Depakote Earns Abbot Labs $1.5 Billion Fine

The United States Dept of Justice has;

Documents and Resources From The May 7th, 2012 Abbot Laboratories Press Conference

For Abbot Labs Statement:

Abbot Reaches Settlement Agreement on Depakote

And if you'd prefer it on One page rather than reading through All of the above:

See Bloomberg for:

Abbot to Pay $1.6 Billion To Settle Depakote Drug Allegations 

By Jef Feeley and Margaret Cronin Fisk - May 8, 2012 12:01 AM ET

"Abbott Laboratories (ABT) said it reached an agreement to pay $1.6 billion to settle federal and state claims resulting from an investigation into its epilepsy medication Depakote, the second-largest drug-marketing settlement in U.S. history.

The company will pay $800 million to resolve civil allegations split among federal and state governments, $700 million for a criminal penalty, the Justice Department said in a statement. Abbott marketed the drug, approved for epilepsy, bipolar mania and migraine prevention, for unapproved uses including dementia, the U.S. said.

The settlement results from a four-year-old investigation into Abbott sales practices that began in 1998, the Abbott Park, Illinois-based company said yesterday in a statement. Abbott said it is also paying $100 million to the states to resolve consumer protection matters.

“Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies,” Acting Associate Attorney General Tony West said in the Justice Department statement. “As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price.”

Continue reading Bloomberg coverage here.

If you want to see Some of What the FDA knew as far back as Dec 2006 about Depakote:

Depakote Adverse Reactions

For the FDA Leaflet on Depakote:

https://www.rxisk.org/Research/DrugInformation.aspx?DrugID=3833&ProductDrugID=942&ProductName=Depakote

And if you look up Depakote at:

http://lamplightersoftware.com/dsm.php

Valproic Acid		Reported By
Adverse Reaction	Cases	MD	CN	OT	PH	LW	NR
Suicidal Ideations	51	9	22	11	7	0	17
Attempted Suicides	86	12	18	18	9	0	49
Completed Suicides	157	42	2	3	16	1	100
Deaths Not From Suicide	342	111	42	99	16	1	208
Homicidal Ideations	2	1	0	1	0	0	0
Homicides	1	1	0	0	0	0	0
Hypomania/Mania	79	25	22	18	6	0	28
Heart Disease	199	52	34	45	7	4	107
Movement Disorders	662	184	181	165	41	2	249
Birth Defects	437	118	51	105	4	19	251
Premature Births	34	12	2	9	0	2	19
Prenatal/Neonatal Deaths	115	34	15	28	4	3	49

"Those who put Profits ahead of Patients will pay a hefty price."

Top 20 Adverse Drug Reactions reported for Valproic Acid and its Brand Names
Adverse Reaction	Cases
Convulsion	639
Drug Exposure During Pregnancy	411
Drug Interaction	350
Somnolence	295
Confusional State	250
Drug Ineffective	246
Tremor	246
Weight Increased	222
Hyperammonaemia	217
Alopecia	216
Thrombocytopenia	215
Ammonia Increased	199
Vomiting	196
Abnormal Behaviour	194
Foetal Anticonvulsant Syndrome	171
Pyrexia	165
Nausea	163
Developmental Delay	161
Completed Suicide	157
Fall	150

If You had $1.5 Billion, would you consider it a 'Hefty Price' to buy back your DEAD family member? 

94% Of Drug Adverse Reactions Are Never Reported To Govt Regulators: Study