New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.
Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.
Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines.
“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered.”
Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.
Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.
Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Similar data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.
Based on the data, topiramate will have a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. The FDA previously designated the drug as Pregnancy Category C because of the lack of human data. More information about the Pregnancy Categories can be found in the FDA’s Drug Safety Communication1.
The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.
Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional.
Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry2, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.
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Showing posts with label defects. Show all posts
Showing posts with label defects. Show all posts
Friday, March 04, 2011
Monday, February 28, 2011
Smoking Early in Pregnancy Raises Risk of Heart Defects in Infants
Maternal cigarette smoking in the first trimester was associated with a 20 to 70 percent greater likelihood that a baby would be born with certain types of congenital heart defects, according to a study by the Centers for Disease Control and Prevention. Congenital heart defects are the most common type of birth defects, contributing to approximately 30 percent of infant deaths from birth defects annually.
The study found an association between tobacco exposure and certain types of defects such as those that obstruct the flow of blood from the right side of the heart into the lungs (right ventricular outflow tract obstructions) and openings between the upper chambers of the heart (atrial septal defects). The study is in the Feb. 28 issue of the journal Pediatrics.
"Women who smoke and are thinking about becoming pregnant need to quit smoking and, if they're already pregnant, they need to stop," said CDC Director Thomas R. Frieden, M.D., M.P.H. "Quitting is the single most important thing a woman can do to improve her health as well as the health of her baby."
Based on the findings of this and other studies, eliminating smoking before or very early in pregnancy could prevent as many as 100 cases of right ventricular outflow tract obstructions and 700 cases of atrial septal defects each year in the United States. For atrial septal defects alone, that could potentially save $16 million in hospital costs.
"Successfully stopping smoking during pregnancy also lowers the chances of pregnancy complications such as preterm delivery and that an infant will have other complications such as low birth weight," said Adolfo Correa, M.D., Ph.D., medical officer in CDC′s National Center on Birth Defects and Developmental Disabilities.
The findings from the study, "Maternal Smoking and Congenital Heart Defects in the Baltimore-Washington Infant Study," are based on a large population-based case-control study of congenital heart defects conducted in the United States; 2,525 case and 3,435 control infants born from 1981 to 1989 were included in this analysis.
Congenital heart defects are conditions present at birth that decrease the ability of the heart to work well, which can result in an increased likelihood of death or long-term disabilities. They affect nearly 40,000 infants in the United States every year.
It is estimated that right ventricular outflow tract obstructions affect approximately 2,500 infants per year and atrial septal defects affect approximately 5,600 infants per year in the United States. In 2004, U.S. hospital costs for all congenital heart defects were estimated at approximately $1.4 billion.
Source: PRNewswire
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The study found an association between tobacco exposure and certain types of defects such as those that obstruct the flow of blood from the right side of the heart into the lungs (right ventricular outflow tract obstructions) and openings between the upper chambers of the heart (atrial septal defects). The study is in the Feb. 28 issue of the journal Pediatrics.
"Women who smoke and are thinking about becoming pregnant need to quit smoking and, if they're already pregnant, they need to stop," said CDC Director Thomas R. Frieden, M.D., M.P.H. "Quitting is the single most important thing a woman can do to improve her health as well as the health of her baby."
Based on the findings of this and other studies, eliminating smoking before or very early in pregnancy could prevent as many as 100 cases of right ventricular outflow tract obstructions and 700 cases of atrial septal defects each year in the United States. For atrial septal defects alone, that could potentially save $16 million in hospital costs.
"Successfully stopping smoking during pregnancy also lowers the chances of pregnancy complications such as preterm delivery and that an infant will have other complications such as low birth weight," said Adolfo Correa, M.D., Ph.D., medical officer in CDC′s National Center on Birth Defects and Developmental Disabilities.
The findings from the study, "Maternal Smoking and Congenital Heart Defects in the Baltimore-Washington Infant Study," are based on a large population-based case-control study of congenital heart defects conducted in the United States; 2,525 case and 3,435 control infants born from 1981 to 1989 were included in this analysis.
Congenital heart defects are conditions present at birth that decrease the ability of the heart to work well, which can result in an increased likelihood of death or long-term disabilities. They affect nearly 40,000 infants in the United States every year.
It is estimated that right ventricular outflow tract obstructions affect approximately 2,500 infants per year and atrial septal defects affect approximately 5,600 infants per year in the United States. In 2004, U.S. hospital costs for all congenital heart defects were estimated at approximately $1.4 billion.
Source: PRNewswire
-----
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www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP
Thursday, February 18, 2010
Chesley: Toyota Apologies Are Not Getting Dangerous Cars Off Roads
/PRNewswire/ -- With the latest news that Toyota may recall its 2009 and 2010 Corollas because of power steering defects, Toyota has now admitted to defects in its vehicles' accelerator, braking and steering systems - the three most important aspects of operating a motor vehicle.
Stanley M. Chesley of the Cincinnati-based law firm of Waite, Schneider, Bayless & Chesley Co., L.P.A. - whose firm has filed a major RICO class action against Toyota for deceiving its customers and dealers about these mounting defects - stated that "when your Toyota's accelerator, brakes and steering are all defective, what you really have is a failure of your car's electronic controls, which function as the car's brain and central nervous system."
Congressman Bart Stupak recently amplified Chesley's suspicion, noting that Toyota's internal documents made clear that, as far back as 2002, Toyota was aware that electronic control system problems may be causing sudden acceleration. Despite this Congressional investigation, however, Toyota continues to bar investigators from examining its electronic control technology.
Now, with Toyota's recall of a staggering 11 million vehicles, Toyota's president and CEO, Akio Toyoda, yesterday indicated that he won't come to the U.S. to testify at upcoming congressional hearings on the recalls.
Chesley stated, "No one is above the law. Presidents of tobacco companies, and even U.S. Presidents, have testified before congressional committees. Akio Toyoda's grand apologies from 6,000 miles away don't release him from appearing before Congress and they don't explain Toyota's nearly decade-long cover up of these defects."
According to news sources, Toyota's faulty engineering and sloppy quality control - all of which stem from decision-making at Toyota's Japanese headquarters - have caused at least 39 confirmed deaths, countless injuries and billions of dollars in economic damage to Toyota drivers. As Chesley remarked, "for Toyota's CEO to even consider refusing to appear before Congress, particularly when he's looking to the United States to make Toyota the world's largest car manufacturer, is outrageous."
Chesley filed the RICO class action, in part, because the evidence continues to disprove Toyota's statements about the defects' causes. All of this evidence highlighting Toyota's deception underscores the company's pattern of corrupt and fraudulent practices, which is what RICO, the federal racketeering statute, prohibits.
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Stanley M. Chesley of the Cincinnati-based law firm of Waite, Schneider, Bayless & Chesley Co., L.P.A. - whose firm has filed a major RICO class action against Toyota for deceiving its customers and dealers about these mounting defects - stated that "when your Toyota's accelerator, brakes and steering are all defective, what you really have is a failure of your car's electronic controls, which function as the car's brain and central nervous system."
Congressman Bart Stupak recently amplified Chesley's suspicion, noting that Toyota's internal documents made clear that, as far back as 2002, Toyota was aware that electronic control system problems may be causing sudden acceleration. Despite this Congressional investigation, however, Toyota continues to bar investigators from examining its electronic control technology.
Now, with Toyota's recall of a staggering 11 million vehicles, Toyota's president and CEO, Akio Toyoda, yesterday indicated that he won't come to the U.S. to testify at upcoming congressional hearings on the recalls.
Chesley stated, "No one is above the law. Presidents of tobacco companies, and even U.S. Presidents, have testified before congressional committees. Akio Toyoda's grand apologies from 6,000 miles away don't release him from appearing before Congress and they don't explain Toyota's nearly decade-long cover up of these defects."
According to news sources, Toyota's faulty engineering and sloppy quality control - all of which stem from decision-making at Toyota's Japanese headquarters - have caused at least 39 confirmed deaths, countless injuries and billions of dollars in economic damage to Toyota drivers. As Chesley remarked, "for Toyota's CEO to even consider refusing to appear before Congress, particularly when he's looking to the United States to make Toyota the world's largest car manufacturer, is outrageous."
Chesley filed the RICO class action, in part, because the evidence continues to disprove Toyota's statements about the defects' causes. All of this evidence highlighting Toyota's deception underscores the company's pattern of corrupt and fraudulent practices, which is what RICO, the federal racketeering statute, prohibits.
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