E-cigarette maker welcomes FDA challenge
MIAMI Despite the ongoing battle between the Food and Drug Administration and electronic cigarette makers, one manufacturer welcomes the challenge as a chance to present its product as a healthier alternative to traditional tobacco.
Green Smoke said it has created an electronic cigarette designed to simulate the smoking experience without carcinogenics. Instead, it emits an odorless vapor of mostly steam, with ingredients like nicotine, water, propylene glycol (an additive used in cake mixes) and others. The nicotine also is available in different strengths.
The company also added that the price for the electronic cigarettes are more cost-efficient than regular tobacco products, with cigarette starter kits ranging from $109 to $270. The starter kits include nicotine cartridges, rechargeable cigarette batteries, home charger and more.
WHO: H1N1 to be included in next year’s seasonal flu vaccine
GENEVA During a press conference held Thursday, the World Health Organization updated the status of the novel H1N1 pandemic and announced that the novel H1N1 influenza vaccine would be incorporated into next season’s seasonal flu vaccine.
The triumvirate vaccine will include protection against the novel H1N1 virus, an H3N2 strain and a type-B virus.
“What the scientists said was that in the past year, the overwhelming number of influenza viruses that were isolated around the world were the pandemic H1N1 virus,” Keiji Fukuda, special adviser to the WHO’s director-general for pandemic influenza, told reporters. “The experts believe based on this information that these viruses will continue to be one of the dominant viruses in wide circulation in the coming fall and winter season in the northern hemisphere.”
However, substituting the pandemic H1N1 virus in place of last year’s seasonal H1N1 inoculation does not suggest that the novel H1N1 pandemic has concluded its course, Fukuda warned. “The recommendation to put the pandemic virus in the upcoming vaccine really means that this has been a dominant virus. And it is expected that it will continue to be a significant virus, circulating around the world as we head into the winter or the coming winter in 2010 and 2011.”
WHO will be convening its Emergency Committee under the International Health Regulations Feb. 23, Fukuda added, noting that the meeting will be both to review the overall epidemiologic and virologic situation, and to provide some guidance to WHO as to whether we can consider ourselves in “the so-called post-peak period.”
The post-peak period is a transition period in which WHO continues to expect to see pandemic activity occur at different levels in different parts of the world, but that the worst has come to pass, Fukuda said. WHO will not be removing the “pandemic” status, however, Fukuda added. “The practical effect of indicating that we are in a post-peak period is really to give a broad signal to the world that even though we may continue to see pandemic activity that we expect that we are transitioning more towards a normal level.”
The highest levels of pandemic activity currently are occurring in parts of Eastern Europe, some parts of Northern Africa and parts of Asia.
Novartis to change name, repackage Maalox Total Relief
ROCKVILLE, Md. Choosing the wrong liquid Maalox product can have harmful consequences, the Food and Drug Administration warned consumers as part of a consumer update posted to its site Wednesday.
The FDA is concerned that consumers may be confused by the similar packaging and labeling of liquid Maalox and Maalox Total Relief. The two products are intended for the relief of different symptoms and contain different active ingredients, the agency noted.
Maalox Total Relief is an upset stomach reliever and antidiarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids.
Novartis Consumer Health has agreed to change the name of Maalox Total Relief to one that does not include the word “Maalox,” and will change the drug’s packaging to avoid further confusion, the FDA stated in a separate press release.
“Maalox Total Relief and Maalox are not interchangeable and shouldn’t be used in place of each other,” state Carol Holquist, director of FDA’s division of Medication Error Prevention and Analysis. “Consumer confusion and incorrect product use due to name confusion are serious public health issues. We appreciate Novartis’ efforts to work collaboratively with FDA and their decision to remedy this situation to avoid any confusion over Maalox products in the future.”
Maalox Total Relief’s active ingredient (bismuth subsalicylate) is chemically related to aspirin and may cause similar harmful side effects such as bleeding. As such, Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder. Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.
The renamed product is expected to begin selling in September 2010. Until that time, FDA is advising consumers and healthcare professionals to carefully check the labels of all Maalox products to ensure the appropriate product is being selected for the patient’s symptoms.