Medication Profile - Lamictal Off-Label Use for Migraine

Nancy Harris Bonk Community Member November 09, 2012
  • There's a wide variety of medications used for Migraine, most of which are prescribed off-label. If Lamictal (lamotrigine) has been prescribed for you, or if you and your doctor have been considering it, here's some information that should be helpful.

     

     BLACK BOX WARNING

     

    SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF LAMICTAL. THE INCIDENCE OF THESE RASHES, WHICH HAVE INCLUDED STEVENS-JOHNSON SYNDROME, IS APPROXIMATELY 0.8% (8 PER 1,000) IN PEDIATRIC PATIENTS (AGE <16 YEARS) RECEIVING LAMICTAL AS ADJUNCTIVE THERAPY FOR EPILEPSY AND 0.3% (3 PER 1,000) IN ADULTS ON ADJUNCTIVE THERAPY FOR EPILEPSY. IN CLINICAL TRIALS OF BIPOLAR AND OTHER MOOD DISORDERS, THE RATE OF SERIOUS RASH WAS 0.08% (0.8 PER 1,000) IN ADULT PATIENTS RECEIVING LAMICTAL AS INITIAL MONOTHERAPY AND 0.13% (1.3 PER 1,000) IN ADULT PATIENTS RECEIVING LAMICTAL AS ADJUNCTIVE THERAPY. IN A PROSPECTIVELY FOLLOWED COHORT OF 1,983 PEDIATRIC PATIENTS WITH EPILEPSY TAKING ADJUNCTIVE LAMICTAL, THERE WAS 1 RASH-RELATED DEATH. IN WORLDWIDE POSTMARKETING EXPERIENCE, RARE CASES OF TOXIC EPIDERMAL NECROLYSIS AND/OR RASH-RELATED DEATH HAVE BEEN REPORTED IN ADULT AND PEDIATRIC PATIENTS, BUT THEIR NUMBERS ARE TOO FEW TO PERMIT A PRECISE ESTIMATE OF THE RATE.

     

    OTHER THAN AGE, THERE  ARE AS YET NO FACTORS IDENTIFIED THAT ARE KNOWN TO PREDICT THE RISK OF OCCURRENCE OR THE SEVERITY OF RASH ASSOCIATED WITH LAMICTAL. THERE ARE SUGGESTIONS, YET TO BE PROVEN, THAT THE RISK OF RASH MAY ALSO BE INCREASED BY (1) COADMINISTRATION OF LAMICTAL WITH VALPROATE (INCLUDES VALPROIC ACID AND DIVALPROEX SODIUM), (2) EXCEEDING THE RECOMMENDED INITIAL DOSE OF LAMICTAL, OR (3) EXCEEDING THE RECOMMENDED DOSE ESCALATION FOR LAMICTAL. HOWEVER, CASES HAVE BEEN REPORTED IN THE ABSENCE OF THESE FACTORS.

     

     NEARLY ALL CASES OF LIFE-THREATENING RASHES ASSOCIATED WITH LAMICTAL HAVE OCCURRED WITHIN 2 TO 8 WEEKS OF TREATMENT INITIATION. HOWEVER, ISOLATED CASES HAVE BEEN REPORTED AFTER PROLONGED TREATMENT (E.G., 6 MONTHS). ACCORDINGLY, DURATION OF THERAPY CANNOT BE RELIED UPON AS A MEANS TO PREDICT THE POTENTIAL RISK HERALDED BY THE FIRST APPEARANCE OF A RASH. ALTHOUGH BENIGN RASHES ALSO OCCUR WITH LAMICTAL, IT IS NOT POSSIBLE TO PREDICT RELIABLY WHICH RASHES WILL PROVE TO BE SERIOUS OR LIFE THREATENING. ACCORDINGLY, LAMICTAL SHOULD ORDINARILY BE DISCONTINUED AT THE FIRST SIGN OF RASH, UNLESS THE RASH IS CLEARLY NOT DRUG RELATED. DISCONTINUATION OF TREATMENT MAY NOT PREVENT A RASH FROM BECOMING LIFE THREATENING OR PERMANENTLY DISABLING OR DISFIGURING.1 

       

    Type of medication:

    Lamotrigine, brand name Lamictal, is a neuronal stabilizing agent (antiseizure medication) that is also prescribed off-label for Migraine and headache prevention. This medication can be used to treat epilepsy, bipolar disorder and help stave off mood episodes. It is also used for Migraine prevention.

     

    Precautions:

    • Don't use lamotrigine if you are allergic or hypersensitive to any of the ingredients in it.
    • Some anti-seizure medications may cause people to become more depressed and/or have suicidal thoughts and tendencies. Make sure you tell your doctor if you experience more depression and/or suicidal ideation while taking lamotrigine or when your dose is changed.   
    • You may experience irritability, agitation, mental and/or physical hyperactivity and hostility while taking lamotrigine and if so, tell your doctor right away. Friends, family and caregivers need to be in tune with changes in your moods and/or symptoms.
    • While taking this medication keep all regularly scheduled appointments with your doctor so he/she can check to make sure you are tolerating it.
    • It is extremely important to take lamotrigine precisely as your doctor prescribed it - do not take more or less. Increased amounts of lamotrigine at the beginning of treatment can increase the risk of a serious life-threatening skin rash. This serious skin rash may happen if valproic acid and lamotrigine are taken together.
    • Sometimes it is necessary to change anti-seizure medications. When doing so it is imperative to follow your doctor's orders exactly as written.
    • Make sure you tell your doctor if you have kidney or liver problems, cannot tolerate or are allergic to other ant seizure medications or if you have suicidal thoughts and/or a history of depression.
    • During your treatment with lamotrigine, the doctor may change the dose and also order bloods test to make sure you are taking the correct dose of lamotrigine.
    • Because lamotrigine can cause blurry vision, drowsiness and reduced reaction time and/or impaired thinking, care must be taken when driving or doing anything that requires you to be focused and alert.
    • Do not stop this medication abruptly (even if you feel better) before you talk to your doctor. Stopping lamotrigine suddenly may increase your risk of seizures.
    • Birth control pills may not be as effective when you take lamotrigine; therefore talk with your doctor about contraception to avoid pregnancy.
    • Taking lamotrigine while taking birth control can change how lamotrigine works in the body. Some women may feel more side effects (double vision, problems with coordination and dizziness) during the week of their birth control placebo pills.
    • It is important for all treating doctors to be aware that you take lamotrigine, therefore it is a good idea to wear a medical ID bracelet and have identification stating you take it.
    • Make sure the doctors who treat you, including dentists, know you are taking lamotrigine, especially before surgery.  
    • Immediate-release lamotrigine (Lamictal ODT) has been used in children as young as two years of age but only in conjunction with other seizure medications. Lamictal ODT is not to be given to children younger than 16-years-old as monotherapy.
    • Extended-release lamotrigine (Lamictal XR) should only be used in adults and children over the age of 13-years-old. 
    • Never break, crush or chew the regular lamotrigine tablet; always swallow it whole.
    • When taking dissolvable lamotrigine, put the pill on your tongue, but don't swallow the entire thing - let it disintegrate as you swallow without chewing. Drinking water as you do this may help.
    • When taking the chewable pill you can do a few different things: chew it first then swallow; swallow the entire pill at once or use one teaspoon of watered down fruit juice or water and let it dissolve, then drink the liquid. 

    Pregnancy and Breastfeeding:

    • FDA Pregnancy Category C: This generally means there are no sufficient studies done on pregnant women OR no animal studies have been conducted. However, there seems to be an increased risk of babies being born with cleft lip or cleft palate when lamotrigine is used during the first trimester of pregnancy. Animal studies have shown that it does in fact cause adverse effect on animal fetus and crosses over the placenta.
    • Taking lamotrigine during pregnancy is only advised when there are no other options and the benefits outweigh the risks.
    • Inform your doctor if you are or are planning to become pregnant. He may want you to join a pregnancy registry for pregnant patients taking antiseizure medications.
    • This medication has been found in breast milk. It is not recommended to use lamotrigine while nursing.   

    Other medical  conditions:

    Be sure to let your doctor know of other medical problems you may have, especially:

    • if you suffer from depression or have had a history of depression or suicidal thoughts and/or actions;
    • if you are hypersensitive or allergic to other antiseizure medications;
    • if you have liver or kidney disease and/or heart issues;
    • if you have certain blood problems.

    Other medications:

    Make sure your doctor knows about ALL the medications you take. The following medications should be avoided while taking lamotrigine;

    • ginkgo
    • medroxyprogesterone (birth control)     
    • oral progestin, contraceptives  
    • St. John’s wort

    Medications that need to be monitored closely while taking lamotrigine include;

    • birth control and oral combinations
    • birth control and other combinations
    • carbamazepine  
    • ethosuximide
    • hormone replacement therapy - estrogen
    • hormone replacement therapy - estrogen/ progestin combinations
    • lopinavir/ritonavir     
    • oxcarbazepine
    • phenobarbital
    • phenobarbital/hyoscyamine/ atropine/ scopolamine
    • phenytoins
    • primidone
    • rifampins
    • ritonavir
    • sevelamer
    • valproic acid

    Please use caution when taking the lamotrigine and the following medications;

    • ethanol
    • ezogabine
    • methotrexate
    • milk thistle
    • pimozide
    • pyrimethamine
    • rufinamide
    • sertraline
    • sulfadoxine/pyrimethamine
    • trimethoprim
    • trimethoprim/sulfamethoxazole

                 

    Make sure to tell your doctor if you take any of the following medications;

    • Any form of birth control including pills, implants, injections or patches
    • Depakene, Stavzor (valproic acid)
    • Depakote (divalproex)
    • Dilantin (phenytoin)
    • Rifadin, Rifater, Rifamate, Rimactane (rifampin)
    • Solfoton (phenobarbital)
    • Tegretol, Carbatrol, Equetro (carbamazepine)
    • Trileptal (oxcarbazepine)

    Potential side effects:

    • Get immediate medical care if you experience the following;
      • difficulty breathing
      • fever
      • sore throat
      • facial or tongue swelling, hives
      • any skin pain that is followed by a rash that is purple or red and spreads, causes peeling and blistering - particulraly in the upper body or face
      • burning sensation in eyes
    • Check with your doctor immediately if any of the following serious side effects occur:
      • any skin rash whether it's mild or severe
      • body aches, fever, flu symptoms
      • swollen glands, headache, neck rigidity and/or lower tolerance to light
      • numbness, tingling, pain, muscle weakness
      • pain in upper stomach and/or loss of appetite
      • yellowing of the eyes or skin (jaundice)
      • rapid breathing or shortness of breath
      • irregular heart beat and/or chest pain
      • sporadic urination which then becomes less or stops, dark urine
      • swelling of legs, feet, ankles and hands
      • nausea and vomiting
      • changes in pallor of skin
      • trouble with concentration
      • more seizure activity
      • your bipolar disorder gets worse
    • Potential side effects that may be less severe include
      • feeling tired of dizzy
      • double or blurry vision
      • tremors
      • problems and/or loss of coordination
      • irregularities with your menstrual period
      • slight nausea, trouble and/or pain with your stomach
      • mouth dryness
      • pain in back
      • sleeping issues
      • cold symptoms like a runny nose and sore throat

     

  • Brand names:

    • U.S.: Lamictal

    Related Information:

     

    ____________

    Sources:

     

    1 Prescribing Information. "Lamictal." GlaxoSmithKline. 2009.

     

    2 Wolters Kluwer. "Lamictal." Drugs.com. Last revised October 2, 2012.

     

    2 Cerner Multum, Inc. "Lamictal." Epocrates.com. Last revised April 18, 2012.

     

    Material on this page is for informational purposes only, and should not be construed as medical advice. Always consult your physician or pharmacist regarding medications.

     

    Thanks for reading,

     

    NancySig

     

     

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    © The HealthCentral Network, 2012
    Last Updated November 6, 2012.

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