The FDA said Chantix and Zyban will carry the warnings to alert consumers to the risks of depression and suicidal thoughts when using the drugs.

The drugs also have been reported to cause changes in behavior, hostility and agitation in users, whether users had a history of psychiatric illness or not. In many cases, side effects started shortly after use began and ended when the medication was stopped. The FDA does not know what is causing the changes and said people taking these products should be monitored by their doctor.

"The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking," said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. "Smoking is the leading cause of preventable disease, disability and death in the United States, and we know these products are effective aids in helping people quit."

The agency also is requiring Pfizer Inc., which makes Chantix, and GlaxoSmithKline, maker of Zyban, to conduct a study looking at how often these serious symptoms occur.

Pfizer says it updated its label in 2007 to include information of neuropsychiatric symptoms and has revised the label again to reflect Wednesday’s warning.

"The labeling update underscores the important role of health care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely," said Dr. Briggs W. Morrison, senior vice president of the primary care development group at Pfizer. "Quitting smoking is one of the best things people can do for their health, but the quitting process is both difficult and complex."

The FDA says that since Chantix was approved in 2006, the agency has had reports of 98 suicides and 188 attempted suicides. Zyban has had reports of 14 suicides and 17 attempts.

Zyban contains the same active ingredient as the antidepressant Wellbutrin and already carried a box warning about the increased risk of suicidal thinking and behavior.

Neither Chantix nor Zyban contains nicotine, and the FDA said some symptoms could be the result of nicotine withdrawal. Still, the agency said, people using these drugs experienced some of these symptoms while they were still smoking.

In a review of side effects in patients using the nicotine patch, the agency said it didn’t find a clear link between those products and suicidal events.

Two anti-smoking drugs to carry mental-health warnings

“Bao” began his journey at St. Louis, Missouri, took a connecting flight at St. Paul, Minnesota, for Tokyo, Japan on May 7th, according to Xinhua state-run news agency.

On May 8, according to the Health Ministry, he flew from Tokyo on flight NW029 and arrived at Beijing Capital International airport on May 9 at 1:30 a.m. At the time of his arrival in Beijing, he had no symptoms and had a body temperature of 37 degrees Celsius (98.6 degrees Fahrenheit).

Soon after, he took a flight onwards to Chengdu and felt feverish, with throat pain, coughing, and a stuffy and slightly running nose and was confirmed with human swine flu on Monday, the Health Ministry said.

The patient is in isolation and is being treated at the Chengdu Infectious Diseases Hospital where he’s listed as having recovered with a normal body temperature, the Health Ministry said.

Most of the passengers aboard the same Beijing-Chengdu flight have been tracked down in 21 different provinces and sent to medical observation, according to the Health Ministry.

The case comes more than a week after a 25-year-old Mexican man with the H1N1 virus arrived in Hong Kong from Mexico via Shanghai, leading to the weeklong quarantine of more than 340 people in the Chinese special administrative region.

There have been 4,657 confirmed human cases of H1N1 in the world as of Sunday.

China confirms mainland swine flu case

Health ministers from the 10-member Association of South East Asian Nations (ASEAN) plus China, Japan and South Korea will intensify cross-border cooperation and establish joint response teams to fight the spread of the virus, also known as swine flu.

According to the statement, the ministers were concerned that most of the production capacity for vaccines was located in North America and Europe and it was inadequate for a global pandemic.

Asia has no capacity to produce vaccines at the moment.

“Despite other regions having begun to acquire the technology to produce influenza vaccines, access to effective pandemic vaccines is a major problem in the region,” the statement said, calling for the transfer of technology to make vaccines and antiviral medicine.

Chinese Health Minister Chen Zhu told reporters Beijing was pressing drug companies in China to increase the existing “quite small” national antiviral stockpile, but admitted it was a tall order to provide enough in a country of 1.3 billion people.

“Our objective is a stockpile for eventually one percent of the population. One percent is already quite huge,” he said.

He defended the quarantine of passengers on a flight from Mexico, lifted Thursday after one week.

“At this time, we think this kind of precaution and measures are still necessary, but things may change according to the analysis of the WHO and our experts,” Zhu said.

NO TRAVEL BANS

The 13 countries will look at screening people leaving affected areas but are not planning travel bans.

Evidence showed that “imposing travel restrictions would have very little effect on stopping the virus from spreading, but would be highly disruptive to the global and regional communities and pose major negative impacts on the current global economic downturn,” the statement said.

Margaret Chan of the World Health Organization (WHO) told the meeting Asian governments had to stay vigilant, but urged them to “refrain from introducing economically and socially destructive measures that lack solid scientific backing and bring no clear benefit.”

“The rational use of travel- and trade-related measures is always wise at a time of severe economic downturn,” she added.

Asia has seen far fewer confirmed cases of the H1N1 virus, which has killed 44 people in Mexico and two in the United States, and spread across Europe.

However, after the damage wrought by SARS and bird flu in recent years, Asian countries are taking no chances this time.

The statement said they would “assess the potential need and increase national stockpiling of antivirals and essential medicines, medical supplies and personal protective equipment to the level necessary for effective responses” if the flu spreads.

They would also “consider the establishment in ASEAN+3 countries of a system to facilitate the sharing of essential supplies in the region in case of emergency needs.”

ASEAN comprises Indonesia, Thailand, Singapore, Malaysia, Myanmar, Vietnam, Cambodia, Laos, Brunei and the Philippines.

Asian countries pledge common fight against flu

“We think very few of the cases we have confirmed are in people over 50,” the U.S. Centers for Disease Control and Prevention’s Dr Anne Schuchat told reporters in a telephone briefing. “Whether this will pan out over the weeks ahead we don’t know.”

The CDC reported 226 cases of the new H1N1 swine flu virus and one death in 30 states. The CDC previously had confirmed 160 cases in 21 states.

Mexican officials say they believe the outbreak there is starting to ease, although they are still trying to get a full picture of just how far the disease has spread.

Schuchat said the virus is fairly widespread in the United States, meaning that most states have reported cases. New York has the most cases with 63, many linked to a school in the New York City borough of Queens. Texas has 40 cases.

U.S. health officials said they were encouraged by signs in Mexico that the number of cases are leveling off and that there was only one death in the United States — a toddler visiting from Mexico.

Most cases in the United States have been reported to be mild. But 30 people, mostly older children and young adults, have been hospitalized with the disease, U.S. officials said.

Schuchat said that with seasonal flu, the elderly and very young are most likely to be sick enough to be hospitalized — 200,000 a year on average.

“I don’t think we are out of the woods yet,” Schuchat said. “From what I know of influenza, I do know there will be more cases, more severe cases and more deaths.”

Health and Human Services Secretary Kathleen Sebelius said on Sunday that flu vaccines for both the new strain of the H1N1 virus and the seasonal flu should be ready by autumn.

She told NBC’s “Meet the Press” that the government is accelerating production of a vaccine against the seasonal flu, which is expected to infect millions of Americans, and is beginning laboratory work on the new H1N1 virus.

Companies already are making the vaccine for the autumn months with a mixture of three influenza viruses that was chosen this year before the new strain broke out.

They have a number of choices — leaving the new strain out of the mix altogether, replacing the current H1N1 component with the new H1N1 strain, or making it a so-called quadrivalent vaccine that includes the new swine H1N1, the circulating seasonal H1N1, the H3N2 component and the influenza B strain.

It takes months to formulate influenza vaccines and they must be made fresh every ear, with new strains of the constantly mutating virus.

CDC says few people in U.S. over 50 hit by new flu

Google said it has put together a flu trends tracking system for Mexico based on the U.S. Google Flu tool launched last fall that is used by U.S. Centres for Disease Control and Prevention to figure out where influenza is heating up.

It is based on Google’s observation that people who are sick with flu tend to search for the same types of information on the Internet, and these searches can be used to predict where an outbreak may be occurring.

“We have seen evidence in Mexico that Google users also search flu-related topics when they are experiencing flu-related symptoms,” Jeremy Ginsberg, lead engineer for Flu Trends at Google, said in a telephone briefing.

Studies show that between 35 and 40 percent of all visits to the Internet are started by people looking for health information.

Ginsberg said the Mexican data have not been cross-checked with years of data on actual flu cases in Mexico like the U.S. flu tracker has, so the data may not be reliable.

But he said the company is optimistic that the system, which generates maps based on peaks in flu-related searches, “may reflect actual flu activity.”

“We did see a small increase in many parts of Mexico before major news coverage began last week,” he said.

Ginsberg said people search for different things when they are sick — like the word thermometer — than they do when they are looking for news about flu outbreaks.

Ginsberg said the group has also seen a spike in U.S.-related flu searches that correspond with increases in U.S. cases being reported.

He said the hope is that the tool might offer one more way to predict hot spots in an outbreak as they happen.

“If it spreads quickly, it may give public health officials the chance to respond quickly,” he said.

Google’s flu tool for Mexico can be found here

Google puts flu tracker to work on swine flu

The boy, whom officials did not identify, traveled to Mexico during spring break. While there, he spent time at a farm, a fair, a couple of different cities and in Mexico City, according to Elyria City Health District officials.

He got back from the trip last Monday and started having symptoms Wednesday. He went to EMH Regional Medical Center in Elyria on Friday with an elevated temperature and cold- and flu-like symptoms, Elyria City Health District Commissioner Kathryn Boylan said.

After learning about the symptoms and the family history, hospital officials decided it could be a case of swine flu.

A specimen was taken to the Ohio Department of Health lab and forwarded to the Centers for Disease Control, Boylan said.

Officials were notified Sunday morning that it was a confirmed case of swine flu.

“The child is doing just fine,” she said.

“And so for that, we are extremely grateful.”

The child, who is taking the antibiotic Tamiflu, is resting at home, officials said.

None of the other immediate family members have any symptoms, but they are taking medication as a precaution.

Elyria City Schools Superintendent Paul Rigda said officials originally did not plan to close Ely, which has about 350 first- through sixth-grade students.

However, the Elyria City Health District later got an advisory from the CDC that there could be a longer incubation period than what was originally thought, Rigda said.

Officials did not want the kids to be together for at least one week after the first case might have created the exposure to the illness. As a result, the school will be closed all week. The closure only applies to Ely.

“This is not a result of any new cases at all,” he said about the decision to close for the week.

He added the decision was just a precaution.

The district used its phone alert system to inform parents about the news, Rigda said. They sent one message to the parents of Ely students and a different message to parents with children at the other schools.

A letter with more information also will be sent home, he added.

Volunteers from the Community Emergency Response Team headed out Sunday to relay the information to families who could not receive the phone message, said Tom Kelley, director of Lorain County Emergency Management and Homeland Security.

Boylan said that if students from Ely have a sore throat, elevated temperature or other flu-like symptoms, they should consult a doctor or go to the emergency room and say they might have been in contact with the student who has swine flu.

The Centers for Disease Control and Prevention defines swine flu as “a respiratory disease of pigs caused by type A influenza viruses that causes regular outbreaks in pigs.”

There was one other case in the county where a person went to Mexico and had flu-like symptoms, said Douglas McDonald, the medical director for the Elyria City Health District. However, the preliminary tests were negative.

The symptoms of swine flu are similar to the regular flu and include a fever of 102 to 103 degrees, runny nose, nasal congestion, coughing, sore throat and lack of appetite, according to information from the Lorain County Office of Emergency Management and Homeland Security.

Swine flu is contagious and can be spread either by people or through contact with infected pigs or in environments that are contaminated with the swine flu viruses, according to information provided by emergency officials Sunday.

It cannot be transmitted by eating pork.

There is not a vaccine for swine flu, but there are medicines to treat it. The seasonal flu vaccine does not protect against swine flu.

EMH spokeswoman Kristen Davis confirmed that the hospital does not currently have any patients with confirmed swine flu and no one there is exhibiting those symptoms.

“Our ER staff is getting supplies available for testing, making them readily accessible and going through the process to increase staff if we do need to do that” in the event that more cases come about, she said.

Jennifer Kennedy, director of marketing and communications for Community Regional Medical Center in Lorain, said no one has come into their hospital with any symptoms.

“Our entire staff has been notified about the signs and symptom of swine flu, and they’re taking the proper precautions,” she said.

“We feel prepared.”

Emergency officials have set up a hot line that people can call with questions. That line, 440-324-3177, will be staffed through at least 11 a.m. today with public health nurses.

Swine flu diagnosed in Elyria

The outbreak of the new virus transmitted from human to human that has killed up to 60 people and infected hundreds in Mexico and infected eight in the United States is a “serious situation” with a “pandemic potential”, the head of the World Health Organization said Saturday.

In Mexico City, where 13 of 20 confirmed deaths occurred, officials said no deaths from swine flu had been registered on Friday, but reassurances came amid the severest public health measures seen here since a 1985 earthquake.

Meanwhile in the United States, where eight non-fatal infections occurred in Texas and California, reports said that 75 students in New York being treated for flu-like symtoms had recently traveled to Mexico, but no swine flu case was confirmed.

“A new virus is responsible” for the cases reported in Mexico and the United States, WHO Director General Margaret Chan said in a telephone press conference Saturday.

How the situation will evolve is “unpredictable,” she said, urging other countries to “increase vigilance”.

“This virus has clearly a pandemic potential,” Chan added.

Mexican Health Minister Jose Angel Cordova confirmed 20 deaths from swine flu late Friday and said authorities were probing another 48 who had died with similar symptoms.

Health officials have been investigating more than 1,000 possible swine flu infections.

Apart from the capital, four other deaths were in central San Luis Potosi, two in Baja California, in northwest Mexico, and one in Oaxaca, in the southeast.

But Cordova added that it was “an epidemic, not a pandemic.”

Mexican President Felipe Calderon said that the government would decree necessary emergency or preventative measures.

Authorities on Friday launched a huge campaign to prevent the spread of the virus, urging people to avoid contact in public.

In Mexico City, schools closed for up to a week, according to the health minister, and numerous public venues, including museums and sports stadia were closed to the public.

Mexico City Mayor Marcelo Ebrard said late Friday that 553 sporting and cultural events had been canceled for at least 10 days to avoid large public gatherings.

The capital did not register any deaths on Friday, Armando Ahued, the local health minister said Saturday.

“The good news is that sick people are reacting adequately to the medication,” Ahued said, without giving further details.

Mexico City authorities initially announced a mass vaccination campaign using regular human flu vaccines, but later admitted that the WHO had advised them that it was better to use antiviral medicines, and said they had more than one million doses of suitable drugs.

The CDC website states that there is no vaccine to specifically protect humans from swine flu, only to protect pigs.

The US Centers for Disease Control and Prevention (CDC) said tests show some of the Mexican victims died from the same new strain of swine flu that affected eight people in Texas and California, who later recovered.

The WHO, which was to send a team of experts to Mexico, said Friday that most Mexican cases had occurred in otherwise health young adults.

“Because there are human cases associated with an animal influenza virus, and because of the geographical spread of multiple community outbreaks, plus the somewhat unusual age groups affected, these events are of high concern,” the Swiss-based body said in a statement.

Seven other countries on the continent on Friday adopted preventative measures to try to avoid the spread of the virus to their territory.

In Mexico City, medical teams were on stand-by at the international airport, and all passengers had to fill out a health questionnaire.

Human outbreaks of H1N1 swine influenza virus were recorded in the United States in 1976 and 1988, when two deaths were recorded, and in 1986. In 1988 a pregnant woman died after contact with sick pigs, according to the WHO.

In recent years, the global focus for a pandemic has shifted to the H5N1 bird flu virus, which has spread from poultry to humans and killed 257 of the 421 people infected by the virus since 2003.

If a pig is simultaneously infected with a human and an avian influenza virus, it can serve as a “mixing vessel” for the two viruses that could combine to create a new, more virulent strain.

Mexico seeks to reassure over deadly swine flu

The study is the first to identify common genetic variants influencing stroke risk in the United States and may lead to better treatments, they reported on Wednesday.

While other stroke-related genes have been discovered, none involved such a wide portion of the population, said Eric Boerwinkle of The University of Texas Health Science Center.

“This is a first step in unraveling the genetic contributions of this debilitating disease,” said Boerwinkle, whose team was one of several contributing to the study published in the New England Journal of Medicine.

Stroke is the third-leading cause of death in the United States and causes serious long-term disabilities for many worldwide.

Boerwinkle said the teams found two genetic variants on chromosome 12 near two genes that are implicated in stroke. One, called WNK1, is associated with blood pressure control and the other, NINJ2, is linked with brain injury repair.

The two genes, next to each other, both are also strongly linked with ischemic stroke, which is the most common type of stroke and is caused by blocked blood vessels in the brain.

Boerwinkle said it is not clear which specific gene is implicated, but he said the most likely suspect is NINJ2.

They found two single-letter changes in the DNA, known as single nucleotide polymorphisms or SNPs — pronounced “snips” — near NINJ2 that seem to send the strongest stroke “signal.” One is found in about 20 percent of whites they checked and 10 percent of African-Americans.

Having just one copy of this genetic variation can raise the risk of ischemic strokes by about 30 percent, he said — although the study says it is unlikely the SNPs are the actual cause of stroke but probably associated with the actual genetic cause.

The findings come from an analysis of the genetic code of more than 19,000 people in the United States and Europe taking part in four long-term studies of cardiovascular risks.

The teams were looking for SNPs among 1,544 people who had strokes, compared with 18,058 people who did not.

Boerwinkle said more work needs to be done to sort out which genes are at play, but he said the findings should give drug companies a new target for researching better treatments.

Dr. Walter Koroshetz, deputy director of the U.S. National Institute of Neurological Disorders and Stroke, which supported the study, said the findings are not strong enough to alter a patient’s stroke prevention strategy.

But he said the results “will lead scientists to direct their attention to new, important biologic mechanisms and hopefully new treatments to prevent stroke.”

Scientists uncover genetic risks for stroke – Health Updates

Patients also showed improvements in the functioning of the insulin-producing cells that are attacked and destroyed in patients with type 1 diabetes.

Four of the 23 patients who took part in the study remained insulin free for at least three years and one patient went without insulin injections for more than four years.

The patients were the first to receive the novel stem cell transplant therapy to treat their type 1 diabetes.

After receiving transplants of their own blood stem cells, about half of the patients in the study became insulin free for an average of two and a half years.

But the treatment, which included the use of highly toxic immune-system suppressing drugs, was not without troubling side effects.

Two patients developed pneumonia while hospitalized for immunosuppression therapy, and nine developed low sperm counts as a result of exposure to one toxic drug. The latest results from the study appear in the April 15 issue of the Journal of the American Medical Association.

Diabetes specialist David M. Nathan, MD, who was not involved with the study, tells WebMD that the stem cell treatment is promising, but he adds that the side effects remain troubling.

“This is a pretty bold intervention that can involve serious complications,” he says. “The hope is that this will lead to more benign treatments that can keep people off insulin.”
Stem Cells for Diabetes

All the patients included in the stem cell study had been diagnosed with type 1 diabetes within six weeks of treatment, and all were producing some insulin on their own, although this production was greatly diminished.

Type 1 diabetes is an autoimmune disease in which the immune system attacks and destroys the insulin-producing cells within the pancreas.

The goal of the treatment was to kill the immune cells that were killing the insulin-producing cells and replace them with immature cells not programmed to disrupt insulin production.

The treatment, called autologous nonmyeloablative hematopoietic stem cell transplantation (HSCT), involved several steps.

Soon after diagnosis, the patients were given drugs to stimulate production of blood stem cells. The blood stem cells were then removed from the body and frozen.

Patients were hospitalized and given the toxic drugs that killed their circulating immune cells, and then the harvested blood stem cells were put back into the patient.

The first patient to receive the treatment did not improve, probably because he had too few functioning insulin-producing cells left.

But 20 of the next 22 patients treated with the experimental therapy were able to do without insulin injections or greatly reduce their insulin use for a few months to several years.

Patients who remained insulin-independent showed significant improvement in their ability to produce insulin two years after treatment, compared to pre-treatment production levels.

The ability to show direct improvement in insulin-producing cell function is important because critics have questioned whether the treatment really works.

Soon after being diagnosed with type 1 diabetes, many patients enter what is known as a “honeymoon” period, thought to result from improved diet and lifestyle.

It has been suggested that the early improvements seen in the patients who got the stem cell treatment was because of this lifestyle-related remission and not the treatment.

“This treatment actually stopped the autoimmune process and the remaining [insulin-producing] cells that were not destroyed worked well enough to keep many of these patients off insulin,” Nathan says.

Stem Cells Promising for Type 1 Diabetes – Health Updates

Researchers at the University of Rochester Medical Center in New York gave teriparatide (Forteo) to 145 people who had bone fractures that had not healed, many for six months or more. They found that 93 percent of them showed significant healing and pain control after eight to 12 weeks.

Teriparatide speeds the healing of fractures by changing the behavior and number of cartilage and bone stem cells involved in the healing process, the researchers found.

"The decreased healing time is significant, especially when fractures are in hard-to-heal areas like the pelvis and the spine, where you can’t easily immobilize the bone — and stop the pain," Dr. Susan V. Bukata, medical director of the university’s Center for Bone Health, said in a news release from the center.

"Typically, a pelvic fracture will take months to heal, and people are in extreme pain for the first eight to 12 weeks," she said. "This time was more than cut in half. We saw complete pain relief, callus formation and stability of the fracture in people who had fractures that up to that point had not healed."

Based on the findings, the news release said, the U.S. National Institutes of Health has funded a clinical trial of the drug’s use on fractures. The study will include men and post-menopausal women older than 50 who have what’s called a low-energy pelvic fracture and who are admitted to the emergency department of Strong Memorial Hospital in Rochester.

Participants in the study will be given either teriparatide or a placebo and will be followed for 16 weeks to measure fracture healing in a number of ways, including pain levels, microscopic bone growth determined through CT scans and functional testing of bone strength.

Teriparatide was approved by the U.S. Food and Drug Administration in 2002 as a treatment for osteoporosis.

If clinical trials prove that the drug speeds bone healing, it could prove especially important for older adults, who suffer the majority of broken bones that heal slowly.

"In many people, as they get older, their skeleton loses the ability to heal fractures and repair itself," J. Edward Puzas, head of orthopedic bone research at the medical center and the lead investigator for the clinical trial, said in the news release. "With careful application of teriparatide, we believe we’ve found a way to turn back the clock on fracture healing through a simple, in-body stem cell therapy."

Bracing and immobilization cannot be used for the approximately 60,000 Americans who suffer a pelvic fracture each year.

"It takes three to four months for a typical pelvis fracture to heal," Bukata said. "But, during those three months, patients can be in excruciating pain, because there are no medical devices or other treatments that can provide relief to the patient."

"Imagine if we can give patients a way to cut the time of their pain and immobility in half?" she said.

Speeding the healing time for pelvic fractures could also reduce the risk of death and medical costs.

Pelvic fractures carry the same risk of death as hip fractures. About "one-quarter of all older women with pelvic fractures will die from complications," Bukata said. "And during that year of recovery, a patient typically puts a greater strain on our health-care system, not to mention their pain and suffering."

Slow-Healing Bones May Get Boost From Drug – Health Updates