Bosnalijek & Tardive Dyskinesia

The Bosnalijek Pharmaceutical and Chemical Company was established in 1951. Headquartered in Bosnia and Herzegovina (BH), the company produces about 175 pharmaceuticals to treat a variety of diseases and disorders. It is currently the largest producer of drugs in BH, marketing its products on three continents – Europe, Asia, and Africa. In the U.S., the company has established partnerships with some well-known pharmaceutical companies in the nation, including Eli Lilly, Novartis, and Hoffman-LaRoche.

Bosnalijek entered the generic drug realm in 1991, with an active research and development division dedicated to the development of new products, working on roughly 50 projects at any given time.

Bosnalijek and Metoclopramide

Bosnalijek produces a large number of generic drugs in pill and capsule form as well as in liquid or injectible form.

Bosnalijek manufactures a form of metoclopramide marketed under the name Pylomid made in three forms – a 10 mg tablet, syrup, and an injectable liquid. These drugs are prescribed internationally for the treatment of a variety of medical problems.

The most prevalent form of metoclopramide in the U.S. is Reglan®. Pylomid is identical to Reglan but costs less because it is marketed as a generic. It also has the same antiemetic uses as Reglan:

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.bosnalijek.ba/eng/Company_profile.pdf
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4167B1_02_11-FDA-Tab11-Review.pdf
http://www.ninds.nih.gov/disorders/tardive/tardive.htm