Reglan: No MDL For Litigation

The JPML heard argument last week regarding a request by Plaintiffs' lawyers to consolidate proceedings involving Reglan. Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.

The Petition was opposed by several drug maker of metoclopramide including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

What's next? Likely a mess of results or rulings in multiple courts, both State and Federal.

Reno Article: Reglan (Georgia, Alabama)

"It's wonderful when prescription medications cure ailments, but what happens when they cause adverse medical side effects?" The article goes on to note:


"I'm angry because I appear to be suffering from permanent central nervous system damage associated with the prescribed drug Reglan (brand name for "metoclopramide"), prescribed over a year ago for a digestive disorder.

I received a letter dated April 30 from my GI's office noting the FDA has placed a "Black Box Warning" on Reglan, explaining, it's possibly linked "with the development of a condition known as "tardive dyskinesia," a permanent CNS condition that's untreatable.

TD is a disorder of the tongue, mouth and jaw, causing them to move uncontrollably in abnormal ways.

The drug can also cause face jerking or involuntary body movements, including:

"Repetitive movements of the extremities

"Lip smacking, pursing, puckering

"Grimacing

"Tongue protrusion

"Rapid eye movements

"Impaired movement of fingers

"The movements are pretty much constant, except during sleep," reported Dr. Jeff Bronstein in a Los Angeles Times article. He's with the UCLA David Gaffen School of Medicine.

If you have taken Reglan, or are taking it now, the FDA says it's time to call your physician, whether you are experiencing side effects or not."

Read the rest here.

Late 2008 - Adverse Drug Event Reports Reach Record Numbers

In 2008, one site reports that there were a record number of reports submitted to the US Food and Drug Administration (FDA) about serious injuries, disabilities, and deaths associated with drug therapy.

Almost 23,000 cases of serious ADEs—including 1,397 cases attributed to error—were reported to the FDA in April-June 2008, nearly 40% higher than the average of reported cases during the four quarters in 2007. The increase came about equally in reports originating from health professionals and consumers. Among the 23,000 ADEs were 2,968 deaths and 585 cases of disability or birth defects. The 2,968 reported deaths in this quarter declined from a record 4,824 deaths in the first quarter of 2008, but deaths remained substantially higher in 2008 than in 2007.

Source here.

Reglan News: Lawyers seeking to Consolidate in Nevada

What we are hearing: Lawyers have filed a Motion with the JPML, asking that all of the filed Reglan cases be consolidated and moved to a US District Court in Nevada.

Reglan (metoclopramide) is a drug which is only approved for short-term use to treat gastrointestinal disorders like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, because those conditions are usually chronic problems, it is often prescribed for longer periods of time. Illnesses include essential tremors, Tardive Dyskinesia, and other movement disorders.

We're investigating this drug and how it may have harmed Georgia consumers. Go here for more information.