Medical accidents kill more people than traffic accidents

by Michael Woodhead
In China there are about 8 million unnatural deaths every years and of these about 400,000 are said to be due to medical accidents - often due to unsafe use of medicines. To try and remedy this poor situation, September has been nominated as national medication safety month by the China State Food and Drug Administration.

According to pharmacist Zhang Jichun of the Chinese Pharmaceutical Association, this high rate of accidents and adverse reactions with medications is due to widespread ignorance in the population about appropriate use of medical drugs. A recent survey of more than one million Chinese found that only about one in ten could answer correctly questions about basic drug safe use.

The higher error rate with drug misuse included allergic reactions to antibiotics in babies and infants, misuse of drugs by pregnant women causing birth defects and adverse birth outcomes, accidental drug overdoses, misuse of sleeping tablets causing accidents, using drugs past their shelf life, taking multiple drugs and causing interactions, abuse of weight loss drugs causing cardiac problems and deaths and failing to use cardiac drugs in sufficient doses leading to heart attacks and strokes.

The survey found that there were many problems with the way Chinese people used medications. About 90% bought prescription drugs from pharmacies and self-treated without getting advice or a diagnosis from a doctor. Almost 70% did not read the package insert and a third made major mistakes in dosing while 25% did not take the medicine correctly and failed o get the expected benefit.

 Zhang Jichun said many of the problems with drugs occurred in children and the elderly, who were more susceptible to their effects. A typical and common avoidable serious problem was deafness seen in 300,000 children due to overuse of some classes of antibiotics. This side effect occurred due to parental medication without being aware of the risks.

In the elderly one of the main problems was excessive medication, he added. Many elderly people take several different drugs for various ailments without understanding that they can interact to cause severe side effects, he said. Elderly people also made the mistake of taking western medicines with Chinese traditional medications, and this could also cause problems he said.

To try address this problem the China Pharmaceutical Association has set up a "medication safety expert advice hotline” and invites all Chinese to seek advice before using medications.

Illegal ambulances in Beijing ... dogs spread H7N9 ... new vaccines for EV71: eight medical news stories from China

by Michael Woodhead

1. Illegal ambulances in Beijing
One of the most bizarre stories of the week is that of the 'fake' ambulances plying their trade around Beijing hospitals. After hearing about fake drugs and fake doctors being widespread in China it should not come as any surprise to hear that shanzhai (山寨) unofficial ambulances are also operating. According to the Beijing Times the illegal ambulances park near major hospitals in the city and offer their transport services to patients. It is said that the poorly-equipped unofficial ambulances work in collusion with the hospital staff (who receive commissions) to charge patients exorbitant prices for transporting patients to and from hospitals and as transfers between hospitals. "Security guards at many hospitals have tried to stop these illegal ambulances from operating in and around their facilities, but they are afraid of being sued by patients and family members for delaying medical treatment," the article says.The unofficial ambulances have found a gap in the market because there is an insufficient number of genuine ambulances, the article says.

2. Dogs spread H7N9
Feral dogs that live around poultry farms and live poultry markets may be a key to spreading of the disease, say researchers from South China Agricultural University, Guangzhou. In a study of 2357 dogs, they found that 4% showed evidence of influenza A infection (though not specifically H7N9). Writing in Clinical Infectious Diseases, they said that feral animals "may increase the risk of the emergence and transmission of novel influenza A viruses and serve as a threat to both veterinary health and human public health ... As man lives in very close contact with dogs in many areas of the world,we posit that surveillance for novel viruses among feral dogs living in close proximity to
live poultry markets or poultry farms could serve as an early warning system of viral threats to man."

3. Zhejiang markets ground zero for avian flu
In the same vein, researchers in Zhejiang have found that poultry kept in local markets carry a veritable cocktail of influenza viruses including H7, H9 and H5 and two NA subtypes (N9 and N2), as well as H7N9-related reassortment intermediates H9N9. "The co-circulation not only reveals that Huzhou is one of the geographic origins of the novel H7N9 virus, but also poses a potential threat to humans in the future," they conclude.

4. Hand foot and mouth vaccine in the pipeline
More optimistic news in relation to another virus, namely EV71 enterovirus, the causative agent fro hand foot and mouth disease. A review article from the Third Military Medical University and National Engineering Research Center for Immunological Products, Chongqing notes that China has developed three promising vaccines against the disease that have passed Phase III trials, and are expected to be available in the near future.

5. Antivirals in more kindergartens
The scandal over the drugging of kindergarten children with antivirals is widening, with claims that a kindergarten in Jilin has also been giving the drugs without parental consent. The initial reports from Shaanxi that children were being given antiviral prophylaxis supposedly to prevent coughs and cold have justifiably caused outrage among parents. The odd thing is why such an obscure antiviral as the biguanide moroxydine was chosen to give children.

6. Ulcers from fat injections
A 38-year old Beijing woman is taking legal action against a Chaoyang health and beauty spa for half a million yuan in compensation after the "fat dissolving injections" she was given resulted in severe ulcers. In a court case the woman said the 'medical' staff at the clinic were unqualified and the "no side effect" lipolysis injections turned out to be albumen that triggered allergies and skin ulceration requiring skin grafts.

7. Gay 'cure' clinics do thriving business
The Economist has a feature on the 'homosexuality cure clinics' in China, where people can pay around $1700 or a three month program of psychological treatments that supposedly deter them from having gay tendencies by giving them unpleasant injections and treatments in while watching sexual imagery. The clinics are said to be encouraged by the Confucian social pressure to be a good child and conform with traditional Chinese values.

8. Fake medical ads still widespread
And while we are on the subject of dodgy treatment Xinhua reports that advertisements for fake and worthless remedies and clinics are as widespread as ever, despite laws intended to crack down on the. In a long article, Xinhua reporters describe how newspapers are still full of ads for fake treatments or treatments for which exaggerated claims are made. Industry insiders said the marketing of fake medical products and services was a high profit, low risk business as there was little enforcement. Government departments said fake products were widespread and it took a lot of time and resources to track them down and prosecute offenders.

Medical news - seven China links

1. With more than 10,000 new cases of HIV a year, Yunnan is to fund more NGO anti-HIV programs and improve healthcare for people with the infection.

2. New regulations on genome sequencing are to stop clinics ripping off consumers by offering the sequencing as part of routine health checks or to help predict children’s potential abilities, officials say.

3. Malnutrition is still a major problem in some parts of rural China, with one in every five children under the age of five years in poor areas needing better nutrition. Local governments have been set a benchmark of 29 kg per capita meat consumption standard to benefit children in underdeveloped region.

4. Pilot schemes have been set up in 27 provinces to allow rural migrants to claim medical insurance benefits away from their home town.

5. About 13 million deaths from smoking-related illness could be avoided if China adopted WHO recommendations on tobacco control, a paper in the BMJ says.

6. Adverse effects from drugs - and especially antibiotics - are a major health burden for hospitals in China and also cost thousands a of yuan a year for hospitals and patients alike in extra care costs, a study has suggested.

7. Only 9% of boys and 2% of girls in China get the minimum amount of physical activity per week to maintain health, a study carried out in 11 cities has found.

China medical news headlines for Tuesday 28 January

Hospital care declines after switch to contract nurses
China's hospitals are no longer employing career nurses but opting for cheaper contract nurses, resulting in inferior levels of care, researchers from the School of Nursing, Sun Yat-sen University,  Guangzhou have shown.  Their study found that hospitals are moving away from the 'bianzhi' system of state-guaranteed lifetime employment to a contract-based nurse employment system with limited job security and reduced benefits. This may adversely affect both nurse and patient satisfaction in hospitals, the study found.

Tamiflu call for H7N9 flu
The increasing threat of H7N9 avian influenza has prompted Shanghai to shut down bird markets after 12 deaths in surrounding areas.  Live poultry trading has been banned in nearby Zhejiang cities, after 49 human H7N9 infections and 12 deaths were reported this month, says the Shanghai Daily.  Meanwhile Zhong Nanshan, director of the Guangzhou Institute of Respiratory Diseases has suggested early and longer use of antiviral drug Tamiflu for H7N9 patients.

Death sentence for hospital attack
The man who killed a doctor at a Zhejiang hospital in a medical dispute has been sentenced to death by a Taizhou court.  The 33-year old man stabbed a doctor to death at Wenling hospital and wounded two other doctors because he was unhappy with surgery to cure a nose problem which he said was causing extreme pain, according to the Global Times.

Boy died after drip infusion
Shanghai authorities are investigating how an allergy-prone boy died after having an IV drip infusion treatment for a cold at a local hospital.  The boys parents allege that the hospital has covered up the incident and switched the infusion packaging to prevent analysis of the fluid used, according to ECNS.

The "Corridor Doctor" - whistleblower or crank?

translated by Michael Woodhead
An interesting follow up to last week's story about the female doctor from Mianyang, Sichuan, who ended up working in a corridor of her hospital for two years after being removed from office for raising concerns about overtreatment and profiteering at the hospital.
In a new article, reporter Chen Xi for the Sichuan office of the Peoples Daily describes how he went to the hospital to follow up her claims and find out the background to her sacking and allegations of 'overservicing'. What he heard was a mixture of  good and bad about the would-be whistleblower.
First he spoke to Dr Lan, who said that she had always aimed to be a 'pure' doctor and wanted to be seen as one of  the 'angels in white' (ie female doctors in white coats).
However, when she started working at the Mianyang hospital she found that every activity involved putting generation of income for the hospital first. She said that practicing good medicine was constrained by the pressure to meet income targets. Patients were often admitted for treatment they did not need, and Dr Lan felt this was a breach of medical ethics. When she took her concerns to the director of the hospital, his reply was: "What are you on?"
As we reported last week, Dr Lan was stood down and barred from using her office in the ultrasound department in 2009 after she questioned the use of a cardiac pacemaker in a 53-year-old patient who had varicose veins. She said there was no need for a pacemaker in a patient who had a stable heart rate and who had already been cleared for vascular surgery.
Dr Lan also had another complaint - she said that the hospital had misappropriated thousands of yuan in earthquake relief funds donated in 2008 by Macau to aid survivors from the Wenchuan earthquake. As head of the ultrasound department, Dr Lan learned there was 235,000 Yuan in donations provided to buy a state-of-the-art Colour Doppler ultrasound scanner. However, when the machine was delivered it turned out to be an out-of-date model that was worth only 160,000 Yuan. It was not clear what had happened to the rest of the money donated from Macau. Dr Lan said she was so angry she left the old machine from the warehouse.

When the reporter tried to put these questions to the hospital management, he was told the hospital director Wang Yanming was not available. However, a deputy director, Feng Jianjun, tried to answer some of the questions.
First of all he rejected Dr Lan's claim that a cardiac pacemaker was not needed for the patient with varicose veins. He said it was usual for patients with vascular disease who needed surgery to have an atropine test. If the patient's heart rate was below 90 beats per minute then this indicated that they needed a pacemaker. In the case  raised by Dr Lan, the patient's heart rate was 60 per minute, showing that a pacemaker was clinically indicated, the hospital deputy director said. The pacemaker was needed to prevent the patient from having an adverse outcome during surgery, he said - so how could this be construed as overtreatment or inappropriate treatment?
Dr Lan ridiculed this claim, saying that it didn't make sense for a patient to be sent for tests after they had been deemed as ready for surgery - this was upside down, as pateints were alsways tested before being referred for an operation, she said.

The reporter sought comments on Dr Lan from other doctors at the hospital. An anaesthetist at the hospital said 'overtreatment' was a grey area and even clinical experts often disagreed strongly on what was the most appropriate treatment for a patient. Therefore, Dr Lan could be right or wrong.
Several doctors said Dr Lan was a hardworking and honest doctor, but with a stubborn individualistic streak and an obsessive personality. Some said she was  a loner who did not communicate or consult well with other doctors. One doctor described Dr Lan's self-image as the only 'pure' doctor as naive, while another said she was known to have strong and unbending opinions about subjects outside her area of expertise. A doctor in the obstetrics department said Dr Lan had often seen his patients and made treatment decisions on obstetrics matters that he did not agree with. She did not accept or understand that ultrasound was an ancillary branch of medicine and that it was inappropriate for her to criticise the diagnosis and treatment decisions of doctors outside her area.
Some doctors told the reporter that Dr Lan was the author of her own troubles, and that it was a joke that she chose to 'practice' in a corridor for two years. For this reason she had become know as "Dr Crazy" by some.
In Mianyang, authorities including the local health department said in a statement that they were now mounting multiple inquiries and audits into the claims made by Dr Lan. The inquiries would look in detail at her claims that patients were being overtreated only to generate income and that unnecessary and inappropriate treatments were being regularly used. As part of the investigation, authorities are  to review all CT scans and ultrasounds of patients for the last three years and check whether the treatments matched the diagnosis.

China medical news headlines for Friday 17 January

Monitor and treat the best way for hepatitis B

Monitoring inactive chronic hepatitis B carriers is a cost-effective strategy for China, a study shows. The findings published in Hepatology, also show that increasing treatment, monitoring and adherence to therapy are necessary to achieve significant health benefits at the population level.
Shanghai researchers compared the current strategy of not monitoring inactive chronic HBV patients to a monitor and treat strategy which included twice-yearly assessment of HBV and ALT levels. For active HBV cases the researchers suggest treatment with the antiviral entecavir, which evidence shows to be a cost-effective antiviral therapy in China.
The study found that there were 1.5 million adult HBV arriers of HBV in Shanghai, of whom 63% were hepatitis B virus e antigen (HBeAg) positive. The number of active cases of chronic HBV, were 258,139 in the eAg-positive group and 152,384 in the HBeAg-negative group. A monitor and treat strategy would reduce liver cancer by 70% and reduce mortality caused by chronic HBV by 83%, according to News Medical.

China too hard for US generic drug maker

One of the world's biggest generic drug manufacturers has quit China, saying it is too hard to do business there. The US generic maker Actavis has said it will exit China because the business climate is just 'too risky' according to its CEO.
“It is not a business friendly environment,” CEO Paul Isaro is quoted as saying by Bloomberg.

Beijing wants foreign medical city

Beijing is to set up an International Medical Service Zone in Tongzhou District in 2014, Xinhua reports. The 15 square kilometre zone is intended to be a model of medical reform that will integrate social and foreign investment. Beijing hopes the zone will attract doctors and medical experts from Beijing's top public hospitals as well as draw in international medical institutions to set up shop in a healthcare hub. The aim is to have world-class medical facilities, education institutions, medical research personnel, rehabilitation and nursing homes and health management facilities all in one place.

TCM a leading cause of liver failure

Traditional Chinese Medicine is a major cause of acute liver failure in China, according to a report in PLOS One. In a review of 177 Chinese patients with liver failure, 17% had received herbal remedies, and TCM was believed to be a more frequent cause than any other factor, the Global Times reports. Of all the patients diagnosed with acute liver failure 44% developed the condition due to drug or herbal remedy toxicity, and herbal remedies, accounted for more liver failure than paracetamol.

Medical stories from the Chinese media: girl dies after infusion to treat common cold

A four year old girl died at a hospital in Anshan, Liaoning after receiving an IV tonic infusion as treatment for a cold. The parents of the girl took her to the Angang Group Main Hospital when she had a cold. She received an IV infusion but started to gasp and feel short of breath and asked to have the drip removed. When the parents asked the doctor to do this he refused and said it was too much trouble and the girl should just try to sleep. The article says the patrents saw their daughter struggling for half an hour and begged the doctor to remove the infusion line, but he refused. The girl then lapsed into unconsciousness and died.
A spokesman for the hospital said everything was done to try save the child, but treatment was unsuccessful, and staff had not done anything wrong. He said an investigation was underway and would have to wait until results of the autopsy and tests on the drug infusion were available.
The article is published at Qianzhan.com

Hepatitis B vaccine in China: the unanswered questions

Commentary by Michael Woodhead

The deaths of 17 Chinese infants reported as having have followed hepatitis B vaccination are a tragedy that needs to be be fully investigated. When the first deaths occurred, the suspicion lay with a vaccine made by Shenzhen BioKangtai, with reports that certain batches of the vaccine were linked to the deaths of newborns in several provinces who had received vaccines with the specific batch number. Matters then became confused when reports were made of deaths of infants who had received other vaccines, including one made by a company called Beijing Tiantan. In all, 17 deaths have been officially reported in relation to hepatitis B vaccine.
When the first deaths were reported, the China Food and Drug Administration (SFDA) and the National Health and Family Planning Commission (NHFPC) ordered a halt to the use of the Biokangtai vaccine in China's newborn vaccination program and an investigation into the vaccine used.

After a rapid investigation of less than two weeks it has been announced that no problems have been found with the batches of Biokangtai's vaccine reportedly involved in the deaths and adverse reactions. The SFDA has also found no problems in the manufacturing, storage, transport or injection of the vaccine. Nevertheless, manufacturing permissions have been suspended for the three major manufacturers of hepatitis B vaccine, on the grounds that their facilities had not met the new GMP criteria for vaccine prodiction that came into effect on 1 January.
Post-mortem investigations into the infant deaths have also excluded the vaccine in nine cases, so far, and the other eight cases are waiting for autopsy results. Thus the hepatitis B infant vaccination campaign has quickly been given the all clear by the various authorities, and this verdict has been endorsed by the local branch of the WHO. The WHO representative rightly pointed out that the hepatitis B program was based on a good vaccine and prevented many cases of diseases and death every year. However, the announcement about the vaccine being safe was met with anger from some of the families of the children who died, and there has been disbelief on online forums about the "all clear" verdict from netizens who have little faith in monitoring of safety and quality of foods and medicines in China.

Despite the endorsement of WHO, there are still areas of doubt and unanswered questions in relation to the safety of China's hepatitis B vaccine and other child vaccine programs. First of all, if a vaccine was not responsible for the infant deaths, what was or were the real causes? With millions of newborns being vaccinated it is statistically probable that some natural infant deaths will co-incide with the time of vaccination. But the reports of 17 deaths in association with hepatitis B vaccination require in-depth investigation. Another question is whether it is possible to confidently rule out the vaccine as a possible factor in the cause of death. The investigations into the child deaths and into the vaccine quality and usage were done very quickly, raising questions about how thorough and comprehensive they were. There was also little transparancy about the process.
By comparison, when a similar series of vaccine-linked adverse events was seen in Australian infants given flu vaccine in 2010, authorities followed this up with several major inquiries. One inquiry was overseen by an independent clinician who examined the timeliness and appropriateness of the responses to the events. A second inquiry looked at the systems in place to monitor vaccine adverse events. A third inquiry looked into the vaccine manufacturing and quality issues. These separate inquires continued for months and in one case extended for more than a year. They concluded that a manufacturing anomaly had caused the vaccine batch for that year to be more 'reactive' than usual and to provoke more adverse effects. As a result, flu vaccine made by this manufacturer was banned from use in children, while products from other manufacturers continued to be allowed to be used. The other inquiries found that vaccine event monitoring and responses could have been better, and that information sharing had been poor and could be improved.

The recommendations from these inquiries were accepted by the Australian government, which has started to implement new vaccine monitoring and oversight systems. China could learn much from the Australian response to a series of vaccine related adverse events, to improve vaccine safety monitoring and response systems and to improve transparency in the whole process.
A clear and open response on the issue is needed from the Chinese authorities to maintain confidence in the safety of vaccination programs for children. It is not enough to point out that 15 million children receive the hepatitis B vaccine each year with the vast majority showing no ill effects and that the vaccine program prevents millions of cases of severe illness and death. Given the previous food and drug quality safety scandals seen in China - and the lack of public faith in the responses from the authorities - it is not surprising that there is now a crisis of confidence in the quality of China's food and drug products. Let us hope that vaccines do not become like milk powder, with parents only having faith in imported foreign brands for their newborns.

China's top 3 hepatitis B vaccine makers ordered to stop production because of GMP failings

by Michael Woodhead
China's three major manufacturers of hepatitis B vaccine have been ordered to suspend production because they have failed to meet new stringent GMP criteria that came into effect in 1 January.
The order from the Chinese Food and Drug Administration (SFDA) applies to Shanzhen Biokangtai, whose hepatitis B vaccine has been linked to a string of deaths among newborns in recent weeks. It also applies to Dalian Hanxin and Tiantan Biologicals.
According to a report from Xinhua, the vaccine manufacturers knew in advance that they had to meet the new GMP criteria by 1 January but failed to do so. The report says the new GMP criteria apply to all aseptic manufacturing plants, of which there are 1319 in China. It says two thirds have already met the new GMP requirements and others are working towards them. However, the three hepatitis B vaccine manufatcurers have not met the criteria and have been told that any further products produced from 1 January will not be accepted for use in China.
The Xinhua report notes that the three manufacturers account for about 80% of hepatitis B vaccine producetion in China. other manufacturers such as Hualan and Huabei have achieved GMP licencing but produce only about 10% of the vaccine supplies.
The SFDA says new GMP criteria apply to all manufacturers, and they estimate that there are GMP-compliant manufacturers for all 171 essential medicines. Mannufacturers who have not yet met the criteria have stockplied supplies of essential medicines, Xinhua notes.
The SFDA empahises that the move is only a temporary suspension of manufacturing and it is not ordering the  manufacturers to shut down the production facilities. Production may be resumed once the manufacturers show they are meeting GMP requirement, the SFDA says.

Doctors warn of oestrogen in meat as Henan girl develops puberty at 4 years of age

by Michael Woodhead
Doctors in Henan says the precocious puberty reported in a 4-year-old girl may have been caused by her mother's use of oestrogen-like drugs while breatfeeding or by her intake of foods such as chicken that were high in added hormones.
The girl from  Pingdangshan is reported to have developed breasts and started menstruating at the age of four. She is now undergoing treatment at the local hospital but her family say they cannot afford the 2000 RMB cost of monthly injections that she will need until the age of 12 to counter the condition, according to a report from Xinhua.
The girl comes from a poor farming family in the mountainous and deprived Ruzhou country. Her parents say the puberty effects first started to appear when she was two years old. Her family took her to the local hospital but it was only a very basic clinic and the doctor there did not have the expertise to examine or diagnose a hormonal condition in a small child. She was only diagnosed properly when they took her too the city of Zhengzhou. Even at that early age, doctors said her skeleton resembled one of an 8 or 9 year old. The Zhengzhou hospital clinicians worked out a long term treatment plan for the young girl who was already showing signs of breast development and menstruation. However, her family struggled to find the 30,000 RMB needed to pay for monitoring tests and hormonal treatment.
A doctor involved in the case siad the girl was showing body changes at 3-4 years of age that would normally only start at 8-9 years of age at the very earliest. He feared that f the girl did not get proper inhibitory treatment she would suffer physiological damage and show premature ageing.
As to the cause of the condition, he said it appeared to be due to external factors rather than an inherited or innate disease. he speculated that the premature puberty might have been caused by early exposure of the girl to high levels of sex hormones such as oestrogen. This might have occurred as she was breast fed and her mother had used medicines that contained the hormone. In addition, the precocious puberty may also have been made more likely due to hormones in the food she and her mother consumed.
"We advise families that food such as chicken, beef, soya milk and egg white can all contain high levels of oestrogen and should be eaten in only small amounts by daughters in particular."

China reports 12th hepatitis B vaccine-related death

An infant in south China's Hainan Province died on Friday after receiving hepatitis B vaccine, local authorities said, bringing the total of such cases to 12 in the country.
Medical specialists are on their way to look into the cause of death in Lin'gao County in Hainan.
This is the third infant death linked to hepatitis B vaccines produced by the Beijing Tiantan Biological Products Co. Ltd.
Source: Peoples Daily

Hepatitis B vaccine death toll rises to seven, questions asked about slow recall

Seven children have now died in China since November following hepatitis B vaccination, raising questions of the effectiveness of the emergency response.
To date, four infants have died in south China's Guangdong Province after hepatitis B vaccinations with products made by Biokangtai,a Shenzhen drug manufacturer, the Provincial Disease Control and Prevention Center said on Monday. The four deaths in Guangdong occurred in Zhongshan, Jiangmen, Shenzhen and Meizhou, but the Zhongshan case was not related to the vaccine. The baby in that case died of pneumonia, according to the center. Autopsy results have not yet been released for the other three cases. Cause of the death can only be confirmed after autopsies which normally take 30 working days. Two babies in neighboring Hunan Province and another in the southwestern province of Sichuan died in similar circumstances, according to the National Health and Family Planning Commission. A circular on Friday ordered suspension of Biokangtai vaccinations,two weeks after the first Biokangtai link was established on Dec. 6. Babies died in Hunan on Dec. 9 and in Shenzhen on Dec. 17.

Guangdong buys extra hepatitis B vaccine to replace suspect batches

Guangdong has purchased 1.45 million doses of hepatitis B vaccine for the province after health authorities halted the use of a vaccine suspected in the deaths of four babies.
A baby boy in Shenzhen died on Tuesday after being inoculated with hepatitis B vaccine produced by Biokangtai, a local pharmaceutical company.
His death was the fourth such recently after babies were inoculated with the hepatitis B vaccine produced by the company, according to China Food and Drug Administration.
Two babies in Hunan province and another in Sichuan province died recently after being injected with the Biokangtai vaccine.
On Friday, the administration and the National Health and Family Planning Commission asked all hospitals to stop using the vaccine produced by Biokangtai, and said it will investigate the cause of the deaths and examine the company's products.

More details released on hepatitis B vaccine deaths and recall

An infant who became sick just minutes after a hepatitis B vaccination and died an hour later may be the fourth victim of vaccines produced by China’s largest hepatitis B vaccine supplier in the southern city of Shenzhen.
The deaths have triggered a nationwide suspension.
An official investigation is underway, while Biokangtai has not said where vaccines from the same batch as the Shenzhen baby received may have been sold.
Last Tuesday, the boy, born at 10:31am and apparently healthy, was given a vaccination six minutes later. At 10:39am, his face turned blue, his cries became faint and his breathing became rapid due to a lack of oxygen, Dr Yang Jinmin at the Nanwan People’s Hospital in Shenzhen, Guangdong Province, said.

Shenzhen Kangtai Hepatitis B vaccine withdrawn after four infant deaths

by Michael Woodhead
The China Food and Drug Administration (SFDA) has suspended the use of recombinant hepatitis B vaccine for children manufactured by Shenzhen Kangtai Biological Products (Shenzen Kangtai Shengwu Zhipin, 深圳康泰生物制品股份有限公司) after the four deaths were reported among children who received the vaccine. According to an announcement by the SFDA on 20 Dec, the four deaths were reported following vacination with batches of the company's vaccine in Hunan, Guangdong and Sichuan. The SFDA says an investigation into the cause of death is still underway and until the results of this investigation are available, the use of all batches of the vaccine is being suspended immediately, in the interests of child safety and safety of the infant vaccination program.

Hunan investigates hepatitis batches after two deaths

Health authorities of Hunan, central China, are investigating three cases of adverse reactions to hepatitis B vaccination, including two deaths.
A one-month-old boy died on December 6 in Hengshan County, two days after being vaccinated. Another eight months old died in Changning City on December 9, one day after vaccination for both hepatitis B and flu. A third newborn in Hanshou County showed a severe adverse reaction after being vaccinated on November 25, the Hunan Provincial Center for Disease Control and Prevention said Monday.

Chinese FDA issues reminder on fluoroquinolone safety

China’s national Food and Drug Administration (SFDA) has issued a reminder to clinicians on the potential for adverse effects with overuse and misuse of fluoroquinolone antibiotics.

In a statement released this week, the SFDA said that fluoroquinolones were potent antibiotics but there was a need for prudence in their use because of the risk of adverse effects. The update in the Adverse Drug Reaction Information Bulletin said that the antibiotics may aggravate myasthenia gravis, cause peripheral neuropathy and increase the risk of hypoglycaemia in diabetes.

The SFDA recommended that clinicians adhere closely to prescribing advice for fluoroquinolone drugs, with attention to appropriate indications, dosage, drug interactions, and use in special populations, The SFDA also recommended that  pharmaceutical companies improve the monitoring of adverse drug reactions, and publicise the rational use of the drugs to prescribers.

Source: SFDA

Vaccine adverse reaction no higher in China than other countries

by Michael Woodhead
A review of vaccine-related adverse effects in China has found hat rates are in line with those seen in other countries.
Researchers from the National Immunisation Program, Chinese Centre of Disease Control and Prevention, Beijing, found that overall rates of adverse events following immunisation (AEFI)  in China were in line with other health systems, though there was considerable regional variation. Rates of adverse events ranged from 2.3–38/100,000 doses.
As in other countries, the highest rates of adverse events were seen after immunisation with diphtheria–tetanus–pertussis (whole-cell) vaccine  and DTP (acellular) (DTaP) vaccines. Lower rates of adverse events were seen for vaccines against hepatitis B virus, poliovirus, and Japanese encephalitis virus.
"Overall adverse events following immunisation  reporting rates in China were consistent with similar post-marketing surveillance systems in other countries. Sources of regional heterogeneity in AEFI reporting rates and their relationships to differing vaccine manufacturers versus differing surveillance practices, and safety of key vaccines suggested higher reporting rates require further exploration," the researchers conclude.
Read more: Vaccine.