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A.B.P.S.T.: Brazilian Association of Thalidomide Syndrome's Victims.
What Thalidomide is.
What Thalidomide is
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Thalidomide or " Alpha N-Phthalylglutaramide".

Thalidomide

Dictionary definition: 'a drug which was once used to help people relax or sleep, and which was found to cause damage to babies inside the womb, especially by stopping the development of their arms and legs, when it was taken by their mothers'.


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These medicine was developed in Germany, in 1954 to be used as a tranquilizer. The drug was commercialized for the first time in 1957. It was found to cause damage to babies inside the womb, especially by stopping the development of their arms and legs, when it was taken by their mothers (Focomelia's Syndrome - stops the development of the fetus limbs, making them similar to seals). When the substance is taken by pregnant women, it can also cause: visual and audio damages, vertebral column damage, digestive system damages and heart disease.

It was discovered that if only a pill of this medicine is taken by women during the three first months of pregnancy, the Focomelia takes place. That was the reason why, in 1961, the drug sales were forbidden all over the world. Another discovery, in 1965, reintroduced the substance in the market when the usage of Thalidomide was proved to be beneficial for Leprosy, not for the disease itself, but in the process of swelling.

Since then, the substance has been used in many other kinds of diseases treatment, such as AIDS, LUPUS, and CHRONIC DEGENERATIVE DISEASE - Cancer and spinal cord transplants.

There are no scientific evidences of how long it is necessary for the substance to get out of the woman body. That is why we do not recommend pregnancy at least 1 year before the end of the treatment.


Treatment for women:

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According to Regulation no. 354, from August 15th, 1997, Thalidomide is forbidden for fertile women in Brazil.

Although Thalidomide is forbidden, doctors can legally prescribe it in some specific cases, but it is necessary for both, the doctor and the patient, to sign a responsibility medical term in order to avoid bad usage of the substance.

All the evidences point out the fact that only the use of contraceptive devices does not prevent fertile women who have taken thalidomide to have disabled children, as the drug inhibits the effect of the contraceptive. Therefore people should use as many contraceptive devices as possible to tighten security against pregnancy. Moreover it is extremely important to do all the medical exams for pregnancy (e.g. urine, BHCG, etc).


Treatment for men:

Accordingly determination n° RDC 140/2003 from ANVISA, the directions for taking themedicine, bulla, says "men who are taking Thalidomide and keep active sexual life with women in fertile age, even if they had submitted to the vasectomy, must be guided to adopt the condom usage during the treatment" and also "Neither blood nor sperm should be donated".

Side effects of the treatment after continuous usage of Thalidomide are pseudo abdomen and neuropathy. These side effects produce unbearable pains and the relief is only possible through molecular ministration, which is too expensive for the patient and the government does not support this kind of therapy.


History

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Prominence Photo

1954: Thalidomide is developed in Germany, to be used as a tranquilizer and seasickness.

1957: The drug begins to be commercialized in 146 countries..

1960: the terrible side effects of the drug in pregnant woman are discovered: during the first three months of pregnancy the drug causes fetal abnormalities - Focomelia (stops the development of the fetus limbs, making them similar to seals').

1961: the drug is removed from the market in all countries, except in Brazil. People from many countries began to ask for indemnification.

1965: An Israeli doctor, Mr. Jacobo Sheskin, discoveres the beneficial effects of Thalidomide in the treatment of Leprosy and the drug begins to be commercialized.


Thalidomide in Brazil:

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Prominence Photo

1957: The commercialization of the drug begins.

1965: After a delay of at least 4 years the drug is out of circulation. In practice, it has been still largely used for the treatment of Leprosy, due to lack of information, distribution without control, governmental omission, self medication and economical power of laboratories. Since the drug had been taken by pregnant women we had the second generation of Thalidomide victims.

1976: The juridical processes against Laboratories and the Brazilian Government begin.

1982: after many manifestations, the government has to set the Law 7.070 on December, 1982. The victims of Thalidomide are able to draw their pensions. The amount of money received by each victim (from half to 4 minimum wages) is determined by four criteria of judgments: nutrition, standards of hygiene, locomotion and physical disability to work.

From 1986 to 1991: the amount of money paid by the government to the victims does not increase in line with the high inflation and inflationary trends in Brazil; as a result their pensions turn to be out of phase.

1992: the ABPST - Brazilian Association of Thalidomide Syndrome's Victims is legally established in order to help many Thalidomide victims request their legal rights.

1994: the first law is published - Regulation 63 on July 04th 1994, against the usage of Thalidomide by fertile women.

1996: a special interest group elaborates a set of rules to control Thalidomide usage.

1997: a law - Regulation no. 354 is published on August 15th 1997, to regulate the registration, production, commerce, prescription and distribution of the products derived from Thalidomide.

2003: sanction of the Law no.10.651 on April 16th 2003, about the usage control of Thalidomide.

2005: publication of Public Consultation no.63 in order to propose a new set of rules for Thalidomide's usage.

2005: publication of Law no. 356 on October 10th 2005 eliminates Public Consultation no. 63.

2006: the ANVISA - National Agency of Sanitary Supervision promotes a Panel for the Therapeutic Usage of Thalidomide.

2007: new meeting is held in ANVISA - National Agency for Sanitary Surveillance aimed at easing the use of Thalidomide.

From 1990 to 2000: the continuous usage of Thalidomide for many other kinds of diseases treatment, such as Lupus, Cancer, Leukemia, Vitiligo, Hoof-and-mouth disease, Tuberculoses, etc. causes lots of new victim births (the Second and Third Generations), thanks to people and doctors' lack of information and SELF-MEDICATION, a very common practice in Brazil.


Telephone: +55 (11) 5562.4922     E-mail: talidomida@talidomida.org.br