Drug Notebook

FDA Alerts

Special Alerts:

[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html and http://www.fda.gov/cder/drug/antidepressants/default.htm.

[Posted 07/19/2006] FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.

One study illustrated the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. In this study, women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were women who continued to take their antidepressant medicine while pregnant.

The second study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk of one drug compared to another. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.

Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.

Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#SSRIpreg and http://www.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm.

[Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.

Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.

Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.

Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Triptans and http://www.fda.gov/cder/drug/advisory/SSRI_SS200607.htm.

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olanzapine
(oh LANZ a peen)

What is olanzapine?
Olanzapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain. Olanzapine is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). Olanzapine may also be used for other purposes not listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Symbyax 12-25MG Capsules LILLY30/$466.3 or 90/$1398.9
Symbyax 12-50MG Capsules LILLY30/$441.86 or 90/$1262.39
Symbyax 6-25MG Capsules LILLY30/$291.4 or 90/$847.7
Zyprexa 10MG Tablets LILLY30/$368.88 or 90/$1068.48
Zyprexa 15MG Tablets LILLY30/$551.18 or 90/$1564.63
Zyprexa 2.5MG Tablets LILLY30/$202.43 or 90/$590.31
Zyprexa 20MG Tablets LILLY30/$654.99 or 90/$1959.81
Zyprexa 5MG Tablets LILLY30/$248.21 or 90/$684.56
Zyprexa 7.5MG Tablets LILLY30/$300.58 or 90/$853.87

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What are the possible side effects of olanzapine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using olanzapine and call your doctor at once if you have any of these serious side effects:

  • fever, stiff muscles, sweating, fast or uneven heartbeats;

  • jerky muscle movements you cannot control;

  • sudden numbness or weakness, especially on one side of the body;

  • sudden headache, confusion, problems with vision, speech, or balance;

  • increased thirst, frequent urination, excessive hunger, or weakness;

  • feeling light-headed, fainting;

  • unusual thoughts or behavior, hallucinations, or thoughts about hurting yourself; or

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dizziness, drowsiness, or weakness;

  • constipation;

  • dry mouth;

  • swelling in your hands or feet;

  • back pain;

  • weight gain, increased appetite; or

  • upset stomach.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take olanzapine?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Take this medicine with a full glass of water. Olanzapine can be taken with or without food. Olanzapine is usually taken once a day. Follow your doctor's instructions. To take olanzapine orally disintegrating tablets (Zyprexa Zydis): Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

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What is the most important information I should know about olanzapine?
Olanzapine is not for use in psychotic conditions that are related to dementia. Olanzapine has caused fatal heart attack and stroke in older adults with dementia-related conditions. Olanzapine may cause you to have high blood sugar (hyperglycemia). Symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. If you are diabetic, check your blood sugar levels on a regular basis while you are taking olanzapine. It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect olanzapine?
Before taking olanzapine, tell your doctor if you are taking any of the following medicines: a medication to treat high blood pressure or a heart condition; carbamazepine (Tegretol); fluvoxamine (Luvox); or a medication to treat Parkinson's disease including levodopa (Sinemet, Larodopa, Atamet), selegiline (Eldepryl, Emsam), pramipexole (Mirapex), ropinirole (Requip), and others. This list is not complete and there may be other drugs that can interact with olanzapine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Olanzapine has been assigned to pregnancy category C by the FDA. Some animal studies have revealed evidence of fetotoxicity at 9 times the maximum human dose on a mg/m2 basis. There are no controlled data in human pregnancy. Olanzapine should only be given during pregnancy when benefit outweighs risk.

A study analyzing 23 prospectively and 11 retrospectively olanzapine-exposed pregnancies found that the rates for spontaneous abortion, stillbirth, prematurity, and malformation fell within the control range. Several additional cases of healthy infants born to olanzapine-treated mothers have also been reported.

Olanzapine is excreted into human milk. A study involving lactating, healthy women reported a mean infant dose at steady-state of approximately 1.8% of the maternal olanzapine dose. Adverse effects (which may not have been caused by the olanzapine) have been described in one nursing infant. The manufacturer recommends that breast-feeding be avoided in women receiving olanzapine.

Two cases of exposure to olanzapine during lactation have been reported. One infant experienced adverse effects which continued after olanzapine was discontinued, suggesting an alternate cause. No problems were reported in the other infant. A study involving 7 mother-infant nursing pairs in which the mother received olanzapine at an average daily dose of 7.5 mg (range = 5 to 20 mg) reported a median infant dose ingested from the milk of approximately 1.02% of the maternal dose. Six infants had olanzapine plasma levels below the detectable level. All infants remained healthy and failed to show signs or symptoms of adverse effects. The maximum olanzapine concentration in the milk was shown to be delayed from the corresponding maximum maternal plasma level; therefore, infant exposure may possibly be reduced by avoiding breast-feeding for approximately 5 hours after olanzapine administration. However, the authors recommend all breast-fed infants of mothers receiving olanzapine be monitored closely and the decision to breast-feed only be made if the benefit outweighs the risk.

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Who should NOT use this medication?

  • Known hypersensitivity to olanzapine or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include drowsiness, agitation, aggression, slurred speech, confusion, increased heart rate, jerky or uncontrolled muscle movements, trouble breathing, or fainting.

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What should I discuss with my healthcare provider before taking olanzapine?
Olanzapine is not for use in psychotic conditions that are related to dementia. Olanzapine has caused fatal heart attack and stroke in older adults with dementia-related conditions. Before taking olanzapine, tell your doctor if you are allergic to any drugs, or if you have: liver disease; kidney disease; heart disease, high blood pressure, heart rhythm problems; high cholesterol or triglycerides; a history of heart attack or stroke; a history of breast cancer; seizures or epilepsy; a personal or family history of diabetes;

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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