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	<title>CPhTLink.com &#187; Drugs</title>
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		<title>One Pill Might Prevent Heart Disease</title>
		<link>http://cphtlink.com/2009/04/02/one-pill-might-prevent-heart-disease/</link>
		<comments>http://cphtlink.com/2009/04/02/one-pill-might-prevent-heart-disease/#comments</comments>
		<pubDate>Thu, 02 Apr 2009 12:27:12 +0000</pubDate>
		<dc:creator>Fred</dc:creator>
				<category><![CDATA[Featured]]></category>
		<category><![CDATA[Drugs]]></category>
		<category><![CDATA[heart disease]]></category>
		<category><![CDATA[Pharmacy]]></category>

		<guid isPermaLink="false">http://cphtlink.com/?p=1436</guid>
		<description><![CDATA[(Health Day) Create a single pill that contains a statin, three blood pressure drugs and aspirin, and you have an inexpensive medication that can reduce the risk of heart attack, stroke and other cardiovascular problems.
Or so researchers hope.
A first trial of the polypill (which already has a brand name, Polycap), has been successful, according to [...]]]></description>
			<content:encoded><![CDATA[<p>(Health Day) Create a single pill that contains a statin, three blood pressure drugs and aspirin, and you have an inexpensive medication that can reduce the risk of heart attack, stroke and other cardiovascular problems.</p>
<p>Or so researchers hope.<span id="more-1436"></span></p>
<p>A first trial of the polypill (which already has a brand name, Polycap), has been successful, according to a report that was to be presented Monday at the American College of Cardiology annual meeting in Orlando, Fla., and online in The Lancet.<!--more--></p>
<p>The polypill contains generic versions of the blood pressure medications atenolol, hydrochlorothiazide and rampiril, as well as simvastatin (Zocor) and aspirin. It is designed to attack three major risk factors of cardiovascular disease &#8212; high blood pressure, high blood cholesterol and formation of artery-blocking blood clots. It is being tested by an Indian company, Cadila Pharma.</p>
<p>The idea was originated by a group of physicians trained in India and now at McMaster University in Canada, said Dr. Koon Teo, a professor of medicine at McMaster and a member of the research team.</p>
<p>&#8220;We know that there are many medications that are beneficial,&#8221; Teo said. &#8220;But often people don&#8217;t like to take many pills, and doctors don&#8217;t give patients all the pills they might need.&#8221;</p>
<p>The first trial enrolled 2,053 people with one risk factor, such as high blood pressure, but no cardiovascular disease. They were divided into nine groups, one taking the polypill, the others various combinations of the medications.</p>
<p>The study, done at 50 centers in India, was designed to answer several questions:</p>
<p>Would the five-drug polypill deliver the same effect as individual pills? What reduction in blood pressure and cholesterol could it achieve? Would there be harmful interactions between the ingredients? Would aspirin reduce the blood-pressure-lowering effect?</p>
<p>The answers were favorable. The polypill reduced systolic blood pressure (the higher of the 120/80 reading) by 7.4 points and diastolic blood pressure by 5.6 points, better than the reduction produced by individual medications. LDL cholesterol reductions were almost as great as those produced by individual doses of simvastatin, the statin in the polypill. Readings showed a reduction in urinary levels of a clot-associated molecule. There was no indication of harmful interactions for those taking the polypill.</p>
<p>The blood pressure reduction caused by the polypill would lower the risk of heart disease by 24 percent and lower stroke risk by 33 percent, the researchers estimated. The cholesterol-lowering effect would reduce heart disease risk by 27 percent and stroke risk by 8 percent, they estimated.</p>
<p>And putting those benefits into one pill would increase the possibility that healthy people would actually take the medications needed to keep them healthy, they said.</p>
<p>&#8220;I think this is a good idea, in that even though all these drugs are available in separate pills, people don&#8217;t take them for lots of reasons &#8212; logistics, costs, availability,&#8221; said Dr. Christopher P. Cannon, an associate professor of medicine at Harvard Medical School, who wrote an accompanying commentary in The Lancet. &#8220;If one had a simple, inexpensive pill, it could open cardiovascular protection to many people.&#8221;</p>
<p>Millions of Americans who are at risk of cardiovascular disease because of common conditions, such as obesity and high blood pressure, are potential beneficiaries of a polypill, Cannon said. &#8220;They should be taking cardiovascular medications, but don&#8217;t, because they are otherwise healthy,&#8221; he said. &#8220;If there were one, simple pill, they might be open to taking it.&#8221;</p>
<p>More studies obviously are needed, Cannon said, and physician care would be necessary if the pill became available. &#8220;You can&#8217;t just give it and walk away,&#8221; he said. &#8220;You would have to monitor for side effects, but once you get past that hurdle, one simple pill would help.&#8221;</p>
<p>Some major regulatory changes by the U.S. Food and Drug Administration would be necessary for the polypill to be available in the United States, Cannon added. &#8220;The current mandates of the FDA are that a combination pill would have to be tested for every combination of every drug included in that pill. That obviously would not be feasible in this case. It would require a re-looking at the rules by the FDA, and for that, one needs larger and longer studies.&#8221;</p>
<p>Even with those hurdles to overcome, a polypill would be &#8220;a major step forward in trying to simplify and broaden the applicability of all the medications that reduce cardiovascular risk,&#8221; Cannon said.</p>
<p>The next step would be a major trial of the polypill among people with clear risk of cardiovascular disease, Teo said. If such a trial succeeded, the hope is that a drug company would pick up the idea, he said.</p>
<p>&#8220;The concept is important, and we are testing the concept,&#8221; Teo said. &#8220;Once the concept is proved, we hope that a company in Europe or the United States could see that something can be done with it.&#8221;</p>
]]></content:encoded>
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		<title>Study: &#8216;Smart drug&#8217; Provigil may be habit-forming</title>
		<link>http://cphtlink.com/2009/03/17/study-smart-drug-provigil-may-be-habit-forming/</link>
		<comments>http://cphtlink.com/2009/03/17/study-smart-drug-provigil-may-be-habit-forming/#comments</comments>
		<pubDate>Tue, 17 Mar 2009 21:59:07 +0000</pubDate>
		<dc:creator>Fred</dc:creator>
				<category><![CDATA[Drugs]]></category>
		<category><![CDATA[addiction]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[provigil]]></category>

		<guid isPermaLink="false">ap/20090317/med_brain_pills</guid>
		<description><![CDATA[<p><a href="http://us.rd.yahoo.com/dailynews/rss/meds/*http://news.yahoo.com/s/ap/20090317/ap_on_he_me/med_brain_pills"><img src="http://d.yimg.com/img.news.yahoo.com/util/anysize/130,http%3A%2F%2Fd.yimg.com%2Fa%2Fp%2Fap%2F20090317%2Fcapt.8f17f3b0729943bbae84ee5577536dd8.med_brain_pills_cx102.jpg?v=2" align="left" height="130" width="99" alt="An undated photo provided by Frazer, Pa.-based Cephalon, Inc., shows bottles of its presription drug Provigil. A small government study shows that the popular brain-boosting drug may carry a risk of addiction like other popular stimulants. Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the company's flagship product. (AP Photo/Cephalon Inc.)" border="0" /></a>AP - A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students.</p><br />]]></description>
			<content:encoded><![CDATA[<p><img class="alignleft" src="http://d.yimg.com/img.news.yahoo.com/util/anysize/130,http%3A%2F%2Fd.yimg.com%2Fa%2Fp%2Fap%2F20090317%2Fcapt.8f17f3b0729943bbae84ee5577536dd8.med_brain_pills_cx102.jpg?v=2" border="1" alt="An undated photo provided by Frazer, Pa.-based Cephalon, Inc., shows bottles of its presription drug Provigil." />AP - A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students.
</p><p>
"It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side effects."
</p><p>
The study, appearing in Wednesday's Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said.
</p><p>
Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pa., and its sales approached $1 billion last year. The company is developing a spin-off called Nuvigil.
</p><p>
Modafinil's reputation as a brain enhancer stems from an Air Force study that found it improved the performance of sleep-deprived fighter pilots. College students buy and sell it illegally, as they do Ritalin and Adderall, to stay alert while studying.
</p><p>
Several scientists recently wrote in the journal Nature that healthy people should have the right to boost their brains with pills like Provigil. One author of that commentary, brain scientist Martha Farah of the University of Pennsylvania, said the new study "goes to show that we need a little caution and a little humility when we're messing around with our brain chemistry."
</p><p>
"But even now, after all the years that it has been on the market, we are still learning things about it that are relevant to its safety," Farah said.
</p><p>
The men in the study were 23 to 46 years old. They received either a dummy pill or modafinil. Effects were measured by PET scans, which showed that the drug increased dopamine, the brain's "feel-good" neurotransmitters.
</p><p>
Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction. Studies in mice and monkeys suggested otherwise.
</p><p>
The new study is the first human evidence that a typical dose of modafinil affects dopamine in the brain as much as a dose of Ritalin, a controlled substance with clear potential for dependence.
</p><p>
Volkow said modafinil acts slowly when swallowed and is difficult to inject, making it less likely to be abused. Its high price, about $10 per pill compared to Ritalin at $2 per pill, also makes it less attractive to people seeking a high. That may change when generics become available in 2012, Volkow said.
</p><p>
Jeffry Vaught, chief science officer for Cephalon, said the company has seen no evidence the drug is highly abused.</p><p>

"If abuse is a problem with modafinil, it's minimal at best," Vaught said. "We're not seeing it used at rave scenes."</p><p>

Prescribing information for the drug warns of severe rashes and other side effects such as headache, nausea and anxiety. Cephalon doesn't support the drug's use as a cognitive enhancer.
</p><p>
"There's no substitute for sleep," Vaught said.</p> ]]></content:encoded>
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		<title>Skin Patches Can Cause Burns During MRIs (HealthDay)</title>
		<link>http://cphtlink.com/2009/03/06/skin-patches-can-cause-burns-during-mris-healthday/</link>
		<comments>http://cphtlink.com/2009/03/06/skin-patches-can-cause-burns-during-mris-healthday/#comments</comments>
		<pubDate>Fri, 06 Mar 2009 04:47:34 +0000</pubDate>
		<dc:creator>Fred</dc:creator>
				<category><![CDATA[Drugs]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[medwatch]]></category>

		<guid isPermaLink="false">hsn/20090306/skinpatchescancauseburnsduringmris</guid>
		<description><![CDATA[HealthDay - THURSDAY, March 5 (HealthDay News) -- The U.S. Food and Drug 
Administration warned Thursday that some medication skin patches can cause 
burns if worn while patients undergo an MRI.]]></description>
			<content:encoded><![CDATA[HealthDay - The U.S. Food and Drug Administration warned Thursday that some medication skin patches can cause burns if worn while patients undergo an MRI.

Thursday's warning applies to brand name and generic patches and those bought over-the-counter -- including nicotine and pain-control patches. <span id="more-1129"></span>

Some of these patches do not include a warning that their backing contains aluminum. Although aluminum is not attracted to an MRI's magnetic field, it can conduct electricity, causing heat that can result in burns, the FDA said.

"Adhesive patches are commonly used to slowly deliver a variety of medications -- there are some to treat pain, some deliver hormonal medications, or nicotine," Dr. Sandra Kweder, deputy director of the Office of New Drugs at FDA's Center for Drug Evaluation and Research, said during a teleconference on Thursday.

"Some, but not all, of these patches contain a little bit of aluminum or other metal -- just enough that they can overheat during an MRI," Kweder said. "The FDA recently learned that there is no standard warning on the patch itself."

There are a total of 60 medication patches on the market, and about 25 percent contain metal, Kweder said.

This is not a major public health problem, Kweder said. "To date, the FDA has only a few reports of patients experiencing skin burns from these patches. It's mostly characterized as a bad sunburn," she said, adding that there have been less than six reports, most involving nicotine patches.

In January, the agency was alerted that the warning was not on Teva Pharmaceuticals' fentanyl transdermal system, which is used by cancer patients to control pain. When the FDA investigated, officials found that warnings were also missing on a variety of skin, or transdermal, patches delivering medications, Kweder said.

The FDA is now reviewing the labeling and makeup of all medicated patches to ensure that they carry a proper warning, if needed. The agency plans to institute standard labeling of medication patches, Kweder said.

"We are making sure at this point in time that we have a comprehensive approach to have consistent labeling across all the products that are affected," Eric Duffy, director of the Division of Postmarket Evaluation in FDA's Office of New Drug Quality Assessment, said during the teleconference.

Until the review is complete, the FDA recommends that people wearing medicated skin patches talk with their doctor about wearing a patch during an MRI. The doctor should tell you to remove the patch before the MRI and put it back on after the procedure.

MRI scanners are machines that use a large magnet and radio waves to look at organs and structures inside the body, to diagnose a variety of conditions, from torn ligaments to tumors, according to the U.S. National Library of Medicine.]]></content:encoded>
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