November 26, 2010, medical journal, Human reproduction The pregnancy drug Clomid (clomiphene citric acid) has found that the risk of nine congenital anomalies is significantly increased after use of preeclampsia is a disease management prevention center (CDC) popular drug.
A related abnormality increased the risk of asymptomatic (open brainless skull) by 130%. The risk of esophageal closure (closed esophagus) increased by 130%. Risk of general paralysis increased by 120% (protrusion of a part of the intestine through the abdomen). Risk of craniosynostosis (early fusion of skull) increased by 90%. The risk of three different types of cardiac defects increased in the range of 60% to 390%. Risk of brain defect (Dandy Walker malformation) has increased by 340%. The ninth disadvantage (outgrowth outgrowth) contains multiple defects in the gastrointestinal tract and urogenital tract, and it is reported that the risk of this severe congenital abnormality increases by 440%.
Dr. Jennita Reefhuis, a CDC epidemiologist and her colleagues, were exposed to drug exposure to 36 birth defects based on 8 years data from birth defect prevention studies, born of 6,500 people without birth defects Control compared to baby. Of the remaining 27 birth defect categories, risks ranging from 10% to 170% were similarly shown after exposure to Clomid, but were insufficient to reach scientific standards for statistical significance.
The FDA is currently facing a dilemma that is difficult to take side steps. The agency had previously ignored the preliminary findings of the CDC study but in July 2008 it was reported that exposure to Clomid was associated with increased risk of four congenital anomalies. The justified reason for challenging these discoveries was that they have not been reported to the journal yet.
However, in previous studies published in the peer review journal, the same drugs were ignored as well. This included an increased risk of cranial fusion in 2003 (Reefhuis, et al.); The risk of neural tube defects increased in 2004 (Medveczky, et al.). Increased risk of under penile syndrome in 2006 (Meijer, et al.); Increased spinal bifid spine risk in 2006 (Wu, et al.). When ovarian cysts are produced by drugs in 2008, the risk of neural tube defects increases (Banhidy et al.). Since both asymptomatic (including skull) and spinal cord myelopathy (including spinal cord) are neural tube defects (NTD), four studies including the association between clomid and NTD presented in the past 6 years There are FDA warnings in both cases.
In December 2007, a citizen petition was filed in the FDA's ruling that the regulatory authorities requested Clomid and its generic drug manufacturers to include prenatal warnings for drugs. labeling. The FDA refused the application after seating the petition for 1 year and 9 months. However, in October 2009, a request for reconsideration was brought up with multiple mistakes due to the FDA's ruling. More than 14 months passed without a final decision and provided the opportunity to announce the recent findings by the CDC.
Will the FDA also ignore the official investigation by another branch of the federal government? After 43 years in the market, will users of this popular fertility medicine eventually be warned about the potential risk of babies inevitably wanting? This saga continues to be developed, so please enjoy. If you are interested in discussions with discussions on civil rights claims, we encourage you to go to http://www.regulations.gov and enter the proceedings number of FDA - 2007 - P - 0234. In addition to discussions on science on issues, these documents reflect institutions that decided not to tolerate federal law obligations, but to decide to maintain the status quo. Potential Significant adverse reactions to drugs.
I understand the time when FDA is committed to protecting the public or whether it will be an industry benefit to be regulated instead.
