Calvin Godfrey

A pair of industry-funded multicenter studies has contributed to the growing call for infant vaccination against severe rotavirus gastroenteritis in the developing world.

The findings come more than a year after the World Health Organization's Strategic Advisory Group of Experts declared that rotavirus vaccines should be included in national immunization programs all over the world – particularly in countries with high diarrheal fatalities (Lancet 2010 Aug. 6 [doi:10.1016/S0140-6736(10)60755-6]).

Previous trials conducted in industrialized nations demonstrated rotavirus vaccine to be both safe and effective. However, far less clinical research has been conducted in low-income populations in Africa and Asia, where an estimated 85% of rotavirus fatalities occur (J. Infect. Dis. 2009;200:S1–8).

The two new studies explored African and Asian infant populations in double-blind, placebo-controlled, multicenter randomized trials.

A comment accompanying the two studies called for long-term subsidies from wealthier countries to ensure effective use of the vaccination in places with the greatest need (Lancet 2010 Aug. 6 [doi:10.1016/S0140-6736(10)60896-3]).

“It is likely that diarrhea deaths in the poorest countries could be reduced by 25%, which will greatly help these [countries] achieve the target of Millennium Development Goal 4,” coauthor Dr. E. Anthony S. Nelson, of the pediatrics department at the Chinese University of Hong Kong, said in an interview.

In the first of the two studies, an international team led by K. Zaman, Ph.D., of the International Centre for Diarrhoeal Disease Research in Bangladesh, carried out its trials in rural Matlab, Bangladesh, and neighborhoods in and around the seaside city of Nha Trang, Vietnam.

A total of 2,036 infants aged 4–12 weeks were randomly assigned three 2-mL oral doses of Merck's pentavalent rotavirus vaccine or placebo. There were no enrollment restrictions based on HIV status. The investigators said the infants showed no signs of preexisting gastrointestinal disorders when they began administering the dosages at roughly 6, 10, and 14 weeks of age.

Over the course of the next 2 years, Dr. Zaman and colleagues noted 38 cases of severe rotavirus gastroenteritis in the vaccinated group, compared with 71 in the placebo group. The investigators calculated the overall vaccine efficacy at 48%, which is lower than efficiencies observed in industrialized countries in Europe and the Americas.

Adverse events were relatively few. A total of 2.5% of the vaccinated subjects and 2.0% in the placebo group had at least one adverse event, and the investigators did not attribute any of those effects to the vaccine.

The second study, led by George E. Armah, Ph.D., of the University of Ghana, Accra, was conducted in Africa, where diarrheal disease remains the second biggest culprit in the continent's 800,000 annual child deaths (Lancet 2007;369:91–2).

Dr. Armah and colleagues employed the same methodology on a larger population − 5,468 infants. HIV-positive cases were not excluded.

They conducted the multicenter trial in clinics located in rural Ghana and Kenya, as well as an urban center in Mali. During the 2-year follow-up, Dr. Armah and colleagues recorded 79 cases of severe rotavirus gastroenteritis in the vaccinated group, compared with 129 in the placebo group. Severe adverse events occurred in 1.5% of those vaccinated and 1.7% of those who received placebos.

The overall vaccine efficacy was calculated at 39.3%. “This protection was especially high through the first year of life (64.2% vaccine efficacy), when the disease burden, including mortality, is highest,” the investigators wrote (Lancet 2010 Aug. 6 [doi:10.1016/S0140-6736(10)60889-6]).

The authors of both studies endorsed the WHO's call for the expansion of rotavirus vaccination.

Both teams, as well as a comment coauthor, stated some financial conflicts. Merck, the manufacturer of the oral vaccine used for both trials, helped design and oversee the studies with substantial input from the international nonprofit group PATH (Program for Appropriate Technology in Health). Merck employees and shareholders participated in the research process and helped fund the projects. Grant funding from GAVI (Global Alliance for Vaccines and Immunization) was contributed to the effort via PATH. Dr. Nelson has funding and other research relationships with Merck, Baxter, Intercell, GlaxoSmithKline, MedImmune, and Wyeth, including a phase III Rotarix vaccine study.

A pair of industry-funded multicenter studies has contributed to the growing call for infant vaccination against severe rotavirus gastroenteritis in the developing world.

The findings come more than a year after the World Health Organization's Strategic Advisory Group of Experts declared that rotavirus vaccines should be included in national immunization programs all over the world – particularly in countries with high diarrheal fatalities (Lancet 2010 Aug. 6 [doi:10.1016/S0140-6736(10)60755-6]).

Previous trials conducted in industrialized nations demonstrated rotavirus vaccine to be both safe and effective. However, far less clinical research has been conducted in low-income populations in Africa and Asia, where an estimated 85% of rotavirus fatalities occur (J. Infect. Dis. 2009;200:S1–8).

The two new studies explored African and Asian infant populations in double-blind, placebo-controlled, multicenter randomized trials.

A comment accompanying the two studies called for long-term subsidies from wealthier countries to ensure effective use of the vaccination in places with the greatest need (Lancet 2010 Aug. 6 [doi:10.1016/S0140-6736(10)60896-3]).

“It is likely that diarrhea deaths in the poorest countries could be reduced by 25%, which will greatly help these [countries] achieve the target of Millennium Development Goal 4,” coauthor Dr. E. Anthony S. Nelson, of the pediatrics department at the Chinese University of Hong Kong, said in an interview.

In the first of the two studies, an international team led by K. Zaman, Ph.D., of the International Centre for Diarrhoeal Disease Research in Bangladesh, carried out its trials in rural Matlab, Bangladesh, and neighborhoods in and around the seaside city of Nha Trang, Vietnam.

A total of 2,036 infants aged 4–12 weeks were randomly assigned three 2-mL oral doses of Merck's pentavalent rotavirus vaccine or placebo. There were no enrollment restrictions based on HIV status. The investigators said the infants showed no signs of preexisting gastrointestinal disorders when they began administering the dosages at roughly 6, 10, and 14 weeks of age.

Over the course of the next 2 years, Dr. Zaman and colleagues noted 38 cases of severe rotavirus gastroenteritis in the vaccinated group, compared with 71 in the placebo group. The investigators calculated the overall vaccine efficacy at 48%, which is lower than efficiencies observed in industrialized countries in Europe and the Americas.

Adverse events were relatively few. A total of 2.5% of the vaccinated subjects and 2.0% in the placebo group had at least one adverse event, and the investigators did not attribute any of those effects to the vaccine.

The second study, led by George E. Armah, Ph.D., of the University of Ghana, Accra, was conducted in Africa, where diarrheal disease remains the second biggest culprit in the continent's 800,000 annual child deaths (Lancet 2007;369:91–2).

Dr. Armah and colleagues employed the same methodology on a larger population − 5,468 infants. HIV-positive cases were not excluded.

They conducted the multicenter trial in clinics located in rural Ghana and Kenya, as well as an urban center in Mali. During the 2-year follow-up, Dr. Armah and colleagues recorded 79 cases of severe rotavirus gastroenteritis in the vaccinated group, compared with 129 in the placebo group. Severe adverse events occurred in 1.5% of those vaccinated and 1.7% of those who received placebos.

The overall vaccine efficacy was calculated at 39.3%. “This protection was especially high through the first year of life (64.2% vaccine efficacy), when the disease burden, including mortality, is highest,” the investigators wrote (Lancet 2010 Aug. 6 [doi:10.1016/S0140-6736(10)60889-6]).

The authors of both studies endorsed the WHO's call for the expansion of rotavirus vaccination.

Both teams, as well as a comment coauthor, stated some financial conflicts. Merck, the manufacturer of the oral vaccine used for both trials, helped design and oversee the studies with substantial input from the international nonprofit group PATH (Program for Appropriate Technology in Health). Merck employees and shareholders participated in the research process and helped fund the projects. Grant funding from GAVI (Global Alliance for Vaccines and Immunization) was contributed to the effort via PATH. Dr. Nelson has funding and other research relationships with Merck, Baxter, Intercell, GlaxoSmithKline, MedImmune, and Wyeth, including a phase III Rotarix vaccine study.

A pair of industry-funded multicenter studies has contributed to the growing call for infant vaccination against severe rotavirus gastroenteritis in the developing world.

The findings come more than a year after the World Health Organization's Strategic Advisory Group of Experts declared that rotavirus vaccines should be included in national immunization programs all over the world – particularly in countries with high diarrheal fatalities (Lancet 2010 Aug. 6 [doi:10.1016/S0140-6736(10)60755-6]).

Previous trials conducted in industrialized nations demonstrated rotavirus vaccine to be both safe and effective. However, far less clinical research has been conducted in low-income populations in Africa and Asia, where an estimated 85% of rotavirus fatalities occur (J. Infect. Dis. 2009;200:S1–8).

The two new studies explored African and Asian infant populations in double-blind, placebo-controlled, multicenter randomized trials.

A comment accompanying the two studies called for long-term subsidies from wealthier countries to ensure effective use of the vaccination in places with the greatest need (Lancet 2010 Aug. 6 [doi:10.1016/S0140-6736(10)60896-3]).

“It is likely that diarrhea deaths in the poorest countries could be reduced by 25%, which will greatly help these [countries] achieve the target of Millennium Development Goal 4,” coauthor Dr. E. Anthony S. Nelson, of the pediatrics department at the Chinese University of Hong Kong, said in an interview.

In the first of the two studies, an international team led by K. Zaman, Ph.D., of the International Centre for Diarrhoeal Disease Research in Bangladesh, carried out its trials in rural Matlab, Bangladesh, and neighborhoods in and around the seaside city of Nha Trang, Vietnam.

A total of 2,036 infants aged 4–12 weeks were randomly assigned three 2-mL oral doses of Merck's pentavalent rotavirus vaccine or placebo. There were no enrollment restrictions based on HIV status. The investigators said the infants showed no signs of preexisting gastrointestinal disorders when they began administering the dosages at roughly 6, 10, and 14 weeks of age.

Over the course of the next 2 years, Dr. Zaman and colleagues noted 38 cases of severe rotavirus gastroenteritis in the vaccinated group, compared with 71 in the placebo group. The investigators calculated the overall vaccine efficacy at 48%, which is lower than efficiencies observed in industrialized countries in Europe and the Americas.

Adverse events were relatively few. A total of 2.5% of the vaccinated subjects and 2.0% in the placebo group had at least one adverse event, and the investigators did not attribute any of those effects to the vaccine.

The second study, led by George E. Armah, Ph.D., of the University of Ghana, Accra, was conducted in Africa, where diarrheal disease remains the second biggest culprit in the continent's 800,000 annual child deaths (Lancet 2007;369:91–2).

Dr. Armah and colleagues employed the same methodology on a larger population − 5,468 infants. HIV-positive cases were not excluded.

They conducted the multicenter trial in clinics located in rural Ghana and Kenya, as well as an urban center in Mali. During the 2-year follow-up, Dr. Armah and colleagues recorded 79 cases of severe rotavirus gastroenteritis in the vaccinated group, compared with 129 in the placebo group. Severe adverse events occurred in 1.5% of those vaccinated and 1.7% of those who received placebos.

The overall vaccine efficacy was calculated at 39.3%. “This protection was especially high through the first year of life (64.2% vaccine efficacy), when the disease burden, including mortality, is highest,” the investigators wrote (Lancet 2010 Aug. 6 [doi:10.1016/S0140-6736(10)60889-6]).

The authors of both studies endorsed the WHO's call for the expansion of rotavirus vaccination.

Both teams, as well as a comment coauthor, stated some financial conflicts. Merck, the manufacturer of the oral vaccine used for both trials, helped design and oversee the studies with substantial input from the international nonprofit group PATH (Program for Appropriate Technology in Health). Merck employees and shareholders participated in the research process and helped fund the projects. Grant funding from GAVI (Global Alliance for Vaccines and Immunization) was contributed to the effort via PATH. Dr. Nelson has funding and other research relationships with Merck, Baxter, Intercell, GlaxoSmithKline, MedImmune, and Wyeth, including a phase III Rotarix vaccine study.

Selective serotonin reuptake inhibitor use may lead to an increased risk of cataract development, a study by Canadian researchers has shown.

In a large nested case-control study, the researchers found that certain SSRIs correlated with an increased likelihood of cataract diagnosis and cataract surgery.

“We don't want people to stop their medicine or switch,” lead author Mahayar Etminan, Pharm.D., of the Vancouver Coastal Health Research Institute– said in an interview. “We don't want to stress the message of 'drug A increases risk over drug B' but rather the overall risk as a class effect. We want to shed light on cataracts as a possible side effect.”

The study considered data from a cohort of 206,624 Quebec residents aged 65 or older. Researchers found that of the study's 18,784 cases diagnosed with cataracts, the 5.7% who were current selective serotonin reuptake inhibitor (SSRI) users were 15% more likely to be diagnosed with cataracts or undergo cataract surgery than non-SSRI users. Overall, the study found that it took an average of 656 days between the commencement of SSRI therapy and a diagnosis of cataracts (Ophthalmology 2010;117:1251-5).

The study did not find a link between past SSRI use (individuals who had ceased taking SSRIs 30 days prior to diagnosis) and cataract development.

The findings come with some precedent. The use of amitriptyline, a tricyclic antidepressant, was linked to an increased risk of cortical cataracts in an earlier study (Ophthalmology 2001;108:1670-4).

Additionally, research conducted in animal models had shown an association between increased serotonin levels and cataract clouding.

Dr. Etminan and colleagues were the first to specifically examine the catarogenic risks of SSRI use in humans, however.

While the study does not prove causation, its findings reveal an association between cataract complications and the use of the SSRIs fluvoxamine and paroxetine and the serotonin and norepinephrine reuptake inhibitor venlafaxine. The results did not reveal a statistically significant association between cataract development and other commonly prescribed SSRIs.

In the study's findings, compared with those who never took SSRIs, current fluvoxamine users had the highest levels of cataract risk, increasing the likelihood of undergoing cataract surgery by 51% (rate ratio 1.51, after adjustment for variables such as sex, hypertension, and antihypertensive use). Users of paroxetine, according to the study, were 23% more likely to undergo surgery. Venlafaxine–which in 2007 was the 12th most-prescribed drug in the United States with 17 million prescriptions–increased the likelihood of surgery 34%, the researchers wrote. In an interview, Dr. Etminan said that the variations between the individual drug results in this early study could be chalked up to random chance or measurement error.

Future studies would be needed to effectively determine the cataract risks of the individual agents, Dr. Etminan said. The study, Dr. Etminan and colleagues acknowledged, could not control for smoking histories or undiagnosed cataracts. The study investigators acknowledged that it “may have lacked adequate power to assess the risk of cataracts with all individual antidepressants.”

Representatives from SSRI manufacturers Pfizer and GlaxoSmithKline responded by saying their companies would need more time to review the study before commenting.

Representatives from Jazz Pharmaceuticals, which manufacturers fluvoxamine, did not respond to requests for comment by press time.

Going forward, Dr. Etminan said he hoped that further research would help doctors identify an antidepressant that would offer a safe choice for, say, an elderly patient recovering from cataract surgery.

The researchers stated that they had no relevant conflicts of interest.

Selective serotonin reuptake inhibitor use may lead to an increased risk of cataract development, a study by Canadian researchers has shown.

In a large nested case-control study, the researchers found that certain SSRIs correlated with an increased likelihood of cataract diagnosis and cataract surgery.

“We don't want people to stop their medicine or switch,” lead author Mahayar Etminan, Pharm.D., of the Vancouver Coastal Health Research Institute– said in an interview. “We don't want to stress the message of 'drug A increases risk over drug B' but rather the overall risk as a class effect. We want to shed light on cataracts as a possible side effect.”

The study considered data from a cohort of 206,624 Quebec residents aged 65 or older. Researchers found that of the study's 18,784 cases diagnosed with cataracts, the 5.7% who were current selective serotonin reuptake inhibitor (SSRI) users were 15% more likely to be diagnosed with cataracts or undergo cataract surgery than non-SSRI users. Overall, the study found that it took an average of 656 days between the commencement of SSRI therapy and a diagnosis of cataracts (Ophthalmology 2010;117:1251-5).

The study did not find a link between past SSRI use (individuals who had ceased taking SSRIs 30 days prior to diagnosis) and cataract development.

The findings come with some precedent. The use of amitriptyline, a tricyclic antidepressant, was linked to an increased risk of cortical cataracts in an earlier study (Ophthalmology 2001;108:1670-4).

Additionally, research conducted in animal models had shown an association between increased serotonin levels and cataract clouding.

Dr. Etminan and colleagues were the first to specifically examine the catarogenic risks of SSRI use in humans, however.

While the study does not prove causation, its findings reveal an association between cataract complications and the use of the SSRIs fluvoxamine and paroxetine and the serotonin and norepinephrine reuptake inhibitor venlafaxine. The results did not reveal a statistically significant association between cataract development and other commonly prescribed SSRIs.

In the study's findings, compared with those who never took SSRIs, current fluvoxamine users had the highest levels of cataract risk, increasing the likelihood of undergoing cataract surgery by 51% (rate ratio 1.51, after adjustment for variables such as sex, hypertension, and antihypertensive use). Users of paroxetine, according to the study, were 23% more likely to undergo surgery. Venlafaxine–which in 2007 was the 12th most-prescribed drug in the United States with 17 million prescriptions–increased the likelihood of surgery 34%, the researchers wrote. In an interview, Dr. Etminan said that the variations between the individual drug results in this early study could be chalked up to random chance or measurement error.

Future studies would be needed to effectively determine the cataract risks of the individual agents, Dr. Etminan said. The study, Dr. Etminan and colleagues acknowledged, could not control for smoking histories or undiagnosed cataracts. The study investigators acknowledged that it “may have lacked adequate power to assess the risk of cataracts with all individual antidepressants.”

Representatives from SSRI manufacturers Pfizer and GlaxoSmithKline responded by saying their companies would need more time to review the study before commenting.

Representatives from Jazz Pharmaceuticals, which manufacturers fluvoxamine, did not respond to requests for comment by press time.

Going forward, Dr. Etminan said he hoped that further research would help doctors identify an antidepressant that would offer a safe choice for, say, an elderly patient recovering from cataract surgery.

The researchers stated that they had no relevant conflicts of interest.

Selective serotonin reuptake inhibitor use may lead to an increased risk of cataract development, a study by Canadian researchers has shown.

In a large nested case-control study, the researchers found that certain SSRIs correlated with an increased likelihood of cataract diagnosis and cataract surgery.

“We don't want people to stop their medicine or switch,” lead author Mahayar Etminan, Pharm.D., of the Vancouver Coastal Health Research Institute– said in an interview. “We don't want to stress the message of 'drug A increases risk over drug B' but rather the overall risk as a class effect. We want to shed light on cataracts as a possible side effect.”

The study considered data from a cohort of 206,624 Quebec residents aged 65 or older. Researchers found that of the study's 18,784 cases diagnosed with cataracts, the 5.7% who were current selective serotonin reuptake inhibitor (SSRI) users were 15% more likely to be diagnosed with cataracts or undergo cataract surgery than non-SSRI users. Overall, the study found that it took an average of 656 days between the commencement of SSRI therapy and a diagnosis of cataracts (Ophthalmology 2010;117:1251-5).

The study did not find a link between past SSRI use (individuals who had ceased taking SSRIs 30 days prior to diagnosis) and cataract development.

The findings come with some precedent. The use of amitriptyline, a tricyclic antidepressant, was linked to an increased risk of cortical cataracts in an earlier study (Ophthalmology 2001;108:1670-4).

Additionally, research conducted in animal models had shown an association between increased serotonin levels and cataract clouding.

Dr. Etminan and colleagues were the first to specifically examine the catarogenic risks of SSRI use in humans, however.

While the study does not prove causation, its findings reveal an association between cataract complications and the use of the SSRIs fluvoxamine and paroxetine and the serotonin and norepinephrine reuptake inhibitor venlafaxine. The results did not reveal a statistically significant association between cataract development and other commonly prescribed SSRIs.

In the study's findings, compared with those who never took SSRIs, current fluvoxamine users had the highest levels of cataract risk, increasing the likelihood of undergoing cataract surgery by 51% (rate ratio 1.51, after adjustment for variables such as sex, hypertension, and antihypertensive use). Users of paroxetine, according to the study, were 23% more likely to undergo surgery. Venlafaxine–which in 2007 was the 12th most-prescribed drug in the United States with 17 million prescriptions–increased the likelihood of surgery 34%, the researchers wrote. In an interview, Dr. Etminan said that the variations between the individual drug results in this early study could be chalked up to random chance or measurement error.

Future studies would be needed to effectively determine the cataract risks of the individual agents, Dr. Etminan said. The study, Dr. Etminan and colleagues acknowledged, could not control for smoking histories or undiagnosed cataracts. The study investigators acknowledged that it “may have lacked adequate power to assess the risk of cataracts with all individual antidepressants.”

Representatives from SSRI manufacturers Pfizer and GlaxoSmithKline responded by saying their companies would need more time to review the study before commenting.

Representatives from Jazz Pharmaceuticals, which manufacturers fluvoxamine, did not respond to requests for comment by press time.

Going forward, Dr. Etminan said he hoped that further research would help doctors identify an antidepressant that would offer a safe choice for, say, an elderly patient recovering from cataract surgery.

The researchers stated that they had no relevant conflicts of interest.

Selective serotonin reuptake inhibitor use may lead to an increased risk of cataract development, a study by Canadian researchers suggests.

In a large nested case-control study, the researchers found that certain selective serotonin reuptake inhibitors (SSRIs) correlated with an increased likelihood of cataract diagnosis and cataract surgery.

“We don't want people to stop their medicine or switch,” lead author Mahyar Etminan, Pharm.D., of the Vancouver Coastal Health Research Institute—said in an interview. “We don't want to stress the message of 'drug A increases risk over drug B' but rather the overall risk as a class effect. We want to shed light on cataracts as a possible side effect.”

The study considered data from a cohort of 206,624 Quebec residents aged 65 or older. Researchers found that of the study's 18,784 cases diagnosed with cataracts, the 5.7% who were current SSRI users were 15% more likely to be diagnosed with cataracts or undergo cataract surgery than non-SSRI users.

Overall, the researchers found that it took an average of 656 days between the commencement of SSRI therapy and the diagnosis of cataracts (Ophthalmology 2010;117:1251-5).

The study did not find a link between past SSRI use (individuals who had ceased taking SSRIs 30 days prior to diagnosis) and cataract development.

The findings come with some precedent. The use of amitriptyline, a tricyclic antidepressant, was linked to an increased risk of cortical cataracts in a study published in 2001 (Ophthalmology 2001;108:1670-4). Additionally, research conducted in animal models had shown an association between increased serotonin levels and cataract clouding.

Dr. Etminan and his colleagues were the first to specifically examine the catarogenic risks of SSRI use in humans, however.

While the study does not prove causation, its findings reveal an association between cataract complications and the use of the SSRIs fluvoxamine and paroxetine and venlafaxine, a serotonin and norepinephrine reuptake inhibitor. The results did not reveal a statistically significant association between cataract development and other commonly prescribed SSRIs.

In the study's findings, compared with those who never took SSRIs, current fluvoxamine users experienced the highest levels of cataract risk, increasing the likelihood of undergoing cataract surgery by 51% (rate ratio 1.51, after adjustment for variables such as gender, hypertension, and antihypertensive use). Users of paroxetine, according to the study, were 23% more likely to undergo surgery. Venlafaxine—which in 2007 was the 12th most-prescribed drug in the United States with 17 million prescriptions—increased likelihood of surgery 34%, the researchers wrote. In an interview, Dr. Etminan said that the variations between the individual drug results in this early study could be chalked up to random chance or measurement error.

Future studies are needed to determine the cataract risks of the individual agents, Dr. Etminan said.

The study's limitations, Dr. Etminan and his colleagues acknowledged, could not control for smoking histories or undiagnosed cataracts. The study investigators acknowledged that it “may have lacked adequate power to assess the risk of cataracts with all individual antidepressants.”

Representatives from SSRI manufacturers Pfizer Inc. and GlaxoSmithKline responded by saying their companies would need more time to review the study before commenting.

Representatives from Jazz Pharmaceuticals Inc., which manufactures fluvoxamine, did not respond to requests for comment by press time.

Going forward, Dr. Etminan said he hoped that further research would help doctors identify an antidepressant that would offer a safe choice for, say, an elderly patient recovering from cataract surgery.

The researchers stated that they had no relevant conflicts of interest.

Selective serotonin reuptake inhibitor use may lead to an increased risk of cataract development, a study by Canadian researchers suggests.

In a large nested case-control study, the researchers found that certain selective serotonin reuptake inhibitors (SSRIs) correlated with an increased likelihood of cataract diagnosis and cataract surgery.

“We don't want people to stop their medicine or switch,” lead author Mahyar Etminan, Pharm.D., of the Vancouver Coastal Health Research Institute—said in an interview. “We don't want to stress the message of 'drug A increases risk over drug B' but rather the overall risk as a class effect. We want to shed light on cataracts as a possible side effect.”

The study considered data from a cohort of 206,624 Quebec residents aged 65 or older. Researchers found that of the study's 18,784 cases diagnosed with cataracts, the 5.7% who were current SSRI users were 15% more likely to be diagnosed with cataracts or undergo cataract surgery than non-SSRI users.

Overall, the researchers found that it took an average of 656 days between the commencement of SSRI therapy and the diagnosis of cataracts (Ophthalmology 2010;117:1251-5).

The study did not find a link between past SSRI use (individuals who had ceased taking SSRIs 30 days prior to diagnosis) and cataract development.

The findings come with some precedent. The use of amitriptyline, a tricyclic antidepressant, was linked to an increased risk of cortical cataracts in a study published in 2001 (Ophthalmology 2001;108:1670-4). Additionally, research conducted in animal models had shown an association between increased serotonin levels and cataract clouding.

Dr. Etminan and his colleagues were the first to specifically examine the catarogenic risks of SSRI use in humans, however.

While the study does not prove causation, its findings reveal an association between cataract complications and the use of the SSRIs fluvoxamine and paroxetine and venlafaxine, a serotonin and norepinephrine reuptake inhibitor. The results did not reveal a statistically significant association between cataract development and other commonly prescribed SSRIs.

In the study's findings, compared with those who never took SSRIs, current fluvoxamine users experienced the highest levels of cataract risk, increasing the likelihood of undergoing cataract surgery by 51% (rate ratio 1.51, after adjustment for variables such as gender, hypertension, and antihypertensive use). Users of paroxetine, according to the study, were 23% more likely to undergo surgery. Venlafaxine—which in 2007 was the 12th most-prescribed drug in the United States with 17 million prescriptions—increased likelihood of surgery 34%, the researchers wrote. In an interview, Dr. Etminan said that the variations between the individual drug results in this early study could be chalked up to random chance or measurement error.

Future studies are needed to determine the cataract risks of the individual agents, Dr. Etminan said.

The study's limitations, Dr. Etminan and his colleagues acknowledged, could not control for smoking histories or undiagnosed cataracts. The study investigators acknowledged that it “may have lacked adequate power to assess the risk of cataracts with all individual antidepressants.”

Representatives from SSRI manufacturers Pfizer Inc. and GlaxoSmithKline responded by saying their companies would need more time to review the study before commenting.

Representatives from Jazz Pharmaceuticals Inc., which manufactures fluvoxamine, did not respond to requests for comment by press time.

Going forward, Dr. Etminan said he hoped that further research would help doctors identify an antidepressant that would offer a safe choice for, say, an elderly patient recovering from cataract surgery.

The researchers stated that they had no relevant conflicts of interest.

Selective serotonin reuptake inhibitor use may lead to an increased risk of cataract development, a study by Canadian researchers suggests.

In a large nested case-control study, the researchers found that certain selective serotonin reuptake inhibitors (SSRIs) correlated with an increased likelihood of cataract diagnosis and cataract surgery.

“We don't want people to stop their medicine or switch,” lead author Mahyar Etminan, Pharm.D., of the Vancouver Coastal Health Research Institute—said in an interview. “We don't want to stress the message of 'drug A increases risk over drug B' but rather the overall risk as a class effect. We want to shed light on cataracts as a possible side effect.”

The study considered data from a cohort of 206,624 Quebec residents aged 65 or older. Researchers found that of the study's 18,784 cases diagnosed with cataracts, the 5.7% who were current SSRI users were 15% more likely to be diagnosed with cataracts or undergo cataract surgery than non-SSRI users.

Overall, the researchers found that it took an average of 656 days between the commencement of SSRI therapy and the diagnosis of cataracts (Ophthalmology 2010;117:1251-5).

The study did not find a link between past SSRI use (individuals who had ceased taking SSRIs 30 days prior to diagnosis) and cataract development.

The findings come with some precedent. The use of amitriptyline, a tricyclic antidepressant, was linked to an increased risk of cortical cataracts in a study published in 2001 (Ophthalmology 2001;108:1670-4). Additionally, research conducted in animal models had shown an association between increased serotonin levels and cataract clouding.

Dr. Etminan and his colleagues were the first to specifically examine the catarogenic risks of SSRI use in humans, however.

While the study does not prove causation, its findings reveal an association between cataract complications and the use of the SSRIs fluvoxamine and paroxetine and venlafaxine, a serotonin and norepinephrine reuptake inhibitor. The results did not reveal a statistically significant association between cataract development and other commonly prescribed SSRIs.

In the study's findings, compared with those who never took SSRIs, current fluvoxamine users experienced the highest levels of cataract risk, increasing the likelihood of undergoing cataract surgery by 51% (rate ratio 1.51, after adjustment for variables such as gender, hypertension, and antihypertensive use). Users of paroxetine, according to the study, were 23% more likely to undergo surgery. Venlafaxine—which in 2007 was the 12th most-prescribed drug in the United States with 17 million prescriptions—increased likelihood of surgery 34%, the researchers wrote. In an interview, Dr. Etminan said that the variations between the individual drug results in this early study could be chalked up to random chance or measurement error.

Future studies are needed to determine the cataract risks of the individual agents, Dr. Etminan said.

The study's limitations, Dr. Etminan and his colleagues acknowledged, could not control for smoking histories or undiagnosed cataracts. The study investigators acknowledged that it “may have lacked adequate power to assess the risk of cataracts with all individual antidepressants.”

Representatives from SSRI manufacturers Pfizer Inc. and GlaxoSmithKline responded by saying their companies would need more time to review the study before commenting.

Representatives from Jazz Pharmaceuticals Inc., which manufactures fluvoxamine, did not respond to requests for comment by press time.

Going forward, Dr. Etminan said he hoped that further research would help doctors identify an antidepressant that would offer a safe choice for, say, an elderly patient recovering from cataract surgery.

The researchers stated that they had no relevant conflicts of interest.