Herbal Treatment of Little Use in Hot Flashes

Here is a great example of what Orac, Notes from Dr.RW, and others on the blogosphere classify as "woo" (unproven complementary alternative medicine) put to the test of evidence-based medicine published in the latest issue of the Annals of Internal Medicine. . .

. . . Black cohosh — an herb that is a member of the buttercup family and is commonly given to ease menopause symptoms — is available in pill or liquid form and is sold over the counter in many health food stores and over the Internet. . .

. . . [a] yearlong study of 351 women suffering from hot flashes and night sweats found that those given black cohosh got about the same amount of relief as those who took a placebo. And those groups saw nothing close to the improvement in women on hormones. >Full Story: Yahoo!News

Let the data speak for themselves.

Ketek -- FDA Advisory Committee Gets it Right

It's all about weighing risk vs benefit. . .

A U.S. Food and Drug Administration advisory committee recommended late Friday that a "black-box" warning be added to the controversial antibiotic Ketek for its use in fighting pneumonia. It's also possible that the drug will lose its approval for two lesser indications, sinusitis and bronchitis.

. . . At the end of the second day, the committees voted 16-to-3 that the benefits of Ketek (telithromycin) outweighed the risks for community-acquired pneumonia, a potentially life-threatening condition. >Full Story: HealthDay News

The FDA will now consider carefully the advisory committee's advice before taking any regulatory action.

Ketek Liver Failure -- Stay Tuned

This reported on CBS News yesterday. . .

Iraq war veteran Chuck Gregg was back home with his family last winter when he got bronchitis. His doctor prescribed Ketek [telithromycin], a relatively new antibiotic, CBS News chief investigative correspondent Armen Keteyian reports. Five days later, Gregg was in the hospital with liver failure. >Full Story: CBS News

. . . and we learn today. . .

Two Food and Drug Administration committees are hosting public meetings today and tomorrow to discuss whether Ketek, used to fight pneumonia, bronchitis and sinusitis, is safe enough to remain on the market. . . The regulators identified 79 reports of liver damage linked to the drug as of April, including four reports of deaths in the U.S., according to the documents. About 390 patients had reported blurred vision and other impairments as of July 7, and 137 patients had some loss of consciousness while taking the drug. >Full Story: Bloomberg

There is no doubt that there has been ongoing controversy regarding FDA review of this issue over that last several years. It's also likely that alternative standard and cheaper antibiotics may have been appropriate in some of these patients. But, keep in mind that although yearly prescriptions for standard antibiotic therapies are of course much higher than with Ketek, it has been estimated that in the U.S. there are some 66 cases annually of acute liver disease resulting in hospitalization with erythromycin, 114 with sulfonamides, and 31 with tetracycline (Carson JL et al. Ann Intern Med 1993;119:576-583.).

Plain English on Prescription Labels Doesn't Cut It

What is it about twice daily that you don't understand?

Many Americans, including those with college degrees, have trouble interpreting the instructions on prescription drug labels. . . according to the study report in Annals of Internal Medicine. . . 9 percent of all those interviewed had trouble with the instruction, "take one tablet by mouth once each day." The problem is most common with the "two tablets twice daily," noted researcher Michael S. Wolf, assistant professor of medicine at Northwestern University's Feinberg School of Medicine. That is often misinterpreted to mean "two tablets a day," he said. But the number of misinterpretations rises with the amount of numbers included in the instructions, Wolf said. So, "take one teaspoon twice a day for seven days" is especially confusing, for example, he noted. >Full Story: YahooNews

I don't know what kind of math and reading comprehension skills are being taught in college these days, but understanding prescription label directions is clearly a problem and we need to spend more time verbally making sure patients understand. . .and don't assume they do.

Print Me a New Femur Please

"Bioprinting" with stem cells could be the wave of the future:

An inkjet device that prints tiny “bio-ink” patterns has been used to simultaneously grow two different tissues from the stem cells of adult mice. Surgeons could one day use the technology to repair various damaged tissues at the same time, the researchers say.

. . .Julie Phillippi at Carnegie Mellon University in Pennsylvania, US, and colleagues have demonstrated a novel bio-ink printer that directs a population of muscle-derived stem cells from adult mice to differentiate into both muscle and bone tissue. It is the first such system to grow multiple tissues from a single population of adult stem cells, the researchers say. >Full Story: NewScientist

This should keep the stem cell controversy going. . .

FDA Orders Unapproved Quinine Drugs from the Market

Unapproved quinine products don't include cautions and warnings about serious adverse events:

The Food and Drug Administration (FDA) today [December 11, 2006] ordered firms to stop marketing unapproved drug products containing quinine, a drug used to treat malaria, citing serious safety concerns, including deaths, associated with quinine products. There are multiple unapproved products containing quinine currently marketed. However, there is only one quinine product approved by the FDA.

As part of its action, FDA is also cautioning consumers about off-label use of quinine to treat leg cramps. . . .One quinine drug product, Mutual Pharmaceutical Company, Inc.’s Qualaquin, is FDA-approved to treat certain types of malaria without complications. Unlike the approved product, many unapproved quinine drug products are marketed without labeling cautioning against use of the product for treatment of leg cramps. The FDA-approved labeling for the product provides extensive warnings regarding serious adverse events associated with use of quinine, potentially serious interactions with other drugs, and conditions under which quinine should not be used. Quinine is a drug with a narrow margin between an effective dose and a toxic dose.

Since 1969, FDA has received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Quinine drugs are associated with serious side effects, such as cardiac arrhythmias, thrombocytopenia (a decrease in blood platelets that can cause hemorrhage or clotting problems), and severe hypersensitivity reactions. There is also the potential for serious interactions between quinine drugs and other drugs, and there are conditions under which quinine should not be used. >Full Story: FDA News

Extended Intern Work Shift Duration Associated with More Medical Errors

This is not surprising and there was probably a great deal of under reporting as well:

A study from the U.S. of doctors in their first postgraduate year (interns) has showed that working extended shifts is associated with increased reporting by the doctors of medical errors, adverse patient events and attentional failures.

. . .The authors conclude that "These results have important public policy implications for post-graduate medical education." >Full Story: ScienceDaily

. . . but maybe the longer physicians in training work the more opportunities they have to make medical mistakes, and maybe they are working during hours when there is just less supervision or other checks and balances (e.g. during night shifts and graveyard shifts). . . could the interns’ desire to work shorter hours have also biased their reporting of these events?

The Fentanyl Patch -- A Misunderstood Dosage Form

Over on Kevin, M.D. comes this:

It seems that most of the overdoses [with the fentanyl patch] are from people who took the medication without a prescription, or by not following instructions:

"One patch is supposed to last for three days, and she used all five patches from Thursday to Sunday," the man said. "She was in such pain, she probably didn't really know what she was supposed to do."

There's a reason why there are instructions on the bottle.

This and many other unfortunate cases of harm resulting from the fentanyl patch likely represent a breakdown in the entire medication use process – from inappropriate prescribing, to a lack of understanding of the patch release characteristics, and to a lack of patient education and clear direction regarding proper administration and secure storage of this highly potent narcotic analgesic. The Institute for Safe Medication Practices has nicely outlined the problem and provide recommendations in their ISMP Canada Safety Bulletin.

Few understand the appropriate use of the fentanyl patch for only chronic pain, the need to remove the previous patch before applying the next, combinations with other drugs that can increase the levels of fentanyl, enhanced absorption that can take place when a heat source is applied to the patch, and the inadvertent (or not) contact with the patch that can occur due to unsafe disposal or poorly secured storage.

It takes vigilance from all healthcare professionals involved in the medication use process and personal responsibility on the part of patients to ensure safe drug use. The fentanyl patch is an example of where things can go very wrong, very quickly if these principles are not applied.

Look-Alike Sound-Alike Drug Errors – Protect Yourself

Medication errors are an important health risk. Human error is of course a factor, however, frequently there is a root cause or system process problem that allows that error to occur. Take for example the antihistamine drug Zyrtec (generic name cetirizine) and the antipsychotic agent Zyprexa (generic name olanzapine). Both are available as white 5 mg and 10 mg tablets and they are often stored near each other on pharmacy shelves. Add to this the possibility of physician handwriting legibility problems and you have well, a prescription for disaster.

This example is just one of many look-alike, sound-alike drug combinations that can and have resulted in the wrong medicine being dispensed to patients – and you can imagine the consequences. Eli Lilly, the maker of Zyprexa responsibly issued a “Dear Doctor” letter last year to warn healthcare professionals about the potential for confusion with Zyrtec because of reported dispensing errors.

There are two important things that you as a patient can do to protect yourself against these types of errors – 1) double check that the drug your physician prescribed for you is the drug on your vial label; and 2) that the actual tablets or capsules in the vial are correct for that drug. Here is what you need to do:

• Make sure you know the name of the drug being prescribed for you by your physician. Have the physician write it down. If your doctor submits the prescription electronically ask for a copy.

• Ask your physician to place the indication for the drug on the prescription. If there is any question by the pharmacist about the look-alike, sound-alike drug, the indication will be a further check for the pharmacist and later for you on your vial label.

• Check your vial label drug name against the one your physician said he was prescribing for you.

• Lastly, many pharmacies now include a tablet description (eg. white coated tablet) and code imprint (like “XYZ 123”) on the vial label. Look carefully at the tablets or capsules in the vial and check them for consistency with this information.

The Institute for Safe Medication Practices has put together a list of drug names that have been confused resulting in medication errors. This doesn't mean that there is always a problem when these drugs are dispensed, but you may want to check to see if you are taking any of the medications on the list.

Medication use has become a very complex process and although healthcare professionals make every effort to be careful, you should consider yourself to be the final check in the medication error prevention process. Taking these steps to protect yourself is not optional. . .you need to be an active participant in your own health care safety.

Holiday Poison Prevention -- Mistletoe and Beyond

I was perusing today's The Bakersfield Californian (Why you ask? – I grew up there many years ago and check in occasionally) and an article on "Holiday Home Safety" caught my eye for some reason. In their checklist they covered the typical kinds of things like chimney and tree safety tips, unattended burning candles, checking smoke alarms, drinking and driving, shopping safety, and they even mentioned mistletoe and holly berry risks to children and small pets. . . all good stuff. But, I was waiting for the punchline – the potential for medication poisoning in small children during holiday gatherings – it wasn't there. . . Check out the California Poison Control System's “Winter Holiday Safety and Poison Prevention" tips.

Medicines: Parents, grandparents and babysitters should be extra cautious during the holidays. Visitors often leave medicines on a nightstand or in the bathroom, making them easily accessible to children. Medications given to seniors often do not have child-resistant closures, allowing children to open them with very little difficulty. Also, purses of visitors may contain medicines and other potentially dangerous items. Remember that the homes of friends and relatives may not be poison-proof, particularly if children do not usually live there.

Also keep in mind that so called child-resistant prescription closures can often be more easily opened by a child than an adult with severe arthritis. Remember that vitamins and minerals (particularly iron), and herbal remedies, can also be potentially dangerous in children. And, if you're hosting the holiday celebration you know that you have way too much on your mind to be keeping track of children who might be getting into things they shouldn't -- poison-proof your home ahead of time. Keep the national poison control line number handy (1-800-222-1222 and you will be connected to your local poison center) though, just in case.

Prescription Drug Information (Package Insert) Format Changes – Are we There Yet?

As many of you know, earlier this year the Food and Drug Administration (FDA) rolled out a major revision to the format of prescription drug prescribing information (the package insert). One of the major reasons for the change was to help reduce the risks of medication use and medical errors by having a package insert in an easier to read format that draws physician and patient attention to the most important pieces of the drug information (FDA Consumer Magazine). The Patient Medication Guide will be included either at the end of the new package insert or accompany the labeling as a separate document.

Revised for the first time in more than 25 years, the new format requires that the prescription information for new and recently approved products meet specific graphical requirements and includes the reorganization of critical information so physicians can find it quickly. Some of the most significant changes include:

• a new section called Highlights to provide immediate access to the most important prescribing information about benefits and risks
• a Table of Contents for easy reference to detailed safety and efficacy
  information
• the date of initial product approval, making it easier to determine how long a product has been on the market
• a toll-free number and Internet reporting information for suspected adverse events, to encourage more widespread reporting of suspected side
  effects.
  

"The new label design makes it easier for doctors to get access to important information about drug safety and benefits, and this in turn will help them have more meaningful discussions with their patients," says Acting Commissioner of Food and Drugs Andrew von Eschenbach, M.D. "This redesigned label is a big step in our commitment to giving health professionals the tools and information they need to optimize their clinical practice and choose among a growing number of effective treatments to make more personalized prescribing decisions for their patients."

In addition to providing a better organizational style for finding information in the insert, the new approach importantly will require that the information be placed in a structured electronic format. The information will then be uploaded and integrated into a new National Library of Medicine online health information clearinghouse called the DailyMed.

This has all been a long time coming…no more fine print on a sideways poorly scanned pdf to read! Although still not the perfect solution to the information overload and medication use problems, I think this is a big step forward and expect further refinements to come. It will also take a while for a substantial number of package inserts on the DailyMed site to reflect the new format. Meanwhile, I’ll be curious to see how patients, physicians, and pharmacists are reacting to these changes. . .and what future suggestions they might have.

Counterfeit “One Touch” Glucose Test Strips

FDA is alerting healthcare professionals and patients about counterfeit blood glucose test strips which are being sold for use with various models of LifeScan’s One Touch blood glucose monitors. LifeScan says that its testing of the counterfeit strips shows erratic test results. These strips could give incorrect blood glucose values, either too high or too low, which might result in a patient taking either too much or too little insulin. This could lead to serious injury or death.

The counterfeit test strips have been identified as certain lots labeled as “One Touch Ultra” or “One Touch Basic/Profile”. To date, the counterfeit product has been limited to 50-count packages for both products.

For the 50-count packages of One Touch Ultra test strips, the counterfeit version will have all three of the following characteristics:

• Lot Numbers 2691191 or 2691261
• Multiple languages - the outer carton is in both English and French.
• No NDC number (normally located on the bottom of the outer carton for US product)

For the 50-count packages of One Touch Basic/Profile test strips with lot numbers 272894A, 2619932 or 2606340, the counterfeit version will have the following characteristics:

• Multiple languages - the outer carton is in English, Greek and Portuguese.
• No NDC number (normally located on the bottom of the outer carton for US product)

For the 50-count packages of One Touch Basic/Profile test strips with lot numbers 2615211 or 227078A, the counterfeit version will have the following characteristics:

• Only English appears on the outer carton.
• Counterfeit vial is labeled “plasma calibrated.”

The counterfeit test strips were distributed to pharmacies and stores nationwide, but primarily in Ohio, New York, Florida, Maryland and Missouri. Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Health care professionals should alert patients who use these test strips about the possibility of counterfeiting. Pharmacists and retailers should check their inventories routinely. For additional information, contact LifeScan at 1-866-621-4855. >Full Story: FDA Patient Safety News ; LifeScan Press Release)

Commentary: Counterfeit drugs world wide have quadrupled since 2000. Although the problem is much worse outside of the U.S., this has become a growing public health concern. There are enormous profits to be made by criminals dealing in fake pharmaceuticals and it's only natural that we would start to see similar patterns with other medically-related items such as test strips and other items. SafeMedicines.org is a good way to find information on this growing problem and keep alerted to suspected counterfeit drugs.

Ok to Call But Please Drive Carefully

Cell Phone Use Not Linked to Cancer Risk

Long or short-term cell phone use is not associated with increased cancer risk, according to a study in the December 6 issue of the Journal of the National Cancer Institute.

The widespread use of cell phones has raised concerns about health risks among users. Cell phone antennas emit electromagnetic fields that can penetrate into the human brain, and scientists have wondered if this might cause tumors in the head or neck.

Joachim Schüz, Ph.D., of the Danish Institute of Cancer Epidemiology in Copenhagen, Denmark, and colleagues performed a study of 420,095 cell phone users who first subscribed between 1982 and 1995 and were followed through 2002 for cancer incidence. >Full Story: ScienceDaily

Commentary: Well, it looks like this finally puts the issue to rest. Now if we can only put them down long enough to drive safely -- although, a hands-free approach may not be the answer either (see the NHTSA FAQ document).

Hair-Loss Drug Lowers PSA Levels

A study appearing today in the journal Lancet Oncology finds that Propecia (1 mg/day finasteride) lowers prostate-specific antigen (PSA) levels by as much as 40%-50% over 48 weeks.

TUESDAY, Dec. 5 (HealthDay News) -- The popular hair-loss drug Propecia can change the results of a common screen for prostate cancer, the prostate-specific antigen (PSA) test, leading to skewed readings that might obscure the presence of disease, a new study found. Men using Propecia "should be aware that their PSA will be falsely lowered" and that small changes upward could be signs of trouble, said study lead author Dr. Anthony D'Amico, chief of genitourinary radiation oncology at Brigham and Women's Hospital in Boston. >Full Story: Healthday News

Commentary: It has been known that Proscar (5 mg/day finasteride) approved for benign prostatic hyperplasia can affect PSA levels, however, this new study demonstrates that the lower dose of finasteride used for hair-loss in men aged 40-60 years has similar affects. This is an important issue given that an estimated 4 million men at risk of prostate cancer have used Propecia to treat male-pattern baldness. Until such studies can be done to determine whether a lower PSA cutoff should be used or an increase above a certain nadir, the study authors suggest using the same recommendations for prostate-cancer screeing as suggested for Proscar (see Proscar Prescribing Information). Futher research is also needed to determine the effects of Propecia on PSA levels beyond 48 weeks of treatment.

Revisions to Coumadin Labeling

New Coumadin Patient Medication Guide Available

If you are taking the drug Coumadin (warfarin) you are likely being followed very closely by your physician and pharmacist. The FDA (see Drug Safety Alerts and scroll down to Coumadin) and Bristol-Myers Squibb recently notified pharmacists and physicians of revisions to the labeling for Coumadin, to include a new patient Medication Guide as well as a reorganization and highlighting of the current safety information to better inform providers and patients.

FDA regulation requires that a Medication Guide be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. Information about all currently approved Medication Guides is available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.

Don't Throw the Baby (Aspirin) Out with the Ibuprofen

If your doctor told you to take aspirin to help prevent a heart attack, you need to know that taking ibuprofen at the same time, for pain relief, may interfere with the benefits of aspirin for the heart. It is all right to use them together, but the FDA recommends that you contact your doctor for more information on the timing of when to take these two medicines, so that both medicines can be effective. >Full Story: FDA Safety Alerts

Commentary: Although there are no clinical endpoint studies conducted specifically to evaluate the interaction, it appears from published and unpublished studies that ibuprofen reduces the cardiovascular effects (antiplatelet effects) of aspirin. The impact of ibuprofen on the effects of aspirin is likely related to the timing of their dosing. The FDA has suggested then that healthcare professionals consider counseling patients about the appropriate timing of ibuprofen dosing if they are also taking aspirin for its cardioprotective effects. The FDA indicates that patients who use immediate release aspirin (not enteric coated) and take a single dose of ibuprofen 400 mg should dose the ibuprofen at least 30 minutes or longer after aspirin ingestion, or more than 8 hours before aspirin ingestion to avoid attenuation of aspirin’s effect. Recommendations about the timing of concomitant use of ibuprofen and enteric-coated low dose aspirin cannot be made based upon available data. Other over-the-counter anti-inflammatory drugs should be viewed as having the potential to interfere with the cardiovascular effects of low-dose aspirin unless proven otherwise. Consult your pharmacist or physician if you are taking low dose aspirin for its cardiovascular effects and also taking ibuprofen.

Pfizer Cholesterol Drug Dies

Pfizer announced December 2, 2006 that in the interest of patient safety it is stopping all clinical trials with its investigational cholesterol drug torcetrapib and that it has informed the Food and Drug Administration (FDA). The company is in the process of notifying all of its investigators for these clinical trials as well as other regulatory authorities.

Torcetrapib clinical trials were stopped because an independent Data Safety Monitoring Board (DSMB) found an unexpected excess of cardiovascular problems and deaths in the study drug group. Pfizer has asked that all clinical investigators conducting trials with torcetrapib warn patients to stop taking the drug immediately.

Commentary: This is a great example of why FDA regulations regarding the need for large, randomized trials are so important -- to address not only how well a drug works to treat a disease, but also whether it is safe. Pfizer will discontinue development of torcetrapib. If you are participating in a clinical trial with torcetrapib you should contact your physician immediately.

Peer-Reviewed Journal of Lifestyle Medicine to Launch

SAGE Publications a leading international publisher of journals, books, and electronic media for academic, educational, and professional markets will launch the American Journal of Lifestyle Medicine (AJLM) in January 2007. This bi-monthly journal will provide commentaries and research reviews on nutrition and diet, cardiovascular disease, obesity, anxiety and depression, sleep problems, metabolic disease, and many other contemporary health issues. The journal is all about helping healthcare providers educate their patients about disease management and on how to maintain health through proper lifestyle choices. The journal will address the impact that lifestyle decisions and activities have on health and tackle the intersection between the use of traditional pharmaceutical and nutritional products and lifestyle modalities to achieve superior outcomes.

The journal will be edited by a leader in the lifestyle medicine field -- cardiologist Dr. James M. Rippe who has also put together an editorial board with extensive expertise in the disciplines covered by the journal. Given the increasing level of research in the area of lifestyle medicine, this journal will meet an important and timely need for a peer-reviewed, data-driven, professional resource covering these important issues. Healthcare providers can receive complimentary free issues of the American Journal of Lifestyle Medicine by subscribing here.