Tagged Articles

nasal spray 9 articles

FDA warns that nasal spray from The Compounding Shop may be contaminated with fungus

The Food and Drug Administration (FDA) is warning patients and health care providers that budesonide solution, used for nasal irrigation, from The Compounding Shop of St. Petersburg, Fla., may be contaminated and should not be used or administered to patients. Visible, white floating material was observed in a 1000mL bottle of the nasal spray and was later identified as a fungus. The FDA is concerned that other budesonide solution products from The Compounding Shop may be contaminated. Budesonide solution is labeled “for inhalation only.” Oral inhalation products, such as budesonide solution, are required to be sterile. Contaminated drug products, whether ... Read More

FDA panel recommends nasal spray be sold OTC despite objections from medical community

An advisory panel to the Food and Drug Administration (FDA) has recommended that triamcinolone acetonide, nasal spray used to relieve symptoms of upper respiratory allergies, be made available to consumers over-the-counter despite strong opposition from medical groups. Triamcinolone acetonide is a prescription-only inhaled nasal corticosteroid that is used to treat symptoms of hay fever and other upper respiratory infections including nasal congestion, runny nose, sneezing, and itching. The most recent studies on the nasal spray show that intranasal cortiososteroids have the potential to adversely affect a patient’s eyes, bones, hypothalamic pituitary-adrenal glands, and can stunt a child’s growth, said Dr. David P. ... Read More

FDA panel sees greater risk than benefit with osteoporosis drug

A Food and Drug Administration (FDA) advisory panel is recommending that marketing of calcitonin salmon for osteoporosis in post-menopausal women should no longer be permitted, and that drug companies with the products in development prove they are effective in reducing fractures. Calcitonin salmon is a synthetic version of the hormone calcitonin that is found in salmon. It is available in injections and nasal sprays under brand names such as Miacalcin and Fortical, as well as in generic versions. A review of calcitonin salmon was conducted following an FDA staff review of the drug in which significant questions were raised about ... Read More

FDA approves first-ever migraine medicine skin patch

NuPathe is launching the first-ever patch to treat migraine headache, a product the device’s maker says is “game changing” to migraine sufferers. The Food and Drug Administration (FDA) gave NuPathe’s Zecuity the nod last week, and the company says it is currently focusing on securing commercial partners for the patch and hopes to have the patch on the market by the end of the year. Zecuity is a single-use, battery-powered patch that actively delivers the migraine medication sumatriptan through the skin. Sumatriptan has been on the market since 1991. It is administered in several forms including tablets, subcutaneous injection, and ... Read More

Contaminated lot of Zicam nasal spray recalled

One lot of Zicam Extreme Congestion Relief nasal gel, an over-the-counter medicine used to treat nasal congestion and sinus pressure, is being recalled because an organism was found in a single sample during a routine review at the manufacturing plant where the medicine is produced. The contaminant, known as Burkholderia cepacia, poses no risk to healthy individuals but in a nasal spray could cause upper airway colonization and secondarily lead to respiratory infections in people with a compromised immune system or people with chronic lung conditions such as cystic fibrosis. Burkholderia cepia is also resistant to many antibiotics and may ... Read More

Non-sterile eye, nose sprays promoted as cough, cold relief recalled

Eye and nasal sprays made by Dallas, Texas-based Wholistic Herbs Inc., are being recalled because the solutions may not be sterile and could lead to infections. The recall includes all quantities of Wholistic Herbs “Koff & Kold” spray with herbal extract and “Kold Sore” spray with liquid sea mineral in 1 fl. oz. sprays distributed from March 2009 through February 2012. “Koff & Kold” is intended to be sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose, and sinus infection. “Kold Sore” spray is intended to be sprayed into the eyes for the treatment of ... Read More

Support group says Chantix ads conceal important information

WhyQuit, an organization that advocates quitting smoking using the cold turkey method, recently published an article that takes Pfizer to task over its latest Chantix ads. The group claims that the pharmaceutical company’s new television commercials hide information from the viewer – information that, if known, would likely dissuade most smokers from using the drug as a smoking cessation aid. WhyQuit reports that in surveys and scientific studies, more people were found to have successfully quit smoking long term using the cold turkey method than nicotine replacement therapies (NRT). NRT delivers smokeless nicotine to the user through chewing gum, lozenges, ... Read More

Reynolds closer to buying smoking cessation products company

Reynolds American, the second largest American producer of cigarettes and other tobacco products, is in the advanced stages of negotiating a purchase of Niconovum, a Swedish company that manufactures smoking cessation products. If the deal works, as it appears it will, it shows the determination of the tobacco giants to cash in on the “whole cycle of a smoker from the first puff to the last piece of gum,” said Chip Brian, a business analyst for SmarTrend. Based in Helsingborg, Sweden, Niconovum produces nicotine-replacement therapies (NRTS), smoking cessation products designed to provide users with a smokeless form of nicotine relief. ... Read More