Clomid

Clomid is a popular fertility drug that has been on the market for nearly 50 years.  During this time thousands, perhaps millions, of women have used the drug in order to help them become pregnant.  However, it was not until recently that studies have shown the drug leads to an increased risk of the child being born with severe birth defects.  If you have taken Clomid, and your child was subsequently born with birth defects, you may be able to take part in a Clomid lawsuit to be compensated for medical expenses and other damages.  Schedule your free initial consultation with an attorney from Arentz Law Group P.C. today by calling 1-800-305-6000, or by filling out the contact form on this page.

What is Clomid?

Clomid is comprised of the chemical clomiphene citrate.  It is an ovulatory stimulant, and helps the body to produce eggs.

One of the main reasons that women are unable to have children is because their ovaries don’t produce eggs.  While there are many causes for non-functioning ovaries, it is known that estrogen will help encourage egg development in the ovaries.  For women who have infrequent or no ovulation, Clomid works to “jumpstart” the ovulation cycle.  It works well too, with nearly 80% of women ovulating within a year of starting the drug.  However the downsides of taking it have led to many women filing their Clomid lawsuit.

Clomid Side Effects

Clomid has two sets of side effects.  There are those that affect the mother and those that can affect the child when it is born.  The drug is one of the safer drugs out there when it comes to side effects on the mother.  

They include:

• Nausea and vomiting
• Breast tenderness
• Flushing
• Headache
• Blurred vision
• Abnormal uterine bleeding

While these are nowhere near normal, many are not life threatening and will quickly go away when the drug has left the system.

Of a more serious note, however, are the side effects that can affect the child when Clomid is not discontinued soon enough after becoming pregnant.  They include birth defects such as:

• Anencephaly – open skull often with little brain development
• Autism Spectrum Disorders
• Blindness
• Cloacal Exstrophy – exposed internal organs
• Clubfoot
• Dandy Walker Syndrome
• Down’s Syndrome
• Esophageal Atresia – undeveloped esophagus
• Heart Defects
• Hernia
• Omphalocele – organs grow outside the body
• Oral Clefts
• Penoscrotal Hypospadias – malformed penis
• Undescended Testes in Males

While a child may be able to live with some of these birth defects, there are many that are always fatal allowing them to live just a few short days before the body shuts down.  The risk of birth defects was never fully disclosed by the drug manufacturer, and it has led to many people filing their Clomid lawsuit.

How Clomid is Used

When the drug was first developed, back in the 1960’s, it was primarily used as a method to treat infrequent menstruation.  Women who only had their period 4 to 9 times per year would use the drug to help even out their flow and frequency.  However, it was discovered that those who were using Clomid became pregnant more often.  Further research showed that the use of Clomid would help with egg production and stimulate ovulation.

But there are other uses for the drug.  Many are “off-label” uses; meaning that the FDA has not approved it for that specific treatment. One of the most prominent off-label uses is for the treatment of hypogonadism, also known as low testosterone.  Testosterone replacement therapy is not only expensive, but using testosterone drugs can lead to a significantly increased risk of heart attack.  However, the use of the drug for this purpose is not approved by the FDA, and will likely never be approved.

Clomid has also been used to treat: low sperm count, male infertility, and ovary stimulation.

CDC Study on Clomid

In early 2011, the Centers for Disease Control (CDC) published a study on the Human Reproduction page of the Oxford Journals.  This study reviewed women from 10 different geographical regions who gave birth to children both with and without major defects between 1997 and 2005.  The study specifically looked at women who used Clomiphene citrate (brand name: Clomid) from 2 months prior to conception, through the first month of pregnancy.

The report went on to talk about the side effects that were most likely to occur with this drug:

While each of these severe birth defects does provide a small chance at living, the fact is most will prove fatal shortly after birth. There is only so much that corrective surgery can accomplish. It is due to this pain and suffering that a family will file a Clomid lawsuit; there should be some sort of recompense for the anguish they are put through.

Types of Infertility

There is no one cause of infertility, but the outcome is always the same.  Some women just have a hard time getting pregnant.  For some it is due to the shape of the uterus.  For others it is due to various genetic factors.  For about 25% of the infertile population, it is due to the fact that the ovaries are not producing eggs.  These women actually have the easiest to treat infertility, and a lot of them turn to Clomid due to its 80% success rate and the fact it can be taken orally.

Types of Fertility Drugs

Clomid is not the only fertility drug on the market.  Other drugs, such as Pregnyl, Novarel, and Profasi are also used to trigger a release of eggs from the ovaries.  Drugs like Pergonal, Lupron, Zoladex, and Cetrotide work to release other hormones that will help to trigger ovulation and hopefully allow the female to become pregnant.  The bottom line is that there are many different options out there, and some may become more popular as many women are filing their Clomid lawsuit due to the severity of the birth defects associated with the drug.

Clomid Lawsuits

Even before the CDC issued this report, it was known that Clomid caused birth defects.  In fact, the FDA was petitioned in 2007 to require a warning on Clomid regarding the risk of birth defects.  There was no response for 2 years when the FDA finally declined to provide the warning.  The petition was resubmitted, and has not yet been acknowledged.

This data released by the CDC, accompanied by greater awareness of the dangers of the drug, have led to a number of Clomid lawsuits.  Many women have realized that they were not responsible for the birth defects their children were suffering from, and are seeking compensation from the drug company for the damages and trauma that they have undergone.

Clomid’s Beginnings

In the early 1960’s the idea for Clomid was well underway.  However, it was not being studied as a way to help women who were unable to ovulate.  Instead, this drug was being developed as a treatment for women suffering from infrequent menstruation.  The idea was they could use this drug to level out their period cycles, and make sure they were having a sufficient number of periods each year.

It was not until a few years after the drug was approved by the FDA that it was discovered to help women produce eggs when before they were unable.  It was discovered that women using the drug were suddenly becoming pregnant at a higher than normal rate.

Throughout the years the drug had its ups and downs, but it remained popular because it works incredibly well.  But it does have a darker side to it.  Clomid has gone under the radar without being issued many warnings or having their label updated to include various side effects like other drugs have.  And despite the petition to the FDA in 2007 to include a warning about severe birth defects, the drug still does not include that warning.

Clomid’s Popularity

Since it has been nearly 5 decades since Clomid was approved by the FDA, and subsequently a number of years since the patent ran out of the medication, there is not a lot of data on how many people actually take the drug.  However, it is safe to assume that nearly everyone who fits the treatment will have used it.

It is estimated that out of all the women who suffer from infertility, it is due to a problem with ovulation in about 25% of them.  This is precisely the problem that Clomid aims to remedy.  Since there are about 6.5 million women out there who are unable to become pregnant, that means there are an estimated 1.6 million potential Clomid users.  If even a fraction of those use this drug, it is still being prescribed hundreds of thousands of times each year.

What that means for the manufacturing company is that Clomid has brought them millions of dollars over the years.  With so many women using the drug, the company has been able to grow incredibly bringing in over $700 million annually.  Despite the drug’s success, there are a number of women who have filed their own Clomid lawsuit because of the harm it causes the unborn children.

Clomid’s Serious Side Effects

When a female becomes pregnant with the help of Clomid, the drug must be discontinued long before conception.  However, since she is already having trouble conceiving, there is no guarantee that conception has occurred.  This means many women continue to use this drug, even though they are already pregnant.

When Clomid is taken during pregnancy, studies have shown it leads to a significantly elevated risk of some serious side effects including: anencephaly (basically the child is born without a brain), septal heart defects (a hole in the heart), Dandy-Walker malformation (incomplete brain development), omphalocele (internal organs sticking out of the belly button), and many more.  These side effects may be corrected, but the child will have to live with scars and other difficulties of daily life.

FDA Warnings About Clomid Use

Before a drug can be made available to the public it undergoes rigorous testing. This testing is designed to bring to light all of the potential side effects of taking a drug. However, there are times when some side effects are not seen during the testing period, and the FDA has warnings and updates for the drug after it has been made available. Clomid, despite the risk of severe birth defects, has surprisingly few of these warnings. In fact, there are none.

2007 Petition for Birth Defect Warning

The only information available is the 2007 citizen petition for the FDA to require a warning label about the risk of birth defects. This petition was based on a number of studies that showed birth defect rates were higher when women took Clomid to become pregnant. The FDA tabled the petition for two years before finally denying it, saying there was not enough evidence to prove correlation.

2009 Appeal

In 2009 an appeal was made regarding the citizen petition. This reopened the petition, and the FDA once again was asked to require a warning label. The FDA has since ignored that request. However, with the 2011 report from the Centers for Disease Control showing that there is indeed an increased risk, the FDA may finally include the warning. As it is now, the description of the drug states that the risk of birth defects is within the range for the general population.

Contact Arentz Law

If you have used Clomid, and your child was born with birth defects, the attorneys with Arentz Law Group want to speak with you right away.  By calling 1-800-305-6000, or by filling out the contact form on this page, you can begin the process to determine if you have a Clomid lawsuit, and if you will be able to recover compensation for medical expenses.

Clomid attorneys with Arentz Law can work with clients in all 50 states.