FDA Approves Inhaled Insulin for Diabetes
Exubera, the first inhaled insulin treatment for diabetes, won approval from U.S. regulatory officials on Friday.
The long-awaited action by the U.S. Food and Drug Administration means millions of people with both type 1 and type 2 diabetes may have the option of avoiding the needles and countless injections that have marked their lives so far.
"This is the first new insulin delivery option introduced since the discovery of this drug in 1920s," said Dr. Steve Galson, director of the FDA Center for Drug Evaluation and Research. "There are more than 5 million Americans who take insulin injections every day, and Exubera may be an option for many of these patients. It will not replace all injectable insulin. . . It's a very highly innovative product that has the potential to improve the quality of life of millions of Americans with diabetes."
"This is highly positive. It will be a major advance for individuals with diabetes, both children and adults," said Dr. Robert Rapaport, director of the division of pediatric endocrinology at Mount Sinai School of Medicine in New York City. "I think there will be some longstanding questions about its ultimate safety because it's the first inhaled medication that will be used like this. But, assuming the safety profile will be good, it will be a major advance."
Added Dr. Stuart Weiss, an assistant clinical professor of medicine at New York University School of Medicine: "There are still some questions as to lung function and diffusion capacity, and smokers can't use it. There are all sorts of things to be concerned about. It's going to take a few years to see whether or not it's as safe as all that."
The announcement follows European regulators' approval of Exubera on Thursday. A U.S. Food and Drug Administration advisory panel recommended approval of the drug in the United States on Sept. 8.
Type 2 diabetes has become a global epidemic, affecting some 12 million people in the United States alone. The condition, which develops when the pancreas does not produce enough insulin or the body cannot use the hormone efficiently, is strongly associated with overweight and obesity. While some people can manage their type 2 diabetes through diet and exercise, others must rely on insulin injections.
Type 1 diabetes, in which the body's insulin-producing capabilities are limited or non-existent, is not linked to body weight.
Insulin is the hormone that converts blood sugar, called glucose, into energy for cells in the body.
If left uncontrolled, either type of diabetes can lead to a multitude of complications, including amputations, blindness, kidney disease, heart attack and strokes.
The first commercial insulin hit the market in the 1920s. Since then, the gold standard for treatment of type 1 diabetes and more advanced type 2 diabetes has been insulin, injected before meals.
In the intervening years, new types of insulin formulations and devices have made the process more efficient.
"Needles are way, way smaller, syringes are easier to use, pen devices are very discreet, all sorts of delivery devices are very impressive," Weiss said. But the premise has remained the same -- delivery by injection.
Exubera, on the other hand, is a dry powder formulation of insulin inhaled into the lungs through the mouth. Like injectable insulin, it is administered before meals using a small, hand-held device.
Studies on safety and effectiveness were done on more than 2,500 adults with type 1 and type 2 diabetes. The drug, manufactured by Pfizer Inc., was as effective as injectable insulin for control of blood sugar, the company stated. Pfizer apparently delayed Exubera's application for U.S. approval for three years to finish safety studies.
"Because this is a new way to deliver insulin to patients, it has been extensively studied with respect to safety and efficacy," said Dr. Robert Meyer, director of the FDA Office of Drug Evaluation II, which oversees the division of Metabolic and Endocrine Drugs. "We have a large amount of data from the clinical trials speaking to the safety of this product overall, and safety in the lungs as well. In addition, there are ongoing, continuing trials to monitor safety that will be reported after approval."
"We feel that there is an extensive and reasonable safety database to allow us to make a determination of efficacy and safety for patients without underlying lung disease and who do not smoke," Meyer said.
In those clinical studies, Exubera reached peak insulin concentration more quickly than some insulins, called regular insulin, administered by injection. Peak insulin levels were achieved at 49 minutes, on average, with Exubera, compared to 105 minutes, on average, with regular insulin, the FDA said.
Prescriptions for Exubera will be accompanied by a "Medication Guide" containing FDA-approved information written especially for patients, the agency said.
Like any insulin product, low blood sugar is a side effect of Exubera and diabetics should carefully monitor their blood sugar regularly. Other side effects associated with Exubera in clinical trials included cough, shortness of breath, sore throat and dry mouth, the FDA said.
Exubera shouldn't be used by smokers or someone who quit smoking within the last six months. The drug is also not recommended in people with asthma, bronchitis or emphysema. Baseline tests for lung function are recommended before beginning treatment, and should be repeated every six to 12 months, according to the FDA.
Inhaled insulin is unlikely to completely replace injectable insulin. But, for many people, it may greatly improve glucose control.
"It's very hard to predict what the impact will be," Weiss said. "A lot of people who need to be on insulin are not on insulin. For that type 2 diabetic who is afraid of needles or will not take a shot, this is an ideal product. The problem is it doesn't address the root cause of diabetes. It could become another treatment that will cause people to overeat and under-exercise."
Exubera is also unlikely to be the only inhaled insulin on the market for long. Eli Lilly and Co., Kos Pharmaceuticals Inc., MannKind Corp. and Novo Nordisk A/S all are developing their own versions.
Company Recalls 500,000 Baby Teethers
At least a half million liquid-filled baby teethers distributed in the United States and Canada were recalled on Friday because of a possible bacterial contamination that could cause serious illness, the Associated Press reported.
The liquid in six types of teethers could be contaminated with the Pseudomonas aeruginosa or the Pseudomonas putida bacteria, according to manufacturer The First Years Inc., of Massachusetts. If the teether is punctured and the liquid ingested, the bacteria can cause serious illness in children, although no cases of illness have been reported.
"FDA would like to caution consumers that Pseudomonas aeriginosa is a bacteria that can cause serious illness, particularly in people with compromised immune systems and in infants who are still developing their immunity, as well as children who are born with immune deficiencies," FDA spokeswoman Julie Zawisza said.
Three of the products are adorned with popular cartoon characters. The Disney Days of Hunny Soft Cool Ring Teether, bearing style number Y1447, and the Disney Soft Cool Ring Teether, bearing style number Y1470 or Y1490, feature Winnie-the-Pooh characters. The Sesame Beginnings Chill and Chew Teether, style number Y3095, features Sesame Street characters.
The other teethers recalled are The First Years Cool Animal Teether (style number Y1473) and The First Years Floating Friends Teether (style number Y1474), which feature fish and other animal graphics.
Major retailers, including grocery, drug and specialty stores, sold the product nationwide and in Canada from July 2005 through January 2006.
New Angina Drug to Hit Market in March
A drug that eases the agonizing pain that can grip angina sufferers when their hearts don't get enough oxygen was given the government's blessing on Friday, the Associated Press reported.
The U.S. Food and Drug Administration approved ranolazine for use in angina patients, agency spokeswoman Laura Alvey said. The drug is approved for patients who take calcium channel blockers, beta blockers or nitroglycerin, according to CV Therapeutics Inc. The California company hopes to begin marketing the drug as Ranexa in March.
More than 6 million Americans have angina. Ranexa allows the heart to pump more efficiently without the need for more oxygen, the company said.
Current drugs used for angina either increase the supply of oxygen-bearing blood or reduce the heart's demand for oxygen. In contrast, Ranexa relaxes contracted heart muscle, Dr. Louis Lange, the chairman and chief executive officer of CV Therapeutics, told the AP. That restores normal blood flow, relieving the pain that accompanies it, Lange added.
The drug will be available as an extended-release tablet.
The European Medicines Agency in October demanded further trials of Ranexa before it would consider approving the drug.
Medical Device Maker Didn't Report Safety Problems: FDA
Medical device maker Boston Scientific has repeatedly failed to disclose serious safety issues with its products and quality-control concerns at its factories, the U.S. Food and Drug Administration warned Thursday.
The FDA said that problems plagued every Boston Scientific plant and every device made by the company. However, the FDA didn't order any product recalls and put no restrictions on the sale of the company's medical devices, The New York Times reported.
The FDA warning came a day after Boston Scientific won a takeover bid for Guidant, another medical device company that has had major problems with some of its defibrillators. Boston Scientific's best-selling item is the Taxus drug-coated stent, which is used to keep coronary arteries open after blockages are removed.
The company failed to collect, analyze and report problems experienced by doctors and patients using its devices, and that's a major failure for a medical device manufacturer, the FDA charged.
"In order to properly design a product, you need to understand what has occurred with the previous generation in order to make corrections both to design and manufacturing," Dr. Daniel G. Schultz, director of the FDA's center for devices and radiological health, said at a news conference.
Boston Scientific executives plan to meet with the FDA on Feb. 3 and the company said it will work closely with the agency to address its concerns, The Times reported.
Chronic Wasting Disease Prions Found in Deer Muscle Meat
The haunch and leg meat, and possibly other muscle meat, of deer with chronic wasting disease contains the infectious prions that spread that disease, says a U.S. study published Friday in the journal Science.
This finding contradicts assurances from state and federal health officials that people eating deer won't be exposed to the disease as long as they don't consume or touch a deer's brain, spinal cord or other nervous tissues. It was believed that these were the only locations where the infectious prions were located, The New York Times reported.
Chronic wasting disease is similar to mad cow disease. To date, there is no evidence that chronic wasting disease has been passed to humans. The disease afflicts deer and elk in 11 states and in two Canadian provinces.
In states where the disease is found, officials routinely caution hunters to freeze deer and elk meat while the animal's head is tested for prions.
"This study is very important. It's frightening that there should be so many prions in the muscle meat of deer," Stanely Prusiner of the University of California, San Francisco, told the newspaper. Prsuiner won the 1997 Nobel in medicine for his research on prions.
Sharp Increase in Children's Asthma Rates
In some parts of North America, children's asthma rates are four times higher than they were 20 years ago, says a report released Friday by the Commission for Environmental Cooperation, which was set up under the North American Free Trade Agreement.
The report cited a number of possible factors, other than heredity, that may influence increased rates of asthma. They include outdoor air pollution, and smoke in homes from secondhand cigarette smoke and wood or charcoal fires, CBC News reported.
A tendency toward allergies and the presence of pet dander, dust mite antigens, molds, pesticides, gases or aerosol in homes and schools may also play a role.
"The air children breathe is an important source of exposure to substances that may potentially harm their health," the report said. "Exposures in early childhood when the lungs and immune systems are not fully developed raise concerns that children may respond more adversely than adults would."
There was some good news in the report. In recent years, there's been a decline in rates of lead contamination and water-related sicknesses among children in Canada, Mexico and the United States, CBC News reported.
Food Fact:
Juice vs. fruit.
A piece of fresh fruit has one key advantage over a glass of juice. When you eat an orange, an apple or a grapefruit, you're getting fiber, which isn't there in a glass of juice. Not only does fiber play a major role against diabetes and heart disease, but it fills you up with fewer calories, helping you control your weight. Fruit juices also tend to be high in added sugar. Citrus fruits in particular are loaded with antioxidant, cancer-preventing compounds, and they're bursting with vitamin C, folate and potassium.
Fitness Tip of the day:
Less is more.
Surprise! A few short exercise sessions a day can be as valuable as one longer session. The key to making exercise a habit is to fit it comfortably into your schedule. If you can't find a 30-minute block of time, try three 10-minute stints over the course of the day.
FAQ of the day:
Should I buy fat-free soy milk?
It's not a good idea; fat-free soy milk lacks the beneficial soy isoflavones. If you're concerned about the calories in whole soy milk, switch to 1%.
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