The World Health Organization (WHO) has raised the pandemic alert level to Phase 6 in response to the global spread of the H1N1 (swine flu) virus. This reflects that the virus has spread to other parts of the world, but it does not mean that the virus has changed or become more severe. However, a bit of a panic has occurred since the outbreak of the H1N1 flu and parents are eager to find out about the vaccine and whether it is important for their children to receive it. The truth is that the H1N1 flu is not so terrible now but the fear is that it will mutate and create more severe disease in the fall. AS a result of this concern, the government is working hard to create a vaccine- and pushing it through testing faster than is usual for a human vaccine. So is it safe?

The H1N1 flu vaccine is due to be available in October, probably in both a nasal spray and a shot. This will be a separate vaccine from the regular seasonal flu vaccine.

The best advice I can give at this time is to watch and wait. Although some people have already been injected with the new vaccine, the details of the vaccine are not yet readily available. For example, what ingredients go into this new vaccine? Will it contain Thimerasol or Mercury? What are the side effects of the vaccine, short-term and long-term? In the 1970s when a swine flu vaccine was developed, there was a significant rise in Guillain-Barre reactions (GBS: temporary muscle weakness and/or paralysis).

For patients in my practice, this is the advice I am giving: keep in close touch with your pediatrician, especially as we approach the flu season next fall. Read the newspaper reports about the clinical trials of the vaccine with a grain of salt- the media has really created a panic where there needn’t be one as yet. More people die of the “regular flu” than swine flu- having had swine flu myself this spring I can tell you it is no fun, but with rest, fluids and good care, most otherwise healthy people can get through it just fine. I definitely suggest waiting at least until the second round of safety trials are done, to see if there are GBS reactions. If the studies prove the vaccine to be safe, then perhaps I will recommend. But those results wont be available until November.

The bigger concern is whether the government will make the vaccine mandatory. Mandatory is very different than required. As you all know, schools require vaccines for your child unless you sign a particular waiver. Mandatory is very different- it means that you wont have a choice at all.

The latest American Academy of Pediatrics report (www.aap.org) does not seem to believe it will be mandatory. However, some news reports from the government seem to say otherwise. That said, there will only be approximately 120 million doses, so the priority will be for those at highest risk of suffering a severe case of the H1N1 flu (or those most likely to spread it to others): Pregnant women, health care workers, and children 6 months and older. Parents and anyone caring for infants, anyone with high-risk medical conditions (such as heart, lung, or immune diseases), and young adults ages 19-24.

Best advice: keep in touch with your child’s doctor and practice good health hygiene.

The CDC recommends:

• Cover your nose and mouth with a tissue when you cough or sneeze.
• If you don’t have a tissue, cough or sneeze into your upper sleeve, not your hands
• Put used tissues in the trash.
• Clean your hands after coughing or sneezing. Wash with soap and water, or with alcohol-based hand cleaner.
• Avoid touching your eyes, nose and mouth.
• If you get sick, stay home from work or school, and limit your contact with others to keep from infecting them. People should stay home at least 24 hours after they are free of fever (100°F), or signs of a fever without the use of fever-reducing medications.

People cannot get swine flu from pork or pork products.

And, as always, be sure your child is eating well and sleeping well to maintain a strong immune system.

Dear Healthcare Professional:

I am writing to inform you that, in consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare is voluntarily initiating a recall of certain lots of Children’s and Infants’ TYLENOL® products that were manufactured between April 2008 and June 2008. The full list of recalled product lots is below.

The company has implemented this recall because examination of bulk raw material detected that one of the inactive ingredients did not meet internal testing requirements. Specifically, the gram-negative bacteria Burkholderia cepacia (B. cepacia) was detected. The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product. However, it was decided, as a precaution, to recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria. Please note: No bacteria has been detected in finished product and the finished product has met all specifications.

A review of the relevant published scientific literature regarding B. cepacia indicates that while ingestion of contaminated pharmaceutical product is not known to be a route of transmission of B. cepacia infection, infection has been reported following the use of contaminated pharmaceutical products such as mouthwashes and nasal sprays. Adverse health consequence of B. cepacia infections could be potentially severe especially in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis or compromised immune systems.

McNeil has conducted an assessment of post-marketing safety surveillance data and did not identify any safety signals or batch-related safety concerns for Infants’ and Children’s TYLENOL® products over the time period, starting with the introduction of these batches, in or around April 2008.

McNeil is advising parents and caregivers who have administered affected product to their child or infant and have concerns to contact their healthcare providers. Parents and caregivers can find the lot numbers on the bottom of the box containing the product and also on the sticker that surrounds the product bottle. If your patients determine that they have affected product, they can contact our Customer Care Center at
1-800-962-5357 and we will send them a coupon for a new bottle.

If you have any questions, please call our Medical Affairs Department at 1-800-962-5357 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time).

Sincerely,
Edwin Kuffner
Edwin K. Kuffner, MD
Vice President, Medical Affairs
McNeil Consumer Healthcare

McNeil Consumer Healthcare
7050 Camp Hill Road
Fort Washington, PA 19034, USA

©McNEIL-PPC, Inc. 2009