Clomiphene citrate, sold under the brand names Clomid and Serophene, is a non-steroidal fertility medicine used by women to stimulate the release of certain hormones needed for ovulation. Clomid can also be used to help regulate ovulation or stimulate the development of multiple eggs. Unfortunately, recent studies conducted by the Centers for Disease Control and Prevention also suggest the use of Clomid by women may increase the risks of birth defects in the unborn.
The U.S. Food and Drug Administration has issued a warning cautioning women not to use Clomid if they are pregnant. This drug has been labeled as a Category X, which indicates it can be dangerous to the fetus. The Center for Disease and Control published a new study in the journal, Human Reproduction, which evaluated the use of clomiphene citrate from 1997–2005. The study, which reviewed data used in a previous study (National Birth Defects Prevention Study) to determine if clomiphene citrate increased the risk of certain birth defects in women who used the drug.
Researchers warned the study could be inconclusive because it gathered data from only a small number of women, many of whom had other underlying issues which could have affected their infertility. In general, however, researchers did indicate that women who used clomiphene citrate reported more birth defects, including anencephaly, septal heart defects, coarctation of the aorta, and esophageal atresia, than mothers who did not take clomiphene citrate. The CDC admits more research needs to be done to conclusively argue that a link between clomiphene citrate and birth defects exists. Experts have concluded, however, that women need to understand how to take the drug properly, including timing the medication so it will not be in their system when the woman becomes pregnant.
Clomiphene citrate is the generic ingredient branded and sold as Clomid and Serophene. Although Clomid was first introduced by Sanofi, Sanofi no longer has exclusive patent rights to this product and it is marketed and sold by other pharmaceutical companies such as Par Pharm, Milex, and EMD Serono. Sanofi, however, was responsible for the development, marketing and manufacturing of this product for many years before other companies were allowed to sell it.
Sanofi is a worldwide research, development, marketing, and manufacturing company who primarily manufacturers prescription and over-the-counter medications. Sanofi, which is a company which has evolved over the years through mergers and acquisitions, began when a small group of pharmacists established a company named Laboratoires Midy. Years later, this company expanded and merged with other companies to grow into a multinational company which produces products in more than a hundred countries for thousands of patients who need help combating a variety of health conditions including cardiovascular issues, diabetes, cancer, and central nervous system disorders.
Infertile women all over the world are looking for solutions to their infertility. Unfortunately, many women may have taken Clomid without understanding the risks to their babies. In fact, many women who have had children born with severe birth defects have decided to file lawsuits against the manufacturers of Clomiphene citrate (Clomid and Serophene). If you have had a child born with anencephaly, coarctation of the aorta (narrowing of the aorta), a septal heart defect, omphalocele, craniosyntosis (premature fusion of an infant’s skull sutures), or esophageal atresia, your child may be entitled to compensation.
All product manufacturers have the responsibility to manufacture and produce products which are not dangerous and are safe when used according to the manufacturer’s specifications. Manufacturers who fail in their duty to produce safe products can be held liable for injuries caused by their dangerous and defective products.