Medical Defects

Problems associated with Reglan

Posted by on Jan 8, 2015 in Medical Defects | 0 comments

Prescription drugs are often the target of civil action because they are typically inherently dangerous even when taken as prescribed. This is the issue with Reglan, (generic name metoclopramide) which was approved by the Food and Drug Administration (FDA) for the short-term (4-12 weeks) treatment of chronic digestive problems such as heartburn, diabetic gastroparesis and gastroesophageal reflux disease (GERD) in 1980.

Several years after FDA approval, long-term use of Reglan began to be linked to tardive dyskinesia, a serious neurological condition characterized by involuntary, repetitive movements of the face, eyes, tongue, fingers and limbs. Statistics show that about 29% of patients that use the drug for more than 12 weeks develop tardive dyskinesia. Another possible side effect from short-term (12 weeks) use Reglan may include Neuroleptic Malignant Syndrome (NMS), an often fatal conditions characterized by fever, sweating, muscle rigidity, unsteady blood pressure, and autonomic dysfunction.

Metoclopramide acts on the digestive tract, speeding up food movement through the digestive system. It has also been shown to have a positive effect on pregnancy-related nausea and migraine headaches, although these conditions are not approved for a Reglan prescription by the FDA. Currently, The FDA has approved Reglan for the treatment of post-surgical nauseas and post chemotherapy nausea as well.

According to the website of Evans Moore, LLC, the consequences of taking dangerous drugs can be minimized if the drug manufacturer gives physicians and the public full disclosure about the associated risks. The first Reglan lawsuits began more than 20 years ago but a series of FDA warnings, the last of which was issued in 2009, increased the public’s awareness of the dangers of using Reglan and its generic counterparts, especially for off-label and long-term use. This resulted in new lawsuits being filed, most of which alleged that the drug’s manufacturer Pfizer failed to provide adequate warning about the risks associated with using Reglan or its generic versions.

If you have acquired a serious medical condition from taking Reglan or its generic counterparts, you will probably have it for the rest of your life. Consult with a dangerous drugs lawyer in your area to find out your legal options.

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History of Risperdal

Posted by on Mar 14, 2014 in Medical Defects | 0 comments

Risperdal is the trade name for the atypical (2nd generation) antipsychotic drug risperidone, developed, manufactured and marketed by Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson (J&J). Antipsychotic drugs have been used as treatment for maladaptive behaviors since the 1950s, when first generation (typical) antipsychotic drugs were first prescribed to children and young adults. Typical antipsychotic drugs include haloperidol and clozapine.

The first generation of antipsychotics, however, were associated with a range of side effects from mild to life threatening, and patients who were taking them formed chemical dependences on the drugs. To counteract these side effects, the 2nd generation antipsychotics were developed and introduce in the 1980s, and are considered a significant improvement on typical antipsychotics in terms of efficacy and extrapyramidal symptoms (movement disorders). However, atypical antipsychotics are not without side effects.

Risperdal was first approved by the Food and Drug Administration (FDA) for the limited time treatment of adults with schizophrenia in 1993. Ten years later, it was also approved for use on adults with bipolar I disorder category (manic depression). Autistic children and teenagers were next in line when Risperdal was approved for their treatment in 2006, and in 2007 it was certified as the go-to drug for children between the ages of 13 and 17 who exhibited symptoms of schizophrenia as well as viable treatment for children between 10 and 17 who exhibited symptoms of bipolar disorder.

The fact that the FDA approved the use of Risperdal as a treatment to pubescent and adolescent patients is remarkable because it was the first time an antipsychotic drugs was deemed safe enough for this population. J&J marketed the drug for all it was worth, eventually making it the most popular antipsychotic in the market. Many parents struggling to cope with the problems associated with dealing with children with psychiatric problems, including conditions such as attention deficit hyperactivity disorder (ADHD) which is not approved by the FDA, hoped that Risperdal would be the final solution. By 2013, J&J was agreeing to a $2.2 Billion settlement for the improper promotion of the drug for unapproved conditions.

The generic version of Risperdal became available in the last quarter of 2008. Risperidone  was manufactured and sold by Dr. Reddy’s Laboratories, Inc., Teva Pharmaceuticals, and Patriot Pharmaceutics.

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