Lek & Tardive Dyskinesia

Lek is part of the Sandoz Company, a leader in the manufacture of generic medicines. Sandoz is a division of Novartis, a well-known producer of medicines, generic pharmaceuticals, preventive vaccines, diagnostic tools, and consumer health products. Lek functions as both a research and development center and a global manufacturing arm of the company. Headquartered in Slovenia, the company employs about 2,400 individuals in addition to its other locations worldwide.

In the early 90s, the company went public and began to be traded on the Ljubljana stock market. In 1995, Lek became the first Central European drug company to place a final product on the U.S. market.

The comapny became part of Novartis in 2002 and continued to obtain approval for drug marketing in America. In 2004, Lek began to expand on the European continent, opening manufacturing plants in Romania and Poland, and in 2007, the company opened Biopharmaceuticals Development Center, one of six centers belonging to Novartis, situated in the Menges section of Slovenia. Today, Lek and its parent company, Sandoz, also operate a facility in Wilmington, North Carolina and other manufacturing and sales facilities in Austria, Croatia, Macedonia, Albania, Kosovo, Bosnia/Herzegovina, Russia, and other former Soviet states.

Lek and Metoclopramide

Lek manufactures a generic capsule, liquid, and injectable metoclopramide under the name degan, most commonly recognized in the U.S. by its brand name, Reglan®. Metoclopramide is usually prescribed for:

Post-surgery patients who experience nausea and vomiting caused by anesthesia.
Cancer patients who experience nausea and vomiting as a side effect of chemotherapy.
Migraine sufferers who experience nausea with their headaches.

The drug is also a prokinetic, facilitating the passing of food from the stomach to the intestines in those who have diseases like diabetic gastroparesis or gastric reflux disease. It is also commonly prescribed for heartburn.

Metoclopramide and Tardive Dyskinesia

In 2004, a study was released which indicated that the drug metoclopramide, which has been widely-prescribed throughout the U.S. since the 1980s, is responsible for the development of tardive dyskinesia when used for long-term treatment of ailments like heartburn. Tardive dyskinesia is characterized by involuntary, rapid and repetitive body movements including repeatedly sticking out the tongue, eye blinking, grimacing, other facial tics, and also spasms of the arms and legs.

While it is recommended that metoclopramide be used for 90 days, patients were prescribed a prolonged length of treatment with the drug, causing those individuals to experience permanent side effects with the onset of the movement disorder, known as TD.

When considering the risks addressed by the 2004 study, the FDA waited five years to add a black box warning on all metoclopramide packaging in 2009. As a result, many had been taking the drug without any awareness of this potentially serious side effect.

In an effort to help patients and their families better understand tardive dyskinesia, Tardivedyskinesia.com is now offering a free informational packet. To receive your packet in the mail, please enter your information below.

Sources:

http://www.lek.si/eng/
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a684035.html
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm149533.htm
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4167B1_02_11-FDA-Tab11-Review.pdf