As a non-steroidal anti-inflammatory drug (NSAID), Arthrotec (generic: diclofenac & misoprostol) assists in the treatment of multiple afflictions. It’s unique dual action formula provides treatment for pain, swelling, and inflammation caused by osteoarthritis or rheumatoid arthritis in patients who are at an increased risk of developing NSAID-induced ulcers. Unfortunately, the use of Arthrotec during pregnancy may coincide with catastrophic complications. Pregnant women who receive Arthrotec treatment may increase their risk of having a child with severe, life-threatening congenital abnormalities.
If you or a loved one has conceived a child with birth defects after taking Arthrotec 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.
Arthrotec Birth Defects Lawsuit Overview
Arthrotec was introduced to the U.S. market in 1997 by G. D. Searle, a division of Pfizer. Its unique dual action formula was approved by the U.S. Food and Drug Administration (FDA) to assist in the reduction of pain, swelling, and inflammation associated with both osteoarthritis and rheumatoid arthritis.
As a non-steroidal anti-inflammatory drug, diclofenac uses a distinct mechanism of action to assist in the treatment of pain and swelling. Diclofenac 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, diclofenac assists in the treatment of pain and swelling.
Unlike similar over-the-counter (OTC) pain relievers, Arthrotec is composed of a dual action formula. As the second ingredient, misoprostol coats the lining of your stomach and lowers the chance of developing ulcers. Accordingly, both medicines are combined into one pill, making it easier to achieve arthritis pain relief and stomach protection.
Unfortunately, the introduction of both diclofenac and misoprostol during Arthrotec treatment may coincide with catastrophic complications. Studies suggest that the pharmacodynamics of these active ingredients may interfere with fetal development when taken during pregnancy. Pregnant women who receive Arthrotec treatment may significantly increase their risk of having a child with a distinct set of severe birth defects. Due to the severe nature of these complications, families may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Arthrotec birth defects lawsuit.
Arthrotec Side Effects
The following is a comprehensive list of the side effects associated with Arthrotec use:
- Chest pain
- Weakness
- Shortness of breath
- Slurred speech
- Vision problems
- Loss of balance
- Black, bloody, or tarry stool
- Coughing up blood
The severity of these side effects may indicate more severe complications associated with Arthrotec treatment.
Arthrotec Birth Defects
According to an article published Reuters, children born to mothers who took NSAIDs similar to Arthrotec during pregnancy experienced a three-fold increase in the development of severe eye conditions. Otherwise known as anophthalmia and microphthalmia, these conditions are characterized by the malformation and undervelopment of the eyes. There was also a three-fold increased risk of infants 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.
Arthrotec has been placed in Pregnancy Category X, acknowledging that studies have demonstrated fetal abnormalities and that there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience. Subsequently, Arthrotec is contraindicated in pregnant women because the misoprostol component can cause unexpected abortions. Misoprostol has been shown to cause the uterus to tear in pregnant women if it is used to induce labor or to cause an abortion after the first trimester of pregnancy.
The following is a comprehensive list of several Arthrotec birth defects that are also associated with its unique dual action formula treatment:
- Cleft lip
- Cleft palate
- Spina bifida
- Anophthalmia
- Microphthalmia
- Pulmonary valve stenosis
- Amniotic band syndrome
NSAID & Arthrotec Birth Defects
As acknowledged by a study published in the American Journal of Obstetrics and Gynecology, NSAIDs like Arthrotec 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.
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 an Arthrotec 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 Arthrotec birth defect lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has conceived a child with birth defects after taking Arthrotec 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.