Posts Tagged ‘ depakote ’

Infographic: Depakote Birth Defects, Off-Label Marketing by the Numbers

March 1st, 2013. By AbiK

Recently, a small British study that was published in the Journal of Neurology, Neurosurgery & Psychiatry (1/30/13), suggested women who take valproate while pregnant have an increased risk of having children with autism and neurodevelopment problems. The study also suggested that damage to the fetus happens during the early stages of pregnancy.

Valproate-based anti-convulsants (drugs used to treat seizure disorders including epilepsy) include brand-name drugs Depakote, Depakene, Depacon and Stavzor–all of which are pregnancy risk Category D drugs. Category D drugs have shown positive evidence of fetal risk based on adverse reaction data from investigation or marketing experience or clinical studies in humans.

The Depakote infographic below highlights some of the potential adverse effects in newborns that have been associated with taking Depakote during the first trimester of pregnancy.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tags: birth defects, Cleft Palate, Depacon, Depakene, depakote, Depakote lawsuit, depakote legal help, heart defects, spina bifida, Stavzor, valproate
Posted in Drugs/Medical, Emerging Issues | No Comments »

ADHD Depakote & Clonidine Cocktail Settlement: No Cheers Heard

January 27th, 2011. By LucyC

Remember Rebecca Riley? The four-year old who died of a clonidine overdose at the hands of her parents, Michael and Carolyn Riley, on December 13, 2006? This utterly tragic cautionary tale reached its final conclusion this week, with the announcement of a $2.5 million settlement to be paid by the Tufts Medical Center psychiatrist Dr. Kayoko Kifuji, who prescribed the clonidine and depakote cocktail as treatment for Rebecca’s attention deficit hyperactivity disorder (ADHD) and bipolar disorder. Most settlement announcements can have an air of the bittersweet coupled with a sense of vindication—but in this case, the settlement was for a cocktail that would never be followed by a “cheers!” from anyone—so there is only the sense of sadness all around.

When this case broke, Dr. Kifuji’s role ignited quite a controversy around her having prescribed these drugs in the first place. Clonidine is a high blood pressure medication that can be used as a sedative in children—for ADHD. Depakote was prescribed for bipolar disorder—it is an anti-convulsant also known as valproate semisodium or divalproex sodium. 

According to the state medical examiner in Massachusetts, the four-year-old girl’s death at her family home was indeed the result of a drug overdose. Dr. Elizabeth Bundock, who served as the deputy chief medical officer in Vermont, concluded in her autopsy that Rebecca died from intoxication after being administered a combination of clonidine, Depakote and two over-the-counter cold and cough medications. Bundock testified during the trial that the drugs affected Rebecca’s brain, heart and lungs, leading to “a pump failure of the heart,” overworked lungs filled with bloody fluid, coma and death. 

In 2007, the father, Michael Riley, and mother Carolyn Riley were charged with first and second degree murder respectively. They were found guilty. During those trials, in the summer of 2009, Dr. Kifuji was cleared of the criminal charges. Consequently, she had her medical licence reinstated and she returned to her practice at Tufts. 

Dr. Kifuji had voluntarily surrendered her medical licence in 2007—when the Riley’s were Read the rest of this entry »

Tags: ADHD, depakote, Rebecca Riley
Posted in Drugs/Medical | 4 Comments »

Depakote Studies Need Cautionary Notes for Pregnant Women

July 27th, 2010. By janem

Some reports put Depakote in a more favorable light over other epilepsy drugs because there isn’t an increased risk of self-harm of suicidal behavior as reported in similar epilepsy meds. But such reports can also be dangerous if read by a soon-to-be pregnant woman or worse, an already pregnant woman on Depakote, because they often neglect to mention that the drug has been linked to Depakote birth defects.

Or perhaps a physician will read these reports and focus only on Depakote and its link to depression, bypassing its association to birth defects.

For instance, a recent UK study (Neurology, July 27, 2010) revealed that those who took relatively new antiepileptic drugs with a higher risk of causing depression, (such as levetiracetam (Keppra), topiramate (Topamax) and vigabatrin (Sabril) were three times more likely to harm themselves or attempt suicide than those who weren’t taking any epilepsy medications. The researchers found that patients who took conventional epilepsy medications, such as divalproex (Depakote, Depakote ER, Depakene) faced no increased risk of self-harm of suicidal behavior.

The Journal of the American Academy of Physician Assistants (July 29, 2010) reported that Depakote, when used as a mood stabilizer in adults with acute bipolar depression, decreases depression symptoms by at least 50 percent in at least one additional patient of every 10 patients who are given treatment instead of placebo. Again, no cautionary words for pregnant women.

Perhaps such studies should list alternative anti-epileptic medications.

But two studies presented at the beginning of July –the UK Epilepsy and Pregnancy Register and the European and International Registry of Antiepileptic Drugs in Pregnancy (EURAP)– found that Depakote and other valproate-based antiepileptic drugs were more than twice as likely to cause major congenital malformations when used by pregnant women than Tegretol (carbamazepine) and Lamictal (lamotrigine), with an overall risk of more than 6 percent.

The EURAP study set the odds of a Depakote birth defect at 9 percent. While those odds sound risky, a study done in 2006 found that about 20 percent of babies born to mothers taking Depakote suffered serious problems, as opposed to other drugs which only had rates anywhere between 1 and 10.7 percent. (Depakote was slapped with a black box warning in 2006). Clearly, the risk of Depakote outweighs the benefits, when it comes to the possibility of a pregnant woman suffering a seizure. After all, there are alternative and much safer medications.

Tags: depakote, depakote birth defects, depakote pregnancy, depakote side effects
Posted in Drugs/Medical | 1 Comment »

Prescription Drugs as Birth Control

June 8th, 2010. By Hunter West

Can a medication designed to minimize epileptic seizures, serve as birth control? 

Can an antidepressant, also serve as birth control? 

Indirectly, yes—if women who depend on various drugs to stabilize their lives opt to shun having children rather than risk the possibility of birth defects. 

It’s an interesting conundrum—that a society that depends more and more on various drugs to treat our diseases and keep us living longer, might suffer a detrimental effect on birth rates and experience a shrinkage of the population. 

But while the long-term effect may be less dramatic, the short-term debate is no less real. 

There are various drugs that are designed to treat specific conditions, such as valproate for the treatment of bipolar disorder, or migraine headaches. While the drug, marketed as Depakote, is without doubt effective for the treatment for that for which it was intended, it can also have a devastating effect on a fetus if taken by an expectant mother. 

The US Food and Drug Administration (FDA) noted in December of last year, “Valproate use during early pregnancy increases the risk of major malformations in the baby,” the FDA said. “The rates for neural tube defects in babies exposed to valproate during the first trimester are 30 to 80 times higher than the rate for neural tube defects in the general US population. In pregnant women with epilepsy, valproate monotherapy is associated with a four-fold higher rate of major malformations than other antiepileptic drug monotherapies. 

“Healthcare professionals should counsel women of childbearing potential taking valproate about the increased risk of major malformations…” 

A far more common drug is the SSRI antidepressant. Critics of antidepressants and the doctors who prescribe them, say that antidepressants are over-prescribed. While there is little doubt many individuals would not be able to get through the day without potentially doing harm to Read the rest of this entry »

Tags: Antidepressants, depakote, SSRI, valproate
Posted in Drugs/Medical | No Comments »