Thoughts of the Day

Picture courtesy of Laurie Avocado

If you think MEDICAL Marijuana has anything to do with south of the border drug cartels, dime bags of weed bought on the street, addiction or gateways drugs -You're wrong and you need to EDUCATE YOURSELF.

Ever wonder why someone using opioids such as Morphine, Demerol or Fentanyl would trade them for MEDICAL Marijuana in a heartbeat if it provided at least the same if not better pain relief?

Ask someone suffering a terminal disease or debilitating chronic pain if they'd use MEDICAL Marijuana if it meant they could be pain free for 10 minutes to do simple things (like standing at the sink washing dishes) you take for granted ever day.

Ask an MS patient with involuntary muscle spasms, an AIDS patient with Wasting Syndrome, or a Chemo patient suffering with severe nausea/vomiting if they think MEDICAL Marijuana has no proven or acceptable medical use.

Before you say anything about SMOKING MEDICAL Marijuana, check out the new delivery systems researchers come up with every day (i.e. Sativex).

And check your facts before you say MEDICAL Marijuana kills. According to FDA data, Marijuana was NOT reported as a primary cause of death at all between January 1,1997 to June 30, 2005.

It's About Time: FDA Finally Approves Botox for Migraine Prevention

Doctors have been using Botox for years to treat chronic Migraine even though it wasn't FDA approved for this disease. As of last Friday, the FDA finally approved it for chronic Migraine prevention.  For those of you who have never tried it because of the cost should now have an easier time getting your health insurance to pay for this treatment.

Botox is a poison that's injected around the head to lessen future head pain. The FDA recommends injections every three months. It doesn't work for everyone but many people have had success with it. If you've never tried it, this might be something to consider.

For more information see FDA approves Botox as a Migraine preventive.

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.

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.

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.

FDA Recall - ETHEX Recalls ADDITIONAL Lots of Extended Release Morphine Sulfate 30mg and 60mg

ETHEX Corporation announced today that it has voluntarily recalled specific additional morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008.

The 30 mg extended release tablets are pink oval tablets with "30" on one side, and "E" on reverse the 60 mg extended release tablets are white oval tablets with "60" on one side, and "E" on the reverse.

This FDA expanded recall can be found HERE.

FDA Recall - Morphine Sulfate 60 mg Extended Release Tablets

ETHEX Corporation announced today that it has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall.

The entire FDA recall can be found HERE.

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!

Serotonin Syndrome in the News

MedlinePlus, a service of the US National Library of Medicine and the National Institutes of Health defines Serotonin Syndrome:

Serotonin syndrome is a life-threatening drug reaction that causes the body to have too much serotonin, a chemical produced by nerve cells.

And cites the cause:

Serotonin Syndrome most often occurs when two drugs that affect the body's level of serotonin are taken together at the same time. The drugs cause too much serotonin to be released or to remain in the brain area.

An example of this is taking a Selective Serotonin Receptor Agonist also known as a Triptan while you are taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI). In other words using Imitrex aka Sumatriptan (a Triptan) while taking Prozac (an SSRI) or Cymbalta (an SNRI) can cause Serotonin Syndrome.

It is believed that changes in serotonin is involved in causing Migraine attacks. More about it can be found HERE. This information has been around for a while so.....

Why is Serotonin Syndrome in the news?

In the May 15 issue of the New England Journal of Medicine, Georgetown University researchers and the U.S. Food and Drug Administration detail 11 cases of Serotonin Syndrome associated with the use of triptans alone that were reported to the FDA's Adverse Event Reporting System (AERS)."

Offie Soldin, an associate professor of medicine and oncology at Georgetown University Medical Center and the study's lead author said:

The FDA has already issued an advisory and an alert that when triptans are used in combination with SSRIs, there is a possibility of serotonin syndrome. The news here is that it doesn't have to be in combination, triptans alone can cause serotonin syndrome

Soldin also stressed that this is very rare and unlike to happen saying:

...you just need to stop taking the drugs when it does happen. If you're taking these medications and you have strange muscular, mental or hyperactivity symptoms, contact your doctor.

More information can be found in this Washington Post article.