More on Sleeping Pills and Older Adults – NYTimes.com.
Now the C.D.C. has reported that a high number of emergency room visits are associated with psychiatric medications in general, and zolpidem — Ambien — in particular. They’re implicated in 90,000 adult E.R. visits annually because of adverse reactions, the study found; more than 19 percent of those visits result in hospital admissions.
Blood-Thinner Pradaxa: What You Should Know.
Concerns about Pradaxa surfaced 2 years ago, he says, when doctors began reporting a larger number of serious and sometimes fatal bleeding problems in older patients on the drug.
The claim by the company that the drug needs no blood-level monitoring is misguided, Moore says. “It turns out the company has had data for several years, showing the amount of anticoagulation [blood thinning] varied [from patient to patient] more than five-fold.”
That means, Moore says, that “the same dose could produce widely varying effects on blood clotting. Some patients would be at extremely high risk of bleeding. Others would not get a strong enough blood clotting effect to serve its purpose, reduce the risk of stroke.”
Do the phrases “serious and sometimes fatal bleeding problems” combined with the drug maker’s withholding of data bother anyone? And yet another example of putting profits before people.
Update 07.27.14
I found another fine article on the Pradaxa mess. Follow the link to The Poison Review. There you will find more details on this story and more links for further reading, including a link to the full text BMJ article.
The Institute for Safe Medication Practices reported that in 2011 there were 3781 serious adverse effects and 542 patient deaths reported in the United States in association with dabigatran. In comparison, warfarin (Coumadin) was associated with only 72 deaths during that same time period. – See more at: http://www.thepoisonreview.com/2014/07/27/must-read-marketing-vs-medicine-in-the-case-of-pradaxa-dabigatran/#sthash.tpAapuE6.dpuf
Must-read: marketing vs. medicine in the case of Pradaxa dabigatran | The Poison Review.
Update 08.22.14
Getting the dabigatran Pradaxa story right… Correcting four common mistakes..
If you’re not totally confused by now you should be.
The Controversial FDA Approval of Zohydro and America’s Infatuation With Opioids — New York Magazine.
I found this article fascinating.
MedicalResearch: What are the main findings of the study?
Answer: We found that within our group of 255 known Emergency Department “super-frequent users,” 77% had with some type of addiction disorder, and 47 percent visited the Emergency Department seeking narcotics for pain. Women were more likely to be narcotic seeking. Using our individualized Electronic Medical Record care plan intervention, created and overseen by our multidisciplinary team (comprised of Emergency Department staff physicians, a psychologist, residents, nurses and support staff), we found that our plan significantly decreased annual rates of visits by these super-frequent users and those who sought pain-relief narcotics and other super-frequent users.
Viagra Frisky Might Be Melanoma Risky.
Men who used the erectile-function drug sildenafil (Viagra) had almost twice the risk of melanoma compared with men who never used the drug, a study of 26,000 men showed.
Recent sildenafil use was associated with an 84% greater risk of melanoma.
ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.
Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.
A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary). Despite these driving and other problems, patients were often unaware they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day.
OK boys and girls, listen up. When you see the terms non-adherence or non-compliance in that APS you’re reading does this mean the risk is better or worse?
One in Three Patients Not Filling Prescriptions, Study Finds — AAFP News — AAFP.
For the study, Canadian researchers evaluated the electronic health records of 15,961 patients in a primary care network that included 131 physicians to estimate the incidence of primary nonadherence (failure to fill a first-time prescription) and to ferret out which drug, patient and physician characteristics might be associated with nonadherence. Patients’ health records were linked to insurer data on drugs dispensed by community-based pharmacies in relation to specific office visits.
The researchers found that slightly more than 31 percent of all initial drug prescriptions were not filled within nine months. Nonadherence was highest for expensive drugs and preventive therapies for chronic conditions such as ischemic heart disease and depression. In addition, patients with higher copayments, recent hospitalization and more severe comorbid conditions were at increased risk for nonadherence.
Aspirin: FDA Says ‘No’ Others Say ‘Yes’.
I found this article quite helpful in my own decision regarding whether or not to continue my daily aspirin 81 mg dose.
The bump I gave myself on the shin a few weeks ago that bled profusely and took hours to clot was also quite helpful in my decision regarding whether or not to continue my daily aspirin 81 mg dose.
Update 06.06.14
Check out the following link. If you’re an older male you might find this of interest.
http://www.webmd.com/erectile-dysfunction/news/20110303/regular-use-of-painkillers-linked-to-ed
Update 07.26.14
This link takes you to the 2012 Circulation article.
Update 08.04.14
More links for your reading and research pleasure.
Aspirin May Not Protect Against Cardiovascular Disease – Prevention.com.
Benefits of aspirin more modest than previously believed — St George’s, University of London.
Researchers from Professor Kausik Ray’s group at St George’s, University of London investigated the drug’s effectiveness in primary prevention and the prevalence of side effects. They also assessed if aspirin had any impact on the risk of death from cancer among people considered at risk of cardiovascular disease.
They analysed data from nine clinical trials involving over 100,000 participants without a history of cardiovascular disease. Half of the participants took aspirin and half took a placebo. The average participant in the aspirin arm of these trials took aspirin for about six years.
The researchers found that although aspirin in conventional daily or alternate day doses reduced the risk of total cardiovascular disease events by 10 per cent, this was largely due to a reduction in non-fatal heart attacks. It did not include a reduction in other cardiovascular disease events including death from heart attack, or fatal or non-fatal stroke.
The study also showed that this benefit was almost entirely offset by a 30 per cent increase in risk of life-threatening or debilitating internal bleeding events. This means that while one cardiovascular disease event was averted for every 120 people treated with aspirin for about six years, one in 73 people suffered from potentially significant bleeding during the same period.
Safety Information > February 2014.
Get to Know an Enzyme: CYP3A4.
I routinely check the FDA drug safety information for personal reasons. One thing led to another, thus the reason for the CYP3A4 link. If you like puzzles, try to figure out why I’m reading up on CYP3A4. My son the molecular biochemist soon to be MD would have no problem figuring this out.
lifeunderwriter.net 
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