Topical NSAID Cream Being Tested in Clinical Trial

Transdel Pharmaceuticals, Inc.'s topical NSAID cream, Ketotransdel® (a form of Ketoprofen), is currently being tested in a phase 3 clinical trial. Ketotransdel® uses the patented proprietary Transdel™ drug delivery system. This cream is for the treatment of acute pain and is applied directly to the skin. It has been shown to relieve inflammation and provide an analgesic effect.

All medications come with the risk of side-effects. Some of the (often dangerous) side-effects that are known to be associated with NSAID tablets are gastrointestinal, renal and cardiovascular problems. The use of this cream may minimize the risk of these side-effects. According to THIS Therapeutics Daily article:

...over one hundred thousand patients are hospitalized each year due to orally administered NSAID-related gastro-intestinal (GI) complications. That is because when one takes a pill, it passes from the GI tract into the bloodstream and organs, exposing one to cardiovascular, renal, and hepatic systemic effects.

Medications applied to the skin may still expose the bloodstream and organs to side-effects and complications. However, the exposure is much less than if used orally. The U.S. Food and Drug Administration's (FDA) Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) provides additional information on this type of medication and it's side-effects.

If all goes well in the clinical trials, Ketotransdel® may be the first FDA-approved topical NSAID cream. To read the article on this click HERE. And click HERE for Transdel Pharmaceutical's product page.

Increase Risk of Migraine and Headache in Overweight People

I just read this article, Obesity may raise headache risk and can't wait until everyone I know emails it to me. (Yeah, right.) If you're a Migraineur you know what I'm talking about. By the end of the day, you'll have 47 copies of this same thing.

This article cites a research study that examined the

...association between body mass index (BMI), the ratio between the weight range an individual falls into, and headache among men and women, 20 years of age or older, who participated in the 1999 to 2002 National Health and Nutrition Examination Survey.

(You can calculate your BMI HERE.)

Before you send me this article, please read it again. The article doesn't say being overweight causes Migraine but says being fat (that's what us un-politically correct people call it) "may increase the likelihood" of Migraine or severe headaches.

And before you go around thinking that if you gain a few (or more) pounds you're going to start having Migraine attacks and/or severe headaches, read this part again:

An increased prevalence of headache may be associated with being underweight as well.

In other words, being skinny may also increase the likelihood of Migraine or severe headaches. However, there were only 152 (2%) skinny people out of the 7,601 study participants so this needs to be investigated further.

The article goes on to say that for those who are overweight:

...weight management might be a useful approach in headache management

So, to all 47 of you who are planning on emailing this article to me with a note that says losing weight will CURE my Migraines...please DON'T.

Migraine and Epilepsy Medication In Pregnant Women May Raise Autism Risk

WebMD reports that a new study published in the journal Neurology shows women who take Valproate for Epilepsy, while pregnant, may increase the risk of having a child with Autism. Rebecca Bromley, a PhD student and one of the researchers at the University of Liverpool told WebMD:

British researchers looked at 632 children, almost half of whom were exposed to epilepsy drugs during gestation. Nine of the 632 have been diagnosed with autism, and one has shown symptoms of the disorder.

Although this study was limited to pregnant women who took this medication for Epilepsy, Valproate is also used to prevent Migraine and an abortive treatment for acute Migraine.

To read the article click HERE.

Not Just For Migraine Sufferers -- Angel Food Ministries

I've helped a lot of people find specific resources to help with financial hardships from locating low or no cost medications to utility assistance programs that help cover the high cost of winter heating. Even though there are a lot of federal, state and private organizations that offer help, many times the help is not enough or someone doesn't qualify. Although this is not Migraine Disease specific or even health related, I'd like to share a wonderful program that is making a big difference in people's life. It's called Angel Food Ministries. Here's what their mission statement says:

Angel Food Ministries is a non-profit, non-denominational organization dedicated to providing grocery relief and financial support to communities throughout the United States. The program began in 1994 with 34 families in Monroe, Georgia (between Atlanta and Athens), and has grown to serve hundreds of thousands of families every month across 35 states. Angel Food Ministries crosses denominational lines...

Here's how it works. If you live near a participating site (locate one HERE) you can order $75.00 (approximate retail value) worth of food for $30.00. This amount of food will feed a family of four for a week or one senior citizen for about a month. You can order more than one box and you can order additional specials with the purchase of one $30.00 box. This is not a scam. It's a real service and I've used it. A few months ago, I compared the cost of a box of food to the grocery store where I shop and determined that I would have spent $97.00 for the same things.

Now here's the best part. There are NO qualifications -- NO income restrictions -- NO minimums -- NO application AND they accept food stamps. Most sites accept debit and credit cards. You can definitely use your debit or credit card if you order online. This will cost an extra $1.00.

There is a one downside of this program. It's not available on a weekly basis and you can only order food one time a month.

It doesn't matter if you're rich or poor. Anyone can participate in this program and no one will ever know if you have a financial need or not (unless you participate in the EBT Food Stamp Program). In fact, this program encourages all people to participate regardless of income level. They suggest that those who don't have a financial need to use this program anyway. Then use the money you save to do something for someone who needs financial assistance or who is less fortunate than you.

To see December's menu click HERE. The ordering deadline varies depending on the location. If you hurry, you may make this months deadline. If you miss it, you can participate next month.

If you are recipe-challenged Hillbilly Housewife may be able to help. She's teamed up with the meal planning experts at Menu Planning Central and created menu plans based on the food provided by Angel Food Ministries.

Back To Blogging

Yes, I know I've been missing for more than a few days.  I think my technical difficulties are over and "We Now Return You To Your Regular Scheduled Program Already In Progress."  Thanks everybody for your patience.

I Will Be Back In A Few Days

Thanks for you patience. I'll be back in a few days.

Migraine Medication for A Headache? No! No! No!

Most Migraineurs know that a Migraine attack is NOT a bad headache. We know that Migraine is a neurological genetic disease similar to Epilepsy. And we know that some of us don't even experience the headache phase during a Migraine attack. Recognizing the difference between head pain associated with a Migraine attack and head pain associated with a headache is difficult for some.

I've been writing a lot lately in the Migraine support group that I co-moderate about distinguishing between the two. I've discussed how to tell the difference between pain that accompanies a Migraine attack and the pain that accompanies a headache. And I've explained why it's important we make this distinction.

One reason why it's important to know these differences is because treatment for Migraine is not the same as headache treatment. For example, using a Migraine-specific medication probably won't do any good for someone who doesn't have Migraines.

The president of the German Pain Aid Association, Ruediger Fabian, now gives another reason why you shouldn't use Migraine-specific medication for the treatment of a headache. Fabian says if you do this, you risk chronic 'pseudo-migraines'. He says:

Even the occasional use of migraine medications by someone without migraines is potentially harmful

and goes on to say

The reactions depend on the person, but they can intensify ordinary headaches

Fabian said the first symptom of an overdose of Migraine-specific medication is "a sour-tasting expulsion of gas from the stomach". Ewwwwww! I'm not sure, but I guess that means a sour-tasting "burp".

He also said those who suffer less than 100 days a year with headaches (He didn't say Migraine) who occasionally didn't get relief from their standard medication could use extra pain medication once in a while.

Source: Migraine medication unsuitable for ordinary headaches

YIPPEE! This Blog No Longer Triggers Migraines

Ahhhhhhh.  This blog template is so much better.  It's nice to be able to look at my blog now without wearing sunglasses!!  No more blinding font colors or shape-shifting letters.  No more color changing backgrounds and no more disappearing sidebar items. 

I have a few more things to do before being completely finished but I'm very happy with what's been done so far.  What do y'all think?

My Blog Is A Migraine Trigger

This blog template has got to go! It's giving me a Migraine! I recently changed templates and this one has been a pain in the ass and a pain in the head. Some days the font color is OK - most days it's blinding. Sometimes the font is too big and sometimes it's too small. Some days the background is black like it should be - some days it's SCREAMING yellow. (I shouldn't have to wear sunglasses to blog.) Everyday something on my sidebar is screwed up. When I fix it something else gets screwed up.

I'm sorry if looking at my blog triggers a Migraine - it triggers mine too and I can't take it anymore! So, if you notice anything different or out of the ordinary in the next few days, it's because I'm eliminating one of my triggers - this blog template.

Army Personnel Show Increased Risk For Migraine; Condition Underdiagnosed, Mistreated

Army Personnel Show Increased Risk For Migraine; Condition Underdiagnosed, Mistreated

ScienceDaily (Aug. 28, 2008) — Two new studies show that migraine headaches are very common among U.S. military personnel, yet the condition is frequently underdiagnosed. The studies, appearing in Headache, the peer-reviewed journal of the American Headache Society, examine the incidence among soldiers within 10 days of returning from a 1-year combat tour in Iraq , as well as U.S. Army officer trainees...
To read the entire article click HERE .

Flying is a headache, literally, for many travelers

NEW YORK (Reuters Health) - Headaches associated with air travel appear to be a "huge and painful problem," Israeli researchers report.

In a study of 906 men and women who had traveled more than once by plane, nearly 6 percent reported that they experienced headaches associated with flying.

Based on 3.3 billion seats available each year on commercial flights, with 70 percent occupancy, Dr. Israel Potasman and colleagues from Bnai Zion Medical Center in Haifa estimate that more than 100 million people suffer from flight-associated headaches annually...
To continue reading this article click HERE.

Migraine Medication May Increase Uric Acid

Rising uric acid levels tied to migraine drug

NEW YORK (Reuters Health) - In migraine patients, treatment with the drug topiramate (sold as Topamax) may result in increasing blood levels of uric acid, a study shows.

Some research has linked high uric acid levels in the body to a higher risk of cardiovascular trouble. Excess uric acid in the body can create oxidative stress, a state that damages body cells and contributes to diseases, including the buildup of artery-clogging plaques...
To read the entire article click HERE.

New Hope For Stroke Patients: Reversing Stroke Damage By Jumpstarting Growth Of Nerve Fibers

ScienceDaily (Aug. 25, 2008) — If a stroke patient doesn't get treatment within approximately the first three hours of symptoms, there's not much doctors can do to limit damage to the brain.

But now researchers report a technique that potentially could restore functions to patients weeks or even months after a stroke. The technique involves jumpstarting the growth of nerve fibers to compensate for brain cells destroyed by the stroke.

"In the best-case scenario, this would open up the window of time that people could recover and go back to normal functional status," said Gwendolyn Kartje, MD, Ph.D., a professor in the department of cell biology, neurobiology and anatomy and department of neurology at Loyola University Chicago Stritch School of Medicine in Maywood, Ill. and chief of neuroscience research at Edward Hines Jr. VA Hospital in Hines, Ill.

Kartje and colleagues described the experimental approach, called anti-nogo-A immunotherapy, in a recent review article in the journal Topics in Stroke Rehabilitation...
To read the entire article click HERE.

School-Age Migraine and Headache Sufferers Head Back to School

Teri Robert has written a very helpful article about going Back To School With Migraines or Headaches. She states:

When your child has a chronic illness, whether it's headaches, Migraines, or a different illness entirely, we really can't afford to put off getting our children ready for school. There are extra steps that need to be taken; extra preparations that need to be made. In the Miss America scholarship pageant program, they have a motto. They call it "the Ps..."

If your kids suffer with Migraine disease or headaches, you may want to read the entire article HERE.

Migraine Expressions: A Creative Journey through Life with Migraine

If you haven't heard of or seen the book, Migraine Expressions: A Creative Journey through Life with Migraine yet, you have got to check it out. This magnificent anthology, compiled and edited by Betsy Baxter Blondin, contains art, poetry, essays and photography contributed by 124 writers and artists, all either Migraineurs or loved ones, from many states and countries.

You can order the 192 page hardcover book from Word Metro Press. The book normally retails for $34.95 but right now you can order it for the special price of $27.95. Part of the proceeds will be contributed to Migraine research and advocacy organizations.

More information can be found in the press release below.

NEW MIGRAINE ART AND LITERATURE BOOK FROM WORD METRO PRESS

Groundbreaking book depicts migraine in insightful visual and written art from migraineurs worldwide


San Diego, California, July 16, 2008 – Migraine Expressions: A Creative Journey through Life with Migraine illustrates in breathtaking art, poetry, essays and photography some of the ways tens of millions of people worldwide live, work, feel and love while trying to minimize attacks and manage symptoms of this often-debilitating disease. The courage and strength that takes is illuminated in this dramatic work from 124 writers and artists in many states and countries.

No other book expresses migraine in both words and art of people who suffer the symptoms and survive the disease; most books about migraine are from experts who define, explain, and offer advice on how to manage it. This book will complement existing information, be instrumental for people with migraine to share experiences and communicate feelings, and serve as a tool for furthering understanding among non-migraineurs.

Migraine is a neurobiological disease impacting more than 30 million people in the United States and similarly 12 to 15 percent of people in most countries of the world. It is a debilitating and little-understood disorder that is finally attracting the long-overdue attention it urgently needs in medical research and treatment arenas as well as in the general media. Celebrities, athletes and well-known professionals appear more and more often to share their stories or in news items of crippling migraine attacks. They represent many millions of others around the world.

Suzanne E. Simons, Executive Director of the National Headache Foundation, commented, “Congratulations! The images and the words are compelling. Migraineurs will relate to the visual images and poems. Those who don’t suffer may be better able to empathize after reading the book.”

The book includes a foreword by leading migraine educator, advocate and author, Teri Robert, Ph.D., who says, “Projects such as Migraine Expressions are rare, priceless, and sorely needed. They offer an intimate view of the impact of migraine disease. The works of art in this book are deeply personal and revealing. They are heart-wrenching and inspiring, filled with both terror and hope.”

And Richard B. Lipton, MD, Professor of Neurology and Director, Montefiore Headache Center, Albert Einstein College of Medicine, claims, "Migraine Expressions reveals a neurobiological disease from many highly personal perspectives as contributors transform their experiences into stunning verbal and visual art. The book will help people with migraine find their individual voices even as they recognize the universality of their shared experiences.”

Book details: Hardcover, 192 pages, full color, 8.5 by 11 inches, available from publisher at www.wordmetropress.com July 21, 2008, $34.95 retail. Editor is available for interviews, appearances and book signings.

FDA Recall - One Lot of Fentanyl Transdermal System Patch

Watson Announces Limited Recall Of Fentanyl

CORONA, CA - August 8, 2008 - Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that one lot of 75 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number 92461850, have expiration dates of August 31, 2009 and were manufactured by Watson Laboratories, Inc. The affected lot of Fentanyl Transdermal System patches was shipped to customers between January 30, 2008 and March 19, 2008. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall.

A small number of patches leaking fentanyl gel have been detected in this lot, potentially exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are leaking should not be used. No injuries have been reported in connection with the recalled lot. However, exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.

Anyone who has 75 mcg/hr Fentanyl Transdermal System patches should check the box or foil pouch for the lot number and expiration date to see if they have patches that are being recalled. Affected patches should not be handled directly. Anyone with 75 mcg/hr Fentanyl Transdermal System patches being recalled should call 888-667-1508, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Fentanyl Transdermal System CII is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.

The entire FDA recall can be found HERE.

Unless otherwise noted, the contents of the FDA Website (www.fda.gov)--both text and graphics--are not copyrighted.

Migraine Medication May Throw a Monkey Wrench In Scheduled Execution

Richard Cooey, a convicted rapist and murderer is scheduled to be executed in Ohio this October. Physician, Dr. Mark Heath, hired by the Ohio Public Defender's Office filed documents with the court last week stating, Topamax, the medication that Cooey uses for Migraine prevention, may make him resistant to the drug Thiopental. This is the medication that puts inmates to sleep before other lethal drugs are administered. Cooey is 5' 7" and 267 pounds. Heath contends that Cooey's obesity combined with this potential drug resistance increases the risk of him not being properly anesthetized before being executed.

source: Ohio inmate says he's too fat for execution

Migraine News: Exercise, Stroke and Heart Risk, Oxygen Therapy

Exercise plus relaxation may lessen migraine pain

NEW YORK (Reuters Health) - A combination of aerobic exercise and muscle relaxation may help ease migraine pain, a small study suggests.



Austrian researchers found that when 15* migraine sufferers added an exercise-and-relaxation routine to their usual care, the patients reported an improvement in migraine pain intensity over six weeks...

To read this entire article click HERE.



*Note: 15 participants IS a very small study.

Gene May Put Women With Migraine At Increased Risk Of Heart Disease And Stroke

Women who experience migraine with aura appear to be at an increased risk of heart disease and stroke if they have a certain gene, according to a study published in the July 30, 2008, online issue of Neurology®, the medical journal of the American Academy of Neurology.



For the study, researchers followed 25,001 Caucasian women for the occurrence of cardiovascular disease, including heart attacks and ischemic stroke. About 18 percent of the women in the study had a history of migraine while 40 percent of those with active migraine reported migraine with aura...

To read this entire article click HERE.



Oxygen Therapy Might Ease Pain Of Migraine, Cluster Headaches



ScienceDaily (July 17, 2008) — Two types of oxygen therapy could offer some relief to adults who suffer from disabling migraine and cluster headaches, according to a new research review from Australia...

To read this entire article click HERE.

Migraine Medication Savings - Part II

If you can't afford your prescription medications, here are a few things you can do.

You may be eligible to use a rebate, coupon, voucher or qualify for a trial offer for the medications that I wrote about in Migraine Medication Savings.

The Wal-Mart generic program offers a 30-day supply of certain generic medication for $4.00. A 90-day supply will only cost you $10.00. If you use a heart (calcium channel blocker, beta blocker) or blood pressure medication or an antidepressant as a preventive, you may benefit from this program. I found some of these medications on the list. There are no Migraine specific medications such as Triptans or Dihydroergotamine (DHE) on the list. There are some pain medications such as Ibuprofen on this list but I did not see any narcotic medications. I also did not see any antiseizure medications.

Other big box discount stores have similar programs. One of these is Target's generic program. A 30-day supply is also $4.00 and a 90-day supply is $10.00. There are many of the same medications on their list. Kmart has a 90-day Generic Program. These medications cost $10.00 and $15.00. Their list can be found HERE. I couldn't find any Migraine medications on their $5.00 Program List. However, some analgesics are listed. Costco offers its members a prescription savings plan for those with no insurance. Information on this program can be found HERE.

A Patient Assistance Program (PAP) may help you with low-cost or no-cost medicatons. Many pharmaceutical companies offer assistance if you have no insurance or cannot pay for your medication. They have strict guidelines (i.e. income and assets) for determining your eligibility. There are a number of sites that will help you locate a PAP. One of the more well known programs is the Partnership for Prescription Assistance Program (PPARx) program. After answering eligibility questions, the site will provide you with any programs that you may possibly qualify for. They can also be reached by calling 1-888-4PPA-NOW (1-888-477-2669).

Another well known site is NeedyMeds. This site has a lot of good information including a Brand Name and Generic directory to see what programs you may be eligible for. This site also offers information on State Health Insurance Assistance Program (SHIP or SHIIP), Disease-Based Assistance programs and some Discount Drug Cards.

Other sites that may help are RxAssist.org (requires you to register an account), Rxhope.com, and National Alliance on Mental Illness (NAMI) .

If you do not qualify for a PAP offered by a pharmaceutical company
through one of these sources you will NOT qualify for it by using another. However, you may find different information about other things such as federal and state programs or discount cards on various sites so you may want to check out more than one. All of these services are FREE.

There are a number of companies that will charge you for this FREE service. The Federal Trade Commission (FTC) warns there is No Need to Pay for Information on Free (or Low-Cost) Rx Drugs and says:

While it’s true that many prescription drug companies offer free or low-cost drugs for people who don’t have prescription drug coverage, can’t afford to pay for medication out of pocket, or have exhausted their insurance’s annual allowance, the programs have strict qualification standards. Factors that affect whether you qualify may include your income and the cost of the drugs you need.

If you’re trying to get free or low-cost prescription drugs, you don’t have to pay for information on how to do it. You just have to know where to look. The information is free — and publicly available — from your physician, pharmacists, and the government.

One of the services that charge for this FREE service is FreeMedicine.com aka FreeMedicineFoundation.com. This service will send YOU the paperwork from each pharmaceutical company so that YOU and your doctor can apply for prescription assistance. This service charges an application processing fee of $10.00 per medication. This service does promise a refund if you are declined for a PAP stating:

If you are determined ineligible by all applicable sponsores [sic], and receive no medicine assistance, send a written request to Free Medicine Foundation, include denial letter(s) for all applicable sponsor(s) within 120 days of original application and your processing fee will be fully refunded.

Other program guidelines can be found HERE.

Articles discussing this company can be found on the Consumer Fraud Reporting site and the Los Angeles Times site. Answers4Families (a partner of the Nebraska Department of Health and Human Services and the University of Nebraska - Lincoln Center on Children, Families, and the Law) states:

An organization called the Free Medicine Foundation www.freemedicinefoundation.com has been recently marketing their services. The Better Business Bureau indicates the Free Medicine Foundation has an unsatisfactory standing with their organization. The BBB points out that this organization is not registered as a "foundation" and the don't actually provide their services for "free." The application process for the Free Medicine Foundation requires that the individual pay them $5* per medication, in order for them to check on whether you qualify for one of the pharmaceutical companies' patient assistance programs.

*Note: The cost has increased from $5.00 to $10.00.

The Better Business Bureau (BBB) Reliability Report states they have:

...processed a total of 43 complaints about this company in the last 36 months, our standard reporting period. Of the total of 43 complaints closed in 36 months, 24 were closed in the last year.

To see the the entire report click HERE.

If you do not qualify for a PAP, you may be eligible to use a discount card. Some of these are SunAssociation, FreeDrugCard.us, PSCard.com, and YourRxCard.com.

Generic Migraine Medication Approved by FDA

FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder

The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.



"Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high quality, safe and effective drug as the name brand product," said Gary J. Buehler, director of the FDA's Office of Generic Drugs. "This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder and migraines."



Generic divalproex sodium will have the same safety warnings as Depakote, including a Boxed Warning that cautions about the risk of liver damage (hepatotoxicity), including fatalities, and pancreatitis, or an inflamed pancreas, including fatal cases. The Boxed Warning also highlights the risk of birth defects (teratogenicity), including neural tube defects.



The following firms have received approval to market divalproex sodium delayed-release tablets: Sun Pharmaceutical Industries Ltd., Mumbai, India; Genpharm Inc., Ontario, Canada; Nu-Pharm Inc., Ontario, Canada; Upsher-Smith Laboratories, Maple Grove, Minn.; Sandoz Inc., Broomfield, Colo.; TEVA Pharmaceuticals USA, North Wales, Penn.; Dr. Reddy’s Laboratories, Hyderabad, India; and Lupin Limited, Mumbai, India.



For more information, see

Consumer Education: Generic Drugs



Information on specific drug products can be found on the Web site "Drugs@FDA"

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/



This is the complete article. Unless otherwise noted, the contents of the FDA Website (www.fda.gov)--both text and graphics--are not copyrighted.

Migraine Medication Savings

As I said in my last post something good has come out of obnoxious pharmaceutical television commercials and radio advertisements - COUPONS, REBATES, VOUCHERS and FREE MEDICATION TRIALS. Listed below are current savings on medications that Migraine sufferers often use. There are different qualifications for each medication offer. Please make sure you read the FAQ's and/or patient eligibility guidelines carefully to see if you qualify.



Savings offers on the following drugs are below:

Treximet, Zomig, Maxalt, Migranal, Frova, Relpax, Topamax, Cymbalta, Kadian, Ambien, Lunesta, Ultram ER, Duragesic, Soma, Skelaxin

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Treximet® - Lower The Pain



Receive your $50* coupon by filling out the brief form below, then clicking “Submit.” We'll also provide you with important news and information about migraine treatment, as well as additional valuable money-saving offers for TREXIMET. Only one $50 trial coupon per person.

source: https://www.treximet.com/optin/registration.jsp



In order to be eligible for this offer: (a) where third-party reimbursement covers a portion of your prescription, this coupon is valid only for the amount of your actual out-of-pocket expenses up to a maximum of $50, (b) your prescription MUST NOT be covered (i.e., reimbursed) by a federal healthcare program, including Medicare or Medicaid, or by any similar federal or state program, including a state pharmaceutical assistance program, and (c) you MUST NOT be Medicare eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees (i.e., you are eligible for Medicare Part D but receive a prescription drug benefit through a former employer). Further, if you are a resident of Massachusetts, this offer is valid only if you are paying the entire cost of the prescription yourself (i.e., your insurance does not cover any of the cost of your prescription). Your acceptance of this offer must be consistent with the terms of any drug benefit provided by your health insurer, health plan, or private third-party payor, and you agree to report acceptance of this offer to your health insurer, health plan, or third-party payor as may be required. This offer may not be used with any other discount, coupon, or offer. Only an original coupon will be accepted and must be presented to your pharmacist at the time you have the prescription filled–not valid if reproduced. Offer good only in USA. Not transferable. Void where prohibited by law, taxed, or restricted. GlaxoSmithKline reserves the right to rescind, revoke, or amend this coupon without notice. Limit 1 per purchase. Only one $50 trial coupon per person.

source: https://www.treximet.com/optin/registration.jsp#

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Zomig® - Living With Migraine Voucher Program

Welcome to the Zomig Cost-Saving Coupon Program. This coupon may cover payment for your co-pay for a ZOMIG prescription up to $35, for up to a maximum of 6 times in 12 consecutive months. If you are not enrolled in a pharmacy benefits program, you may receive $35 off your ZOMIG prescription purchase or the amount paid for your prescription, whichever is less, for a maximum of 6 times in 12 consecutive months. Please see enrollment requirements and other terms and conditions.

source: https://www.activatethecard.com/zomig/appSecZomigWelcome.jsp

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Maxalt® - Free Trial Offer

Merck is pleased to provide a free trial offer of MAXALT or MAXALT-MLT. To receive your voucher for a free trial of up to 3 tablets or 3 orally disintegrating tablets, click on the PRINT VOUCHER FOR A FREE TRIAL button at the bottom of this page and print out the voucher form.



If MAXALT / MAXALT MLT is the appropriate therapy for you, your doctor will write a prescription for you. Then take your prescription and the voucher to your pharmacist to get your free trial of up to 3 tablets or 3 orally disintegrating tablets. This offer is valid only with a prescription from your doctor. Offer expires 12/31/2008.



Limitations apply. Please see Terms and Conditions on the voucher for details.

source: http://www.maxalt.com/rizatriptan_benzoate/maxalt/consumer/special_offers/free.jsp?WT.svl=5

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Relpax® - Step Up to the Challenge and Get a $10 RELPAX Coupon

To qualify for the rewards program, you must be taking RELPAX. If you are not currently a RELPAX user, ask your doctor if RELPAX is right for you and enroll once you’ve tried it.

source: https://www.relpaxchallenge.com/content/coupon-registration.jsp

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Migranal® - It's Never Too Late for Relief

Let MIGRANAL^® help you gain control of your migraines.

Do you wait until your migraine is already at full strength before taking your medication?



Do you “hoard” your medication and only use it when the pain becomes unbearable?

$20 off your next prescription of MIGRANAL

source: http://prescriptionmigrainerelief.com/HTML-INF/4_0_Try_Migranal_Today/index.shtml

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Frova® - Rebate save up to $35

Offer expires 12/31/08

source: http://www.frova.com/dtp/_pdf/FROVA_Rebate_Voucher.pdf

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Topamax® - Free Trial Offer for up to 42 (25mg) tablets

1. Talk to your doctor to find out if TOPAMAX is right for you. TOPAMAX is available by prescription only.


2. If your doctor prescribes TOPAMAX, you can get up to 42 TOPAMAX 25 mg tablets free from your pharmacist with this offer.


3. Present your written prescription for up to 42 TOPAMAX 25 mg tablets AND this trial offer to your pharmacist to receive your free trial of TOPAMAX.

source: http://www.topamax.com/topamax/tools-resources--free-trial-offer.html

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Cymbalta® - This voucher is valid for 14 Capsules of CYMBALTA (all strengths covered) and must be accompanied by a valid prescription.

Thank you for your interest in a free sample of Cymbalta® (duloxetine HCl). Remember, only your doctor or healthcare professional can diagnose your condition and determine proper treatment.



To receive your free voucher, please enter your age and select your indication below, then click "Submit." When the voucher page appears, be sure to follow all instructions listed. Because there is a 1-voucher limit per person, you will not be able to return to the voucher page once you have left it. Please print the voucher page before leaving it. If you have difficulty, please call 1-800-LillyRx (1-800-545-5957).

source: http://voucher.cymbalta.com/

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Kadian® - Save up to $50 on each KADIAN® monthly prescription

To receive a co-pay assistance card in the mail for up to $50 off each KADIAN^® monthly prescription, please provide the following information or call 1-877-265-2861

source: http://www.kadian.com/pages/getpage.aspx?id=4F94959E-FE71-4158-9276-83A0FF8F20102010

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Ambien CR® - Try our free 7-night invite and get up to $100 off when you join

If you're having trouble sleeping and think you could be experiencing insomnia, you've come to the right place. Two layer AMBIEN CR not only helps you fall asleep, but has a second layer to help you stay asleep*, so you wake up less frequently and fall back to sleep faster. And now we have two offers to make it easy for you to try AMBIEN CR and save on your prescription.

To get your offers:

• Click on GET CERTIFICATES


• Print your certificates and take them to your healthcare provider


• If your provider thinks AMBIEN CR is right for you, take your AMBIEN CR prescription and certificate to your pharmacist for your FREE trial offer


• Start experiencing the 2-layer difference of AMBIEN CR

You can also continue to save up to $20^† on each of your next 5 AMBIEN CR prescriptions—that's up to $100 in savings!



Start making a difference in your life today.

* Proven effective for up to 7 hours in clinical studies.

^† Maximum benefit is $20 off, on up to 5 prescriptions, depending on your out-of-pocket costs. Not valid for patients participating in Medicare, Medicaid, government (public insurance) programs, or any private payor in the state of Massachusetts and where prohibited by law.

source: http://www.ambiencr.com/cr-extras/ambien-coupon-free-trial.aspx

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Lunesta® - SIGN UP FOR 7 NIGHTS OF LUNESTA FREE AND FOR SPECIAL LUNESTA OFFERS AND UPDATES.

Are you ready to find out whether or not LUNESTA is right for you? We're ready to help you do just that with this special offer. Getting a good value is as nice as getting a good night's sleep.

Try LUNESTA for 7 Nights Free.

As with all medications, individual results vary, so the only way to find out if LUNESTA works for you is to give it a try. Talk to your doctor about your symptoms and about LUNESTA. If you and your doctor decide that LUNESTA is right for you, use this coupon for 7 free nights of LUNESTA.



Follow these simple steps to take advantage of this free trial offer:

STEP 1: Complete the form below.

STEP 2: Click the Submit button to display the Trial Script® Coupon.

STEP 3: Click the Print button located at the bottom of the Trial Script ® Coupon, bring it to your doctor and ask if LUNESTA is right for you.

STEP 4: After your doctor attaches the coupon to a completed, signed prescription form, go to your pharmacist and receive your free tablets of LUNESTA

Source: https://secure.lunesta.com/lunestaPromos/lunesta-coupon.cfm

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Ultram ER® - Free Trial offer or up to 2 weeks free

Get more information - and up to 2 weeks of ULTRAM® ER, free

or

Special offer if you are already taking ULTRAM® ER -- Save $25 on your ULTRAM® ER prescription and up to two refills.

source: http://www.ultram-er.com/ultram-er/age_check.do?coupontype=voucher&source=Web

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Duragesic® - Instant Savings up to $50

Please be advised that we will not collect any of your personal information when you generate the savings coupon for DURAGESIC^®. To learn more about the information collection practices for this savings coupon, please refer to the DURAGESIC^® Coupon Privacy Policy. The information found within the DURAGESIC^® Coupon Privacy Policy applies only to this savings coupon and differs from the general Privacy Policy for www.DURAGESIC.com.

source: http://www.duragesic.com/duragesic/exit_coupon.html?&newURL=http://69.20.85.102

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Soma® 250mg - Instant Savings Up to $30 off your SOMA® 250 mg prescription

1. Fill out the form below

2. Print out your money saving coupon

3. Presenting the coupon to your pharmacist along with your insurance card and a valid prescription for SOMA® 250 mg

coupon expires 12/31/2008

source: https://www.drtms.net/Acquire/Acquire.aspx?client=MPTSoma&product=Loyalty+Card&grpnum=OH5101031&c=24&p=W1&s=1&action=print

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Skelaxin® - Good for up to $30 off 1 prescription

SKELAXIN 800MG (metaxalone) Tablets Prescription Savings Coupon

If your healthcare professional decides that SKELAXIN^® is right for you, you can take advantage of this special offer to save up to $30 on your next prescription for SKELAXIN^®. Simply download and print the form below, fill it out, and take it to your healthcare professional. Then take it to your pharmacist when you fill the prescription.

source: http://www.skelaxin.com/skelaxin-coupon.aspx?text=1

Pharmaceutical Ads - Give Me a Break!

I've had it up to my eyeballs with pharmaceutical advertising! If you're like me, you're probably sick of these controversial ads too. Every time we turn on the TV, we're bombarded with ads for conditions such as Migraine, Elevated Cholesterol, Depression, Peripheral Arterial Disease (PAD), Attention Deficit Hyperactivity Disorder (ADHD), and of course Erectile Dysfunction.

Do you know who Dr. Robert Jarvik is? My tweenager does. He watches enough TV to know that Dr. Jarvik is the spokesman for Pfizer's cholesterol lowering medication, Lipitor, and that he invented the artificial heart. He can also recite the words verbatim, “When diet and exercise aren’t enough, adding Lipitor significantly lowers cholesterol”. The New York Times tells us what my son and millions of other people in TV land don't know:

...though Jarvik graduated from medical school, he's not licensed to practice medicine or to write prescriptions. He doesn't see patients. He was a consultant to Lipitor maker Pfizer, under contract for $1.35 million. And he didn't start taking Lipitor until a month after he started doing the ads. Oh, and that wasn't him rowing; it was someone who looked like him in a similar jacket.

Because of these ads, my preteen can also explain what Erectile Dysfunction is, tell you about Viagra, warn you "in the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury" and sing all the words to the "Viva Viagra" song.

Even though I'm sick of these commercials, one good thing has come out of this...COUPONS, REBATES, VOUCHERS AND FREE TRIALS. For more information on this see my next post.

Migraine/Epilepsy Drug Linked to Birth Defects

Topamax May Raise Risk of Birth Defects

Small Study Shows Increase in Birth Defects When Epilepsy/Migraine Drug Is Used During Pregnancy

The epilepsy and migraine prevention drug Topamax has been linked to an increased risk of birth defects in babies born to epilepsy patients who took it during pregnancy, a small study shows.

In a study published in the latest issue of the journal Neurology, taking Topamax (topiramate) during pregnancy was associated with a birth defect risk within the range of risk seen in other anti-epileptic drugs, researchers reported.

To read the entire article click HERE.

Abnormal Sleep Patterns in Women Linked to Stroke

NEW YORK (Reuters Health) - Sleep patterns in middle-aged women can increase their risk for stroke, researchers in the United States have found. The greatest increase in stroke risk -- 70 percent -- was noted among women who slept 9 hours or more per night, according to their report in the medical journal Stroke.

To read the entire article click HERE.

Cymbalta Approved For Fibromyalgia Treatment

Cymbalta (Duloxetine) has just been approved to treat Fibromyalgia. Until now, there was only one medication, Lyrica (Pregabalin), approved to treat this illness.

In addition to the side effects of Cymbalta, Medpage Today warns:

Duloxetine should not be taken by patients who are using or have recently used a monoamine oxidase inhibitor, patients taking thioridazine (Mellaril) or patients with uncontrolled glaucoma. Severe and sometimes fatal liver problems have been reported among patients taking duloxetine. Duloxetine may increase the risk of hemorrhage among patients taking NSAIDs, aspirin, or other blood thinners.

Cymbalta is also approved for Major Depressive Disorder, the pain caused by Diabetic Peripheral Neuropathy and Generalized Anxiety Disorder.

Migraine and Fibromyalgia are often comorbid. Other illnesses comorbid with Migraine include but are not limited to Thyroid Disease, Temporomandibular Disorders, Depression, Anxiety, Epilepsy, Hypertension, and Stroke.

The Drew Carey Project Releases Another Medical Marijuana Reason.tv Video

Although the Drug Enforcement Administration (DEA) tells us in Exposing the Myth of Smoked Medical Marijuana that there are no potential benefits of medical marijuana, many states have laws that allow those with specific debilitating medical conditions the right to use it. It is a well documented remedy for many health conditions including Migraine, Glaucoma, Multiple Sclerosis, Cancer, HIV and Aids.

However, federal legislation prohibits the use of Medical Marijuana. Since federal law supersedes state law, the DEA continues to raid and prosecute both users and distributors in the states that allow it's use.

Drew Carey, (yes, that Drew Carey) host of The Drew Carey Project. has released another Reason.tv video on medical marijuana. In this video Carey asks:

Are we really helping minors by keeping them from medical marijuana at all costs? Or are we treating their parents like children?

Do you know what position your presidiential candidates takes on this issue? A press release issued by Reason Foundation points out:

The two major presidential candidates have taken completely opposite positions on medical marijuana and the DEA raids. Last month, Oregon's Willamette Week asked Sen. Barack Obama, "Would you stop the DEA's raids on Oregon medical marijuana growers?" Obama responded, "I would because I think our federal agents have better things to do, like catching criminals and preventing terrorism."

In March, Obama told Oregon's Mail Tribune, "When it comes to medical marijuana, I have more of a practical view than anything else. I mean, my attitude is that if it's an issue of doctors prescribing medical marijuana as a treatment for glaucoma or as a cancer treatment, I think that should be appropriate because there really is no difference between that and a doctor prescribing morphine or anything else."

The Republican National Committee attacked Sen. Obama's response to the Willamette Week's question and Sen. John McCain says he'll continue the Bush administration's aggressive efforts. McCain, who once supported states' rights on the issue, now says, "I don't believe that medical marijuana is necessary for alleving pain, relief of pain. I don't believe it's healthy…I believe it is a national issue and not a statewide issue."

When asked what he'd do to stop federal raids in states where voters have made medical marijuana legal, McCain said, "Nothing."

You can view Drew Carey's other medical marijuana video HERE and additional Drew Carey videos HERE.

The Drug Policy Alliance Network offers lots of additional information including Marijuana: The Facts and Medical Marijuana Fact Sheet.