Tardive Dyskinesia News

Neurocrine Tardive Dyskinesia Drug Enters Phase II of Clinical Trials

On Sept. 19, 2011, Neurocrine Biosciences Inc. announced that phase II clinical trial of a new drug to treat tardive dyskinesia has begun. The drug, labeled as NBI-98854, works by controlling the release of dopamine, a neurotransmitter that affects movement.

According to Christopher F. O’Brien, chief medical officer for Carmel Valley-based Neurocrine, there are 32 participants in the placebo-controlled study. The North County Times reports that results from the trial will help the company determine the dose and treatment for larger studies that are planned to begin in 2012.

The drug might also help with symptoms of other disease such as Huntington’s, schizophrenia, Tourette’s syndrome and tardive dystonia, according to Neurocrine.

(Source: North County Times)

Reglan Linked to Tardive Dyskinesia, Says FDA

Patients treated with Reglan® should be aware of the risk of tardive dyskinesia, and should visit their doctors right away if they experience involuntary movements of the tongue, face or extremities.

The U.S. Food and Drug Administration (FDA) has issued warnings to notify patients and health care providers of the link between Reglan® and the movement disorder.

In 2009, the agency required that the drug maker add a boxed warning to the drug’s label to warn of the risk. The agency approved updates in November 2010.

According to the FDA, treatment with metoclopramide (generic Reglan®) can cause tardive dyskinesia.

“The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose,” the FDA said in the 2010 update. The agency advised against using the drug for more than 12 weeks.

If you’ve taken Reglan® and have been diagnosed with tardive dyskinesia, we may be able to help you seek compensation. Contact our tardive dyskinesia attorneys for help today.

FDA Petitioned to Change Regulations for Generic Drug Makers

The consumer advocacy group, Public Citizen, is urging the FDA to revise regulations that prevent generic drug makers from changing warning labels about potential health risks associated with their drugs.

Under current regulations, brand name drug manufacturers are able to make changes to their drugs’ warning labels without approval from the FDA. But, generic drug makers are not allowed to update their drug labels, as they are supposed to match the brand name drugs.

This prevents generic drug makers from notifying and warning consumers about serious side effects and risks, according to Public Citizen. The group filed a petition with the FDA on Aug. 30, arguing that this type of change could help consumers learn about potential risks associated with the drugs.

As of now, generic drug makers are arguing that they cannot be held accountable for withholding information from consumers.

This petition could affect generic drug makers such as Teva Pharmaceuticals, maker of metoclopramide, generic Reglan®.