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Reglan's pregnancy warning is as follows:
“During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.”
The Reglan warning is based on Reglan's pregnancy category, which is "Class B" — that is, the class of medicines that haven't been adequately studied in pregnant women. Class B medications’ risk to a fetus is thus not yet known. Although Reglan's effects on animals were studied and it was found that Reglan (metoclopramide hydrochloride) did not hurt the animals (e.g., rats), it is well established that animals do not necessarily respond to drugs the same way that humans do.
Reglan is in the same pregnancy category as Zofran (ondansetron), a relatively new drug used to prevent and treat nausea and vomiting induced by chemotherapy. Such Class B medications should be used by a pregnant woman only if she and her doctor conclude that the benefits for her outweigh any possible risks to her unborn child.
Although Reglan was never approved by the FDA for treating morning sickness — the nausea, vomiting and food/smell aversion syndrome that pregnant women often experience — it has been prescribed for this purpose, usually as 5-mg-dose metoclopramide tablets.
Reglan is FDA-approved as a treatment for nausea and GERD (gastroesophageal reflux disease, one symptom of which is heartburn), and plenty of pregnant women report symptoms of nausea and heartburn to their doctors, but Reglan should not be a first-choice treatment for these symptoms.
A pregnant woman experiencing nausea, heartburn, GERD or diabetic gastroparesis should discuss the potential side effects of Reglan treatment with her doctor — and again with her pharmacist if she begins Reglan treatment. Even the relatively mild Reglan side effects can be quite troubling:
The more dangerous, perhaps permanent and even life-threatening potential side effects of Reglan use are tardive dyskinesia and neuroleptic malignant syndrome.
If you or a woman in your life suffered adverse effects of Reglan treatment while pregnant, contact a knowledgeable attorney today to discuss your concerns. An experienced Reglan lawyer will help you recover the compensation you are entitled to for injuries sustained.
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