ROCKVILLE, Maryland --
The US Food and Drug Administration has announced today that it will require the manufacturers of anti epileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors. The action includes all anti epileptic drugs including those used to treat psychiatric disorders, migraine headaches, and other conditions, as well as epilepsy.
The FDA is also requiring that the manufacturers submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of anti epileptic medications.
"Patients being treated with anti epileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," said Russell Katz, MD, Division of Neurology Products, FDA's Center for Drug Evaluation and Research, Rockville, Maryland. "Patients who are currently taking an anti epileptic medicine should not make any treatment changes without talking to their health care professional."
Healthcare professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.
The FDA's actions are based on the agency's review of 199 clinical trials of 11 anti epileptic drugs which showed that patients receiving anti epileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43%) compared with patients receiving a placebo (0.24%). This difference was about 1 additional case of suicidal thoughts or behaviors for every 500 patients treated with anti epileptic drugs instead of placebo.
Of the patients who were randomized to receive one of the anti epileptic drugs, 4 committed suicide, whereas none of the patients in the placebo group did.
Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides.
The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with anti epileptic drugs are unknown.
Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of anti epileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict time lines for resolving the issue and allows the agency to initiate an enforcement action if necessary.
The following anti epileptic drugs are required to add warnings about the risk of suicidality:
carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR); clonazepam (Klonopin); clorazepate (Tranxene); divalproex sodium (Depakote, Depakote ER, Depakene); ethosuximide (Zarontin); ethotoin (Peganone); felbamate (Felbatol); gabapentin (Neurontin); lamotrigine (Lamictal); lacosamide (Vimpat); levetiracetam (Keppra); mephenytoin (Mesantoin); methosuximide (Celontin); oxcarbazepine (Trileptal); phenytoin (Dilantin Suspension); pregabalin (Lyrica); primidone (Mysoline); tiagabine (Gabitril); topiramate (Topamax); trimethadione (Tridione); and zonisamide (Zonegran).
Some of these medications are also available as generics.
Health care professionals and consumers may report serious adverse events or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
-- Online : www.fda.gov/MedWatch/report.htm
-- Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
-- Fax: (800) FDA-0178
-- Phone: (800) FDA-1088
SOURCE: US Food and Drug Administration
Showing posts with label meditation. Show all posts
Showing posts with label meditation. Show all posts
Friday, December 19, 2008
Friday, June 27, 2008
Ideas to Empower YOU in Pain Survival !!
Remember to have fun—and seize the day!
Self-Care -- Relaxation/Meditation
* Take a long bubble bath and light some candles.
* Slow down—and breath deeply…
* Use aromatherapy—relax to your favorite scents.
* Meditate, with a group or by yourself.
* Listen or make music (i.e., play a CD, sing or play an instrument.)
* Get a massage by a professional masseuse – or someone you love…
* Seek out things that make you laugh—remember, laughter is the best medicine!
* Buy a bouquet of flowers to cheer up your surroundings!
* Grow something—commune with Mother Nature!
* Stir your imagination—imagine a pleasant experience, moment, sensation…
* Make or craft something (i.e., knit a scarf, do pottery, etc.)
* Go to an outdoor concert, and don’t forget to pack a picnic.
* Treat yourself to a manicure and/or pedicure. Be a Queen for a day!
* Explore an antique store—lose yourself among the treasures…
Cognitive/Mental Strategies
* Practice mindfulness—be in the moment…
* Try art therapy (i.e., paint or draw a picture that shows how you feel!)
* Use narrative therapy (i.e., write your pain experience.)
* Keep a gratitude/affirmation log (write down three things you’re grateful for each day.)
* When depression and/or anxiety hits, don’t fight it. Know it’s a part of the natural pain experience.
But don’t hold on for too long…
* Accept that everything you’re feeling is real and normal.
* Take a class, learn something new—and stimulate your mind!
* Wear a bright color—they excite the senses!
* Reflect upon affirming, positive memories…
* Read a great book—or a breezy romance novel.
* Express your true and authentic self. You’re the only you!
* Think positive, affirming things about yourself.
* Take a trip, even if it’s a virtual one.
* Seek support through a professional pain counselor.
* Make a change and surprise yourself (i.e., get a new haircut, try a new recipe, etc.)
* Get dressed up and put your make-up on, just because it makes you feel good!
* Keep a positive attitude, hang in there and keep the faith!
* Practice appreciation for your healthcare providers—more often than not, they’re trying their best to help…
* On a bad day, remember what Scarlet O’Hara said, “Tomorrow is another day!”
* Notice and appreciate the splendor of the season changes…
* Learn a foreign language…or two! Exercise that part of the brain that doesn’t read pain signals.
* Choose something you love, and do it every week, same day and time. A joyful routine gives you something sweet to look forward to…
* Don’t let your pain define you. Remember that while pain is now a part of your life experience, it’s not your identity.
Care of the Body
* Exercise regularly and keep your body moving. Hydrotherapy in warm water is especially effective with pain conditions.
* Eat a healthy diet (fruits, vegetables, lean meats, etc.)
* Avoid or quit smoking!
* Practice good sleep habits—enjoy waking up refreshed and renewed.
* Be open to alternative and complimentary therapies (i.e., acupuncture, guided imagery, etc.)
* Have realistic expectations about therapies (i.e., have you given your physical therapy regimen enough time to help?)
* Educate yourself about your pain condition. But don’t obsess and let it consume you…
* Listen to your body talk—you know it better than anyone else!
* Learn to say “no”—avoid stress by not over-burdening/committing yourself.
* Spend time in the sun—and don’t forget that all-important sun block!
* Practice good posture. A well-aligned and supported spine is virtually guaranteed to help any pain condition.
Relationships
* Do something nice for someone—it feels good, and that energy is sure to come back your way.
* Learn to forgive those who have disappointed you throughout your pain experience; anger is further fuel for pain!
* Adopt a pet. Unconditional love is good for the soul…
* Give someone a hug—who knows, you might just get two back!
* Volunteer for your favorite charity, school or organization. Doing good is chicken soup for the soul!
* Throw yourself a party. Celebrate an accomplishment with family and friends!
* Get involved in your community (i.e., attend neighborhood council meetings, help plan a block party, etc.)
* Seek out fellow chronic pain sufferers through on-line discussion boards and support groups at medical centers. These bonds could last a lifetime.
* Don’t forget about lovemaking with your partner. Intimacy is second to none to revive the soul and senses!
* Spend quality time with a child or children (yours, nieces or nephews, etc.)—they’ll help you see the world with eyes of wonder!
* Have an afternoon tea with some girlfriends.
* Accept an invitation to a party or other social event, even if you’re in pain. It’s great misdirection—and you’ll probably find yourself having a dandy time!
* Be open to talking to family and friends about your pain experience—and answering their naturally inquisitive questions. If they’re curious, they probably care. Try not to shut them out…
* Remove toxic people from your life—as stress and strain that comes from bad relationships makes pain worse. It’s appropriate to walk away from inappropriate people!
Assertiveness
* Remember it’s your body—and ultimately all possible treatment options are your choice.
* Be prepared for your doctor visits (i.e., have questions ready, be educated about your pain condition(s), etc.)
* Partner with your doctor. You’ll get better pain care results if you work as a team.
Find a good advocate at your health insurance company.
* Bring a family member or friend with you when you go to a doctor’s appointment. They can advocate for you—and it’s good for your doctor to know someone cares and is watching out for you.
* Examine and weigh your therapy options—the biggest “guns” may not be the answer for you.
* Don’t let your doctor pressure you into a therapy that you don’t want to do!
* Interview your pain management provider (i.e., What kind of therapies do you support for my condition?, Are you open to alternative/complimentary therapies?, etc.)
* Remember, one size doesn’t fit all when it comes to pain treatments. We’re all unique—and what helps one person may not help another.
* Seek out references with any doctor referral (i.e., talk to other patients, look up his/her standing with the state medical board, etc.)
* Make sure your treating healthcare professional is assessing your pain level during each visit—remember, pain assessment is “the fifth vital sign.”
* Find out if your hospital and/or clinic has a “Patient’s Bill of Rights”—and if so, make sure your treating healthcare professionals are following it.
* Learn about the potential side effects of any and all medications you are considering or presently taking. Sometimes their adverse side effects can create more harm than the problem you’re taking the medication(s) for.
* Run—don’t walk!—from any physician or other healthcare professional who doubts, dismisses and/or discounts your report of pain!
* Encourage your family and friends to educate themselves about your pain condition(s) (i.e., provide them with website resources, articles, etc.)
* Educate yourself about all of your therapy/treatment options (including complimentary and alternative choices)—this will enable you to make the best, most informed decisions about your pain management care.
Clinical Advice
* Using a rating scale such as 0 to10 (0 = no pain, 10 = worst pain) is a useful way to communicate your pain to others and assess changes in your own pain.
* Use the rating scale to rate how much relief you are receiving. For example, if your pain therapy relieves your pain from a “10” to a “7”, this is a good step. But knowing your pain is a “7” should suggest that you still require additional help.
* Prevention of pain is key. Anticipate things that bring your pain on (exhaustion, dehydration, stress, etc.) and make every attempt to prevent pain versus responding only when it happens.
* When taking pain medication, always consider what non-drug treatment you could use along with it. Using heat/cold/massage/relaxation can diminish anxiety and distract you from the pain until the medication can begin working.
* Discover accurate and effective words to describe your pain (i.e., burning, stabbing, aching, pins and needles, electrical, throbbing, etc.) to help your healthcare provider with diagnosis and treatment.
* For chronic pain problems, it is generally better to take medications on a regular, around-the-clock schedule rather than only on a “prn”/as needed basis only when pain is severe.
* Fortunately, there are many choices of analgesics (be it traditional, complementary or alternative)—so if a particular pain therapy that has been prescribed doesn’t work or causes side-effects, ask to try another.
* In general for chronic pain, long-lasting medications are preferred to offer several hours of undisturbed sleep or activity.
* If your doctor prescribes physical therapy, be sure to find a therapist you have a repore with. Explain your symptoms carefully, and go over your doctor’s report together. Also be sure to immediately alert your therapist to any pain you’re experiencing as a result of a therapy exercise.
* “Breakthrough pain” is pain that occurs in episodes between doses of medications. Discuss this with your physician to determine if breakthrough medications are needed.
* Inactivity or decreased function is a major problem in chronic pain and results in muscle weakness, dependence, depression—and this cycle only worsens over time. Try to maintain activity if at all possible.
* Depression and anxiety are generally an integral part of the pain experience—and can become severe. Don’t hesitate to tell your pain management provider about these feelings and indeed ask for a referral for a support group and/or psychologist. Your doctor should know psychologists who specialize in pain.
Together, we THRIVE!!
Self-Care -- Relaxation/Meditation
* Take a long bubble bath and light some candles.
* Slow down—and breath deeply…
* Use aromatherapy—relax to your favorite scents.
* Meditate, with a group or by yourself.
* Listen or make music (i.e., play a CD, sing or play an instrument.)
* Get a massage by a professional masseuse – or someone you love…
* Seek out things that make you laugh—remember, laughter is the best medicine!
* Buy a bouquet of flowers to cheer up your surroundings!
* Grow something—commune with Mother Nature!
* Stir your imagination—imagine a pleasant experience, moment, sensation…
* Make or craft something (i.e., knit a scarf, do pottery, etc.)
* Go to an outdoor concert, and don’t forget to pack a picnic.
* Treat yourself to a manicure and/or pedicure. Be a Queen for a day!
* Explore an antique store—lose yourself among the treasures…
Cognitive/Mental Strategies
* Practice mindfulness—be in the moment…
* Try art therapy (i.e., paint or draw a picture that shows how you feel!)
* Use narrative therapy (i.e., write your pain experience.)
* Keep a gratitude/affirmation log (write down three things you’re grateful for each day.)
* When depression and/or anxiety hits, don’t fight it. Know it’s a part of the natural pain experience.
But don’t hold on for too long…
* Accept that everything you’re feeling is real and normal.
* Take a class, learn something new—and stimulate your mind!
* Wear a bright color—they excite the senses!
* Reflect upon affirming, positive memories…
* Read a great book—or a breezy romance novel.
* Express your true and authentic self. You’re the only you!
* Think positive, affirming things about yourself.
* Take a trip, even if it’s a virtual one.
* Seek support through a professional pain counselor.
* Make a change and surprise yourself (i.e., get a new haircut, try a new recipe, etc.)
* Get dressed up and put your make-up on, just because it makes you feel good!
* Keep a positive attitude, hang in there and keep the faith!
* Practice appreciation for your healthcare providers—more often than not, they’re trying their best to help…
* On a bad day, remember what Scarlet O’Hara said, “Tomorrow is another day!”
* Notice and appreciate the splendor of the season changes…
* Learn a foreign language…or two! Exercise that part of the brain that doesn’t read pain signals.
* Choose something you love, and do it every week, same day and time. A joyful routine gives you something sweet to look forward to…
* Don’t let your pain define you. Remember that while pain is now a part of your life experience, it’s not your identity.
Care of the Body
* Exercise regularly and keep your body moving. Hydrotherapy in warm water is especially effective with pain conditions.
* Eat a healthy diet (fruits, vegetables, lean meats, etc.)
* Avoid or quit smoking!
* Practice good sleep habits—enjoy waking up refreshed and renewed.
* Be open to alternative and complimentary therapies (i.e., acupuncture, guided imagery, etc.)
* Have realistic expectations about therapies (i.e., have you given your physical therapy regimen enough time to help?)
* Educate yourself about your pain condition. But don’t obsess and let it consume you…
* Listen to your body talk—you know it better than anyone else!
* Learn to say “no”—avoid stress by not over-burdening/committing yourself.
* Spend time in the sun—and don’t forget that all-important sun block!
* Practice good posture. A well-aligned and supported spine is virtually guaranteed to help any pain condition.
Relationships
* Do something nice for someone—it feels good, and that energy is sure to come back your way.
* Learn to forgive those who have disappointed you throughout your pain experience; anger is further fuel for pain!
* Adopt a pet. Unconditional love is good for the soul…
* Give someone a hug—who knows, you might just get two back!
* Volunteer for your favorite charity, school or organization. Doing good is chicken soup for the soul!
* Throw yourself a party. Celebrate an accomplishment with family and friends!
* Get involved in your community (i.e., attend neighborhood council meetings, help plan a block party, etc.)
* Seek out fellow chronic pain sufferers through on-line discussion boards and support groups at medical centers. These bonds could last a lifetime.
* Don’t forget about lovemaking with your partner. Intimacy is second to none to revive the soul and senses!
* Spend quality time with a child or children (yours, nieces or nephews, etc.)—they’ll help you see the world with eyes of wonder!
* Have an afternoon tea with some girlfriends.
* Accept an invitation to a party or other social event, even if you’re in pain. It’s great misdirection—and you’ll probably find yourself having a dandy time!
* Be open to talking to family and friends about your pain experience—and answering their naturally inquisitive questions. If they’re curious, they probably care. Try not to shut them out…
* Remove toxic people from your life—as stress and strain that comes from bad relationships makes pain worse. It’s appropriate to walk away from inappropriate people!
Assertiveness
* Remember it’s your body—and ultimately all possible treatment options are your choice.
* Be prepared for your doctor visits (i.e., have questions ready, be educated about your pain condition(s), etc.)
* Partner with your doctor. You’ll get better pain care results if you work as a team.
Find a good advocate at your health insurance company.
* Bring a family member or friend with you when you go to a doctor’s appointment. They can advocate for you—and it’s good for your doctor to know someone cares and is watching out for you.
* Examine and weigh your therapy options—the biggest “guns” may not be the answer for you.
* Don’t let your doctor pressure you into a therapy that you don’t want to do!
* Interview your pain management provider (i.e., What kind of therapies do you support for my condition?, Are you open to alternative/complimentary therapies?, etc.)
* Remember, one size doesn’t fit all when it comes to pain treatments. We’re all unique—and what helps one person may not help another.
* Seek out references with any doctor referral (i.e., talk to other patients, look up his/her standing with the state medical board, etc.)
* Make sure your treating healthcare professional is assessing your pain level during each visit—remember, pain assessment is “the fifth vital sign.”
* Find out if your hospital and/or clinic has a “Patient’s Bill of Rights”—and if so, make sure your treating healthcare professionals are following it.
* Learn about the potential side effects of any and all medications you are considering or presently taking. Sometimes their adverse side effects can create more harm than the problem you’re taking the medication(s) for.
* Run—don’t walk!—from any physician or other healthcare professional who doubts, dismisses and/or discounts your report of pain!
* Encourage your family and friends to educate themselves about your pain condition(s) (i.e., provide them with website resources, articles, etc.)
* Educate yourself about all of your therapy/treatment options (including complimentary and alternative choices)—this will enable you to make the best, most informed decisions about your pain management care.
Clinical Advice
* Using a rating scale such as 0 to10 (0 = no pain, 10 = worst pain) is a useful way to communicate your pain to others and assess changes in your own pain.
* Use the rating scale to rate how much relief you are receiving. For example, if your pain therapy relieves your pain from a “10” to a “7”, this is a good step. But knowing your pain is a “7” should suggest that you still require additional help.
* Prevention of pain is key. Anticipate things that bring your pain on (exhaustion, dehydration, stress, etc.) and make every attempt to prevent pain versus responding only when it happens.
* When taking pain medication, always consider what non-drug treatment you could use along with it. Using heat/cold/massage/relaxation can diminish anxiety and distract you from the pain until the medication can begin working.
* Discover accurate and effective words to describe your pain (i.e., burning, stabbing, aching, pins and needles, electrical, throbbing, etc.) to help your healthcare provider with diagnosis and treatment.
* For chronic pain problems, it is generally better to take medications on a regular, around-the-clock schedule rather than only on a “prn”/as needed basis only when pain is severe.
* Fortunately, there are many choices of analgesics (be it traditional, complementary or alternative)—so if a particular pain therapy that has been prescribed doesn’t work or causes side-effects, ask to try another.
* In general for chronic pain, long-lasting medications are preferred to offer several hours of undisturbed sleep or activity.
* If your doctor prescribes physical therapy, be sure to find a therapist you have a repore with. Explain your symptoms carefully, and go over your doctor’s report together. Also be sure to immediately alert your therapist to any pain you’re experiencing as a result of a therapy exercise.
* “Breakthrough pain” is pain that occurs in episodes between doses of medications. Discuss this with your physician to determine if breakthrough medications are needed.
* Inactivity or decreased function is a major problem in chronic pain and results in muscle weakness, dependence, depression—and this cycle only worsens over time. Try to maintain activity if at all possible.
* Depression and anxiety are generally an integral part of the pain experience—and can become severe. Don’t hesitate to tell your pain management provider about these feelings and indeed ask for a referral for a support group and/or psychologist. Your doctor should know psychologists who specialize in pain.
Together, we THRIVE!!
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