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Reglan–New Black Box Warning

Reglan (generic: metoclopramide) is a drug used to treat heartburn and slow gastric emptying in diabetes patients. The drug is commonly used to treat gastroesophageal reflux disease (GERD), gastroparesis, and other conditions affecting the digestive system.

The danger that Reglan lawyers are investigating is tardive dyskinesia (also known as TD), a neurological disorder that manifests as repeated involuntary movements. Injured patients may experience grimacing, protrusion of the tongue, lip-smacking, rapid eye blinking, and movement of the extremities. There is no treatment for tardive dyskinesia.

Not to say that heartburn isn’t painful, but how many of us would risk contracting tardive dyskinesia just to compensate for bad eating habits? Reglan lawyers have discovered that the label, unfortunately, minimized that risk, implying that there wasn’t much danger. The original label said it “may produce extrapyramidal reactions, although these are comparatively rare.” Other sections of the label likewise indicate that tardive dyskinesia is a low risk.

However, earlier this year the FDA required makers of Reglan and other metoclopramide medications to put a black box warning on their labels, the most stringent act the FDA can take. That label now reads:

Tardive Dyskinesia
Chronic treatment w/ metoclopramide may cause tardive dyskinesia, a serious, often irreversible movement disorder; risk increases with treatment duration and cumulative dose, and in elderly patients, especially women; Discontinue metoclopramide if signs or symptoms of tardive dyskinesia develop; avoid prolonged treatment over 12 weeks in all but rare cases where benefit may outweigh risk.

Reglan drug injury lawyers are accepting these cases on an individual basis—no class actions are filed, and none are expected. However, Reglan lawyers have petitioned for consolidation and/or coordination into an MDL (“MultiDistrict Litigation”). Basically, the hope is that these cases are grouped together for the purpose of common discovery, then individually litigated. If approved, this makes these cases more inexpensive for injured clients. The Judicial Panel on MultiDistrict Litigation (JPML) is hearing arguments for and against consolidation today. Rulings typically come within about 2 months after the hearing.

Other Reglan Side Effects

One of the most common side effects of Reglan is drowsiness or fatigue. This can impair an individual’s ability to drive or perform other tasks that require alertness. It’s important to avoid performing these tasks if you experience drowsiness while taking Reglan.

Another common side effect of Reglan is headaches. If you experience frequent or severe headaches while taking Reglan, you should speak with your doctor about alternative treatment options.

Some people may experience changes in their mood while taking Reglan. This can include depression, anxiety, and irritability. In rare cases, individuals taking Reglan have experienced hallucinations or delusions. If you experience changes in your mood or experience hallucinations or delusions while taking Reglan, you should contact your doctor immediately.

One of the more serious side effects of Reglan is tardive dyskinesia, a condition that causes involuntary movements of the face, tongue, and other parts of the body. The risk of developing tardive dyskinesia increases the longer Reglan is taken and the higher the dose. If you experience any unusual movements while taking Reglan, you should contact your doctor immediately.

Reglan can also cause a condition known as extrapyramidal symptoms (EPS). EPS is characterized by muscle stiffness, tremors, and other involuntary movements. If you experience any of these symptoms while taking Reglan, you should contact your doctor immediately.

In rare cases, individuals taking Reglan have experienced serious heart problems, including irregular heartbeat and heart attack. If you experience any symptoms of heart problems while taking Reglan, you should seek medical attention immediately.

Reglan can also cause a condition known as neuroleptic malignant syndrome (NMS), which is a life-threatening condition that causes muscle rigidity, high fever, and other symptoms. If you experience any symptoms of NMS while taking Reglan, you should seek medical attention immediately.

In rare cases, individuals taking Reglan have experienced seizures. If you experience a seizure while taking Reglan, you should seek medical attention immediately.

Reglan can also cause an allergic reaction in some individuals. Symptoms of an allergic reaction can include skin rash, hives, itching, and difficulty breathing. If you experience any of these symptoms while taking Reglan, you should seek medical attention immediately.

It’s important to note that not all individuals will experience these side effects while taking Reglan. In addition, some individuals may experience side effects that are not listed here. If you experience any unusual symptoms while taking Reglan, you should contact your doctor immediately.

Overall, Reglan is an effective medication for treating certain digestive conditions, but it can cause serious side effects in some individuals. If you are taking Reglan, it’s important to be aware of the potential side effects and to seek medical attention if you experience any unusual symptoms. Additionally, if you are considering taking Reglan, it’s important to discuss the potential side effects with your doctor to ensure that the benefits of taking the medication outweigh the risks.

Reglan Tardive Dykinesia Lawsuits

Reglan has been the subject of numerous lawsuits due to its potential to cause serious side effects, particularly tardive dyskinesia. Tardive dyskinesia is a condition characterized by involuntary movements of the face, tongue, and other parts of the body. The risk of developing tardive dyskinesia increases the longer Reglan is taken and the higher the dose.

Many individuals who have developed tardive dyskinesia as a result of taking Reglan have filed lawsuits against the manufacturers of the medication, alleging that they failed to adequately warn about the risks associated with the medication. In some cases, these lawsuits have resulted in settlements for the plaintiffs.

For example, in 2009, a group of individuals who developed tardive dyskinesia as a result of taking Reglan reached a settlement with the manufacturers of the medication. The exact terms of the settlement were not disclosed, but it was reported that the plaintiffs received compensation for their medical expenses and other damages.

Generic Reglan Lawsuits

Teva Pharmaceuticals was also sued for Reglan injuries.  A Pennsylvania appeals court ruled in 2020 followed other judges in dismissing these claims.  Essentially, generic Reglan lawsuited failed becasue drugmakers did not have a duty under federal law to communicate warnings by a Dear Doctor letter or any other means beyond the package insert.