ID :
20082
Thu, 09/18/2008 - 22:03
Auther :
Shortlink :
https://oananews.org//node/20082
The shortlink copeid
Thalidomide to possibly return to Japan as blood cancer medication+
TOKYO, Sept. 18 Kyodo - Japan may allow the manufacture and sale of thalidomide as a treatment for blood cancer after the drug caused severe birth defects and was banned in the
country in 1962, government officials said Thursday.
This prospect has emerged after a panel of experts at the Ministry of Health,
Labor and Welfare on Thursday approved a package of safety measures filed by a
drug maker which has applied for government permission to manufacture and sell
thalidomide as a treatment of multiple myeloma, a form of bone marrow cancer.
An official go-ahead needs approval from the Pharmaceutical Affairs and Food
Sanitation Council, an advisory body to the health minister, which is expected
to convene a committee meeting shortly to discuss the safety measures, the
officials said.
Late last month, a subcommittee of the advisory body endorsed the set of safety
measures and recommended that the higher-level committee approve it.
If everything goes smoothly, the manufacture and sale of thalidomide will
resume by the end of this year, 46 years after it was banned in Japan.
Thalidomide is known to have caused thousands of children to be born with
severe malformations, notably phocomelia, after their mothers had taken it
during pregnancy.
The package of safety measures filed by Fujimoto Pharmaceutical Corp. proposes
establishing a registration system of physicians, pharmacists and patients on
the use of the drug, recovering any unneeded drugs and creating a third-party
organization to check the use of the drug.
It also calls for representatives of patient groups and of the central
government to join the third-party panel. The central government is expected to
share the cost of running the third-party body.
In recent years, thalidomide was found to be effective as a medication against
multiple myeloma. The United States and 16 other countries have approved the
use of thalidomide.
In Japan, many physicians have recently come to import thalidomide drugs from
abroad individually for multiple myeloma patients.
Patient groups have therefore sought the approval of the manufacture and sale
of thalidomide as a multiple myeloma medication.
Fujimoto Pharmaceutical applied for government permission for the manufacture
and sale of thalidomide in August 2006 as a drug for patients who would not get
better on other medications or whose disease has come back.
Fujimoto Pharmaceutical is a maker and seller of drugs based in Matsubara,
Osaka Prefecture.
Thalidomide was sold as a sleep agent for the first time in then West Germany
in 1957.
European countries began to recall thalidomide drugs in 1961 after a West
German doctor published a report saying that thalidomide caused such birth
defects as phocomelia.
In Japan, thalidomide was sold from 1958, but was recalled, starting in
September 1962, following Europe's recall.
The number of victims of the drug worldwide topped the 3,000 mark. The number
of recognized victims in Japan stands at 309, according to health ministry
data.
country in 1962, government officials said Thursday.
This prospect has emerged after a panel of experts at the Ministry of Health,
Labor and Welfare on Thursday approved a package of safety measures filed by a
drug maker which has applied for government permission to manufacture and sell
thalidomide as a treatment of multiple myeloma, a form of bone marrow cancer.
An official go-ahead needs approval from the Pharmaceutical Affairs and Food
Sanitation Council, an advisory body to the health minister, which is expected
to convene a committee meeting shortly to discuss the safety measures, the
officials said.
Late last month, a subcommittee of the advisory body endorsed the set of safety
measures and recommended that the higher-level committee approve it.
If everything goes smoothly, the manufacture and sale of thalidomide will
resume by the end of this year, 46 years after it was banned in Japan.
Thalidomide is known to have caused thousands of children to be born with
severe malformations, notably phocomelia, after their mothers had taken it
during pregnancy.
The package of safety measures filed by Fujimoto Pharmaceutical Corp. proposes
establishing a registration system of physicians, pharmacists and patients on
the use of the drug, recovering any unneeded drugs and creating a third-party
organization to check the use of the drug.
It also calls for representatives of patient groups and of the central
government to join the third-party panel. The central government is expected to
share the cost of running the third-party body.
In recent years, thalidomide was found to be effective as a medication against
multiple myeloma. The United States and 16 other countries have approved the
use of thalidomide.
In Japan, many physicians have recently come to import thalidomide drugs from
abroad individually for multiple myeloma patients.
Patient groups have therefore sought the approval of the manufacture and sale
of thalidomide as a multiple myeloma medication.
Fujimoto Pharmaceutical applied for government permission for the manufacture
and sale of thalidomide in August 2006 as a drug for patients who would not get
better on other medications or whose disease has come back.
Fujimoto Pharmaceutical is a maker and seller of drugs based in Matsubara,
Osaka Prefecture.
Thalidomide was sold as a sleep agent for the first time in then West Germany
in 1957.
European countries began to recall thalidomide drugs in 1961 after a West
German doctor published a report saying that thalidomide caused such birth
defects as phocomelia.
In Japan, thalidomide was sold from 1958, but was recalled, starting in
September 1962, following Europe's recall.
The number of victims of the drug worldwide topped the 3,000 mark. The number
of recognized victims in Japan stands at 309, according to health ministry
data.
