What Your Doctor May Not Be Telling You About Depakote
Depakote and Depakote ER are brand names for the drug valproate and are marketed in the United States by Abbott Laboratories. Depakote was approved by the FDA to treat epileptic seizures, bipolar mania and for the prevention of migraines.1
Are advertising claims about Depakote correct?
Studies of valproate (Depakote) found that it demonstrated more effectiveness in treating the symptoms of bipolar disorder than placebo2, reduced frequency and severity of migraine attacks3 and reduced incidence of epileptic seizures.4
However, Abbott Laboratories has made some marketing claims about Depakote and Depakote ER that were not supported by research and were not among the uses approved by the FDA.
Prior to January 2009, Abbott Labs created and distributed pharmacy flashcards that promoted Depakote for uses it wasn’t approved, made claims of its effectiveness that were unsupported and didn’t prominently display safety and side effects information. Instead, safety and side information was on the back of the card, with only a line of small print in the bottom left corner, saying safety information was on the back. 5
In May, 2012, Abbott Labs agreed to a $1.6 billion settlement of federal and state claims that it marketed Depakote for unapproved, off-label use. Although Depakote was never approved for treatment of schizophrenia, dementia and autism, Abbott created and trained a sales force specifically to target nursing directors, geriatric doctors and other long-term care providers and gave doctors illegal kickbacks to promote off-label use to boost Depakote sales.6
The FDA alleged that “from 1998 through 2008, Abbott unlawfully promoted Depakote for unapproved uses, including behavioral disturbances in dementia patients, psychiatric conditions in children and adolescents, schizophrenia, depression, anxiety, conduct disorders, obsessive-compulsive disorder, post-traumatic stress disorder, alcohol and drug withdrawal, attention deficit disorder and autism.” Abbott Labs’ promotion of Depakote included false and misleading statements about the safety, effectiveness and cost of Depakote for unapproved uses.7
Abbott Labs sales people promoted Depakote to nursing home staff and administrators “to control behavioral disturbances in dementia patients” and that it would help nursing homes avoid the administrative burdens and costs of complying with regulatory requirements dealing with psychotics. Abbott Labs’ own research had shown that Depakote was not effective in treating psychotics and Abbott had closed a 1999 study on dementia due to “increased incident of adverse events including somnolence, dehydration and anorexia in elderly study participants.” 7
What should I ask my doctor about before I decide to take Depakote?
Depakote has many side effects, some of them severe and even life threatening. Depakote may cause suicidal thoughts and actions,8 birth defects, liver and kidney problems, pancreatitis and other symptoms.4
What if I’m already using Depakote?
Never stop using a prescription medication except on the advice of your doctor. If you are concerned about Depakote or have noted adverse effects you think may be due to Depakote, speak to your doctor.
Learn everything you can about Depakote before you start taking it.
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1 Abbott Laboratories, http://www.depakoteer.com/; Food and Drug Administration, “May 7, 2012: Abbott Labs to Pay $1.5 Billion to Resolve Criminal and Civil Investigations of Off-Label Promotion of Depakote,” Food and Drug Administration, Office of crimi http://www.fda.gov/ICECI/CriminalInvestigations/ucm303539.htm
2 Cochrane Database Syst Rev., Marritchie K., “Valproate for acute mood episodes in bipolar disorder” (2003), http://www.ncbi.nlm.nih.gov/pubmed/12535506
3 Facta Unversitatis, Spasic M., “Prophylactic Treatment of Migraine by Valproate,” Medicine and Biology (2003), http://facta.junis.ni.ac.rs/mab/mab200303/mab200303-02.pdf
4 Food and Drug Administration Box Warning, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018723s039lbl.pdf
5 Forbes.com, Ruiz, Rebecca, “Ten Misleading Drug Ads” (2 February 2010) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm085224.pdf
6 Los Angeles Times, Frost, Peter (7 May 2012) “Abbott Labs agrees to pay $1.6 billion to settle Depakote cases,” http://articles.latimes.com/2012/may/07/business/la-fi-abbott-depakote-20120507
7 Food and Drug Administration, “May 7, 2012: Abbott Labs to Pay $1.5 Billion to Resolve Criminal and Civil Investigations of Off-Label Promotion of Depakote,” Food and Drug Administration, Office of crimi http://www.fda.gov/ICECI/CriminalInvestigations/ucm303539.htm
8 Food and Drug Administration (16 December 2008) “FDA Requires Warnings about Rick of Suicidal Thoughts and Behavior for Antiepileptic Meidcations,” http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100197.htm; Food and Drug Administration, “Suicidal Behavior and Ideation and Antiepileptic Drugs,” (5 May 2009) http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100190.htm