Pharmaceutical Defects Involving Depakote and Risperdal
For millions of Americans suffering from epilepsy, bipolar disorder or migraine headache, U.S. FDA-approved Depakote served to be a great relief for their debilitating health conditions. Depakote, an anticonvulsant drug, was approved by the FDA: in 1983 to reduce or prevent severe epileptic seizures; in 1995 to treat manic episodes linked to bipolar disorder; and, in 1996 to prevent migraine attacks. In the US alone, about 125,000 individuals are added annually to the more than two million Americans already suffering from epilepsy, while those affected by migraine number to more than 20 million. The drug’s effectiveness in treating the health concerns it was approved for eventually made it one of the most prescribed drugs in the nation.
Abbott Laboratories, maker of Depakote, was soon faced with reports and lawsuits due to adverse cases associated with its drug. Some of the recorded severe effects of Depakote are pancreatitis, liver toxicity, confusion, unusual bruising or bleeding, joint weakness, difficulty swallowing and/or breathing, and so many others.
The most serious health conditions caused by Depakote, though, can be those found in babies, whose mothers were prescribed with the drug during their pregnancy. Women, who took the drug, were in a great chance of delivering dead babies of babies with birth defects, like facial dysmorphism (deformity in a child’s facial structure), spina bifida (a condition wherein the spinal column of an unborn child does not close totally), deformity of the cardiovascular system, and brain defect, which can be fatal.
Depakote, however, was not the only drug (for bipolar disorder) introduced in the early 90s that was prescribed to millions of individuals, but which also caused severe harm to those who used it. Another drug was Risperdal – approved by the US Food and Drug Administration in 1994 to treat symptoms of schizophrenia, autism and bipolar disorder.
Due to its effectivity, Risperdal ended up being prescribed for non-label use too (not approved by the FDA), namely, for obsessive-compulsive disorder, attention deficit disorder (ADD) in children, anxiety and depression, behavioral disorder, Tourette syndrome (a neurological disorder typified by uncontrollable utterance of obscenities, vocalizations, and involuntary tics.
Before 2003, 16 cases of deaths and 37 incidences of strokes or stroke-like occurrences were linked to Risperdal. Besides these, there were also reports of Neuroleptic Malignant Syndrome (NMS), which is a potentially deadly condition characterized by irregularity in pulse and blood pressure, and Tardive Dyskinesia, which is a disorder in the central nervous system that leads to twitching of the tongue and face and uncontrolled movements of the limbs, as having been caused by the drug.
Both Abbott Laboratories and Janssen-Cilag, a subsidiary of Johnson & Johnson, manufacturers of Depakote and Risperdal, respectively, have faced, and are still facing, thousands of lawsuits from individuals who have been harmed by the drugs.
While those harmed by the said drugs can still file claims lawsuits against the manufacturers, being represented by a highly competent lawyer, like a Depakote lawyer or a Risperdal lawyer, may easily sway the judge’s decision to benefit the victim and award to him/her the maximum amount of compensation allowed by the law.