CJF Comments on University of Utah School of Medicine Study Examining Valproic Acid Effectiveness in the Treatment of Spinal Muscular Atrophy

The Consumer Justice Foundation comments on a University of Utah School of Medicine study (“Phase II Open Label Study of Valproic Acid in Spinal Muscular Atrophy,” ncbi.nlm.nih.gov) evaluating the effectiveness of valproic acid (Depakote) in treating spinal muscular atrophy. The researchers faced several limitations in the study, which underscores the need for additional clinical trials involving valproic acid. Previous studies have explored the potential adverse side effects of valproic acid treatment, including the development of birth defects among children exposed to the drug during pregnancy. For more information about the potential dangers of valproic acid (Depakote), visit http://www.DepakoteBirthInjury.com, a comprehensive online resource developed by the Consumer Justice Foundation to better educate consumers about the dangers of certain pharmaceutical drugs.

(PRWEB) August 30, 2011

The Consumer Justice Foundation (CJF) comments on a study (“Phase II Open Label Study of Valproic Acid in Spinal Muscular Atrophy,” ncbi.nlm.nih.gov) conducted by the University of Utah School of Medicine, in which researchers examined the effectiveness of valproic acid (Depakote) in treating patients with spinal muscular atrophy. According to the study (“Phase II Open Label Study of Valproic Acid in Spinal Muscular Atrophy,” ncbi.nlm.nih.gov), preliminary in vitro and in vivo studies with valproic acid in patients with spinal muscular atrophy (SMA) demonstrated increased expression of the survival motor neuron (SMN), which is the SMA disease-causing gene.

These results suggest that valproic acid may offer a therapeutic benefit in patients with spinal muscular atrophy. However, previous studies (“The Teratogenicity of Anticonvulsant Drugs,” nejm.org) have identified a number of adverse side effects possibly linked to valproic acid (Depakote), including an increased risk of major birth defects in children exposed to the drug in utero. These adverse events may be severe enough to outweigh any SMA-treatment benefits, and the CJF calls for further research weighing the possible benefits of valproic acid in treating SMA against the potential risk for adverse side effects.

Valproic acid is the generic form of the antiepileptic drug Depakote, which is currently manufactured by drug company Abbott Laboratories. Since its introduction to the U.S. market in 1983, valproic acid, marketed as Depakote, has been approved to treat epilepsy, migraines, seizures and bipolar disorder. In recent years, valproic acid has become one of the most commonly prescribed antiepileptic drugs available in the U.S.

Significant focus (“Valproic Acid Monotherapy in Pregnancy and Major Congenital Malformations,” nejm.org) has been placed on the potential adverse effects of fetal exposure to valproic acid in recent years. According to previous FDA warnings (fda.gov), children whose mothers take valproic acid while pregnant may have an increased risk of developing severe birth defects like neural tube defects, craniofacial birth defects and heart defects. A more recent FDA safety announcement (http://www.fda.gov/Drugs/DrugSafety/ucm261543.htm) warns patients about the increased risk of cognitive impairment among infants exposed to valproic acid during pregnancy.

Healthcare professionals have been urged by the FDA (http://www.fda.gov/Drugs/DrugSafety/ucm261543.htm) to carefully consider all possible benefits and potential risks of valproic acid before prescribing the drug to certain patients, particularly women of childbearing age. In fact, the FDA has classified Depakote as a pregnancy category D medication (http://www.fda.gov/Drugs/DrugSafety/ucm261543.htm) due positive human evidence suggesting the drug may cause serious harm to a fetus when taken during pregnancy. Because valproic acid (Depakote) has the potential to cause serious adverse side effects in patients, the CJF believes more information is needed regarding the benefits of the antiepileptic drug in treating SMA in order for consumers to make an educated decision about the safety of the drug for this indication.
Researchers in the University of Utah study (“Phase II Open Label Study of Valproic Acid in Spinal Muscular Atrophy,” ncbi.nlm.nih.gov) acknowledge that there are several limitations of their study, including several factors which may limit the effectiveness in treating spinal muscular atrophy with valproic acid. Patients considering treating their SMA with valproic acid (Depakote) should consult a healthcare professional to discuss the possible benefits and potential risks of the treatment. For more information about the adverse events potentially linked to valproic acid treatment, visit http://www.DepakoteBirthInjury.com, a free educational guide developed by the Consumer Justice Foundation to offer consumers accurate information about dangerous drug side effects and pregnancy risks.

About the Consumer Justice Foundation: The Consumer Justice Foundation (CJF) is an organization developed by consumer advocates who strive to help consumers protect their legal rights against big businesses like drug companies and insurance companies. Some consumers need help fighting for justice or defending their rights against companies who might otherwise take advantage of them during their time of need. For consumers seeking additional information about the Consumer Justice Foundation and protecting their legal rights, the CJF has developed http:// http://www.ConsumerJusticeFoundation.com as a free online resource.

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