The CDC study on birth defects includes a popular fertility drug
On November 26, 2010, the medical journal Human Reproduction published online the results of a study by the Centers for Disease Control and Prevention (CDC), which showed that the fertility drug clomid (clomiphene citrate) was associated with an increased risk of 9 different types of birth defects the use of the popular drug.
The abnormalities included a 130% increase in anencephalic risk (open skull without brain); a 130% increased risk of esophageal atresia (closed esophagus); a 120% increased risk of omphalocele (part of the intestine protruding through the abdominal wall); a 90% increased risk of craniosynostosis (premature fusion of the cranial bones); increased risk of 3 different types of heart defects between 60% and 390%; and a 340% increased risk of brain failure (dandy walker deformity). The ninth defect (exstrophy of the cloaca) is associated with several defects in the gastrointestinal and urogenital tract, and the study showed a 440% increase in the risk of this serious birth defect.
Based on data from the National Birth Defects Prevention Study from 8 years, the CDC epidemiologist, Dr. Jennita Reefhuis and colleagues exposed the drug to 36 types of birth defects with 6,500 unborn live birth birth defects, used as controls. 22 of the 27 categories of remaining birth defects also showed an increased risk, which was between 10% and 170% after exposure to Clomid, although the numbers are not sufficient to achieve the scientific standard of "statistical significance".
The FDA is now facing a dilemma that will be more difficult to deal with. Previously, the agency had ignored preliminary results from the CDC study, which reported in July 2008 that exposure to clomid was associated with an increased risk of developing four different types of birth defects - a list that has now increased to nine , , The alleged justification for challenging these results was that they had not yet been reported in a newspaper.
However, previous studies published in peer-reviewed journals using the same drug have also been overlooked. These include reports of an increased risk of craniosynostosis in 2003 (Reefhuis et al.); an increased risk of neural tube defects in 2004 (Medveczky et al.); an increased risk of penoscrotal hypospadias in 2006 (Meijer et al.); an increased risk of spina bifida in 2006 (Wu et al.); and an increased risk of neural tube defects if the drug produces ovarian cysts in 2008 (Banhidy et al.). Since anencephaly (cranial involvement) and spina bifida (spinal involvement) are both neural tube defects (NTDs), 4 studies with an association between Clomid and MTN have been published in the course of the past 6 years - neither of which prompted the FDA to request a warning.
In December 2007, a citizen petition was submitted to the FDA stating, among other things, that the regulatory agency should ask Clomid manufacturers and its generics to include a warning about birth defects in drug labeling. After being present for one year and nine months, the FDA rejected the application. However, in October 2009, a renewed review request was made, citing several reasons for the FDA's decision. Another 14 months have passed without a final decision - a delay that gives an opportunity to present the latest CDC results.
Will the FDA ignore an official study from another federal government? After 43 years on the market, are consumers of this popular fertility drug finally being warned of the potential risks to babies that they desperately need? Stay tuned as this saga continues to unfold. For anyone interested in discussing the petition, I recommend that you consult the FDA-2007-P-0234. In addition to a scientific debate on the subject, these documents reflect an organization that is committed to maintaining the status quo rather than following the mandate of federal law to require warnings of possible serious adverse drug effects.
Time will tell if the FDA has an obligation to protect the public or, on the contrary, the interests of the industry that need to be regulated.
Increase your fertility
Women today have more choices than ever before and choose not to have children. It may be good for their careers, but it can also make pregnancy difficult as they get older. To increase their chances, some women consider taking fertility drugs despite the risks they pose.
Having a child is a crucial moment in a couple's life together, so many women do everything they can to be fertile.
The drug Clomid or Clomiphene Citrate has become a popular fertility drug for mothers who have failed to conceive naturally. This is despite the fact that the drug is said to cause hair loss in some women. Their desire to have children is so great that they are ready to endure the side effects.
Hair loss is just one of the many possible side effects of Clomid or Clomiphene. The drug is known to cause multiple births. Some mothers had twins, triplets, and even quadruplets after using it. This may be good news for some couples, but others may not want to risk it.
Carrying multiple fetuses can be problematic for mothers and unborn children. Mothers may experience abdominal pain, flatulence, increased appetite, rashes, depression, dizziness and tiredness.
As mentioned earlier, Clomid can cause hair loss in some women, but it has been shown to increase fertility. Fertility drugs often have many side effects.
If you have considered the possibility of side effects and are still determined to have a baby, you should discuss Clomid or Clomiphene with your doctor.
Many couples dream of starting a family, but do not get it naturally. If you want to increase your chances, fertility drugs are known. However, they have a price. A variety of side effects, some minimal and some serious, have been documented by users. Discuss your options with your doctor and he or she will help you decide what is right for you.