ANI Parmaceuticals and Tardive Dyskinesia

Headquartered in Baudette, Minnesota, ANI Pharmaceuticals develops, produces, and markets specialty generic prescription and over-the-counter pharmaceuticals. ANI has two manufacturing locations in the U.S. – Baudette, Minnesota and Gulfport, Mississippi.

In Baudette, ANI manufactures solid and liquid-dose hormone medications which require special handling and containment. In Gulfport, ANI manufactures liquid, tablet, powder, and bulk magnesium hydroxide medications.

Currently, ANI’s customers include wholesale distributors McKesson and Cardinal Health as well a number of very well known U.S. pharmacy and retail chains, including Walgreens, CVS, Rite Aid, and Wal-Mart.

In 2007, ANI acquired Solvay Pharmaceuticals’ two Baudette facilities, adding about 170,000 square feet to their manufacturing and laboratory capabilities. Solvay is headquartered in Brussels and is an international chemical and pharmaceutical group. The company employs 30,000 people in 50 countries around the world.

ANI Pharmaceuticals and Metoclopramide

ANI produces a variety of generic drugs, including metoclopramide, which the company dispenses in 5 mg and 10 mg tablets as well as in an oral solution form. This generic drug is the same as the widely-prescribed brand name drug known as 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.anipharmaceuticals.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