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Chronic metoclopramide use linked to tardive dyskinesia
The FDA notified health care professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.
Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment.
Metoclopramide is available in a variety of formulations, including tablets, syrups, and injections. Names of metoclopramide-containing products include Reglan® tablets, Reglan oral disintegrating tablets, metoclopramide oral solution, and Reglan injection.
Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide that discusses this risk. Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment.
Licorice blocks absorption of cyclosporine used by transplant patients
Chemists in Taiwan are reporting that an ingredient in licorice, which is widely used in various foods and herbal medicines, appears to block the absorption of cyclosporine, a drug used by transplant patients to prevent organ rejection.
This drug interaction could potentially result in transplant rejection, causing illness and even death among patients worldwide who take cyclosporine and licorice together, the researchers caution.
The study is the first report of this potential drug interaction, the scientists say. Their findings were presented at the American Chemical Society's 237th National Meeting, held March 22-26, 2009, in Salt Lake City, UT. Pei-Dawn Lee Chao, PhD, a chemist at China Medical University in Taichung, Taiwan, presented the research findings.
The researchers say they do not know exactly how much licorice it takes to have a toxic effect in humans. Licorice-based products vary widely in the content of their main active ingredient, a substance called glycyrrhizin.
Also, thousands of patients also take cyclosporine for rheumatoid arthritis, certain skin conditions, and other diseases.
Other medications, foods, and herbs that can reduce levels of cyclosporine in the body and should be avoided when taking that immunosuppressant drug include St. John's wort, quercetin, onions, ginger, and ginkgo. Other studies show that some substances, such as grapefruit juice, can actually boost cyclosporine levels.
Researchers will continue to study the reasons why licorice interferes with cyclosporine.
Previous studies have indicated that licorice can interfere with the effectiveness of high blood pressure medications, aspirin, anti-inflammatory drugs, insulin and oral contraceptives.
Mycophenolic acid has new medication guide
The FDA and Novartis notified health care professionals of the introduction of a Myfortic® Medication Guide to provide important safety information in language that patients can easily comprehend.
By May 15, 2009, a copy of the Myfortic Medication Guide will be enclosed with every Myfortic bottle. Pharmacists are required to distribute a copy of the Medication Guide with every Myfortic prescription.
Zencore Plus® is recalled because of undeclared drug
Bodee LLC and the FDA notified consumers and health care professionals of a nationwide recall of all the company's supplement product sold under the name Zencore Plus®.
FDA lab analysis of Zencore Plus samples found the product contains benzamidenafil, an undeclared drug product and a PDE5 inhibitor.
The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates.
Zencore Plus is sold in health food stores and by mail order on the internet nationwide. Hospital patients who use organic nitrates should be screened for use of Zencore Plus.