A drug maker’s newly approved blood test may detect a serious side effect linked to one of its own drugs. Abbott Laboratories announced March 28 that the U.S. Food and Drug Administration approved its Architect alpha-fetoprotein test.
Abbott’s statement referred to alpha-fetoprotein as a biomarker, a bodily substance that “physicians can measure to identify the progress of diseases or conditions as well as to evaluate the effectiveness of treatments. AFP has unique traits that help doctors detect two very different health issues: fetal birth defects and the progression of testicular cancer.”
Birth defects detection could have benefitted women who took the Abbott drug Depakote (divalproex sodium), an antiepileptic valproate-containing medication that the FDA approved in 1983 and that the agency alerted patients and health care professionals about in 2009 because of the “increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed” to it.
“Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches,” according to the administration.
The drug maker’s Architect AFP statement explains the nature of the birth defects and how the test may help to identify them.
“Neural tube defects (NTDs) are serious fetal birth defects of the brain and spine that occur very early in development,” Abbott’s release reads. “When the neural tube, a structure that develops into the brain and spinal cord, fails to close properly, AFP is thought to leak directly from the fetus into the mother’s amniotic fluid, causing unexpectedly high levels of AFP in the mother’s blood. A blood test that measures AFP can help doctors determine if a woman is carrying a fetus affected with birth defects, such as anencephaly (the absence of a large part of the brain and the skull) and spina bifida (the incomplete closing of the backbone and spinal canal).”
Pharmacological advancement can be wondrous, albeit too late, in this case, for a lot of Depakote mothers.
And the absence of progress can be devastating. Consider the passage of time from the introduction of Depakote in the early 1980s to the FDA’s issuance of birth defects warnings nearly four years ago. Only the manufacturer’s knowledge of the increased risk of birth defects and the concomitant warnings about those heightened risks and scientific abatement thereof could have helped thousands of families. Many of them have been plaintiffs in Depakote lawsuits.
An October 2008 analysis of Australian Pregnancy Register data showed that valproate was associated with the highest risk of “fetal malformations” among numerous antiepileptic drugs. Results were released electronically in October 2009, the year in which the FDA put the nation on Depakote birth defects alert. The findings would appear also in the May 2010 edition of the medical journal Epilepsia.
The study tracked 1,073 pregnancies marked by fetal exposure to antiepileptic drugs, also known as AEDs, throughout the term; the registry data “included 106 in which no AEDs were taken.”
The analysis broke down the outcomes of pregnancies in which the mother used a single AED and those in which the mother exposed her fetus to more than one. The babies were examined when they were a month old and when they were a year old. There were no “stillbirths and spontaneous abortions” in the analysis.
Valproate did poorly.
The “rates of occurrence of pregnancy with malformations” for those who took either an AED other than valproate or no AED were in the 3 percent to 6 percent range, but for valproate exposure, the malformation rate was 18.5 percent.
Further, the risk of fetal malformation was roughly halved when the patient took valproate and another AED — or, as the authors wrote it, “when valproate was used in polytherapy as compared with monotherapy.”
The “relative risks” of birth defects didn’t differ that much between monotherapy and polytherapy when valproate was not one of the AEDs. In the scientists’ words, “The RR values for fetal malformation were not significantly different for AED polytherapy and monotherapy when valproate was not involved.”
Additionally, regardless of whether the mother was on strictly valproate or on valproate in a combination, the “risk of pregnancy involving a fetal malformation increased with the valproate dose.” As the authors put it, “It has been shown that the risk of [fetal malformation] associated with valproate exposure is dose dependent.”
Abbott’s legal woes in 2012 were related to Depakote, and not solely from pharmaceutical injury lawsuits stemming from birth defects.
Abbott pleaded guilty in May 2012 to a criminal misdemeanor for marketing Depakote for uses unapproved by the FDA, including the treatment of schizophrenia and of “behavioral disturbances in dementia patients,” according to a statement that the United States Attorney for the Western District of Virginia released Oct. 2, 2012. The manufacturer was ordered to pay a $500 million criminal fine, a forfeiture of $198.5 million, and $1.5 million to the Virginia Medicaid Fraud Control Unit.
Valproate did a lot of damage and the victims deserve compensation, say the experienced Depakote attorneys at Reich & Binstock. For a free consultation to determine whether one is entitled to recoverable damages, the law firm, which operates in every state, may be reached toll-free at 1-866-LAW-2400. One also may visit www.reichandbinstock.com to submit an electronic request for a free-of-charge case evaluation.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.