't get a prescription
without a pregnancy test and must undergo regular additional pregnancy tests
throughout the period of use. Women will also have to agree to use two
reliable forms of contraception, and even though it is not known whether
thalidomide passes into sperm, male patients will receive warnings about the
need to use condoms. All patients will view a disturbing video warning,
delivered buy a thalidomide victim.
Thalidomide, which is synthesized from the amino acid glutamine, has many
effects on the body. For patients with leprosy, which is also known as
Hansen's disease, the drug can treat painful lesions by suppressing a chemical
in the body called tumor necrosis factor alpha.
Many other potential uses for thalidomide are under scientific review.
EntreMed Inc. in Gaithersburg, MD., for example, is studying the drug's
potential to treat cancer and a blinding eye condition, macular degeneration,
by slowing the growth of blood vessels.