31.01.2014

Klonopin pregnancy birth defects

Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. The effectiveness of Klonopin in the treatment of panic disorder was demonstrated in two double-blind, placebo-controlled studies of adult outpatients who had a primary diagnosis of panic disorder (DSM-IIIR) with or without agoraphobia. Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Klonopin is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV.
The efficacy of Klonopin was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials).
The effectiveness of Klonopin in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. Klonopin should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease.
Since Klonopin produces CNS depression, patients receiving this drug should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery or driving a motor vehicle. Antiepileptic drugs (AEDs), including Klonopin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
Anyone considering prescribing Klonopin or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Recent reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. In children of women treated with drugs for epilepsy, reports suggesting an elevated incidence of birth defects cannot be regarded as adequate to prove a definite cause and effect relationship. There may also be non-teratogenic risks associated with the use of benzodiazepines during pregnancy.
In general, the use of Klonopin in women of childbearing potential, and more specifically during known pregnancy, should be considered only when the clinical situation warrants the risk to the fetus. Because of experience with other members of the benzodiazepine class, Klonopin is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. When used in patients in whom several different types of seizure disorders coexist, Klonopin may increase the incidence or precipitate the onset of generalized tonic-clonic seizures (grand mal). Periodic blood counts and liver function tests are advisable during long-term therapy with Klonopin. The abrupt withdrawal of Klonopin, particularly in those patients on long-term, high-dose therapy, may precipitate status epilepticus. Metabolites of Klonopin are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function.
A Klonopin Medication Guide must be given to the patient each time Klonopin is dispensed, as required by law. Because benzodiazepines have the potential to impair judgment, thinking or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Klonopin therapy does not affect them adversely. Patients, their caregivers, and families should be counseled that AEDs, including Klonopin, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with Klonopin (see WARNINGS: Pregnancy Risks).
To provide information regarding the effects of in utero exposure to Klonopin, physicians are advised to recommend that pregnant patients taking Klonopin enroll in the NAAED Pregnancy Registry.
Because of the possibility that adverse effects on physical or mental development could become apparent only after many years, a benefit-risk consideration of the long-term use of Klonopin is important in pediatric patients being treated for seizure disorder (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION). Clinical studies of Klonopin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.


Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Klonopin and observed closely.
The adverse experiences for Klonopin are provided separately for patients with seizure disorders and with panic disorder. Adverse events during exposure to Klonopin were obtained by spontaneous report and recorded by clinical investigators using terminology of their own choosing.
Overall, the incidence of discontinuation due to adverse events was 17% in Klonopin compared to 9% for placebo in the combined data of two 6- to 9-week trials. Events reported by at least 1% of patients treated with Klonopin and for which the incidence was greater than that for placebo. In the pool of two short-term placebo-controlled trials, adverse events classified under the preferred term "depression" were reported in 7% of Klonopin-treated patients compared to 1% of placebo-treated patients, without any clear pattern of dose relatedness. Following is a list of modified CIGY terms that reflect treatment-emergent adverse events reported by patients treated with Klonopin at multiple doses during clinical trials. There is no clinical trial experience with Klonopin in seizure disorder patients 65 years of age and older. There is no clinical trial experience with Klonopin in panic disorder patients under 18 years of age. There is no clinical trial experience with Klonopin in panic disorder patients 65 years of age and older.
Read this Medication Guide before you start taking Klonopin and each time you get a refill.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how Klonopin affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Klonopin until you talk to your healthcare provider.
Like other antiepileptic drugs, Klonopin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Children born to mothers receiving benzodiazepine medications (including Klonopin) late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, hypothermia, and withdrawal symptoms. If you become pregnant while taking Klonopin, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. Talk to your doctor about slowly stopping Klonopin to avoid getting sick with withdrawal symptoms. Klonopin is a federally controlled substance (C-IV) because it can be abused or lead to dependence. It is not known if Klonopin is safe or effective in treating panic disorder in children younger than 18 years old. In these studies, Klonopin was shown to be significantly more effective than placebo in treating panic disorder on change from baseline in panic attack frequency, the Clinician's Global Impression Severity of Illness Score and the Clinician's Global Impression Improvement Score.
In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. The physician who elects to use Klonopin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
They should also be warned about the concomitant use of alcohol or other CNS-depressant drugs during Klonopin therapy (see PRECAUTIONS: Drug Interactions and Information for Patients).
There are intrinsic methodologic problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors (eg, genetic factors or the epileptic condition itself) may be more important than drug therapy in leading to birth defects. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy.
Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant.


In these same trials, adverse events classified under the preferred term "depression" were reported as leading to discontinuation in 4% of Klonopin-treated patients compared to 1% of placebo-treated patients. In general, elderly patients should be started on low doses of Klonopin and observed closely (see PRECAUTIONS: Geriatric Use). Therefore, the physician who elects to use Klonopin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. Because stopping Klonopin suddenly can also cause serious problems, do not stop taking Klonopin without talking to your healthcare provider first. When taken with alcohol or drugs that cause sleepiness or dizziness, Klonopin may make your sleepiness or dizziness worse. These defects can happen as early as in the first month of pregnancy, even before you know you are pregnant.
You and your healthcare provider should decide if you will take Klonopin while you are pregnant. Talk to your healthcare provider about the best way to feed your baby if you take Klonopin.
Stopping Klonopin suddenly can cause seizures that do not stop, hearing or seeing things that are not there (hallucinations), shaking, and stomach and muscle cramps.
In addition, children born to mothers receiving benzodiazepines late in pregnancy may be at some risk of experiencing withdrawal symptoms during the postnatal period. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. While Klonopin is being gradually withdrawn, the simultaneous substitution of another anticonvulsant may be indicated. Because of this and the possibility of respiratory depression, Klonopin should be used with caution in patients with chronic respiratory diseases.
This registry is collecting information about the safety of antiepileptic drugs during pregnancy.
It is important to emphasize that, although the events occurred during treatment with Klonopin, they were not necessarily caused by it. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
The difference between Klonopin and placebo in reduction from baseline in the number of full panic attacks was approximately 1 panic attack per week. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. To enroll, patients can call the toll free number 1-888-233-2334 (see PRECAUTIONS: Pregnancy). In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy; however, it cannot be said with any confidence that even mild seizures do not pose some hazards to the developing embryo or fetus. Patients should also be advised that if they become pregnant during therapy or intend to become pregnant, they should communicate with their physician about the desirability of discontinuing the drug.



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