- Joined
- Feb 20, 2021
Isotretinoin is one of the most potent fetal teratogens on Earth. Even very brief exposure to it or to other oral retinoids within a few days prior to conception or at any time during pregnancy has been known since the 1980s to cause a characteristic pattern of catastrophic congenital anomalies in both laboratory models and in the human fetus.Asking a girl to get a pregnancy test to make sure accutane doesn't fuck her shit up? DYSPHORIC.
Retinoic acid embryopathy is associated with spontaneous abortion (miscarriage), and approximately 35% of individuals surviving to birth will have at least one major malformation, or "structural changes that have significant medical, surgical, social or cosmetic consequences for the affected individual, and typically require medical intervention".
Isotretinoin has been designated a Pregnancy Category X drug by the United States Food and Drug Administration, which means that there is positive evidence for its teratogenicity in human beings and its use is absolutely contraindicated during pregnancy and in women who are trying to conceive. Exposure during the periconception period and into the first trimester is particularly pernicious, and women who aren't actively trying to get pregnant may have no idea they have conceived that early unless they are tested. In this situation, you cannot take a patient at her word, because if she's wrong or lying, the outcome can be grave.
Isotretinoin has been designated a Pregnancy Category X drug by the United States Food and Drug Administration, which means that there is positive evidence for its teratogenicity in human beings and its use is absolutely contraindicated during pregnancy and in women who are trying to conceive. Exposure during the periconception period and into the first trimester is particularly pernicious, and women who aren't actively trying to get pregnant may have no idea they have conceived that early unless they are tested. In this situation, you cannot take a patient at her word, because if she's wrong or lying, the outcome can be grave.
Because of its teratogenicity, isotretinoin is subject to an FDA program called a Risk Evaluation and Mitigation Strategy (REMS). A REMS imposes additional legal restrictions upon the use of a very small number of drugs which are approved for use in humans but are known to be associated with a particular serious adverse event. According to FDA, the program "focus[es] on preventing, monitoring, and/or managing a specific serious risk(s) associated with certain drugs by informing, educating, and/or reinforcing actions to reduce the frequency and/or severity of a particular adverse event(s)." In theory, the program makes it safer to provide access to medications that would otherwise not be granted FDA approval because of patient safety concerns.
The actual provisions of a REMS are specific to each drug. In the case of isotretinoin products, the REMS program is called iPLEDGE. Physicians, other healthcare providers, pharmacists, and patients are required by law to enroll in iPLEDGE in order to prescribe, dispense, or receive oral isotretinoin products. The requirements for female patients of childbearing age are necessarily draconian. Women must agree to either abstain completely from sexual intercourse or to use at least 2 different forms of contraception*, not just during active treatment with isotretinoin, but also for 30 days prior to taking the first dose and 30 days after taking the last dose. Two negative pregnancy tests, taken at a certified lab least 19 days apart, are required prior to receiving a prescription, and monthly pregnancy tests must be taken in order for the prescription to be refilled. The physician must document the results of each pregnancy test and record the 2 forms of contraception being used within 7 days of writing a prescription.
The actual provisions of a REMS are specific to each drug. In the case of isotretinoin products, the REMS program is called iPLEDGE. Physicians, other healthcare providers, pharmacists, and patients are required by law to enroll in iPLEDGE in order to prescribe, dispense, or receive oral isotretinoin products. The requirements for female patients of childbearing age are necessarily draconian. Women must agree to either abstain completely from sexual intercourse or to use at least 2 different forms of contraception*, not just during active treatment with isotretinoin, but also for 30 days prior to taking the first dose and 30 days after taking the last dose. Two negative pregnancy tests, taken at a certified lab least 19 days apart, are required prior to receiving a prescription, and monthly pregnancy tests must be taken in order for the prescription to be refilled. The physician must document the results of each pregnancy test and record the 2 forms of contraception being used within 7 days of writing a prescription.
Very high dose isotretinoin is now commonly used in the last phase of frontline treatment of a rare but deadly pediatric cancer called neuroblastoma. Even preadolescent girls with cancer must be enrolled in the iPLEDGE REMS program and agree not to become pregnant while receiving isotretinoin therapy.
The typical malformations associated with isotretinoin exposure are horrifying; we are not talking about a cute little supernumerary digit or two. The physician iPLEDGE prescriber guide indicates that the following anomalies have been described in fetuses exposed to isotretinoin.
External Abnormalities
Skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate.
Internal Abnormalities
CNS abnormalities including cerebral
abnormalities, cerebellar malformation,
hydrocephalus, microcephaly, cranial nerve deficit; cardiovascular abnormalities; thymus gland abnormalities; parathyroid hormone deficiencies.
In some cases, death has occurred with certain of the abnormalities noted.
Skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate.
Internal Abnormalities
CNS abnormalities including cerebral
abnormalities, cerebellar malformation,
hydrocephalus, microcephaly, cranial nerve deficit; cardiovascular abnormalities; thymus gland abnormalities; parathyroid hormone deficiencies.
In some cases, death has occurred with certain of the abnormalities noted.
So, no shit you had to take a pregnancy test, you reprehensible pooner. Fuck you.
" teens and enormous black cocks to wank to like a normal degenerate?
