[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.
BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.
RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: [Web] and [Web].
REMS:
FDA approved a REMS for clozapine to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of clozapine and consists of the following: elements to assure safe use and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
CLOZAPINE (KLOE za peen) is used to treat schizophrenia. This medicine is only used when others have not worked. It has a risk of serious side effects and is only available through a monitoring and dispensing system that includes special doctors, pharmacists, and laboratories. For the first few months of treatment, you will be required to have routine blood testing before your prescription can be refilled.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth. Follow the directions on the prescription label. These tablets are made to dissolve in the mouth. Place the tablet in the mouth and allow it to dissolve, then swallow. While you may take these tablets with water, it is not necessary to do so. This medicine may be taken with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not suddenly stop taking this medicine. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.
The tablets should stay in the unopened blister package until immediately before you take your dose. If you split the tablet as part of your dose, the half-tablet that is not taken should be destroyed. Do not save this half-tablet for later use.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you miss your medicine for more than 2 days, you should not restart your medicine at the same dose. Contact your doctor for instructions.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. It may be several weeks before you see the full effects of this medicine. Contact your doctor or health care professional if your symptoms get worse or if you have new symptoms.
You must have a weekly blood test when you first begin this medicine. If your blood counts stay in the right range, your tests may be reduced after 6 months to every other week. Your name will go on a national registry of patients that take this medicine, to make sure that you have never had a serious reaction to it.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.
Do not treat yourself for colds, fever, diarrhea or allergies. Ask your doctor or health care professional for advice, some nonprescription medicines may increase possible side effects.
If you are going to have surgery tell your doctor or health care professional that you are taking this medicine.
If you have phenylketonuria, you should be aware that each 25 mg, orally-disintegrating tablet contains 3.1 mg of aspartame (1.74 mg of phenylalanine) and each 100 mg, orally-disintegrating tablet contains 12.4 mg of aspartame (6.96 mg of phenylalanine).
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep the tablets in the packaging until the time of use. Protect from moisture. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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