FDA ALERT [9/2006]

New information suggests that babies exposed to Lamictal during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate.  Babies born with cleft lip or cleft palate have a gap in the upper lip or roof of the mouth. 

If you take Lamictal and are pregnant or are thinking of becoming pregnant, talk with your doctor.  Lamictal is used for seizures or bipolar disorder, serious conditions that need treatment even during pregnancy.  Do not start or stop using Lamictal without talking to your doctor. 

More research is needed to be sure about this possibly increased chance of cleft lip or cleft palate in babies born to mothers who take Lamictal.

This is a summary of the most important information about Lamictal.  For details, talk to your healthcare professional.

What Is Lamictal?

Lamictal is used to:

• treat certain types of seizures
• increase the time between episodes of depression, mania, and other abnormal moods in patients with bipolar I disorder

What Are The Risks?

The following are the risks and potential side effects of Lamictal therapy. However, this list is not complete.

Lamictal may cause serious rashes that may need to be treated in a hospital. Rarely, deaths have been reported. Tell your doctor if you are taking valproic acid (Depakene) or divalproex (Depakote), because taking these medicines with Lamictal may increase your chance of developing a serious rash.

Some side effects can be serious. If you experience any of the following symptoms, call your doctor right away:

• seizures that happen more often, last longer, or are different than the seizures you had in the past
• rash, hives, fever, painful sores in the mouth or irritation around the eyes, or swelling of lips or tongue
• depression

Some common side effects that may occur with Lamictal include:

• dizziness
• headache
• blurred or double vision
• loss of balance or coordination
• sleepiness
• nausea
• vomiting
• difficulty falling asleep or staying asleep
• rash

What Should I Tell My Healthcare Professional?

Before you start taking Lamictal tell your healthcare professional if you:

• are trying to become pregnant, are already pregnant, or are breast-feeding
• have or had heart, liver or kidney disease
• have a blood disorder

Can Other Medicines Or Food Affect Lamictal?

Lamictal and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Especially tell your healthcare professional if you take:

• valproic acid (Depakene)
• divalproex (Depakote)
• carbamazepine (Tegretol)
• phenobarbital
• phenytoin (Dilantin)
• primidone (Mysoline)
• birth control pills
• hormone replacement therapy (HRT)
• rifampin (Rifadin)

Is There Anything Else I Need to Know?

Some patients taking Lamictal have been given the wrong medication at the pharmacy because other medications have similar names.  Examples of drugs with similar names are Lamisil, lamivudine, Ludiomil, labetalol and Lomotil.  Therefore, if your Lamictal tablet looks different, check with the pharmacist to be sure that you have been given the correct medication. continue reading........

Date created: September 28, 2006