January 2nd, 2011 by Glenn Laffel, M.D., Ph.D. in Better Health Network, News
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The FDA has been tough on diet drugs of late. Three years ago it scuttled an attempt to get the European diet drug rimonabant approved for use in the U.S. More recently it rejected, at least temporarily, applications for Qnexa and Lorcaserin.
But that trend may have been reversed last week, when an advisory committee set the stage for possible FDA approval of Orexigen’s investigational diet drug, Contrave. By a 13-7 vote, the committee said in essence that the somewhat modest beneficial effects of the drug outweighed its tendency to increase blood pressure.
The FDA will make final decision on the matter by the end of January. It is not required to follow the advice of its advisory committees, but as was the case for the three diet drugs mentioned above, it usually does. Read more »
*This blog post was originally published at Pizaazz*
December 28th, 2010 by RyanDuBosar in Opinion, Research
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This is a guest post by Dr. Juliet Mavromatis:
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The emergence of a new generation of anticoagulants, including the direct thrombin inhibitor, dabigatran and the factor Xa inhibitor, rivaroxaban, has the potential to significantly change the business of thinning blood in the United States. For years warfarin has been the main therapeutic option for patients with health conditions such as atrial fibrillation, venous thrombosis, artificial heart valves and pulmonary embolus, which are associated with excess clotting risk that may cause adverse outcomes, including stroke and death. However, warfarin therapy is fraught with risk and liability. The drug interacts with food and many drugs and requires careful monitoring of the prothrombin time (PT) and international normalized ratio (INR).
Recently, when I applied for credentialing as solo practioner, I was asked by my medical malpractice insurer to detail my protocol for monitoring patients on anticoagulation therapy with warfarin. When I worked in group practice at the Emory Clinic in Atlanta I referred my patients to Emory’s Anticoagulation Management Service (AMS), which I found to be a wonderful resource. In fact, “disease management” clinics for anticoagulation are common amongst group practices because of the significant liability issues. Protocol based therapy and dedicated management teams improve outcomes for patients on anticoagulation with warfarin. Read more »
*This blog post was originally published at ACP Hospitalist*
December 24th, 2010 by PeterWehrwein in Better Health Network, Health Tips, News, Research
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Perhaps as many as one in every five American adults will get a prescription for a painkiller this year, and many more will buy over-the-counter medicines without a prescription. These drugs can do wonders — getting rid of pain can seem like a miracle — but sometimes there’s a high price to be paid.
Remember the heavily marketed COX-2 inhibitors? Rofecoxib, sold as Vioxx, and valdecoxib, sold as Bextra, were taken off the market in 2004 and 2005, respectively, after studies linked them to an increased risk of heart attack and stroke.
The nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin, ibuprofen (sold as Advil and Motrin), and naproxen (sold as Aleve) seem like safe bets. But taken over long periods, they have potentially dangerous gastrointestinal side effects, including ulcers and bleeding. Kidney and liver damage are possible, too. More recently, some of the NSAIDs have been linked to an increased risk of cardiovascular disease. Low doses of aspirin (usually defined as 81 mg) is an exception and is often prescribed to lower the risk of heart and stroke.
Even acetaminophen, which is often viewed as the safest pain drug and a low-risk alternative to the NSAIDs because it doesn’t have their gastrointestinal side effects, comes with a caution about high doses possibly causing liver failure. Read more »
*This blog post was originally published at Harvard Health Blog*
December 21st, 2010 by Debra Gordon in Health Policy, Opinion
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“With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug. . . We can’t allow this government takeover of health care to continue any longer.”
That quote, courtesy of this morning’s [Dec 17th] Washington Post, incensed me to such a degree that I am writing this blog despite the two deadlines I have today. The speaker is Sen. David Vitter (R-La). The “disappointing decision” he refers to: The FDA’s decision to remove the breast cancer indication for Avastin (bevacizumab).
I wrote about this earlier, and you can read the post here, but that was before yesterday’s [Dec 16th] decision. I’m not going to comment here on the benefits or risks of Avastin. . . except to say that I’m sure there are individual women who are alive today because of it, and, quite possibly, individual women who are dead today despite it. But that’s not how we do medical science, based on individual patients. We do medical science based on large clinical studies (which are often designed with and approved by FDA officials). It’s not a perfect system, but it’s the system we have. Read more »
*This blog post was originally published at A Medical Writer's Musings on Medicine, Health Care, and the Writing Life*
December 15th, 2010 by admin in Health Tips
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This is a guest post from Dr. Mary Lynn McPherson.
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Rescuing Patients On Darvon Or Darvocet With Zero Tolerance For Pain
On November 19, 2010 the Food and Drug Administration (FDA) called for a halt in the use of the popular opioid pain relievers Darvocet and Darvon. These products contain the opioid propoxyphene, and it has been used to treat mild to moderate pain for over 50 years. However, concerns have long been raised about the effectiveness of this drug, and the risk of death (accidental and suicide). Darvon and Darvocet were banned in Britain in 2005, followed by the European Union in 2009. Over the past 30 years, the FDA has received numerous petitions to take these drugs off the U.S. market.
Research has shown that Darvon and Darvocet are no more effective for treating moderate pain than over the counter drugs like acetaminophen, aspirin or ibuprofen. Unfortunately, Darvon and Darvocet cause a lot more side effects such as dizziness, drowsiness, nausea and vomiting, hallucinations and constipation (all pretty typical of opioids used to treat pain). But, the side effects don’t stop there. The data is in, and it’s not a pretty picture. A recent study requested by the FDA showed that when used at the recommended doses, Darvon and Darvocet cause significant changes in the electrical activity of the heart, which can lead to a fatal irregularity in your heartbeat, even after only short-term use.
Among those advocating for the removal of these drugs from the market were pharmacists. The American Society of Health-System Pharmacists approved a policy in 2007 advocating for the withdrawal of Darvon and Darvocet from the U.S. market, and recently testified at the FDA Advisory Committee to this effect. As an often overlooked member of the medical team, pharmacists have a vital role to play in providing safe and effective treatments. We serve as the last line of defense against improper or unwise prescribing of drugs — especially those for pain. We are drug experts, and we can help patients and doctors switch from Darvon or Darvocet to safer and more effective treatments. Read more »
The FDA has been tough on diet drugs of late. Three years ago it scuttled an attempt to get the European diet drug rimonabant approved for use in the U.S. More recently it rejected, at least temporarily, applications for Qnexa and Lorcaserin.
