The well-known consumer advocacy group Public Citizen is asking the FDA to add black-box warnings to the labels of Viagra, Levitra, and Cialis. The drugs, used to treat impotence, have been linked to an increase in incidences of blindness among patients.  

The petition calls for the FDA to add the highest level of drug warning to the labels of Viagra, Cialis, and Levitra as well as Revatio, a drug used to treat hypertension.

A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored.  NAION is one of the most common causes of abrupt vision loss in older individuals.  

People with diabetes and heart disease are specifically at risk for developing NAION.  Incidentally, these two risk factors are also two of the leading causes of impotence.

In July, two less severe warnings were added to the labels of Viagra, Cialis, and Levitra regarding sudden vision loss but the FDA said that it could not yet be determined if the drugs were the reason for the reported cases of NAION.  

At that time, the FDA advised patients to stop taking the pills and to notify their physician immediately if they experienced a sudden or decreased loss of vision in one or both eyes.  

In order to further examine this risk, however, Public Citizen looked at FDA data and compared the rates of individuals who were taking impotence drugs and those taking Lipitor, a cholesterol lowering drug that is used by people with similar risk factors.  

The findings indicated that the number of reports of NAION per million prescriptions was 18 times higher for Viagra patients and 25 times higher for Cialis patients compared to individuals taking Lipitor.  

Pubic Citizen has argued that this indicates a higher risk of blindness for patients taking impotency drugs than previously acknowledged by the FDA.

Between 1998 and 2004 the FDA reported 48 cases of NAION in individuals taking Viagra.  Other visual problems were reported by an additional 50 people.

Yet out of some 89 million prescriptions that were issued during that time period, only a handful of people actually experienced this adverse risk.

Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group argues that the FDA must take responsibility to immediately inform consumers about the risk relating to impotence drugs.  The only acceptable solution, he says, is for a black-box warning to be issued. 

The well-known consumer advocacy group Public Citizen is asking the FDA to add black-box warnings to the labels of Viagra, Levitra, and Cialis. The drugs, used to treat impotence, have been linked to an increase in incidences of blindness among patients.  

The petition calls for the FDA to add the highest level of drug warning to the labels of Viagra, Cialis, and Levitra as well as Revatio, a drug used to treat hypertension.

A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored.  NAION is one of the most common causes of abrupt vision loss in older individuals.  

People with diabetes and heart disease are specifically at risk for developing NAION.  Incidentally, these two risk factors are also two of the leading causes of impotence.

In July, two less severe warnings were added to the labels of Viagra, Cialis, and Levitra regarding sudden vision loss but the FDA said that it could not yet be determined if the drugs were the reason for the reported cases of NAION.  

At that time, the FDA advised patients to stop taking the pills and to notify their physician immediately if they experienced a sudden or decreased loss of vision in one or both eyes.  

In order to further examine this risk, however, Public Citizen looked at FDA data and compared the rates of individuals who were taking impotence drugs and those taking Lipitor, a cholesterol lowering drug that is used by people with similar risk factors.  

The findings indicated that the number of reports of NAION per million prescriptions was 18 times higher for Viagra patients and 25 times higher for Cialis patients compared to individuals taking Lipitor.  

Pubic Citizen has argued that this indicates a higher risk of blindness for patients taking impotency drugs than previously acknowledged by the FDA.

Between 1998 and 2004 the FDA reported 48 cases of NAION in individuals taking Viagra.  Other visual problems were reported by an additional 50 people.

Yet out of some 89 million prescriptions that were issued during that time period, only a handful of people actually experienced this adverse risk.

Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group argues that the FDA must take responsibility to immediately inform consumers about the risk relating to impotence drugs.  The only acceptable solution, he says, is for a black-box warning to be issued. 

The well-known consumer advocacy group Public Citizen is asking the FDA to add black-box warnings to the labels of Viagra, Levitra, and Cialis. The drugs, used to treat impotence, have been linked to an increase in incidences of blindness among patients.  

The petition calls for the FDA to add the highest level of drug warning to the labels of Viagra, Cialis, and Levitra as well as Revatio, a drug used to treat hypertension.

A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored.  NAION is one of the most common causes of abrupt vision loss in older individuals.  

People with diabetes and heart disease are specifically at risk for developing NAION.  Incidentally, these two risk factors are also two of the leading causes of impotence.

In July, two less severe warnings were added to the labels of Viagra, Cialis, and Levitra regarding sudden vision loss but the FDA said that it could not yet be determined if the drugs were the reason for the reported cases of NAION.  

At that time, the FDA advised patients to stop taking the pills and to notify their physician immediately if they experienced a sudden or decreased loss of vision in one or both eyes.  

In order to further examine this risk, however, Public Citizen looked at FDA data and compared the rates of individuals who were taking impotence drugs and those taking Lipitor, a cholesterol lowering drug that is used by people with similar risk factors.  

The findings indicated that the number of reports of NAION per million prescriptions was 18 times higher for Viagra patients and 25 times higher for Cialis patients compared to individuals taking Lipitor.  

Pubic Citizen has argued that this indicates a higher risk of blindness for patients taking impotency drugs than previously acknowledged by the FDA.

Between 1998 and 2004 the FDA reported 48 cases of NAION in individuals taking Viagra.  Other visual problems were reported by an additional 50 people.

Yet out of some 89 million prescriptions that were issued during that time period, only a handful of people actually experienced this adverse risk.

Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group argues that the FDA must take responsibility to immediately inform consumers about the risk relating to impotence drugs.  The only acceptable solution, he says, is for a black-box warning to be issued. 

Alan Best, a former MG Rover worker, from Bromsgrove, Worcs (UK), has been awarded £750,000 ($1,400,000) by the High Court in Birmingham (UK) as a result of being given a tainted blood transfusion from which he contracted a form of the HIV virus.

One of the five units of blood the 64-year-old Mr. Best received during an operation at a private hospital was infected with the T-Cell Lymphotophic Virus Type 1 (HTLV-1).

The National Blood Service (NBS) admitted providing defective blood, which it had failed to screen for the virus.
At the time of the surgery in 1995, the UK did not test blood for the rare virus. The NBS began testing for HTLV in 2002. It introduced the use of leucodepletion, which greatly reduces the risk of transmitting the illness, only in 1998-99.

As a result of receiving the infected blood, Mr. Best developed HTLV-associated myelopathy, a rare and debilitating blood-transmitted disease which affects the central nervous system and which could eventually confine him to a wheel chair.

Mr. Best explained that, because of physical deterioration, he had to give up his job as a toolmaker at the former Longbridge factory in 2000, where he had worked for more than 40 years.

He said he began to have physical problems a year after the operation when his legs became unsteady.  "Although I had lost more than four stone in weight and had been left very weak (after the operation), I thought it was just a matter of time before I got back to normal. Then I started having unsteadiness in my legs.”
After he lost sensation in his toes, it was two years before doctors diagnosed him with HTLV-1. When the National Blood Service was notified of Mr. Best’s illness, an investigation was quickly organized and, under Consumer Protection legislation laws, a settlement was finally negotiated, after seven years.

Major Study Shows Asians Suffer Same Dire Consequences from Smoking as Everyone Else 

The largest study into the effects of smoking in Asia indicates that Asian populations are just as susceptible to the negative impacts of tobacco use, including coronary heart disease and stroke, as Westerners
The results of the study will be published in a paper from the George Institute for International Health in the International Journal of Epidemiology.

The paper indicates the myth that smoking is less harmful to Asians than to Caucasians may contribute to the high prevalence of smoking in Asian countries, the low quitting rates amongst Asian male smokers, and the spread of smoking among Asian women.

The new study is considered more accurate in estimating the relative effects of smoking than previous ones because of the number of individuals involved.

Prof. Mark Woodward, Director of the Epidemiology and Biostatistics at the George Institute, who lead the study, commented that "the study, which involved data analysis of almost 500,000 Asians and 100,000 Australasians, shows that smoking poses the same risks to Asian men (and an even greater risk to Asian women) as compared to Western populations. The study also makes clear that there are real benefits to be gained, in terms of huge numbers of lives to be saved, by effectively implementing campaigns in Asia to quit smoking."

An important finding of the research was the identification of smoking is an independent risk factor for hemorrhagic stroke.

The most common type of stroke in Asia, hemorrhagic stroke, is more likely than ischemic stroke to lead to death in a short time.

Even more significantly, the study showed that Asians who smoke have roughly the same increased proportional cardiovascular risks as Westerners and a similar relative reduction in risk from quitting.

The results of the study also indicate that younger people and women have increased relative risks of cardiovascular disease from smoking than others. The study estimated that there will be over 500 million female smokers worldwide within 20 years.

Prof. Woodward underscored the importance of public health programs in Asia to dispel the prevalent belief that quitting smoking can be harmful. Anti-tobacco campaigns, he says, should especially be directed at Asian women to counteract the increase in smoking in this population,

British Pharmaceutical giant GlaxoSmithKline (Glaxo) has agreed to pay over $150 million in settlement of federal (U.S.) charges that it fraudulently inflated prices for drugs bought by government health-care programs.

According to the U.S. Department of Justice, Glaxo allegedly violated the federal False Claims Act in the sale and marketing of Zofran and Kytril, two nausea drugs used by cancer patients who are undergoing treatment.

The Justice Department suspected Glaxo was engaged in a scheme to fix and maintain inflated prices for the two drugs knowing that federal healthcare programs based their reimbursement rates on those prices.

Federal officials stated that the Justice Department "will not tolerate fraudulent pricing practices designed to reap profits for drug companies and doctors at the expense of health care programs for the poor and the elderly."

Although GlaxoSmithKline issued a statement claiming it did nothing wrong, the company agreed to settle to avoid litigation. $26 million of the settlement will be paid to the whistle-blowers who prompted the investigation and another $10 million will go to state governments.

A new study by scientists at the University of Liverpool suggests there may be a way of identifying families at high risk of pancreatic cancer.

The Liverpool research group called EUROPAC (European Registry Of Hereditary Pancreatitis And Familial Pancreatic Cancer), in cooperation with a counterpart organization in Germany, has found that familial pancreatic cancer develops at an increasingly younger age as is it is passed down through generations.

The team has developed a new way of testing for pancreatic cancer that will allow doctors to treat the disease in its preliminary stages and to trace how the risk of cancer in these patients changes with age.

The researchers conducted the largest study on this subject, evaluating 600 families with a history of pancreatic cancer. They also identified a subgroup of more than 80 families who had a 50% risk of developing the cancer in their lifetime.

Dr. Bill Greenhalf of the University’s Division of Surgery and Oncology and his team have developed a new method for analyzing the pancreatic juice of patients from families with a high risk of pancreatic cancer.
By analyzing DNA, scientists were able to identify specific genetic mutations that indicate a patient’s changes of developing the cancer (from a 0.1% chance to a 90% certainty) in the short term.

Dr. Greenhalf said: "Of those families with the highest incidence of pancreatic cancer, we found that members developed the disease at a younger age in each generation. As well as giving important clues about the nature of the disease, this allows a more accurate estimate of the risk an individual faces of developing cancer in the short term so we can treat the cancer as soon as possible."

Greenhalf expects to conduct further studies of his new methods with the hope that pancreatic cancer screening procedures will be widely adopted.

The well-known consumer advocacy group Public Citizen is asking the FDA to add black-box warnings to the labels of Viagra, Levitra, and Cialis. The drugs, used to treat impotence, have been linked to an increase in incidences of blindness among patients.  

The petition calls for the FDA to add the highest level of drug warning to the labels of Viagra, Cialis, and Levitra as well as Revatio, a drug used to treat hypertension.

A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored.  NAION is one of the most common causes of abrupt vision loss in older individuals.  

People with diabetes and heart disease are specifically at risk for developing NAION.  Incidentally, these two risk factors are also two of the leading causes of impotence.

In July, two less severe warnings were added to the labels of Viagra, Cialis, and Levitra regarding sudden vision loss but the FDA said that it could not yet be determined if the drugs were the reason for the reported cases of NAION.  

At that time, the FDA advised patients to stop taking the pills and to notify their physician immediately if they experienced a sudden or decreased loss of vision in one or both eyes.  

In order to further examine this risk, however, Public Citizen looked at FDA data and compared the rates of individuals who were taking impotence drugs and those taking Lipitor, a cholesterol lowering drug that is used by people with similar risk factors.  

The findings indicated that the number of reports of NAION per million prescriptions was 18 times higher for Viagra patients and 25 times higher for Cialis patients compared to individuals taking Lipitor.  

Pubic Citizen has argued that this indicates a higher risk of blindness for patients taking impotency drugs than previously acknowledged by the FDA.

Between 1998 and 2004 the FDA reported 48 cases of NAION in individuals taking Viagra.  Other visual problems were reported by an additional 50 people.

Yet out of some 89 million prescriptions that were issued during that time period, only a handful of people actually experienced this adverse risk.

Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group argues that the FDA must take responsibility to immediately inform consumers about the risk relating to impotence drugs.  The only acceptable solution, he says, is for a black-box warning to be issued. 

The well-known consumer advocacy group Public Citizen is asking the FDA to add black-box warnings to the labels of Viagra, Levitra, and Cialis. The drugs, used to treat impotence, have been linked to an increase in incidences of blindness among patients.  

The petition calls for the FDA to add the highest level of drug warning to the labels of Viagra, Cialis, and Levitra as well as Revatio, a drug used to treat hypertension.

A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored.  NAION is one of the most common causes of abrupt vision loss in older individuals.  

People with diabetes and heart disease are specifically at risk for developing NAION.  Incidentally, these two risk factors are also two of the leading causes of impotence.

In July, two less severe warnings were added to the labels of Viagra, Cialis, and Levitra regarding sudden vision loss but the FDA said that it could not yet be determined if the drugs were the reason for the reported cases of NAION.  

At that time, the FDA advised patients to stop taking the pills and to notify their physician immediately if they experienced a sudden or decreased loss of vision in one or both eyes.  

In order to further examine this risk, however, Public Citizen looked at FDA data and compared the rates of individuals who were taking impotence drugs and those taking Lipitor, a cholesterol lowering drug that is used by people with similar risk factors.  

The findings indicated that the number of reports of NAION per million prescriptions was 18 times higher for Viagra patients and 25 times higher for Cialis patients compared to individuals taking Lipitor.  

Pubic Citizen has argued that this indicates a higher risk of blindness for patients taking impotency drugs than previously acknowledged by the FDA.

Between 1998 and 2004 the FDA reported 48 cases of NAION in individuals taking Viagra.  Other visual problems were reported by an additional 50 people.

Yet out of some 89 million prescriptions that were issued during that time period, only a handful of people actually experienced this adverse risk.

Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group argues that the FDA must take responsibility to immediately inform consumers about the risk relating to impotence drugs.  The only acceptable solution, he says, is for a black-box warning to be issued. 

The well-known consumer advocacy group Public Citizen is asking the FDA to add black-box warnings to the labels of Viagra, Levitra, and Cialis. The drugs, used to treat impotence, have been linked to an increase in incidences of blindness among patients.  

The petition calls for the FDA to add the highest level of drug warning to the labels of Viagra, Cialis, and Levitra as well as Revatio, a drug used to treat hypertension.

A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored.  NAION is one of the most common causes of abrupt vision loss in older individuals.  

People with diabetes and heart disease are specifically at risk for developing NAION.  Incidentally, these two risk factors are also two of the leading causes of impotence.

In July, two less severe warnings were added to the labels of Viagra, Cialis, and Levitra regarding sudden vision loss but the FDA said that it could not yet be determined if the drugs were the reason for the reported cases of NAION.  

At that time, the FDA advised patients to stop taking the pills and to notify their physician immediately if they experienced a sudden or decreased loss of vision in one or both eyes.  

In order to further examine this risk, however, Public Citizen looked at FDA data and compared the rates of individuals who were taking impotence drugs and those taking Lipitor, a cholesterol lowering drug that is used by people with similar risk factors.  

The findings indicated that the number of reports of NAION per million prescriptions was 18 times higher for Viagra patients and 25 times higher for Cialis patients compared to individuals taking Lipitor.  

Pubic Citizen has argued that this indicates a higher risk of blindness for patients taking impotency drugs than previously acknowledged by the FDA.

Between 1998 and 2004 the FDA reported 48 cases of NAION in individuals taking Viagra.  Other visual problems were reported by an additional 50 people.

Yet out of some 89 million prescriptions that were issued during that time period, only a handful of people actually experienced this adverse risk.

Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group argues that the FDA must take responsibility to immediately inform consumers about the risk relating to impotence drugs.  The only acceptable solution, he says, is for a black-box warning to be issued. 

The well-known consumer advocacy group Public Citizen is asking the FDA to add black-box warnings to the labels of Viagra, Levitra, and Cialis. The drugs, used to treat impotence, have been linked to an increase in incidences of blindness among patients.  

The petition calls for the FDA to add the highest level of drug warning to the labels of Viagra, Cialis, and Levitra as well as Revatio, a drug used to treat hypertension.

A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored.  NAION is one of the most common causes of abrupt vision loss in older individuals.  

People with diabetes and heart disease are specifically at risk for developing NAION.  Incidentally, these two risk factors are also two of the leading causes of impotence.

In July, two less severe warnings were added to the labels of Viagra, Cialis, and Levitra regarding sudden vision loss but the FDA said that it could not yet be determined if the drugs were the reason for the reported cases of NAION.  

At that time, the FDA advised patients to stop taking the pills and to notify their physician immediately if they experienced a sudden or decreased loss of vision in one or both eyes.  

In order to further examine this risk, however, Public Citizen looked at FDA data and compared the rates of individuals who were taking impotence drugs and those taking Lipitor, a cholesterol lowering drug that is used by people with similar risk factors.  

The findings indicated that the number of reports of NAION per million prescriptions was 18 times higher for Viagra patients and 25 times higher for Cialis patients compared to individuals taking Lipitor.  

Pubic Citizen has argued that this indicates a higher risk of blindness for patients taking impotency drugs than previously acknowledged by the FDA.

Between 1998 and 2004 the FDA reported 48 cases of NAION in individuals taking Viagra.  Other visual problems were reported by an additional 50 people.

Yet out of some 89 million prescriptions that were issued during that time period, only a handful of people actually experienced this adverse risk.

Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group argues that the FDA must take responsibility to immediately inform consumers about the risk relating to impotence drugs.  The only acceptable solution, he says, is for a black-box warning to be issued.