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.

UPDATE: Getting the Correct Information on Migraine Drug Treximet

The comments I made to the The Real Cougar Woman in reference to the misinformation in the article Migraine Sufferers - This New Drug Might Help You are now showing. I don't know if they were removed intentionally or if it was just one of those "things" that sometimes happens in cyberspace.

I was hoping that because my comments weren't there, the article might be corrected. But noooooo, the article remains the same. Wait, something has been fixed. It's so small that I almost missed it. The last sentence no longer says:

If you are a migraine sufferer ask your doctor if treximent is for you.

Now it says:

If you are a migraine sufferer ask your doctor if treximet is for you.

The spelling of the word "treximent" has now been corrected to "treximet". YIPPEE!

One down, a bunch to go...

This updates my previous blog entry Getting the Correct Information on Migraine Drug Treximet

The Pitfalls of Over-The-Counter Pain Medications for Migraine and Other Types of Pain

Next time you grab that bottle of over-the-counter (OTC) pain medicine for your Migraine, neck, headache, back, knee or other pain make sure you know the facts. Acetaminophen, aspirin, ibuprofen, ketoprofen and naproxen CAN hurt you. Two articles published this past week discuss the overuse of OTCs. The June 2008 issue of Consumer Reports features the article, Beware of overusing over-the-counter pain relievers and U.S. Pharmacist features the May 20, 2008 article, Common Adverse Events and Interactions with OTC Pain Medications.

The Consumer Reports article contained the results of an online survey regarding how people use OTCs. The Consumer Reports National Research Center surveyed 47,283 subscribers in 2007. They found that 14,658 (31%) of the survey participants did not always follow instructions on the label. The also found that:

• 5 percent used OTC pain relievers daily for two weeks or more without a health expert's approval, ignoring label directions.

• 4 percent routinely took excessive doses without consulting a health professional.

• 4 percent experienced serious side effects, including ulcers and kidney, liver, and heart problems, that a health professional said could be traced to use of OTC drugs.

The three main excuses reasons survey participants used to explain why they were overusing OTCs were 1) They were in severe pain, 2) They didn't experience any side effects, or 3) They weighed more or they were taller than average.

Published research indicates OTC overuse is more prevalent nationally than among Consumer Reports subscribers. A 2005 study, published in The Journal of Rheumatology, claims:

...36 million Americans are using OTC pain medications daily, with roughly 23 million using NSAID. Further, one-fourth of users exceeded the recommended dose of OTC medication, and the belief that OTC are safer than prescription doses was common. More disturbing is that about half of the interviewees either were unaware of the potential toxicity of these agents or were unconcerned. These findings strongly underscore the need for educational interventions directed to the general public as well as physicians.

There are dangers of OTC analgesics that many people are not aware of. Most healthcare providers believe that using analgesics for Migraine pain, regardless of whether they are prescribed by your healthcare provider or purchased OTC, more than 2 or 3 DAYS a WEEK or consecutively can cause Medication Overuse Headache (MOH) also known as Rebound Headaches. The article, Medication Overuse Headache - When the Remedy Backfires explains:

Medication-overuse headache is an interaction between a medication used excessively and a susceptible patient...
... What is crucial is that treatment (resulting in MOH) occurs both frequently and regularly, i.e., on several days each week...
...the headache associated with medication overuse often has a peculiar pattern shifting, even within the same day, from having migraine-like characteristics to having those of tension-type headache (i.e., a new type of headache).
The diagnosis of medication-overuse headache is clinically extremely important because patients rarely respond to preventative medications whilst overusing acute medications.

Acetaminophen is not recommended for those with liver disease, kidney disease or those who consume 3 or more alcoholic drinks per day. The FDA warns that exceeding the recommended dosage or overdosing on acetaminophen can lead to liver damage.

NSAIDs, include aspirin, ibuprofen, ketoprofen and naproxen. With the exception of aspirin, NSAIDs can increase stroke and heart attack risk. (Aspirin combined with another NSAID carries the same risk.) They can also be harmful to the liver, kidneys and stomach. NSAIDs can cause ulcers, bleeding, perforation and other gastrointestional effects. The FDA says:

The risk for bleeding is low for those who take these products intermittently. For those who take the products on a daily or regular basis, the risk is increased, particularly for those over 65 years of age or those who take corticosteriods (such as prednisone). Those who use hormone therapy (estrogens and progestins) for post-menopausal symptoms or birth control do not have an increased risk for bleeding.

In addition, consumers should ask health care providers about NSAID use if they have kidney disease or are taking diuretics (fluid pills).

The U.S. Pharmacist article, geared towards pharmacists rather than the public, discusses the dangers of these medications in more detail:

OTC pain medications should be used at the lowest effective dose for the shortest duration possible to minimize the potential risk for an adverse event. Patients taking acetaminophen should not exceed the recommended maximum daily dose, while patients taking NSAIDs should not exceed the recommended single or daily dose.

The article also discusses the pharmacist's duty to play a critical role in educating patients of the dangers of OTCs and how to use them safely. To decrease accidental overdoses, pharmacists should encourage people to read labels and learn the ingredients in the product. To prevent using a combination of products containing the same ingredient, pharmacists should provide educational material on generic names. And to prevent dangerous or fatal results, pharmacists should caution people on the misuse and overuse of OTCs.

WOW! What a novel idea; pharmacists educating patients about their medications regardless of whether it's available OTC or requires a prescription! Sarcasm aside, this would be great but there's no way our pharmacists can do this alone. The Consumer Reports article tells us:

Debra Latimore, 52, of Whiting, Ind., told us she's been taking Advil for osteoarthritis pain daily since 2006 without telling her internist. "I forget to list it on doctor forms because it's over-the-counter," she says. "It's not something I think of as a drug."

How are our pharmacists supposed to educate people about OTCs if they don't know who the consumers are? Latimore didn't tell her doctor she was taking an OTC medicine every day, so how is her pharmacist supposed to know about the bottle of ibuprofen she (probably) bought at Wally World? The majority of responsibility must lie with us patients. We have to be the ones to seek out our pharmacist's guidance and we have to be the ones to initiate discussions with them. It's our responsibility to be informed patients and learn all we can so that we use OTCs properly and according to their labels. Way better than my advice though, is Schoolhouse Rocky's great words to live by:

As your body grows bigger,
Your mind must flower,
It's great to learn,
'Cuz knowledge is power!

Getting the Correct Information on Migraine Drug Treximet

I was just over at Migraine News Network reading Raingem's interesting article, "Treximet or TrickThem-et?" She provides us with good information about this new Migraine medication and points us to something:

Debbie who runs Down The Rabbit Hole blog:, has noticed something interesting - a little subversive disinformation campaign as propagated by sloppy journalists and uninformed patients alike. There are plenty of little news blips if you care to search for them that say pretty much the same as this little article: New Drug Could Be Best Migraine Medicine On Market.

I find all this ironic. Two days ago I was reading Migraine news. It seemed that article after article was bullshit, misinformation, unreliable and lies. So when I stumbled on this Treximet article Migraine Sufferers - This New Drug Might Help You on The Real Cougar Woman I started to get mad. This article was filled with inaccurate and misleading information and I couldn't take it anymore, So I did something I usually don't do. I wrote a letter to the author, pointed out the incorrect information and provided her with the correct information. I told her that she didn't have to post my comments but I would like her to fix the stuff that was wrong. She ended up posting my comments instead.

You can read them below or read them in context on The Real Cougar Woman. Since my comments were removed two days after being approved, here's part of the article including the incorrect information in red:

...This month, a new drug is expected to land in pharmacies that combines two existing migraine drugs. It promises to offer relief without the fear of addiction. It's called treximet.

Apparently it works by combining two existing drugs that control two different aspects of migraine headaches. First, it prevents blood vessels in the head from narrowing. Second, it blocks the brain from releasing chemicals that signal pain.

If you are a migraine sufferer ask your doctor if treximent is for you.

My comments in their entirety follows:

Treximet is NOT the combination of two existing Migraine drugs. It combines a Migraine medication with an NSAID. The Migraine medication, Sumatriptan, is a Triptan (technical name is selective serotonin receptor agonists), and is the ingredient found in Imitrex. The NSAID is naproxen sodium, the same ingredient found in the over-the-counter medicine Aleve. This is used for many other conditions. You say "It promises to offer relief without the fear of addiction". Even though it's not very common, NSAID addiction can occur. Additionally, using these products separately and/or together can cause a serious condition for Migraine sufferers called Medication Overuse Headache also known as Rebound Headaches.

I know that all medications including vitamins and supplements have side effects but your article makes it sound as if there are no risks associated with using this medication. Yes, there are benefits of both medications but it should be noted that NSAIDs can be FATAL. It increases heart attack and stroke risk and can be harmful to the liver, kidneys and stomach. NSAIDs can also cause ulcers, bleeding, perforation and other gastrointestinal effects.

You're incorrect to say that this medication prevents blood vessels in the head from narrowing. Treximet does NOT prevent blood vessels in the head from narrowing. During a Migraine attack the blood vessels in the head DILATE. Sumatriptan causes vasoconstriction. This means that this medication does the exact opposite of what you said it does and constricts, or narrows, the blood vessels. You can verify this information on MAGNUM, the same site you cited http://www.migraines.org/treatment/treathis.htm

Treximet is misspelled "treximent" in the last sentence.

Using the phrase "Migraine Headache" is also inaccurate. Migraine is a genetic neurological disease. Migraines are NOT headaches. Headache is just one symptom of a Migraine and there are many other symptoms such as, aura, nausea, vomiting, photophobia, phonophobia and vertigo. Some people don't have headaches during a Migraine attack so calling it a "Migraine Headache" is misleading.

I'm not asking you to publish my comment, I'd just like you to fix the misinformation.
Pam
http://pinkpurlgurl.blogspot.com