December 28, 2009

H1N1 Vaccines Recalled by AstraZeneca’s MedImmune Unit

H1N1 VaccineAstraZeneca’s MedImmune unit has issued a recall on 4.7 million doses of their nasal spray vaccine for H1N1. The recall was voluntary from the company, and they claim that the cause was due to potency concerns, not a failure or defect in the vaccine itself. The FDA says that those that have already been vaccinated with their medication do not need to be revaccinated.

MedImmune is not the first to recall H1N1 vaccines due to an error in the potency. Sanofi-Aventis recalled about 800,000 doses of their pediatric H1N1 vaccines, due to the potency not being high enough.
However, MedImmune’s recall is a bit different in nature than Sanofi-Aventis. MedImmune has recalled their vaccines not because of safety reasons, but as a precautionary measure. The company is worried about the potency in vaccines that are being stored. Apparently, some of the vaccines have diminished in terms of their strength and the company is worried about a significant part of their vaccine losing all of it potency. By recalling some of their product they can make sure a potent, working vaccine will be kept on the market, not a “watered-down” version.

There is no reason anyone should worry about this recall. If you haven’t already been vaccinated, now is still a great time to go and get yourself some added protection.

June 18, 2009

FDA Warns Against Zicam Cold Medicines

Filed under: FDA,Loss of smell,Zicam — @ 5:44 pm

Recently the United States Food and Drug Administration (FDA), has been warning all consumers to immediately stop using and dispose of three types of the Zicam intranasal products, Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size. The warning came after more than 130 reports claiming a loss of smell after the use of the products. Anosmia, the loss of the sense of smell, may be long-lasting or even permanent in some cases.

Obviously the loss of smell can have a very negative impact on a person’s life. The agency says that the loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The first reports of the loss of smell due to the use of Zicam products were back in 1999. Furthermore, in many reports the loss of smell occurred after the first dose. However, some reports said that the loss of the sense of smell occurred after multiple uses. Matrixx agreed to pay $12 million to settle the claims of 340 plaintiffs in 2006, all of which said they had lost their sense of smell.

Even today Matrixx is facing lawsuits due to the products, but goes on to say on their Website, “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”

The FDA is advising anyone experiencing a loss of their sense of smell, or any other problem, to immediately contact their health care provider. Physicians and consumers are also encouraged to report adverse events that may be related to the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

– Online
– Regular mail: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
– Fax: 800-FDA-0178
– Phone: 800-FDA-1088

Information provided on this website is for general purposes only. It is not intended to take the place of advice from your practitioner.

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