Actavis & Tardive Dyskinesia

Founded in 1956, Actavis Group Pharmaceuticals is headquartered in Iceland but boasts 10,000 employees in more than 40 countries around the world. One of the world’s largest sellers of generic pharmaceuticals, the company is also heavily involved in research and development and is consistently delivering new products to the marketplace. It owns development and manufacturing facilities in Europe, the United States and Asia.

In the United States, the Actavis Group owns three manufacturing sites: Elizabeth, NJ – a solid-oral-dose facility that makes tablets and capsules; Totowa, NJ – a similar facility that was opened in 2007 along with a packaging facility nearby; and Lincolnton, NC – a facility where creams, ointments, liquids, and suppository medications are produced, both over-the-counter and branded. The North Carolina facility is also a supplier of first aid, feminine hygiene, hydrocortisone and anti-fungal products for both private-label and own-label series.

The company mission indicates a desire to “create value in pharmaceuticals,” providing the customer with a high-quality product at an affordable price, and Actavis indicates a belief that generic medicines contribute greatly to the long-term health of society in general. Currently, the company has more than 800 generic products on the market and more than 300 under development and pending registration. Actavis’ products are registered in more than 60 companies.

Actavis and Metoclopramide

Actavis produces literally hundreds of generic products. Generics drugs are chemically the same as brand name drugs but generally marketed under their chemical name and usually without advertising. Often the drugs look the same and they certainly act the same as the identical brand name drug and are safe to take, despite what some people may surmise.

One of the many drugs Actavis continues to make is metoclopramide, a generic equivalent of the popular drug Reglan®. This round, white tablet is available in 100 mg or 500 mg. sizes and simply marketed as metoclopramide. The product is distributed in the U.S. and in many other countries.

Metoclopramide and Tardive Dyskinesia

It has been observed that extended use of this drug may result in the development of tardive dyskinesia, a severe movement disorder characterized by repetitive and involuntary arm and leg spasms and facial tics such as blinking, lip smacking and grimacing. A 2004 study reported that the longer the metoclopramide use and the higher the dosage, the more likely the individual taking the drug would be to develop this serious disease. Older women were at highest risk because they were the demographic most often prescribed Reglan for long-term use, but all men, women, children and infants are at risk of developing TD following exposure to metoclopramide.

It would seem logical that this study would have prompted a recall of metoclopramide or, at least, immediate warnings about the use of the drug. However, it took five years for those warnings to come in 2009 from the Food and Drug Administration, which demanded that Schwarz Pharma and other producers of metoclopramide post black box warnings on all labels, warning individuals of the high incidence of tardive dyskinesia among long-term users. In the meantime, those who were unaware of the toxic properties of the drug continued to take it. Some developed irreversible tardive dyskinesia due to this negligence.

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.actavis.com/en/default.htm
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

Free information packet on Tardive Dyskinesia

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