Lindsey C. Whitener

Nearly a year later, Whitener saw a television commercial about the adverse events linked to the heartburn drug Reglan. The medication had recently been hit with a black box warning after numerous reports of consumers who took Reglan and developed a serious involuntary movement disorder known as Tardive Dyskinesia. Whitener also learned that the drug was not approved by the Food and Drug Administration (FDA) for use during pregnancy, though some studies suggested it was a safe treatment for morning sickness. Whitener spoke with various health care professionals and none could rule out the possibility of Reglan causing or contributing to her son’s birth defects.

Whitener and Lucas’ father Joshua A. Whitener, Sr., both individually and on behalf of Lucas, have filed a lawsuit against Pliva Inc., Pliva USA, Pliva Pharmaceuticals Inc., Barr Laboratories, Barr Pharmaceuticals, Watson Pharmaceuticals, Teva Pharmaceuticals Industries, Teva Pharmaceuticals USA, Rue De Sante Women’s Center, and John McCrossen. The Whiteners are seeking damages for pain and suffering, permanent disabilities, fear, mental anguish, loss of love and affection, loss of companionship, grief and mental anguish, loss of society and consortium, loss of personal service, loss of support, medical expenses, lost wages, and other financial loss/detriment.

SOURCE: Reglan Side Effects › Lawsuit blames Reglan for causing son’s birth defects

Metoclopramide

This is promising news, considering there are no FDA-approved drugs to treat morning sickness, and drugs once thought safe for unborn babies, such as Thalidomide and Bendectin, were later linked to serious birth defects such as limb deformities.

Critics argue that there is not enough good-quality evidence that metoclopramide is safe for pregnant women or that it is effective in curtailing nausea and vomiting. One study of 40 women found that steroids worked better than metoclopramide for women, resulting in fewer times a woman vomited and eliminating the need for hospitalization.

Another concern about metoclopramide is the black box warning that is now on the drugs. The new labeling warns patients treated with metoclopramide of the risk of developing a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. The symptoms, which include jerking, facial twitches and involuntary movements of the hands and tongue, often do not go away after treatment is discontinued.

The risk of Tardive Dyskinesia is even greater for patients who take the metoclopramide for 12 weeks or longer, with some studies showing as many as 20 percent of long-term users developing the condition.

Serious morning sickness can cause problems for both the mother and her unborn child, which is why women who suffer from morning sickness should thoroughly discuss their treatment options with their physician to better understand the benefits and risks.

SOURCE: Reglan Side Effects › Pregnant women should weigh risks of morning sickness medications

While researchers are calling this encouraging news to pregnant women, the U.S. Food and Drug Administration (FDA) says more studies must be conducted before the agency will grant approval for the drug to be used in the treatment of morning sickness. After all, the drug carries a black box warning to consumers and health care providers of a serious, debilitating and often irreversible movement disorder called Tardive Dyskinesia. Other problems, it appears, may occur when the medication is taken on a long-term basis, even for pregnant women. 

According to the Canadian research, the length of time on the drug seemed to play a role in the likelihood of birth defects. Children from mothers who took the drug just one week during the first trimester had a 4.9 percent birth defects rate, while babies from mothers who used the drug for more than three months had a 6.1 percent rate of birth defects.

Reglan is approved in the U.S. by the FDA to treat heartburn and a condition known as diabetic gastroparesis. Earlier this year, the FDA issued a black box warning on the medication warning of the increased risk of Tardive Dyskinesia. Individuals who take the medication for longer than 12 weeks are at greatest risk of developing the condition. Elderly women, especially women, are also at greater risk than the general population. Some studies put the risk as high as 20 percent among long-term uses of Reglan.

Source: Calorie Lab

SOURCE: Reglan Side Effects › Study: Effect of Reglan on increased risk of birth defects

A study of more than 80,000 births to Israeli women, a country where Reglan, also known as metocloparmide, is routinely prescribed to treat nausea in pregnant women, found that there was no difference in birth defects or other problems among women whether they were taking the drug or not. The study results were reported in this week’s New England Journal of Medicine.

No drugs to treat morning sickness are currently approved for use in the U.S. Many women worry about using medication to treat morning sickness for fear of birth defects. In the 1960s, use of Thalidomide in Europe and Canada resulted in babies born with missing or shortened limbs. Another medication, Bendectin, was pulled from the market in 1983 after reports of limb deformities.

Reglan may cause side effects, such as sedation, insomnia, depression and anxiety. Long-term use of the medication has been linked to a permanent involuntary muscle movement known as Tardive Dyskinesia, which has prompted the FDA to require its manufacturer to include a black box warning on its label. Tardive Dyskinesia is a serious condition in which a person develops Parkinson’s-like symptoms such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking and facial grimacing. Even after the medication is discontinued, the condition may not go away and may severely affect one’s ability to work or perform household duties.

An estimated 2 million people use some form of metoclopramide.

SOURCE: Reglan Side Effects › Promising treatment for morning sickness, but beware of long term use