Tag Archives: drug

A path to lower-risk painkillers: Newly-discovered drug target paves way for alternatives to morphine

Now, new research from the University of Michigan Health System and a major pharmaceutical company has identified a novel approach to moderate and severe pain therapy that paves the way for lower dosage painkillers. The findings appear in Proceedings of the National Academy of Sciences. Drugs such as hydrocodone (the main ingredient of Vicodin) and oxycodone (Oxycontin) are often the best options for the treatment of moderate to severe pain for patients facing medical conditions ranging from a wisdom tooth extraction to cancer. The drugs bind to specific molecules (opioid receptors) on nerve cells in the brain and spinal cord to prevent the feeling of pain…

FDA panel votes to relax Avandia restrictions

U.S. health advisers voted on Thursday to recommend relaxing market restrictions on GlaxoSmithKline's diabetes drug Avandia, the former blockbuster at the center of one of the biggest drug controversies in recent years. The vote, by a divided Food and Drug Administration advisory committee of outside health experts, could modestly enlarge the market for Avandia in the United States and lay the groundwork for further research into the drug's health risks. FDA will now take the vote into consideration for a final decision on how the pill also known by the generic name rosiglitazone can be used. The committee did not consider a specific change in protocol. But 13 experts on the 26-member panel who backed modification said current restrictions that require prescribing physicians and pharmacists to be certified should be relaxed or eliminated after a reexamination of Glaxo safety data settled longstanding concerns about the danger of death from cardiovascular disease. “In general, this drug doesn't look any different than any other diabetes drug,” said Dr. William Hiatt, a cardiologist from the University of Colorado, who was among seven experts who backed lifting restrictions altogether. Five committee members favored keeping the current sales restrictions, while one voted to withdraw Avandia from the market altogether. Glaxo, which no longer plans to promote Avandia, issued a statement saying the company would work with FDA as it considers its decision. “We continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labeling,” Dr. James Shannon, Glaxo's chief medical officer, said in a statement. The British drugmaker's stock closed nearly 1.5 percent lower in London trading before the committee voted. Avandia was once the world's best-selling treatment for type 2 diabetes, with annual sales of $3.2 billion. In 2010 its use in the United States was heavily restricted and it was withdrawn from the market in Europe because of the possibility of increased risk of heart attack and stroke. Only 3,000 people in the United States take it today, down from about 120,000 just before the restrictions were put in place. Much of the advisory committee's two-day meeting focused on a Duke University reexamination of a Glaxo safety study known as Record that confirmed initial findings of no significant increased heart risk from the drug. That reassured some experts that earlier concerns with the quality of the research had been unwarranted and encouraged support for the restrictive protocols, while retaining continued guidance on potential dangers for patients and care providers. A departing train But others said the original data was incomplete and compiled through a flawed study design, while other research pointed to the possibility of significant increased risk of cardiovascular death. “When you look at the overall totality of evidence, it is not sufficient enough to either implicate or exonerate rosiglitazone versus cardiovascular risk,” said advisory panel member Dr. Sanjay Kaul of the Cedars-Sinai Heart Institute. Several committee members endorsed suggestions for a major new clinical trial to determine precisely the drug's risks in the face of a growing worldwide diabetes threat. But other experts concluded that years of negative publicity made funding major research unfeasible except for new diabetes treatments now in the pharmaceutical pipeline. “The train has left the station,” said Gerald van Belle, director of the Clinical Trials Center at the University of Washington. Experts including the advisory committee's chairman, Dr. Kenneth Burman of the Washington Hospital Center, favored the creation of a registry to monitor the health of patients who currently take the drug if major studies into safety and efficacy were not an option. Some experts view Avandia as a potential alternative to other diabetes treatments, including insulin, that could become more important as the incidence of obesity and diabetes grows, bringing with it a host of costly chronic ailments ranging from heart and kidney disease to blindness and dementia. “When treating diabetes we really do need drugs that lower blood sugar without causing hypoglycemia, and there's not a lot that's available,” Dr. Ellen Seely of Harvard Medical School. “When you're dealing with individual patients, you come up often against dead ends on what you can do. And it's important to have options,” she said. But panel members agreed the market potential for Avandia may never again be large. Glaxo has settled lawsuits filed by tens of thousands of U.S. patients who had taken Avandia and claimed Glaxo failed to inform them about safety risks. Several thousand other cases remain pending. The drugmaker last July agreed to pay $3 billion to settle what U.S. officials called the largest case of healthcare fraud in U.S. history. The agreement resolved allegations that Glaxo failed through 2007 to provide the FDA safety data on Avandia and that the company improperly marketed other drugs.source : http://www.foxnews.com/health/2013/06/07/fda-panel-votes-to-relax-avandia-restrictions/

Study: Cannabis may prevent brain damage

Marijuana continues to be a paradox as it makes its way from illicit drug to wonder medicine being used to treat a number of symptoms and disorders more safely than traditional pharmaceuticals. In the latest news, cannabis, which has been associated with long-term cognitive deficits in chronic users, is now being tested as a treatment to preserve brain function after traumatic injury. Amidst the many “it-damages-your-brain” studies, some reports have shown that cannabis has neuroprotective effects. Studies have suggested that it has protective effects in neurodegenerative diseases like multiple sclerosis, Alzheimer’s, Huntington’s and Parkinson’s diseases. The author of the new study, Dr. Yosef Sarne of Tel Aviv University's Adelson Center for the Biology of Addictive Diseases, theorized that ultra-low doses of tetrahydrocannabinol (THC), the main psychoactive component of marijuana, induces minor damage to the brain, which may actually “precondition” the brain to protect it against more severe damage from injuries such as lack of oxygen, seizures or toxic drug exposure. In other words, it may act as a sort of vaccine against more traumatic harm. In Dr. Sarne's animal study, published in the journals Behavioural Brain Research and Experimental Brain Research, researchers injected mice with a single, very low dose of THC — around 1,000 to 10,000 times less than what is found in a conventional “joint” — either several days before or after exposing the mice to a brain trauma. They found that the treated mice had enhanced biochemical processes, which protected brain cells and preserved cognitive function over time, compared to control mice that were not treated with THC. Specifically, when the mice were examined three to seven weeks after the brain injury, those in the THC group performed better in learning and memory tests. They also showed increased amounts of neuroprotective chemicals compared to the control group. In past laboratory experiments, Sarne’s group found that ultra-low doses of THC affected cell signaling, preventing cell death and promoting certain growth factors.   The researchers concluded that the use of low doses of THC can prevent long-term cognitive damage that results from brain injury in mice, but the drug needs to be tested in human trials. “Since we deal, in this case, in a basic process (THC is protective against a variety of insults, not just a specific condition), I personally believe it will go beyond rodents,” Sarne wrote in an email. Aside from treating patients with traumatic injury to the brain, Sarne suggested several ways of using THC preventively, before an injury occurs. One use could be for patients on cardiopulmonary heart-lung machines used in open heart surgery. These come with a risk of interrupting the blood supply to the brain. Sarne said that THC could be injected beforehand as a preventive measure in case the brain is deprived of oxygen. It could also be tested for use in patients such as those with epilepsy, who are at constant risk of brain injury, or those with a high risk of heart attack. Sarne is currently testing the ability of low doses of THC to prevent heart damage during a heart attack, to prevent the death of heart muscle cells that are deprived of oxygen.Laurie Tarkan is an award-winning health journalist whose work appears in the New York Times, among other national magazines and websites. She has authored several health books, including “Perfect Hormone Balance for Fertility.” Follow her on Twitter and Facebook.source : http://www.foxnews.com/health/2013/06/06/study-cannabis-may-prevent-brain-damage/

Dr. Manny: Government must stop bamboozling Americans about Plan B

I am now totally convinced that our current federal government loves confusion. When you have a single agenda, and many ways to spin it, the American public never gets a clear answer and that is exactly what has happened with the Plan B emergency contraception controversy. A U.S. appeals court ruled on Wednesday that the U.S. Food and Drug Administration (FDA) must make certain forms of the emergency contraception pill available to children of all ages, without a prescription. This is exactly what I have been warning the American public about. One has to remember that the FDA first approved this form of over-the-counter contraception for women of all ages back in 2011. When that initial FDA ruling came out, there was a loud public outcry and restrictions were quickly put in place barring women under the age of 17 from purchasing these pills. But of course, that was just one spin on the story. In April, a New York judge ruled that restricting access to Plan B was inappropriate, forcing the FDA to reconsider their initial finding that emergency contraception should be available to children of all ages. And then, we got a third spin on the story, as the FDA tried to lower the age limit for access to emergency contraception to15 in May. There was another outcry and more criticism, because we know perfectly well that a 15-year-old may not have a clear understanding of how to utilize emergency contraception. Now, we see that an appeals court is forcing the FDA to do what they wanted to do in the first place. How convenient. And the final ruling is still unclear, after the court decided on Wednesday that while the two-pill version of emergency contraception can now be sold over-the-counter to women of all ages, the one-pill version will still only be sold to women age 17 or older. The court did not explain its reasoning. While there is still a lot of confusion about the ruling, it seems as though the FDA will ultimately get its way. So, what’s the message here?

Dr. Manny Alvarez: Government must stop bamboozling Americans about Plan B

I am now totally convinced that our current federal government loves confusion. When you have a single agenda, and many ways to spin it, the American public never gets a clear answer and that is exactly what has happened with the Plan B emergency contraception controversy. A U.S. appeals court ruled on Wednesday that the U.S. Food and Drug Administration (FDA) must make certain forms of the emergency contraception pill available to children of all ages, without a prescription. This is exactly what I have been warning the American public about. One has to remember that the FDA first approved this form of over-the-counter contraception for women of all ages back in 2011. When that initial FDA ruling came out, there was a loud public outcry and restrictions were quickly put in place barring women under the age of 17 from purchasing these pills. But of course, that was just one spin on the story. In April, a New York judge ruled that restricting access to Plan B was inappropriate, forcing the FDA to reconsider their initial finding that emergency contraception should be available to children of all ages. And then, we got a third spin on the story, as the FDA tried to lower the age limit for access to emergency contraception to15 in May. There was another outcry and more criticism, because we know perfectly well that a 15-year-old may not have a clear understanding of how to utilize emergency contraception. Now, we see that an appeals court is forcing the FDA to do what they wanted to do in the first place. How convenient. And the final ruling is still unclear, after the court decided on Wednesday that while the two-pill version of emergency contraception can now be sold over-the-counter to women of all ages, the one-pill version will still only be sold to women age 17 or older. The court did not explain its reasoning. While there is still a lot of confusion about the ruling, it seems as though the FDA will ultimately get its way. So, what’s the message here? The polarizing health care agenda of this federal government is like a train without a stop and parents need to be aware of this. As I have said before, this is a medication. Yes, I know that it is safe – but it does have side effects. Side effects to Plan B can include, but are not limited to: migraines, high cholesterol, high blood pressure and blood clots. If this drug is available to young children, it might lead to problems including the misuse of the medication and the risk that children will utilize this as a regular form of contraception. Furthermore, it will exclude parents from the decision-making process. And in my opinion, parents can be very valuable in counseling children about proper behavior and doing the right thing. This is taking parents and caregivers out of the equation and inhibiting their ability to help their children live a healthy and happy life. America, we are being bamboozled. Wake up and pay attention.source : http://www.foxnews.com/health/2013/06/05/dr-manny-government-must-stop-bamboozling-americans-about-plan-b/

Merck melanoma drug shrinks tumors in 38 percent of patients

A Merck & Co drug designed to unmask tumor cells and mobilize the immune system into fighting cancer helped shrink tumors in 38 percent of patients with advanced melanoma in an early-stage study, U.S. researchers said on Sunday. Based on the findings about the drug lambrolizumab, published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology meeting in Chicago, Merck says it will move directly into a late-stage clinical trial, which will start in the third quarter. “This is a top priority at Merck,” Dr. Gary Gilliand, senior vice present and head of oncology at Merck Research Laboratories said in a meeting with investors. “We're going flat out to deliver benefit to patients with this novel mechanism.” The moves may heap pressure on market leader Bristol-Myers Squibb, maker of Yervoy - the only approved immune system drug for the treatment of advanced melanoma, the deadliest form of skin cancer. Bristol-Myers is conducting three phase-three studies of its own drug called nivolumab in advanced melanoma, and is studying the drug's effect on a range of other cancers, including lung cancer. Both nivolumab and lambrolizumab are part of a promising new class of drugs that disable programmed death 1 or PD-1, a protein that keeps the immune system from spotting and attacking cancer cells. “Even though it's (lambrolizumab) the second player in the field and even though it's all early, it impressed me,” said Dr. Antoni Ribas of the University of California Los Angeles' Jonsson Comprehensive Cancer Center, the lead author of the study. Last month, the U.S. Food and Drug Administration deemed the treatment a “breakthrough therapy,” a designation FDA cancer drugs chief Dr. Richard Pazdur described as “knock-your-socks-off therapies.” Results of an early-stage study of nivolumab in advanced melanoma released at the cancer meeting showed 31 percent of patients overall responded to different doses of the drug. Among those who took the 3 milligram per kilogram dose, 41 percent of patients responded. The drug response lasted an average of two years, and in many patients the drug kept working even after they stopped taking it. Analysts expect the drugs to generate billions of dollars in sales. Nivolumab alone is forecast to have sales of $1.2 billion in 2017, according to Wall Street analysts tracked by Thomson Reuters Pharma. Merck's study Merck's results are from the first clinical trial of lambrolizumab in advanced melanoma. They are based on analysis of 135 patients with metastatic melanoma who were divided into three groups with different treatment regimens. Overall, lambrolizumab resulted in 38 percent of patients having confirmed improvement of their cancer across all dose levels given after 12 weeks of treatment. But there was a wide range among doses, with only a 25 percent rate among patients who got the lowest dose and 52 percent among those who got the highest dose. In the highest dose group, 10 percent had a complete response, meaning their tumors could not be detected on scans. Side effects were generally mild and included fatigue, fevers, skin rash, loss of skin color and muscle weakness. More severe side effects were seen in 13 percent of patients, including inflammation of the lung or kidney and thyroid problems. “This study is showing the highest rate of durable melanoma responses of any drug we have tested thus far in this cancer, and it is doing it without serious side effects in the great majority of patients,” Ribas said. Merck said it plans to start a late-stage randomized trial of the drug in melanoma and in non-small cell lung cancer in the third quarter of this year. The company recently started a global, randomized mid-stage study of the drug versus standard chemotherapy in patients whose disease had progressed. And it is studying the drug as a treatment for triple negative breast, metastatic bladder and head and neck cancers. Researchers at the meeting marveled at responses to new immune system treatments after decades of failed studies among patients with melanoma. Only about one in five patients respond to Yervoy, approved in 2011 as the first immunotherapy to extend survival in patients with advanced melanoma. Yervoy works by blocking CTLA-4, a different molecule that also keeps the immune system from attacking cancer. Ribas said he has followed one patient on Yervoy for 12 years now. “She's not supposed to be around, and she's alive and well and melanoma free. That is why we've been doing these immunotherapies,” he said. With Yervoy, Ribas said these types of responses were few and far between. With the new PD-1 drugs, they are much more common, with fewer side effects. However, an early-stage Bristol-Myers' study released this month showed that 53 percent of patients who got a combination of Yervoy and nivolumab had at least a 50 percent reduction in tumor size, with fewer side effects. Tim Turnham, executive director of the Melanoma Research Foundation, said combination treatments would make a major difference for patients because they help overcome cancer's “sneaky” ability to evade treatment. But, at this point, he said, “Nobody knows which one is better.”source : http://www.foxnews.com/health/2013/06/03/merck-melanoma-drug-shrinks-tumors-in-38-percent-patients/

Dispute flares within FDA over safety of popular blood pressure drugs

The top-selling class of blood-pressure drugs is under attack from an unusual source: a senior regulator at the Food and Drug Administration. Bucking his bosses, Thomas A. Marciniak is seeking stronger warnings about the drugs known as angiotensin receptor blockers, or ARBs, according to internal documents reviewed by The Wall Street Journal. The drugs, which are taken by millions of people and generated $7.6 billion in U.S. sales in 2012, may be linked to higher cancer rates, Dr. Marciniak argues, a view shared by some outside doctors. Top FDA officials say evidence doesn't support a link. The debate over ARBs highlights the question of whether the U.S. drug-safety agency devotes enough effort to examining the safety of long-marketed blockbusters as it focuses on new drugs. In a rare rebellion by an FDA reviewer, Dr. Marciniak has clashed with his bosses over his desire to spend time on ARB safety, instead of just on new-drug applications. Ellis Unger, chief of the drug-evaluation division that includes Dr. Marciniak, called the complaints a “diversion,” and said in an interview, “We have no reason to tell the public anything new.” ARBs on the market in the U.S. include Novartis AG's Diovan, Daiichi Sankyo Co.'s Benicar, Merck & Co.'s Cozaar, Boehringer Ingelheim GmbH's Micardis; Avapro, from Sanofi SA and Bristol-Myers Squibb Co.; and AstraZeneca PLC's Atacand. Patients take these medicines daily to avoid heart attack, stroke and heart failure. In a 2010 study published in Lancet Oncology, Ilke Sipahi and colleagues at University Hospitals in Cleveland looked at five studies involving 68,402 patients and found that people taking ARBs had an 11 percent greater risk of new cancer overall and a 25 percent greater risk of new lung cancer, compared with patients who didn't get the drugs. But within a year, the FDA gave the all-clear signal, saying its own analysis found “no increase in risk” from taking ARBs. Europe's drug regulator also dismissed the cancer concerns. Dr. Marciniak wasn't persuaded. In its analysis, the FDA combined different studies to look at more patients, multiplying its statistical power to find possible side effects from the drugs, a technique called meta-analysis. If the original studies have flaws, however, meta-analyses can simply compound the problem, researchers say. That is what happened to the FDA, says Dr. Marciniak, who warned others in the agency that taking results tabulated by companies was likely to produce unreliable results: “Garbage in, garbage out,” he wrote. Among other things, Dr. Marciniak said in an internal analysis viewed by the Journal that the FDA meta-analysis didn't count cases of “lung carcinomas” as lung cancers, which they are. Click for more from The Wall Street Journal.source : http://www.foxnews.com/health/2013/05/31/dispute-flares-within-fda-over-safety-popular-blood-pressure-drugs/

Medical marijuana for your pet?

More people are using medical marijuana to treat pets for a variety of conditions, ranging from separation anxiety and noise phobia to cancer, according to the Journal of the American Veterinary Medical Association (JAVMA) News. Now, as more states begin to legalize the drug for humans, veterinarians and pet owners are calling for more research into the use and safety of the drug in pets. After using medical marijuana to treat his own chronic back pain, Enest Misko, a 77-year-old from Chatsworth, Calif., decided to use a form of the drug to treat his pet cat, Borzo, who was having difficulty walking. Misko gave the cat a glycerin tincture of marijuana made for pets, and within a few days of taking the drug, Misko said the cat appeared to be pain-free. The drug can be found in licensed medical marijuana dispensaries in Los Angeles. “I don’t get high from (marijuana), but the pain goes away. So I tried it on my cat, my 24-year-old cat, who’s feeling better,” Misko told the JAVMA News. Within the past few years, veterinarians have noticed an uptick in people claiming to use medical marijuana treatments for their pets and some have even begun to experiment with it on their own pets.  Dr. Douglas Kramer, a veterinarian in Los Angeles, Calif., who runs a mobile office focused on pain management and palliative care for pets, noted that approximately 300 people have told him they’ve treated their pets with medical marijuana since 2011. Kramer became intrigued by the drug’s potential when his Siberian husky, Nikita, was diagnosed with terminal cancer. “Nikita was wasting away, and she’d stopped eating,” he told JAVMA News. “I’d exhausted every available pharmaceutical pain option, even steroids. At that point, it was a quality of life issue, and I felt like I’d try anything to ease her suffering.” After Kramer began feeding Nikita small amounts of marijuana, the dog’s appetite returned, and she rested more comfortably during her final months. Based on his own reviews of medical marijuana research, Kramer believes the drug may be suitable for use in veterinary patients and that it deserves more attention from the veterinary research community. “I don’t want to come across as being overly in favor of giving marijuana to pets,” Kramer told JAVMA News. “My position is the same as the (American Medical Association’s position). We need to investigate marijuana further to determine whether the case reports I’m hearing are true or whether there’s a placebo effect at work. We also need to know what the risks are.” Other veterinarians note that medical marijuana has the potential to be used in pet treatments but agree that more research needs to be done. Dr. Dawn Boothe, director of the Clinical Pharmacology Laboratory at Auburn University’s College of Veterinary Medicine, said it wouldn’t surprise her to see FDA-approved drugs made from cannabinoid derivatives being used in pets one day. “My gut reaction is they do probably provide some therapeutic effect benefit,” said Boothe. “But, I’m never going to say there’s enough benefit that marijuana should be given to pets. I’m saying there’s enough justification that we need to study it.” Click for more from the JAVMA News.source : http://www.foxnews.com/health/2013/05/31/medical-marijuana-for-your-pet/

Allergy meds can pose driving hazard, FDA says

Allergy medications may help you get through the spring and summer months, but it's important to know that the drugs could affect your ability to drive, the Food and Drug Administration is reminding consumers. These medications, which contain antihistamines, can sometimes cause drowsiness and slower reaction times, the FDA said. Consumers should read the drug facts label on their medication to see whether drowsiness is a side effect. If an allergy medication causes drowsiness, people need to be cautious about deciding to drive or operate machinery, the FDA says. People should avoid using alcohol, sedatives (sleep medications) and tranquilizers when taking allergy medication because these substances may increase drowsiness. [See Will Allergies Be Worse in 2013?] Those who switch to a new antihistamine drug should not assume they can take the same dose as they did with the older drug, the FDA says. Different allergy medications may be dosed differently, and people may need to alter the dose they take. People should not take more than the recommended dose. If the correct dosage isnt providing you the relief you expect, dont simply keep taking more and more of that product, FDA pharmacist Ayana Rowley said in a statement. Instead, people should consult a health care professional, Rowley said. Allergy sufferers should be aware that some allergy medications take longer to work than others. In addition, the drowsiness you feel after taking the medication may last some time, including into the next day, the FDA said. Copyright 2013 LiveScience, a TechMediaNetwork company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.source : http://www.foxnews.com/health/2013/05/29/allergy-meds-can-pose-driving-hazard-fda-says/