Asthma Inhalers Are No Longer Using Ozone Destroying CFCs
The down side: The new inhalers cost more, $30 to $60 compared to as little as $5 or $10 for the disappearing generic CFC inhalers.
And patients face a learning curve. HFA inhalers must be used differently than the old-fashioned kind. The medicine feels and tastes different, sometimes alarming new users despite doctors assurances that it works just as well.
“Theres still significant confusion,” says Dr. Harvey Leo of the University of Michigans C.S. Mott Childrens Hospital. “Patients will tell you, I dont feel the puff anymore.”
Calls from parents unsure how to use the new inhalers, or even what they are, have increased in the past two months as more drugstores run out of CFC-powered inhalers and automatically switch people whod been expecting a mere refill, he adds.
The change shouldnt be a surprise. The Food and Drug Administration has long warned it was coming, and lung specialists have spent the past year easing many of the nations 20 million asthma patients – as well as millions of emphysema sufferers who also use albuterol to ease breathing – into it.
But industry figures show that in mid-November, 20 percent of all albuterol prescriptions still were being filled with CFC versions.
Some patients may purposefully be buying up cheaper CFC inhalers before the sales ban. But many patients dont see a lung specialist, or their prescription may not expire until next year so they havent been seen recently enough to be told.
Reaching the last fraction “is, as you can imagine, a very difficult task,” says Dr. Bidrul Chowdhury, FDAs pulmonary drugs chief. “How to get to somebody who is not tuned in?”
The CFC-free options: GlaxoSmithKlines Ventolin HFA, Schering Ploughs Proventil HFA and Teva Specialty Pharmaceuticals ProAir HFA all contain albuterol. Also, Sepracors Xopenex HFA contains the similar medication levalbuterol.
Albuterol inhalers are for emergencies, for quick relief of wheezing. Patients also need daily medication to control their asthma and prevent flare-ups. Someone whos using the albuterol inhaler more than a few times a month isnt well-controlled, and his or her doctor needs to determine why, stresses Dr. Paul Greenberger of Northwestern University, president-elect of the American Academy of Allergy, Asthma & Immunology.
Heres the rub: Recent research suggests only one in five children has their asthma under good control; no one knows how many adults do.
Albuterol manufacturers are providing free samples and posting coupons on their Web sites.
Still, specialists worry that some patients will try to save money with a decades-old nonprescription inhaler that contains a different drug, epinephrine, best known by the brand name Primatene Mist – inhalers that also contain ozone-harming CFCs. National asthma guidelines argue against such self-treatment as too risky and less effective than albuterol. The government will allow sale of those over-the-counter inhalers until December 2011 as manufacturers reformulate.
Leo has another concern: Only one of the new inhalers counts doses used. Hes monitoring emergency-room statistics to see if cost-conscious patients trying to squeeze out last drops wind up using empty inhalers.
What do patients need to know as they switch?
-Expect a softer puff instead of the CFC versions cold blast of air in the back of the throat.
Source: sccha
Gout Drug Uloric Manufactured By Takeda
In healthy people, uric acid is dissolved in the blood and excreted from the body in urine. But high levels lead to the formation of needle-like crystals that become deposited in the joints, causing intense pain and swelling. Many patients experience their first attack of gout in the big toe. The disease can progress, causing deformities.
Food and Drug Administration medical reviewers were concerned because early trials of Uloric found a higher risk of death and heart problems from the drug. But Takeda Inc., which makes Uloric, commissioned a much larger clinical study that found no difference in heart risks when compared with the currently available drug, allopurinol.
Takeda said its medication works better for patients with kidney problems. “A lot of gout patients suffer from kidney disease,” said Dr. Nancy Joseph-Ridge, head of research and development for the company. “This is something of real need. Patients who could not take the other drug will now have treatment.”
The FDA arthritis advisory committee voted 12-0 to recommend approval of Uloric for chronic gout. One member abstained. The FDA usually follows the recommendations of its advisers.
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On the Net:
Food and Drug Administration: http://www.fda.gov
Source: ctnhr
Exercise No Magic Cure For Heart Failure Patients, So Few Stuck With The Program Making It Difficult To Show A Positive Result
Although there were some encouraging trends and clear benefits for certain people, exercise failed to deliver on the main goal – keeping people out of the hospital and improving their survival rates.
“Its a shame,” said Dr. Harlan Krumholz, a quality-of-care researcher at Yale University who had no role in the study. “Exercise is not that magic elixir that we had hoped,” at least for these patients.
About 5 million Americans have heart failure. It kills more than 300,000 of them and accounts for a million hospitalizations each year. Those numbers are expected to grow as the nations population gets older.
The condition occurs when the heart muscle weakens over time and can no longer pump effectively. Fluid can back up into the lungs, leaving people gurgling and gasping for breath as they struggle to climb stairs or walk around the block.
Exercise has long been known to help prevent the clogged arteries that develop in heart disease and to help heart attack patients recover. But smaller, previous studies have made conflicting findings about whether it helps heart failure patients or even is safe for them.
Doctors had hoped that exercise would prove as effective as drugs for these patients, sparing them the cost and potential side effects.
The study involved 2,231 people with moderate heart failure in the United States, Canada and Europe. It was led by Dr. Christopher OConnor at Duke University.
All of the patients were getting optimal medical care, with more than 90 percent on an ideal mix of medicines. Those who needed them also had implanted heart devices to maintain good rhythm.
They were randomly placed in two groups – one given usual care and the other usual care plus an exercise training program. Exercisers were given 36 supervised training sessions lasting half an hour three times a week. After 18 such sessions, they were given a treadmill or an exercise bike to use at home, for five 40-minute sessions each week.
Three months into the study, only half were exercising at least three times a week for 40 minutes. After one year, only one-fourth were exercising five times a week.
The fact so few stuck with the exercise program made it difficult to show a positive result, OConnor said.
However, after doctors adjusted for factors like how long people were able to tolerate exercise, how badly damaged their hearts were and rates of depression, they did find a modest but significant benefit for exercise.
“Its disappointing,” said Dr. Robert Eckel, a former heart association president and an exercise specialist at the University of Colorado at Denver. “You cannot make strong conclusions about subgroups.”
Insurers now do not pay for exercise training for people with heart failure, and “this study is not going to help” convince them to start, Eckel said.
“We all would have liked to see a huge benefit to exercise,” said Dr. Lawton Cooper, medical officer at the National Heart, Lung and Blood Institute, which paid for the study.
Still, for most people, “it is worth your while,” Cooper said. “We know there are all kinds of benefits of exercise.”
Source: sccha
United States Infant Formula Found To Contain Melamine By FDA
Melamine is the chemical found in Chinese infant formula – in far larger concentrations – that has been blamed for killing at least three babies and making at least 50,000 others ill.
Previously undisclosed tests, obtained by The Associated Press under the Freedom of Information Act, show that the FDA has detected melamine in a sample of one popular formula and the presence of cyanuric acid, a chemical relative of melamine, in the formula of a second manufacturer.
Separately, a third major formula maker told AP that in-house tests had detected trace levels of melamine in its infant formula.
The three firms – Abbott Laboratories, Nestle and Mead Johnson – manufacture more than 90 percent of all infant formula produced in the United States.
The FDA and other experts said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally.
The U.S. government quietly began testing domestically produced infant formula in September, soon after problems with melamine-spiked formula surfaced in China.
Sundlof said there have been no reports of human illness in the United States from melamine, which can bind with other chemicals in urine, potentially causing damaging stones in the kidney or bladder and, in extreme cases, kidney failure.
Melamine is used in some U.S. plastic food packaging and can rub off onto what we eat; its also contained in a cleaning solution used on some food processing equipment and can leach into the products being prepared.
Sundlof told the AP the positive test results “so far are in the trace range, and from a public health or infant health perspective, we consider those to be perfectly fine.”
Thats different from the impression of zero tolerance the agency left on Oct. 3, when it stated: “FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns.”
FDA scientists said then that they couldnt set an acceptable level of melamine exposure in infant formula because science hadnt had enough time to understand the chemicals effects on infants underdeveloped kidneys. Plus, there is the complicating factor that infant formula often constitutes a newborns entire diet.
Still, the announcement was widely interpreted by manufacturers, the news media and Congress to mean that infant formula that tested positive at any level could not be sold in the United States.
The Grocery Manufacturers Association, for example, told its members: “FDA could not identify a safe level for melamine and related compounds in infant formula; thus it can be concluded they will not accept any detectable melamine in infant formula.”
It was not until the AP inquired about tests on domestic formula that the FDA articulated that while it couldnt set a safe exposure for infants, it would accept some melamine in formula – raising the question of whether the decision to accept very low concentrations was made only after traces were detected.
On Sunday, Sundlof said the agency had never said, nor implied, that domestic infant formula was going to be entirely free of melamine. He said he didnt know if the agencys statements on infant formula had been misinterpreted.
In China, melamine was intentionally dumped into watered-down milk to trick food quality tests into showing higher protein levels than actually existed. Byproducts of the milk ended up in infant formula, coffee creamers, even biscuits.
Source: midtn
Lead Ammunition Poisoning Deer Hunters
People font of killing animals and eating their meat might find a sour taste, as the lead shot can be poison if ingested. Officials in North Dakota and other states have warned about eating venison killed with lead ammunition since the spring, when a physician conducting tests using a CT scanner found lead in samples of donated deer meat.
The findings led North Dakotas health department to order food pantries to throw out donated venison. Some groups that organize venison donations have called such actions premature and unsupported by science.
The North Dakota Community Action Partnership distributed 17,000 pounds of venison from 381 donated deer after last years hunting season, a number that has tripled since the program began in North Dakota in 2004, Pollert said. At least 4,000 pounds of venison were in food pantries in the state when the health department issued its warning, she said.
Pollert said her group had been waiting on findings from the federal Centers for Disease Control and Prevention, which has been studying potential health risks for people who eat venison killed with high-velocity ammunition.
The results of the federal study were expected last month but have been delayed. North Dakotas deer season opens Friday.
“We had to make a decision,” Pollert said.
A draft report has been completed but it has not been released, said Dr. Stephen Pickard, a CDC epidemiologist who works with the state Health Department in Bismarck.
“It has to go through clearance and cross-clearance,” he said. “The wheels of government are just grinding.”
North Dakota health officials and the CDC collected blood samples in May from 738 people as young as 2, Pickard said. Most were collected from adults who had eaten venison killed with high-velocity ammo, though some samples were taken from people who had eaten pheasants and waterfowl shot with either lead or non-lead pellets, he said.
A study by Minnesotas Department of Natural Resources that fragments from lead bullets spread as far as 18 inches away from the wound. That states health department has advised that children under 6 and pregnant women avoid eating venison.
Those groups are most at risk from lead poisoning, which can cause confusion, learning problems and convulsions, and in severe cases can lead to brain damage and death.
Steinwand said he suspects some hunters will switch to non-lead bullets but most will opt for traditional ammo. His department has made no recommendations to hunters on the type of ammunition that should be used, he said.
“Hunters should take good care of the kill and make well-placed shots to minimize the risk of lead contamination,” Steinwand said.
Source: vanov
Brain Stimulation Pacemaker For OCD Treatment Causes Side Effects
The treatment involved an experimental brain pacemaker, and it reduced repetitive thoughts and behaviors in some of the patients – just as it blocks tremors for some Parkinsons sufferers.
The researchers came up with the approach after noticing that two Parkinsons patients who got the treatment also saw an improvement to their obsessive-compulsive disorders. Other small studies have targeted a different part of the brain for that disorder and depression.
In the French study, symptoms were reduced more than 25 percent, the researchers said.
The results are “very encouraging,” said the studys lead author, Dr. Luc Mallet of Pitie-Salpetriere Hospital in Paris. In an e-mail, he said the procedure should be used only in medical studies at the moment because of the possible side effects.
The findings are reported in Thursdays New England Journal of Medicine.
About 2.2 million American adults have obsessive-compulsive disorder. It involves recurring, unwanted thoughts, such as a fear of germs, and people who have it engage in rituals such as repeatedly washing their hands or checking on something again and again.
Standard treatment, antidepressants and psychotherapy, doesnt work in everyone. The patients in the French study were severe cases who didnt respond well to treatment.
All had surgery to have the pacemaker – similar to a heart pacemaker – implanted in their chest and connected to electrodes inserted into their brains. Each patient had the pacemaker turned on for three months and turned off for three months. Neither the patients nor their doctors knew when the device was on or off.
The researchers used different tests to measure changes in symptoms. In one evaluation, after three months of stimulation, the severity of symptoms overall had dipped to 19 on a 40-point scale, compared to a score of 28 after three months of no treatment.
Eleven patients had serious side effects; one had bleeding in the brain and two had infections from the surgery. For some patients, the stimulation resulted in a mild form of mania and other problems that went away when adjustments were made.
Mallet said the area of the brain they targeted – the subthalamic nucleus – deals with motion, thinking and emotion. Previous studies for obsessive-compulsive disorder, or OCD, focused on regions involving mood and anxiety, he said.
Goodman said he was initially alarmed by the serious side effects but noted that many were temporary and others were not unexpected. He said the challenge will be deciding whether the risks are worth it for individual patients.
Another French researcher, Dr. Antoine Pelissolo, said the patients in the study, who now all have their pacemakers turned on, are still being followed. Researchers are also testing stimulating two areas of the brain at the same time, he said.
The pacemakers used in the study were bought from Medtronic Inc., which had no role but paid for the researchers meetings. Some of the scientists have received consulting fees and grants from Medtronic.
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On the Net:
Source: mabed
Cholesterol Medicine May Save Lives A Study Claims
Some medications that address high cholesterol were the subject of a study. “This takes prevention to a whole new level, because it applies to patients who we now wouldnt have any evidence to treat,” said Dr. W. Douglas Weaver, a Detroit cardiologist and president of the American College of Cardiology.
The study also gives the best evidence yet for using a new test to identify people who may need treatment, according to a statement from Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute. The new research will be considered by experts reviewing current guidelines.
However, some doctors urged caution. Crestor gave clear benefit in the study, but so few heart attacks and deaths occurred among these low-risk people that treating everyone like them in the United States could cost up to $9 billion a year – “a difficult sell,” one expert said.
About 120 people would have to take Crestor for two years to prevent a single heart attack, stroke or death, said Stanford University cardiologist Dr. Mark Hlatky. He wrote an editorial accompanying the study published online by the New England Journal of Medicine.
“Everybody likes the idea of prevention. We need to slow down and ask how many people are we going to be treating with drugs for the rest of their lives to prevent heart disease, versus a lot of other things were not doing” to improve health, Hlatky said.
Statins are the worlds top-selling drugs. Until this study, all but Crestor have already been shown to cut the risk of heart attacks and death in people with high LDL, or bad cholesterol.
But half of all heart attacks occur in people with normal or low cholesterol, so doctors have been testing other ways to predict who is at risk.
One is high-sensitivity C-reactive protein, or CRP for short. It is a measure of inflammation, which can mean clogged arteries as well as less serious problems, such as an infection or injury. Doctors check CRP with a blood test that costs about $80 to have done.
A co-inventor on a patent of the test, Dr. Paul Ridker of Harvard-affiliated Brigham and Womens Hospital in Boston, led the new study. It involved 17,802 people with high CRP and low LDL cholesterol (below 130) in the U.S. and 25 other countries.
One-fourth were black or Hispanic, and 40 percent were women – important because previous statin studies have included few women. Men had to be 50 or older; women, 60 or older. None had a history of heart problems or diabetes.
They were randomly assigned to take dummy pills or Crestor, the strongest statin on the market, made by British-based AstraZeneca PLC. Neither participants nor their doctors knew who was taking what.
Full results were announced Sunday. Crestor reduced a combined measure – heart attacks, strokes, heart-related deaths or hospitalizations, or the need for an artery-opening procedure – by 44 percent.
“We reduced the risk of a heart attack by 54 percent, the risk of a stroke by 48 percent and the chance of needing bypass surgery or angioplasty by 46 percent,” Ridker said.
Looked at another way, there were 136 heart-related problems per year for every 10,000 people taking dummy pills versus 77 for those on Crestor.
Remarkably, every single subgroup benefited from the drug.
“If youre skinny it worked, if youre heavy it worked. If you lived here or there, if you smoked, it worked,” Ridker said.
Source: txbea
Avandia Allows Heart Artery Plaque Buildup
The new study tested Avandia against glipizide, sold as Glucotrol by Pfizer Inc. and in generic form, in 672 people in 19 countries. All had Type 2 diabetes, the most common form of the disease and the one linked to obesity. All were at high risk for heart problems and many were very overweight.
Doctors measured the thickness of plaque starting to form in a heart artery of each participant at the start of the study and 18 months later. Those on Avandia had a slight reduction in buildup versus a little increase in those on glipizide, but the difference was so small that the results were a statistical draw.
Avandia did show a significant advantage in a second measure of artery plaque, but this was not the main result being tested.
Dr. Richard Nesto of Lahey Clinic in Burlington, Mass., and Brigham and Womens Hospital in Boston led the study and reported results Wednesday at an American Heart Association conference.
“This is now the second study that was unable to show a beneficial effect,” said Dr. James Stein, director of preventive cardiology at the University of Wisconsin-Madison, who had no role in the research.
“People really shouldnt be using this to treat diabetes” because safer and more effective medicines are available, Stein said.
The results give “one more reason” to use Avandia with caution, said Dr. Steven Nissen, the Cleveland Clinic cardiologist who did the 2007 analysis that suggested heart risks from the drug. He also led a similar study of Avandias chief competitor – Actos, by Japan-based Takeda Pharmaceuticals – which did show reduction in artery plaque.
Studies so far have been too small to confirm or rule out safety issues with Avandia. A large study aimed at doing that is not expected to finish for two years.
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On the Net:
Heart meeting: http://www.americanheart.org
Source: mabed
Contaminated Heparin Destroyed By FDA
The Food and Drug Association has taken and destroyed more of the contaminated heparin. The FDA had inspected the Cincinnati company, Celsus Laboratories, Inc., in April and at the time found contaminated heparin in two different kinds of products, officials said. A little over 2 pounds of the blood thinner was intended for use directly with patients, and another 31 pounds was to be utilized in diagnostic test kits and medical devices.
The FDA seized the heparin after informing the company that its efforts to notify customers of the contamination problem were unsatisfactory, the agency said in a statement. Drug seizures are a rare penalty for the FDA, since regulators prefer to negotiate with manufacturers to resolve disputes.
The corporation was suspected to be sitting on reserves of the infected material and distributing it.
A representative who answered the phone at Celsus said the company would have no comment.
Source: vtbra