DENVER -- The following is a statement from Proctor Gamble received by the DenverChannel.com on Dec. 12, 2003.

Pepto-Bismol does not cause Reye's Syndrome. There have been no medically confirmed cases of Reye's syndrome resulting from treatment with Pepto-Bismol. Pepto-Bismol is a safe and effective product that has been used by consumers in the U.S. for the treatment of upset stomach, indigestion, nausea, heartburn, and diarrhea for over one hundred years.

In support of the Reye's Foundation, P and G has voluntarily included a label warning on Pepto Bismol about the symptoms of Reye's syndrome since 1985. This communication encourages consumers and parents to consult a doctor for children and teenagers who have or are recovering from the flu or chicken pox, if nausea or vomiting occurs. These symptoms can be an early sign of Reye's syndrome, a rare but serious illness. Self treatment with any product when Reye's syndrome is suspected should not delay appropriate medical treatment. Those suffering from Reye's syndrome should contact a doctor as soon as possible.

There is no aspirin in Pepto Bismol. The active ingredient in Pepto Bismol is bismuth subsalicylate, a non-aspirin salicylate. Salicylates are commonly used as flavoring agents (wintergreen) in food. The United States Food and Drug Administration's Final Monograph on over-the-counter medications states that there is no definitive evidence that associates use of non-aspirin salicylates with an increased risk of Reye's syndrome.

Historically, aspirin has been incriminated as a causative agent in the development of Reye's syndrome. Recently published expert reviews of this medical condition have also questioned this cause-effect relationship.

Dr. Larry Wolk's Statement:

After reviewing the information presented by Proctor and Gamble, I would like to qualify any statement regarding Pepto-Bismol I made to more correctly identify the active ingredient as a salicylate, which is related to aspirin, but not aspirin itself. While there is no direct proof that this type of salicylate can cause Reye's syndrome in children with the flu, there is enough information related to aspirin and viral illnesses (such as the chicken pox and flu) to warrant informing parents of the potential risk in giving Pepto-Bismol to children with flu symptoms. This opinion is shared by Proctor and Gamble who includes this warning on Pepto Bismal package labels.

Following is the original story:

Did you know that using a common household remedy to help treat the flu could be fatal? If your child has flu symptoms, including an upset stomach, and you go to the cabinet and get Pepto-Bismol to relieve their pain, it could be a fatal mistake, doctors said.

Studies have shown that giving Pepto-Bismol to children with the flu or chicken pox can sometimes lead to Reye's Syndrome, which wreaks havoc on a young person's immune system. Dr. Larry Wolk, a pediatrician for Rocky Mountain Youth, said aspirin is the catalyst.

"Pepto-Bismol contains aspirin and the flu being viral, that combination with children can be potentially fatal," said Wolk.

"I'm surprised. I knew that it happened with aspirin, but I had no idea it happened with Pepto-Bismol," said mother Kim Anderson.

Fatal cases are rare, but it's enough of a concern that bottles of Pepto-Bismol contain a specific warning about the dangers for children suffering from the flu.

Colorado Flu Hotline: (877) 462-2911 Find Flu Clinic: (888) 692-0269 SLIDESHOW:Tips For Fighting Flu At Work QUIZ:Flu Shots: True Or False? Why It Takes So Little To Catch Flu School Reacts To Student's Flu Death How Flu Killed An 8-Year-Old Boy Doctors: Don't Use Common Remedy On Flu Doctors Race To Slow Flu Spread FAQs Prevention Protect Kids Flu Shots Chicken Soup? Did You Get The Flu? Immunize Colorado: Find Flu Clinic Colo. Flu Surveillance Cold Or Flu? CDC Flu Site

"My warning to parents is to read labels. Any over-the-counter medication can be unsafe and it can be potentially fatal," Wolk said.

Anderson said she now knows better.

"I think it's wise for the doctors to be warning people and getting the warning out and I thank you for doing the same," said Anderson.

Meanwhile, two more children in the state died Wednesday and another child died on Thursday -- all the deaths have been linked to the virus.

The latest victims are an 11-year-old girl from Colorado Springs, a 2-year-old from Pueblo and a 14-month-old child from El Paso County.

Colorado is just one of 10 states in the nation reporting widespread cases of the flu, with 6,306 confirmed cases as of Wednesday. That is more flu cases than the last two seasons combined and this year's flu season isn't even over, doctors said.

There are six confirmed flu deaths -- all children ranging in age from 21 months to 15 years.

Flu Vaccine Shortage Reported

There is also growing concern over shortage of flu shots.

"We do consider this to be a public health crisis. We have children who are dying, we know what we need to do and that is to vaccinate and we are concerned that we may be running out of vaccine," said Rosemary Bakes-Martin with the El Paso County Health Department.

The El Paso County Health Department said it has enough vaccine to last through Wednesday. The nation's largest vaccine supplier said it has shipped nearly everything it has and it takes four months to manufacture more.

Chiron and Aventis Pasteur, which have made about 80 million doses of the vaccine, said the outbreak has brought an unexpected surge in demand.

The state Department of Public Health said there should still be enough vaccine to go around for people who need it and among the priorities are children ages 6 months to 23 months, people 65 years old and older, and anyone with underlying health conditions.

The first priority in the state will go to children 6 months through 23 months. The second priority will be children 2 years of age through 4 years of age with chronic conditions. And the third priority goes to children and adults 5 years of age and older with chronic conditions. Those chronic conditions include heart or lung conditions (including asthma), diabetes, chronic kidney disease, and weakened immune system.

The El Paso County Health Department said it has no vaccine currently available for children 2 years through 3 years old.

Dr. Ned Calonge, the state's chief medical officer, said that healthy Coloradoans from 5 to 49 years of age, who want to avoid getting the flu, should get the new nasal flu vaccine mist, which is in more ample supply.

However, this year's vaccine does not exactly match the type of flu strain that's currently making people sick. But doctors said the shot or mist will still protect against the strain, and at the very least, if you do get the flu, it could make your symptoms less severe.

Symptoms of the flu include fever, sore throat, chills, headache, muscle aches, and sometimes nausea and vomiting, especially in kids.

If you are sick, see a doctor, stay home from work or school, drink a lot of liquids, get plenty of rest, and take your medicine, either over-the-counter drugs or prescription drugs from your doctor. Avoid giving aspirin or products containing aspirin to children.

Call your doctor immediately if you or your child has difficulty breathing, are irritable, have a fever that can't be controlled or brought down with acetaminophen or ibuprofen, seem lethargic, and are dehydrated. If a child can't keep fluids down, keep vomiting, suffers from diarrhea, or are not wetting diapers every 6 hours or scant amounts, consult a doctor immediately.

If you have questions about the flu, or if your clinic has run out of the vaccine and you need to find another location to get the shot, call the state's flu hot line at (877) 462- 2911. The hot line is open from 7 a.m. to 11 p.m. The state's Web site ImmunizeColorado.com also has great information for parents concerned about their children.

Additional Information

Pepto-Bismol's Warning
National Reye's Syndrome Foundation
Reye's Syndrome
Warning About Pepto-Bismol and Children With Flu