Arthrotec Lawsuits

Research published in December 2011 found a link between the maternal use of NSAID painkillers (a class of drugs that includes Arthrotec) and an increased risk of having a baby with cleft lip, cleft palate, spina bifida, amniotic band syndrome, and two types of severe eye birth defects that cause permanent blindness. These rare birth defects can cause lifelong disability or death.

Arthrotec Overview

Arthrotec is an arthritis medication that is actually a combination of two drugs: diclofenac and misoprostol. Diclofenac is an NSAID anti-inflammatory medication, and misoprostol helps protect a user’s gastrointestinal tract. Arthrotec is commonly prescribed to treat the symptoms of rheumatoid arthritis and osteoarthritis, two inflammatory conditions that cause chronic pain, tenderness, stiffness, and swelling of the delicate lining between the joints.

Diclofenac belongs to a class of medications known as “Non-Steroidal Anti-Inflammatory Drugs” or NSAIDs for short. This class of medications includes aspirin, naproxen, and ibuprofen, making them the most commonly used medications in the world. Millions of people use these medications to treat mild to moderate pain, inflammation, reduce fever, and more. Unfortunately, the chronic use of these medications has been linked to stomach ulcers and other gastrointestinal problems. Because arthritis is a chronic condition, many people who were taking an NSAID as a treatment were suffering from gastrointestinal problems. As a solution, the makers of Arthrotec combined diclofenac with another drug, misoprostol.

Diclofenac inhibits enzymes in the body that are involved in pain and inflammation. These enzymes also help protect the lining of the stomach and promote clotting. Misoprostol is a synthetic enzyme that stimulates the stomach to produce mucus, which protects the lining of the stomach and the gastrointestinal tract.

Arthrotec and Pregnancy

Unfortunately, new research has emerged that has found a link between the maternal use of NSAIDs (such as Arthrotec) and an increased risk of several severe, debilitating birth defects. Researchers now recommend that women who are pregnant avoid taking all NSAID painkillers while they are pregnant, and talk to their doctor about alternative painkillers that are less risky to an unborn baby.

The following birth defects were linked to the maternal use of NSAIDs:

• Clubfoot: This is a birth defect that can affect one foot or both feet. Clubfoot is diagnosed in a physical examination when the baby is born. The foot is turned inward or downward at the ankle, resembling a club. One treatment option involves gradually stretching and casting the foot. A typical regimen of stretching, casting, and wearing a brace will last three years. Ideally, the child will have a normal foot by the time he or she is learning how to walk.
• Amniotic Band Syndrome (ABS): The severity of ABS varies greatly. ABS may cause no problems, or it can cause amputations, deformities, miscarriage, and death. On its own, ABS is not a birth defect, but rather a complication that occurs during fetal development. It is thought to occur due to a partial rupture in the amniotic sac that causes bands of the sac to separate. Fibrous bands float in the amniotic fluid and can entangle a developing baby.
• Cleft Lip and/or Cleft Palate: These birth defects are 30-80% more likely to occur in babies born to mothers who took an NSAID, such as Arthrotec, during pregnancy. They can cause serious problems eating, sucking, and swallowing, and can lead to severe nutritional deficits if they are not managed properly. Fortunately, advancements in modern surgery have greatly improved the outcome for children born with cleft lip or cleft palate.
• Anophthalmia / Microphthalmia: When a baby is born with no eyes, this condition is called anophthalmia. When a baby is born with abnormally small eyes that are almost always blind or nearly blind, this is called microphthalmia. The two terms are sometimes used interchangeably. There is no cure for either of these conditions. Advancements in modern surgery can improve the facial appearance of a baby born with one of these conditions, and may include fitting the child with a prosthetic eye. The risk of anophthalmia and microphthalmia increases by a three-fold rate when mothers take NSAIDs during pregnancy.
• Spina Bifida: The risk of spina bifida was 60% higher in babies born to women who took an NSAID, such as Arthrotec, during pregnancy. Many children who are born with spina bifida have some level or paralysis and will need to use a wheelchair or other assistive device. In the most severe cases of spina bifida, the child is born with severe paralysis of the legs and may also be incontinent. Spina bifida is caused by the abnormal development of the neural tube, which normally protects and covers the spinal cord. If there is an opening in the neural tube, the spinal cord can become permanently damaged.

Scientific Studies of Arthrotec and Birth Defects

The researchers who found the link between common NSAIDs and the aforementioned birth defects announced the results of their study in December 2011 in the American Journal of Obstetrics and Gynecology. They were pleased to report that the maternal use of medications does not increase the risk of most birth defects. However, a few rare birth defects were more likely when a woman took an NSAID during pregnancy. The risk was greatest when she took the medications early in pregnancy.

The researchers analyzed the following data: information on 15,000 women who participated in the National Birth Defects Prevention study, compared with information on 5,500 women whose babies had no birth defects.

The researchers looked for links between the maternal use of painkillers and 29 different birth defects. Of these 29 birth defects, 7 birth defects were associated. However, because these birth defects were exceptionally rare, even a three-fold increase in the rate of these birth defects translates to relatively few cases. Even so, the researchers concluded that women who are pregnant should avoid using NSAIDs, including Arthrotec, during pregnancy until more conclusive research is conducted.