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Last Updated: Dec 27th, 2006 - 19:07:47 |
Editor's note: We list here 1) FDA news on Paxil released on Dec. 8, 2) FDA advisory on the drug, and 3) Patient information on Paxil.
Paroxetine hydrochloride is marketed under these names:
* Paroxetine HCL
* Paxil
* Paxil CR
FDA Public Health Advisory: Paroxetine
The Food and Drug Administration (FDA) has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D and added new data and recommendations to the Warnings section of paroxetine’s prescribing information. Paroxetine is available as Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride.
The FDA’s conclusions and changes in paroxetine’s prescribing information are based on preliminary analyses of two recent unpublished epidemiology studies.
* In a study using Swedish national registry data, women who received paroxetine in early pregnancy had an approximately 2-fold increased risk for having an infant with a cardiac defect compared to the entire national registry population (the risk of a cardiac defect was about 2% in paroxetine-exposed infants vs. 1% among all registry infants).
* In a separate study using a United States insurance claims database, infants of women who received paroxetine in the first trimester had a 1.5-fold increased risk for cardiac malformations and a 1.8-fold increased risk for congenital malformations overall compared to infants of women who received other antidepressants in the first trimester. The risk of a cardiac defect was about 1.5% in paroxetine-exposed infants vs. 1% among infants exposed to other antidepressants.
* Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common type of congenital malformations. They range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve on their own. It is of note that the data in these studies was limited to first trimester exposures only, and there are not currently data to address whether this or any other risk extends to later periods of pregnancy.
The FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine. In the interim, FDA recommends the following:
Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. In individual cases, the benefits of continuing paroxetine may outweigh the potential risk to the fetus. If the decision is made to discontinue paroxetine and switch to another antidepressant or cease antidepressant therapy, paroxetine discontinuation should be undertaken only as directed in the prescribing information. Paroxetine should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future.
Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.
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Patient Information Sheet
Paroxetine hydrochloride (marketed as Paxil)
This is a summary of the most important information about paroxetine. For details, talk to your healthcare professional.
FDA Alert [12/2005] – Increase in the Risk of Birth Defects
Pregnant women
Early results of new studies show that paroxetine increases the risk of birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paroxetine should usually not be taken during pregnancy, but for some women who have already been taking paroxetine, the benefits of continuing paroxetine may be greater than the potential risk to the baby. Women taking paroxetine who are pregnant, think they may be pregnant, or plan to become pregnant should talk to their physicians about the potential risks of taking paroxetine during pregnancy.
The early results of two studies showed that women who took paroxetine (Paxil) during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants, and women in the general population. Most of the heart defects in these studies were not life-threatening, and happened mainly in the inside walls of the heart muscle where repairs can be done if needed (atrial and ventricular septal defects). Sometimes these septal defects resolve without treatment. In one of the studies, the risk of heart defects in babies whose mothers had taken paroxetine early in pregnancy was 2%, compared to a 1% risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken paroxetine in the first three months of pregnancy was 1.5%, compared to 1% in babies whose mothers had taken other antidepressants in the first three months of pregnancy. This study also showed that women who took paroxetine in the first three months of pregnancy were about twice as likely to have a baby with any birth defect as women who took other antidepressants.
The FDA is currently in the process of gathering additional data to better understand these observations.
This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
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FDA Alert [07/2005] – Suicidal Thoughts or Actions in Children and Adults
Patients with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants, especially early in treatment or when the dose is changed. Patients who become irritable or anxious, or have new or increased thoughts of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away.
Children
Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. Although paroxetine is prescribed for children, FDA has not approved paroxetine for use in children.
Adults
Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidal thinking or behavior in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.
This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
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What Is Paroxetine?
Paroxetine is in a class of medicines called selective serotonin reuptake inhibitors (SSRIs).
Paroxetine tablets and oral suspension are used to treat:
* Depression
* Panic disorder
* Social anxiety disorder (SAD)
* Obsessive-compulsive disorder (OCD)
* Posttraumatic stress disorder (PTSD)
* Generalized anxiety disorder (GAD)
Paroxetine CR is used to treat:
* Depression
* Panic disorder
* Social anxiety disorder (SAD)
* Premenstrual dysphoric disorder (PMDD)
Who Should Not Take Paroxetine?
* Never take paroxetine if you are taking another drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking paroxetine close in time to an MAOI can result in serious, sometimes fatal reactions including:
o High body temperature
o Coma
o Seizures (convulsions)
* MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands. Never take paroxetine if you are taking Mellaril (thioridazine), used to treat schizophrenia, because it can result in serious heart beat problems.
What Are The Risks?
* Suicidal thoughts or actions: See FDA Alert.
* Stopping paroxetine: Do not stop taking paroxetine suddenly because you could get side effects. Your healthcare professional will slowly decrease your dose.
* Bleeding problems: Paroxetine may cause bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding.
* Mania: You may become hyperactive, excitable or elated.
* Seizures: You may experience a seizure (convulsion) even if you are not taking paroxetine close in time with a MAOI.
* Pregnancy: Tell your healthcare professional if you are or may be pregnant (see FDA Alert [11/2005] above). In addition to the issues discussed in the alert, babies delivered to mothers taking paroxetine late in pregnancy have developed problems, such as difficulty breathing and feeding.
* Sexual problems: You may have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire).
* Other side effects include weakness, dry mouth, constipation, yawning, infection, diarrhea, sweating, dizziness, tremor, nervousness, nausea, difficulty sleeping, decreased appetite, and sleepiness.
* Tell your healthcare professional about all your medical conditions, especially if you have liver or kidney disease, or glaucoma. Tell your healthcare professional if you are breast-feeding or plan to breast-feed your baby.
Are There Any Interactions With Drugs or Foods?
* Paroxetine may interact with medicines other than the ones already mentioned in this information sheet. These interactions can cause serious side effects. Tell your healthcare professional about all medicines, vitamins, and herbal supplements you take.
* If you plan to drink alcohol, talk to your healthcare professional.
How Do I Take Paroxetine?
* Paroxetine is taken by mouth, with or without food, once a day.
* Swallow paroxetine tablets whole. Do not crush or chew them.
Is There Anything Else I Need to Know?
You can get more information about antidepressants at: http://www.fda.gov/cder/drug/antidepressants/default.htm
Paxil FDA Approved 1992
Patient Information Sheet Revised 07/2005
Patient Information Sheet Revised 11/2005
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570
Druginfo@cder.fda.gov
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FDA News
FOR IMMEDIATE RELEASE
P05-97
December 8, 2005
Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Advising of Risk of Birth Defects with Paxil - Agency Requiring Updated Product Labeling
The Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression and several other psychiatric disorders. FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil.
FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.
FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus. Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy. Women taking Paxil should not stop taking it without first talking with their physician.
The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.
In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.
FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.
Based on results of the preliminary data, GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.
Source: FDA
© 2004-2005 by foodconsumer.org unless otherwise specified
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