Clomid (clomiphene citrate) is an orally administered, non-steroidal, ovulatory stimulant intended to assist in the process of ovulation in women who are unable to do so themselves. In doing so, Clomid may assist in the treatment of infertility and help women become pregnant. Unfortunately, the prolonged use of Clomid may coincide with catastrophic complications. Women who continue Clomid treatment may significantly increase the risk of their child developing a distinct set of severe, life-threatening congenital birth defects.
If you or a loved one has been injured by Clomid, you should contact our lawyersimmediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Clomid Lawsuit Overview
Clomid was originally developed on February 1, 1967 by Sanofi Aventis. After garnishing the approval of the U.S. Food and Drug Administration (FDA), Clomid became a viable treatment option in the fight against infertility for millions of women across the United States.
Clomiphene citrate, the active ingredient found in Clomid, resides in a class of medications known as ovulatory stimulants. As their name suggests, ovulatory stimulants function much like estrogen, a female hormone that promotes the development of eggs in the ovaries. Clomiphene citrate is capable of interacting with estrogen-receptor-containing tissues. Furthermore, it may compete with estrogen for estrogen-receptor-binding sites and may delay replenishment of intracellular estrogen receptors. As a result, clomiphene citrate initiates a series of endocrine events culminating in a preovulatory surge and subsequent follicular rupture. This initiates the growth of the ovarian follicle and an increase in the circulating level of estradiol. The culmination of which results in the creation of fertile eggs.
Unfortunately, studies suggest that clomiphene citrate may readily come into contact with a developing fetus. In doing so, Clomid may significantly increase the risk of a child being born with a number of severe, life-threatening birth defects. Clomid birth defects include heart defects, esophageal atresia and Dandy Walker Malformation of the brain.
Clomid Birth Defects
The following Clomid birth defects have been associated with prolonged use of the medication:
- Esophageal atresia
- Numerous heart defects
- Dandy Walker malformation
- Cloacal extrophy
- Spina bifida
- Autism spectrum disorders
- Penoscrotal hypospadias
- Down’s Syndrome
- Cleft lip & cleft palate
- Undescended testes in males
Due to the severity of Clomid birth defects, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Clomid lawsuit.
Centers for Disease Control (CDC) Clomid Study
According to a study published in an online journal known as Human Reproduction, there continues to be a profound association between Clomid and nine distinct types of congenital birth defects. Conducted by the Centers for Disease Control (CDC), the study reportedly involved women who used Clomid during the two months prior to becoming pregnant and the following month after conception. Researchers acknowledged an increased rate of severe, life-threatening side effects that include: anencephaly, esophageal atresia, omphalocele, three unique heart defects, Dandy Walker malformation and cloacal extrophy.
Petition for Clomid Label Change
December 2007 witnessed the filing of a citizen petition that requested the FDA, among other things, to require the manufacturers of Clomid to include a birth defect warning on the drugs’ labeling. To no avail, the citizen petition lay dormant for almost two years until the FDA denied the request. However, in October 2009, a petition for reconsideration was filed, citing multiple errors in the reasoning of the FDA’s ruling. Unfortunately, a considerable amount of time has passed since the petition asked for reconsideration. However, the delay has provided a window of opportunity for presentation of the recent findings by the CDC. Findings that should prove significant enough to update the Clomid label with the appropriate birth defect warnings.
Significant Birth Defect Studies
A number of other studies have detected a significant association between Clomid and severe, life-threatening birth defects. Most notably, however, was a 2003 study conducted by CDC epidemiologist Dr. Jennita Reefhuis and her colleagues. Borrowing data from an eight year old National Birth Defects Prevention Study, Reefhuis compared the drug’s exposure to 36 types of birth defects with 6,500 live born babies born without major birth anomalies, used as controls. No less than 22 of the remaining 27 birth defect categories likewise showed an increased risk, ranging as high as 10% after exposure to Clomid.
Do I Have a Clomid Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Clomid lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Clomid, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.