Tell The FDA To Take Accutane Off The Market & To Help Stop Disabling Birth Defects in This Country!
- von: Laura Ferguson
Urge the FDA to take ACCUTANE off the market! We as U. S. Citizens should have the right to ban drugs that cause BIRTH DEFECTS in this Country!
This Drug was televised this morning to warn women not to take this medicine and if the do to enrole in a program to to be tested to see if they are preganant. If this drug causes birth defects as it is clearly stated in the warning label, why even sell or prescribe it to anyone! How do these people know how much and what levels of this drug is safe for women and what about future pregnancy after taking this medicine? Is our skin worth the risk of our children? NO!
Here is what is stated in the Warning Label of ACCUTANE!
CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by females who are pregnant or who may become pregnant while undergoing treatment. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can result if pregnancy occurs while taking Accutane in any amount even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. Presently, there are no accurate means of determining after Accutane exposure which fetus has been affected and which fetus has not been affected.
Major human fetal abnormalities related to Accutane administration have been documented: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); skull abnormality; external ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); cardiovascular abnormalities; facial dysmorphia; cleft palate; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. Cases of IQ scores less than 85 with or without obvious CNS abnormalities have also been reported. There is an increased risk of spontaneous abortion. In addition, premature births have been reported.
It is strongly recommended that a prescription for Accutane should not be issued by the prescriber until a female patient has had negative results from two urine or serum pregnancy tests, one of which is performed in the prescribers office when the patient is qualified for Accutane therapy, the second of which is performed on the second day of the next normal menstrual period or 11 days after the last unprotected act of sexual intercourse, whichever is later. It is also recommended that pregnancy testing and counseling about contraception and behaviors associated with an increased risk of pregnancy be repeated on a monthly basis. To assure compliance, the prescriber should not issue a prescription for a female patient, until after the second negative pregnancy test result is obtained. In addition, the prescriber should prescribe no more than a 1-month supply of the drug for all Accutane patients and no automatic refills should be permitted. Roche will supply urine pregnancy test kits for female Accutanepatients for the initial, second, and monthly testing during therapy.
Effective contraception must be used for at least 1 month before beginning Accutane therapy, during therapy, and for 1 month following discontinuation of therapy even where there has been a history of infertility, unless due to hysterectomy. The patient must be counseled about and understand the limitations of any chosen contraceptive method. The patient must also understand the risks associated with not using two contraceptive methods, even when one of the chosen methods is a hormonal contraceptive method.
Any birth control method can fail. Therefore, it is critically important that women of childbearing potential use two effective forms of contraception simultaneously, unless absolute abstinence is the chosen method, even when one of the forms is a hormonal contraceptive method. Although hormonal contraceptives are highly effective, there have been reports of pregnancy from women who have used oral contraceptives, as well as injectable/implantable contraceptive products. These reports are more frequent for women who use only a single method of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with Accutane.
IF a pregnancy does occur during treatment, the prescriber and patient should discuss the desirability of continuing the pregnancy. Prescribers are encouraged to report all cases of pregnancy with specific information about the contraceptive forms used during Accutane therapy and for 1 month following therapy, either to the Roche Medical Services @ 1-800-526-6367 or to the Food and Drug Administration MedWatch Program @ 1-800-FDA-1088. (this info is courtsey of the FDA and the site address is: http://www.fda.gov/cder/foi/label/2000/18662s40lbl.pdf )
This is not just a warning for those women who take it but any women who handle this drug!
This is an unsafe drug that needs to be taken off the market!
If you have a disabled child or know someone who has a disabled child then you know that have drugs such as ACCUTANE on the market is unsafe for women and their future children!
Help stop Disabling Birth Defects in this Country!
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