Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Monthly Archives: August 2013

Large, multicenter studies show danger of Depacon in pregnancy

Posted in Depacon / Depakene / Depakote

Multi-institutional or multicenter studies play an important role in the comprehensive understanding of the damaging capabilities antiepileptic drugs (AEDs) have on an embryo or fetus.   Nakane Y., author of a report titled “Multi-institutional Study on the Teratogenicity and Fetal Toxicity of Antiepileptic drugs: a Report of a Collaborative Study group in Japan”, explains his report… Continue Reading

Study Shows: Sodium Valproate Linked to Birth Defects

Posted in Depacon / Depakene / Depakote

Future studies are in high demand to accurately understand the fetus- and embryo-damaging capabilities of antiepileptic drugs (AEDs).  Much research has been done on older antiepileptic drugs, but there has been little research done on the newer generations of AEDs.  The aim of an article titled “The Australian Register of Antiepileptic Drugs in Pregnancy: the… Continue Reading

Olympia Pharmacy (FL) recalls “all sterile drug products”

Posted in Recalls

Citing concerns about sterility, Lowlite Investments (d/b/a Olympia Pharmacy) in Orlando, FL has recently recalled “all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product,” according to a recent FDA report. With respect to the present concern over the safety of products sold as sterile by… Continue Reading

“Congenital Malformations Due to Antiepileptic Drugs”

Posted in Depacon / Depakene / Depakote

In an article from the Department of Neuropsychiatry at  Hirosaki University in Japan, called “Congenital Malformations Due to Antiepileptic Drugs”, author Kaneko S. writes the goal of the study was “to identify the major risk factors for the increased incidence of congenital malformations in offspring of mothers being treated for epilepsy with antiepileptic drugs (AEDs)… Continue Reading

Depacon, other AEDs dangerous for developing child

Posted in Depacon / Depakene / Depakote

Over the past 30 years, studies have shown that antiepileptic drugs (AEDs) are capable of interfering with development an embryo, potentially causing serious birth defects and developmental malformations.  The ability of AEDs to harm an embryo fetus is associated with etero exposure and a dose-response relationship has been highly accepted in the medical world, and… Continue Reading

ER visits from illegal ADD drug use quadruples in recent years

Posted in Public Health

A recent New York times article has reported that “The number of young adults who end up in the emergency room after taking Adderall, Ritalin or other such stimulants has quadrupled in recent years,” according to “federal health officials.” This data comes from a report by the Substance Abuse and Mental Health Services Association (SAMHSA),… Continue Reading

Nationwide FDA Recall: ‘All sterile products’ from Specialty Compounding

Posted in Recalls

On August 11th of this year, the United States Food and Drug Administration issued a “nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, TX.  There have been recent reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.”[1] So far, “The FDA has… Continue Reading

FDA: Tylenol linked to rare, dangerous skin condition

Posted in Safety Alerts

On August 1st, the FDA issued a safety alert for acetaminophen, the main ingredient in Tylenol and other painkillers, based on new data that has shown exposure to the drug can trigger several rare but dangerous skin reactions. An excerpt from the FDA report: “These skin reactions [associated with acetaminophen], known as Stevens-Johnson Syndrome (SJS),… Continue Reading

Role of folic acid in AED-induced birth defects questionable

Posted in Depacon / Depakene / Depakote

Studies done on the general population have shown that folic acid supplementation during pregnancy may reduce the risk of neural tube defects (NTDs) and other major congenital malformations (MCMs). Many doctors recommend that pregnant epileptic women start on a folic acid regiment, for folic acid has shown to reverse the antifolate effects that come from… Continue Reading

Two-fold increased risk for birth defects with maternal AED use

Posted in Depacon / Depakene / Depakote

Studies show that children born from women with epilepsy have an increased risk for congenital malformations.  These malformations are most likely connected to the antiepileptic drugs or AEDs that the mother was exposed to during pregnancy. An article from the Tampere school of Public Health, University of Tampere, Tampere, Finland, titled “Congenital Structural Anomalies in… Continue Reading

Study investigates how AEDs cause birth defects

Posted in Depacon / Depakene / Depakote

Antiepileptic drugs (AEDs) have many unwanted and many times unpreventable side effects.  Some of these unwanted side effects are the teratogenic effects these AEDs are known to have.  Teratogenic abnormalities are commonly known as “birth defects, “ which are damages caused to a fetus or embryo.  Experiments done on both animals and humans have shown… Continue Reading

Researchers concerned with safety of AEDs for fetus

Posted in Depacon / Depakene / Depakote

Medical researcher J. Campistol of the Neurological Department at the University of Barcelona wrote an article titled “Teratogenic effects of epilepsy and antiepileptic drugs”, aiming to “review the main studies on teratogenicity related to epilepsy and especially use of anti epileptic drugs (AED), with special emphasis on recently acquired knowledge regarding the new AED.”  Teratogenicity… Continue Reading

Rate of birth defects 2.7 times higher with in utero AED exposure

Posted in Depacon / Depakene / Depakote

There are many risks involved with epileptic women when they become pregnant, and complications can occur both during pregnancy or delivery.  Many studies have found that children of epileptic women, particularly those exposed to antiepileptic drugs (AEDs) during pregnancy, have a higher chance of developing congenital malformations, perinatal mortality, and maturational delay. Perinatal mortality refers… Continue Reading

High rate of complications with TVM use, study shows

Posted in Vaginal Mesh

The use of transvaginal mesh for both the repair of prolapsed pelvic organs and incontinence has led to numerous transvaginal mesh lawsuits because of the high failure rate experienced clinically, and vaginal mesh-related infections.  These issues have been recently traced by researchers, who currently believe that the lack of postoperative research done on these products… Continue Reading

2011- Study shows vaginal mesh cost-ineffective

Posted in Vaginal Mesh

As nearly 1 in 10 of all women who experience pelvic organ prolapse, numerous efforts have been made to treat its symptoms.  The use of transvaginal mesh has grown substantially in its clinical popularity, leading to its being the preferred method for surgical treatment of pelvic organ prolapse.  However, it has been noted that a… Continue Reading

Many “issues surrounding” the use of TVM

Posted in Vaginal Mesh

Vaginal mesh devices have recently been used to vaginal wall prolapse and incontinence in women, but unfortunately they have been proven to be problematic in a number of ways.  Legal issues have been arising as treatment involving the surgical use of vaginal mesh kits have led to complications related to both abnormal injury and inadequate… Continue Reading

Risk of AEDs for developing fetus explored

Posted in Depacon / Depakene / Depakote

In 2000, G. Regesta et al. published a paper in Neurology titled “Old and new anti-epileptic drugs in pregnancy,” a literature review aimed at evaluating the safety of antiepileptic drugs for a developing fetus. Regesta et al. (2000) found that many different countries have approved the use of new anti-epileptic drugs with a doctor mandated… Continue Reading

“Birth defects after prenatal exposure to anti-epileptic drugs”

Posted in Depacon / Depakene / Depakote

A recent paper in The Lancet Neurology titled “Birth defects after prenatal exposure to anti-epileptic drugs” highlights the fact that use of antiepileptic drugs containing sodium valproate (Depacon, others) during pregnancy is correlated with an increased for birth defects, especially when AEDs are used during the first trimester. In the past, collaborative multinational studies have… Continue Reading

Depacon (sodium valproate) linked to neurological birth defects

Posted in Depacon / Depakene / Depakote

In 2006, GK Motamedi et al. published a highly-informative paper concerning neurodevelopmental hazards resulting from in utero exposure to antiepileptic drugs.  In their paper, titled “Anti-epileptic drugs and neurodevelopment” Motamedi et al. (2006) found that during testing, certain drugs such as Valproate and Phenobarbital have been linked to an increase of major congenital malformations during… Continue Reading

2004 – Depacon associated with risk for congenital malformations

Posted in Depacon / Depakene / Depakote

In 2004, a team of researchers led by PW Kaplan et al. published a report in Neurology showing “Women with epilepsy also have elevated rates of congenital anomalies and major malformations in their offspring, for which exposure of the developing fetus to AEDs taken by the mother appears to be responsible.” (“AED” stands for “antiepileptic… Continue Reading

2003 – Researchers Aware of Risks Associated with Sodium Valproate

Posted in Depacon / Depakene / Depakote

In 2003, a report by C. Barrett and A. Richens titled “Epilepsy and pregnancy: Report of an Epilepsy Research Foundation Workshop” published in Epilepsy Research aimed to identify factors that heighten the risk for congenital malformations in children born to mothers with epilepsy. Since the publication of this article, scores of peer-reviewed studies have been… Continue Reading

FDA: Victoza Investigated for Possible Cancer Link

Posted in Safety Alerts

WARNING: FDA TO INVESTIGATE VICTOZA-CANCER LINK Recently, the FDA has moved to evaluate whether or not Victoza (liraglutide), a drug used in GLP-1 therapy for the treatment of type II diabetes is associated with an increased rate for cancer. Victoza and other GLP-1 therapy drugs have been previously linked to asymptomatic pancreatitis, and it is… Continue Reading

Depacon associated with serious congenital abnormalities

Posted in Depacon / Depakene / Depakote

Recently, research was published evaluating the “Efficacy of medical care of epileptic pregnant women based on the rate of congenital abnormalities in their offspring.” The intention of this study was to check the effectiveness of the medical care provided for epileptic pregnant women on the basis of decreasing the chance they would pass on congenital… Continue Reading