Link:  http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2009/11/18/state/n170843S88.DTL&type=health

Link:  http://www.who.int/csr/disease/swineflu/notes/briefing_20091119/en/index.html

19 NOVEMBER 2009 | GENEVA — To date, WHO has received vaccination information from 16 of around 40 countries conducting national H1N1 pandemic vaccine campaigns. Based on information in these 16 countries, WHO estimates that around 80 million doses of pandemic vaccine have been distributed and around 65 million people have been vaccinated. National immunization campaigns began in Australia and the People’s Republic of China in late September.

Vaccination campaigns currently under way to protect populations from pandemic influenza are among the largest in the history of several countries, and numbers are growing daily. Given this scale of vaccine administration, at least some rare adverse reactions, not detectable during even large clinical trials, could occur, underscoring the need for rigorous monitoring of safety. Results to date are encouraging.

 Common side effects

 As anticipated, side effects commonly reported include swelling, redness, or pain at the injection site, which usually resolves spontaneously a short time after vaccination.

Fever, headache, fatigue, and muscle aches, occurring shortly after vaccine administration, have also been reported, though with less frequency. These symptoms also resolve spontaneously, usually within 48 hours. In addition, a variety of allergic reactions has been observed. The frequency of these reactions is well within the expected range.

 Guillain-Barre syndrome

 To date, fewer than ten suspected cases of Guillain-Barre syndrome have been reported in people who have received vaccine. These numbers are in line with normal background rates of this illness, as reported in a recent study. Nonetheless, all such cases are being investigated to determine whether these are randomly occurring events or if they might be associated with vaccination.

WHO has received no reports of fatal outcomes among suspected or confirmed cases of Guillain-Barre syndrome detected since vaccination campaigns began. All cases have recovered. WHO recommends continued active monitoring for Guillain-Barre syndrome.

 Investigations of deaths

 A small number of deaths have occurred in people who have been vaccinated. All such deaths, reported to WHO, have been promptly investigated. Although some investigations are ongoing, results of completed investigations reported to WHO have ruled out a direct link to pandemic vaccine as the cause of death.

In China, for example, where more than 11 million doses of pandemic vaccine have been administered, health authorities have informed WHO of 15 cases of severe side effects and two deaths that occurred following vaccination. Thorough investigation of these deaths, including a review of autopsy results, determined that underlying medical conditions were the cause of death, and not the vaccine.

 Safety profile of different vaccines

 Campaigns are using nonadjuvanted inactivated vaccines, adjuvanted inactivated vaccines, and live attenuated vaccines. No differences in the safety profile of severe adverse events among different vaccines have been detected to date.

Although intense monitoring of vaccine safety continues, all data compiled to date indicate that pandemic vaccines match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years.

Date: Thu 19 Nov 2009
Source: Thaindian.com [edited]
<http://www.thaindian.com/newsportal/health1/rabies-scare-haunts-himachal-hamlet_100276795.html>

An entire hamlet near here is eerily emptying out day by day due to a
rabies scare. Villagers say they cannot take any chances as 2 dozen
farm animals have died, and no medical assistance has reached them in 10 days.

Bara Bhangal, which has the state’s remotest polling station, is
located in Kangra district [see map at <http://healthmap.org/r/00-H>]
at an altitude of over 2800 metres and is not accessible by road.
While officials are yet to confirm whether the disease is spreading
there, the village of 400 people is running scared and migrating
despite snow-laden pathways.

“More than 12 cattle and an equal number of sheep have died due to
rabies. A large number of animals have symptoms of the disease.
Despite repeated requests to the administration, no veterinarian team
has been deputed to the village so far,” said Kanchana Devi, head of
the gram panchayat of the village.

She along with other villagers have migrated to Bir in Baijnath
subdistrict, near Palampur town, some 250 km from the state capital Shimla.

“After trudging more than 75 km, we managed to reach Bir in 3 days.
Most of the areas are under a thick blanket of snow (following heavy
snowfall),” she said.

According to her, 4 people who are still stuck in the village have
reported symptoms of the disease.

Sheep and cattle rearing is the main occupation of the people, who are nomads.

Akshay Jasrotia, a member of the Kangra Zila Parishad, who is taking
up their cause with the administration, said the situation is quite
grim. “Since the satellite telephone installed in the village is not
working, it’s difficult to get the exact information. The people who
have migrated say the situation is quite grim there. We are
requesting the government to airlift a team of veterinarians and
doctors to the village to treat both animals and humans,” he said.

He said since most trekking routes leading to Bara Bhangal are out of
bounds due to snow, the helicopter is the only mode of transportation
to reach there. Bara Bhangal is also accessible through the Thamsar
Pass, located at an attitude of 4700 metres.

Kangra Additional District Magistrate Sandeep Kumar told IANS that a
team of doctors was sent to the village last week, but it returned
mid-way due to harsh climatic conditions.

“A 2nd team was sent from another route in Chamba district 2 days
ago. But so far, we have not been able to establish contact with
them. If the team again fails to reach, then we will arrange a
helicopter for them,” he said.

On the spread of rabies, he said: “From initial reports, it seems
that animals had died due to rabies. However, there is no official
confirmation regarding the spread of the disease in humans. So far,
80 people have migrated to Bir. But this is their annual practice. We
have vaccinated both the humans and the livestock. We have not
noticed any symptoms of rabies,” he said.

Bara Bhangal is part of the Dhauladhar Wildlife Sanctuary, which is
spread over 944 sq km at an altitude above 3000 metres.

[Byline: Vishal Gulati]

Link:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191471.htm

Cardiac Science Corp. Powerheart and CardioVive Automated

 External Defibrillators: Initial Communication

Audience: Cardiology healthcare professionals, hospital risk managers, biomedical engineering staff, emergency responders

[Posted 11/19/2009] Cardiac Science Corporation has received multiple complaints related to defective components in these AEDs that indicate the affected devices may not deliver electric shocks and that the devices’ self-test may not detect the defect in advance of their use. 300,000 Cardiac Science AEDs worldwide are potentially affected by this problem. The G3 Series devices were manufactured between August 2003 and August 2009. Affected models include the following:

• Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; and
• CardioVive 92531, 92532 , and 9253

Because the AED display screen and/or audible indicators may not accurately indicate whether the device is functioning properly or will function properly at time of use, FDA encourages users of the affected AEDs to follow the additional precautions provided in this communication. FDA is gathering more data about this situation to better understand its potential public health impact and will make available any new information that might affect the use of these AED devices. Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. FDA encourages anyone who suspects any electronic or mechanical problem(s) with an AED to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

[11/19/2009 - Initial Communication - FDA]

Recall — Firm Press Release (http://www.fda.gov/Safety/Recalls/ucm191416.htm)

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

P&G Voluntarily Recalls Specific Lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom

P&G Media Contacts:

U.S. Media
Tom Millikin, +1.513.622.1522
millikin.tm@pg.com

Paul Fox, +1.513.884.2592
fox.pd@pg.com

U.K. Media
Lee Bansil, + 44.7780.223895
bansil.l@pg.com

German Media
Andrea Riepe, +49.172.302.3253
riepe.a@pg.com

FOR IMMEDIATE RELEASE – Nov. 19, 2009 – Cincinnati – The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries:  the United States, Germany and the United Kingdom.

The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany.  There have been no reports of illness.  However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis.  B. cepacia poses little medical risk to healthy individuals.

P&G detected this problem during routine quality control at the plant and promptly took action.  The company’s analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product.  These three lots were sold only in the United States, Germany and the United Kingdom

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

The lot numbers of the products involved are:

This lot number is listed on both the outer carton and the bottle.  Consumers should simply discard the affected product as they would any OTC medicine.

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at the following numbers:

From the United States, please call:  1.877.876.7881 (Hours of operation:  Monday – Friday, 9AM – 6PM US ET, Saturday – Sunday, 9AM – 4PM US ET)

From the United Kingdom, please call:  0800.5555.15 (Hours of operation:  19 November, 4PM – 9PM local time and will continue Monday – Friday, 8AM – 6PM local time, Saturday – Sunday, 9AM – 5PM local time)

From Germany, please call:  0800.111.6131 (Hours of operation:  19 November, 4PM – 9PM local time and will continue Monday – Friday, 8AM – 6PM local time, Saturday – Sunday, 9AM – 5PM local time)

Any adverse events with the use of this product and/or quality problems should be reported via the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.