Vioxx (generic: rofecoxib), was intended to assist in the treatment and prevention of several conditions. As an over-the-counter (OTC) painkiller, Vioxx was specifically developed to relieve symptoms associated with pain, swelling, and inflammation. However, Vioxx was removed from the U.S. market approximately eight years ago due to adverse cardiovascular events. Compounding the already volatile situation even further, are studies that suggest Vioxx treatment may interfere fetal development. Pregnant women who took Vioxx during pregnancy may have increased their risk of giving birth to a child with severe, life-threatening congenital abnormalities.
If you or a loved one has given birth to a child with congenital abnormalities after taking Vioxx during pregnancy, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Vioxx Birth Defects Lawsuit Overview
Merck, a worldwide leader in the pharmaceutical industry, introduced Vioxx to the U.S. market on May 20, 1999. Prior to being released, the U.S. Food and Drug Administration (FDA) bestowed Vioxx with their approval. Accordingly, Vioxx was intended to assist in the treatment and reduction of pain, inflammation, and stiffness caused by osteoarthritis, rheumatoid arthritis and certain forms of juvenile rheumatoid arthritis. Subsequent applications include the treatment of acute pain, migraines, and menstrual pain.
As a non-steroidal anti-inflammatory drug, Vioxx utilizes a distinct mechanism of action to assist in the treatment of pain and swelling. Vioxx is able to prohibit the actions of cyclooxygenase, an enzyme responsible for the production of prostagladins and thromboxane. Subsequently, prostagladins and thromboxane act as catalysts for the process of inflammation. Therefore, by preventing the actions of cyclooxygenase, Vioxx assists in the treatment of pain and swelling.
However, Vioxx was withdrawn from the U.S. market in 2004. The manufacturer of Vioxx reluctantly announced a voluntary withdrawal of the drug from the U.S. and worldwide market. The withdrawal was due to safety concerns regarding an increased risk of cardiovascular events (including heart attack and stroke) in patients taking Vioxx. Nearly eight years after its withdrawal, studies suggest that Vioxx may be responsible for additional complications. According to data, the pharmacodynamics of Vioxx may have interfered with fetal development in pregnant women. Subsequently, pregnant women who used Vioxx may have increased their risk of giving birth to a child with severe, life-threatening congenital abnormalities. Due to the severe repercussions of combining Vioxx and pregnancy, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Vioxx birth defects lawsuit.
Vioxx Birth Defects
According to an article published Reuters, children born to mothers who used NSAIDs while they were pregnant exhibited a propensity for a three-fold increase in the development of anophthalmia and microphthalmia. Women also experienced a three-fold increased risk of their child being born with amniotic band syndrome (ABS), a defect that occurs when strands of the amniotic sac tear in the womb and entangle digits, limbs, or other parts of the developing fetus.
Compounding concerns are recent statistics acknowledged by the Centers for Disease Control and Prevention (CDC). According to their studies, anophthalmia and microphthalmia occur in approximately one out of every 5,300 live births in the United States, while ABS was found in about one in 10,000 newborn babies.
The following is a comprehensive list of several Vioxx birth defects that are also associated with rofecoxib treatment:
- Cleft lip
- Cleft palate
- Spina bifida
- Pulmonary valve stenosis
- Amniotic band syndrome
NSAID & Vioxx Birth Defects Study
As acknowledged by a study published in the American Journal of Obstetrics and Gynecology, NSAIDs like Vioxx may be responsible for a moderate increase in the development of several birth defects. Accordingly, the study was conducted to determine if the use of NSAIDs during early pregnancy are associated with a distinct range of structural and anatomical birth defects.
As a multi-site population-based, case control study of risk factors for birth defects, officials examined women from all over the United Sates. During the course of the interview process, women were frequently asked about the specific NSAID drugs they took during their first trimester of pregnancy.
Among the women who participated in the National Birth Defects Prevention Study, 22.6% reported the use of NSAIDs in their first trimester of pregnancy, most commonly ibuprofen, aspirin, and naproxen. Out of the 29 defect groups examined, several exhibited a small to moderate increase after ibuprofen, aspirin, and naproxen exposure.
Several abnormalities exhibited a larger increase in their occurrence rate than others. Distinct birth defects were slightly increased in babies whose mothers reported taking ibuprofen, aspirin or naproxen during their first trimester of pregnancy. The risk of cleft palate rose by as much as 80% in some cases, while spina bifida jumped by 60%.
Do I Have a Vioxx Birth Defects 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 Vioxx birth defects lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has given birth to a child with congenital abnormalities after taking Vioxx during pregnancy, 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.