Schwarz Pharma & Tardive Dyskinesia

Schwarz Pharma US is a division of Germany-based Schwarz Pharma AG, now part of UCB Inc., a global biopharma company based in Brussels, Belgium with operations in more than 40 countries. The U.S. arm of the company is headquartered in Atlanta, Georgia.

UCB was established in the United States in 1994, when the company acquired Whitby Pharmaceuticals and Northampton Medical. Ten years later, UCB acquired Celltech and then acquired majority shares of Schwarz Pharma AG in December 2006, making it the fifth largest biopharma company in the world. Currently, UCB has research offices in Raleigh, NC; a manufacturing facility in Rochester, NY; and a distribution center in Birmingham, AL.

Schwarz Pharma primarily produces drugs that are used in the treatment of cardiovascular diseases, central nervous system disorders, and gastrointestinal problems. Schwarz was, historically, a generic drug maker. However, it slowly moved into proprietary drug development within the last decade or so. Recognizable drugs produced by Schwarz Pharma (but not necessarily proprietarily developed by Schwarz Pharma) include Neupro®, for Parkinson’s Disease; Toviaz®, for bladder problems; and Reglan®, for heartburn and gastric reflux disease. Schwarz Pharma employs about 10,000 individuals worldwide.

Schwarz Pharma and Metoclopramide

All of the products on Schwarz Pharma’s manufacturing list may cause side effects, as do most other drugs. Sometimes, side effects are very mild; other times they can be severe. In the case of the company’s Reglan, a metoclopramide drug, users have reason to be alarmed about side effects. While single use or short-term use of Reglan only causes mild side effects like headache or diarrhea, long-term use of the drug is dangerous according to the Food and Drug Administration (FDA).

Reglan and its metoclopramide equivalents are generally used for two purposes. First of all, it can be given in single doses to treat post-surgical nausea or may be given when needed to cancer patients who get nauseous or vomit due to the effects of chemotherapy. Often, however, it is used to treat gastrointestinal problems including diabetes-related gastroparesis, heartburn and acid reflux disease. These are some instances for which some doctors may prescribe metoclopramide for long-term use, although it is recommended by the FDA that it be used for no longer than 90 days.

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.ucb.com/
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