Reglan Recall and Effects

The FDA, in March of 2009, finally responded to grave concerns over the pharmaceutical drug Reglan.  Specifically, as doctors and patients have alleged for years, the FDA mandated Reglan drugs come with what is known as an FDA “Black Box” warning noting the links between Reglan use and tardive dyskinesia.  Research has shown that metoclopramide, which is the main drug present in Reglan, poses serious long-term side effects in patients. 

What Is Reglan?

Reglan was first used in the mid 1960’s as a means of preventing postoperative vomiting and nausea, as well as for other gastrointestinal issues.  Overtime, the drug became available to patients to treat a wide variety of symptoms, ranging from infection to migraines to nausea and others.  Currently, the medical community regularly uses Reglan to treat chemotherapy and migraine suffering patients’ nausea issues, as well as persons suffering from other gastrointestinal issues, such as acid reflux.  The drug also is used to treat gastroparesis patients, as well as others exhibiting symptoms of stomach and abdominal fullness that does not respond to other treatments.  Suggested use of the drug is for no more than nine to twelve weeks.  The benefits of Reglan, however, may not outweigh the potential risks, which many patients have already experienced. 

Effects of Reglan

Research by independent entities, as well as the FDA has proven that Reglan promotes an exceptionally high risk for patients.  The main risk associated with the drug is the development of tardive dyskinesia in patients.  These symptoms are irreversible in many cases, and in others, may only lessen over time, but will never fully subside.  In response, the FDA now mandates all manufacturers of the drug Reglan to carry a black box warning on all Reglan products, including the tablets, orally disintegrating tablets, solutions, and injections. In the modern pharmaceutical industry, a black box warning is viewed as the strongest warning issued by the FDA.  According to research, prolonged use of Reglan, especially those in large doses, presents a grave risk of patients developing tardive dyskinesia, which has been noted in up to one-fifth of patients. 

Symptoms of Tardive Dyskinesia

Persons suffering from tardive dyskinesia exhibit symptoms, such as:

• Involuntary, repetitive movements
• Constant twitching or shaking
• Rapid limb movement, sometimes involuntary or poorly coordinated
• Facial grimacing, twitching, or movement
• Lip pursing, smacking, or involuntary tongue licking

These symptoms, unfortunately, are typically permanent in patients, and depending on the level of damage incurred from Reglan use, may only subside slightly during the remainder of their lifetime.  High-risk groups include young individuals less than twenty years of age, as well pregnant women.  Additionally, persons suffering from depression should not take this drug, as there is an increased chance of suicide.  The patients typically exhibiting detriments from Reglan endured long-term treatment with the drug at higher dosages.  According to FDA research, patients taking the drug longer than three months developed tardive dyskinesia symptoms in over twenty percent of the cases reviewed.