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The FDA has issued an early communication warning to inform healthcare professionals of a possible connection between the use of tumor necrosis factor (TNF) blockers and the development of cancer in children and young adults.
According to recent reports, the drugs, which are used to treat juvenile idiopathic arthritis, Crohn's disease and other conditions, have shown cancer occurring in children and young adults who began taking TNF blockers when they were no older than 18. The FDA is investigating approximately 30 reports of cancer in children and young adults who took these medications, according to officials.
FDA officials said until their evaluation is completed, healthcare providers should be aware of the possible risk of lymphoma and other cancers in children when deciding how to best treat patients.
Allergies Costing Americans Billions of Dollars The price of treating allergies is nothing to sneeze at, according to recently released government statistics released.
Statistics that surfaced June 11 show Americans spent $11 billion on doctor bills, prescription drugs and other treatments for allergies in 2005, say officials from the Agency for Healthcare Research and Quality (AHRQ).
That's nearly double the $6 billion spent in 2000 on allergies. More than 22 million Americans went to a doctor in 2005 to seek help from their allergies, which typically causes sneezing and itchy eyes.
Of the $11 billion, doctor visits account for $4 billion while prescription drugs cost $7 billion, according to the AHRQ.
FDA Advises Patients on Inhalers The FDA is alerting healthcare professionals who use chlorofluorocarbon (CFC)-propelled inhalers to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because the former will not be available in the U.S. after Dec. 31.
According to the FDA, CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment in that they contribute to the depletion of the ozone layer above the Earth's surface.
Three HFA-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.
Albuterol inhalers are used to treat bronchospasm (wheezing) in patients with asthma and COPD, which includes chronic bronchitis and emphysema. Patients use albuterol inhalers to deliver medicine directly into the lungs.
The discontinuation of CFC inhalers is reportedly the result of the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the U.S. has agreed to phase out production and importation of ozone-depleting substances including CFCs. No CFC-propelled albuterol inhalers may be produced, marketed or sold in the United States after Dec. 31, according to the FDA.
The FDA is urging providers to talk with their patients about switching to HFA-propelled albuterol inhalers immediately. These products are safe and effective replacements for CFC-propelled albuterol inhalers, officials said.
Providers should also advise patients that HFA-propelled albuterol inhalers may taste and feel different than the CFC inhalers. The spray of an HFA inhaler may feel softer than that of a CFC inhaler. Patients must also prime and clean HFA inhalers. Doing so prevents buildup of the drug in the inhalation device, and buildup can block the medicine from reaching the lungs. Each HFA inhaler has different priming, cleaning and drying instructions, and patients should be instructed to read and understand the instructions before using the inhaler.
Manufacturers have been reportedly increasing production of HFA albuterol inhalers so an adequate supply is expected to be available.
FDA Announces Warning for Foot Ulcer Medication The FDA has issued a new warning for Regranex, which is prescribed to treat severe foot and leg ulcers in diabetics. According to officials, the drug could heighten cancer risk.
A boxed warning for the product now states that patients who've used 3 or more tubes of the drug over a 20-month period are five times more likely to die of cancer. Patients who've used lower amounts of the cream have smaller chances of developing cancer and are no higher than patients who've never used the drug, the FDA claims.
The findings come from a long-term analysis of records from healthcare providers comparing 1,600 patients who took Regranex with 2,800 patients who did not.
Regranex is a man-made version of a substance produced by the human body that helps heal ulcers. Because the drug causes cells to divide more rapidly, the FDA said manufacturer Johnson & Johnson closely monitored patients for reports of cancer.
Parkinson Drug Could Help Decrease Symptoms A study by Duke University Medical Center reportedly shows the drug Istradefylline, may be useful as a supplement in helping patients combat some symptoms of Parkinson's disease, including tics, spasms and tremors experienced when their main medication wears off.
The findings, which are published in the June 3 issue of Neurology, suggest the drug works by helping nerve and brain signals bypass the damaged dopamine system in the brain.
Through the study of 395 patients on levodopa, a popular Parkinson's drug, researchers reportedly found those using Istradefylline experienced 24 percent less "off" time, defined as when the physical symptoms appear after levodopa wears off. A group of those studied who took a placebo showed a 10 percent decrease in "off" time, according to FDA officials.
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