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*1/1/98 to 12/31/04; total number of reports was 258. To put into context and further understand the relevance of the disproportionate percentage of cases of ION in which Viagra was the primary suspect drug, we studied another drug with a well-recognized but rare adverse effect: Lotronex and ischemic colitis (the label for Lotronex now begins with a prominent black box warning). As was the situation for ION, a small number of drugs accounted for a vastly disproportionate percent of reports, showing that unusual adverse events can be identified among the background noise in the AERS system (Table 2). Lotronex and Zelnorm (the first and second in the list) are both drugs approved for irritable bowel syndrome.

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*1/1/98 to 12/31/04; total number of reports was 258. To put into context and further understand the relevance of the disproportionate percentage of cases of ION in which Viagra was the primary suspect drug, we studied another drug with a well-recognized but rare adverse effect: Lotronex and ischemic colitis (the label for Lotronex now begins with a prominent black box warning). As was the situation for ION, a small number of drugs accounted for a vastly disproportionate percent of reports, showing that unusual adverse events can be identified among the background noise in the AERS system (Table 2). Lotronex and Zelnorm (the first and second in the list) are both drugs approved for irritable bowel syndrome. Although the Zelnorm label lacks Lotronex’s black box warning, it does have a paragraph under precautions titled “Ischemic colitis”.

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*1/1/98 to 12/31/04; total number of reports was 852. Because reports to the FDA’s AERS database may not have used the same preferred terms to describe ION, we used six search terms recommended by neuro-ophthalmologist Dr. Jonathan Trobe at the University of Michigan Medical School: ischemic optic neuropathy (ION), visual field defect, blindness, blindness unilateral, scotoma, or optic nerve infarction. We broke the results into two parts: the reporting rate for ION and that of the other five terms (non-ION). A patient could have ≥1 of these terms. Although the Zelnorm label lacks Lotronex’s black box warning, it does have a paragraph under precautions titled “Ischemic colitis”. *1/1/98 to 12/31/04; total number of reports was 852. Because reports to the FDA’s AERS database may not have used the same preferred terms to describe ION, we used six search terms recommended by neuro-ophthalmologist Dr. Jonathan Trobe at the University of Michigan Medical School: ischemic optic neuropathy (ION), visual field defect, blindness, blindness unilateral, scotoma, or optic nerve infarction. We broke the results into two parts: the reporting rate for ION and that of the other five terms (non-ION).

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A patient could have ≥1 of these terms. We tabulated the number of cases of ION for the three PDE5 inhibitors as well as for two statin drugs, since the statins would be given to a similar group of people, i.e., older men more likely to have heart disease and/or diabetes. By dividing the number of cases by the total number of prescriptions filled, we were able to estimate the ION reporting rate for each drug (Table 3). The rate of ION with Viagra was 18 times higher than that with Lipitor, the largest-selling statin drug; Cialis was 25 times higher, but the number of Cialis cases in the database, thus far, is small. Even though the number of cases of ION is still very small with Cialis, the numbers of prescriptions is very low compared with Viagra (Cialis was approved in November 2003, Levitra in August 2003, and Viagra in March 1998). It is clear, however, looking at the vision-related non-ION terms, that all of these drugs clearly have an adverse effect on the eye.

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It could be that there were many more cases of ION not reported to the FDA as such, since the numbers of non-ION cases (corrected for the number of prescriptions) are an order of magnitude higher with all three PDE5 inhibitors compared with the two statins. * visual field defect, blindness, blindness unilateral, scotoma, or optic nerve infarction Patient information leaflets are provided by private companies, not the FDA, and so are not regulated. Some of the current patient information leaflets contain no clear warnings, lump serious and less serious adverse events together, and bury information in large amounts of other material. Readability varies greatly, with small font-sizes and single-spacing being common (see Attachment). Two general types of risk factors for NAION have been studied: disease/lifestyle factors and those relating to the anatomy around the optic disc.

Medical uses

Many studies have measured the optic cup and optic disc in the unaffected eye in patients with viagra jellys NAION (the optic disc is measured in the non-affected eye because it is obscured by swelling in the affected eye). The optic disc is where the optic nerve enters the back of the eye; the optic cup is where the central retinal artery and vein emerge from within the optic nerve. Measurements from the unaffected eye often showed a relatively small optic nerve head (disc) and a small to absent cup resulting in a cup-to-disc ratio of 0.1 to 0.2[12] (see Figure). “postulate that the pathogenesis of n-AION [NAION] is multifactorial with the size of optic disc as one important factor”, and Bollinger and Lee state that, “Nearly all patients with NAION have a small, crowded optic nerve head (“disk at risk”) . Back of eye showing optic disc and cup where arteries and veins enter the eye.

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The disc represents the optic nerve and the cup the region within the optic nerve where the central retinal artery and vein emerge. Because of so many occurrences of NAION within hours after dosing with PDE5 inhibitors, most authors find it hard not to strongly suspect a cause-and-effect relationship. [14],[15],[16],[17],[18],[19],[20],[21],[22],[23] One case in the literature is especially compelling: a patient suffered somewhat reversible visual field defects within 2 hours of taking each of four doses of Cialis with permanent loss of vision shortly after the fifth dose. Although the manufacturers deny any causal effect, Cunningham and Smith state that, “The temporal relationship between the doses of sildenafil citrate [Viagra] and the onset of visual loss make it difficult to accept the notion that these were unrelated coincidental events.”[25] Now that sildenafil is also available under the brand name Revatio as long-term therapy for pulmonary arterial hypertension (PAH) with dosing of 20 mg three times a day[26] (on a par with the 25, 50, or 100 mg doses of Viagra), it is even more urgent to determine whether a link exists between these drugs and the development of NAION. Revatio (sildenafil) for PAH is used as long-term daily therapy compared to the sporadic use of Viagra (sildenafil) when indicated for erectile dysfunction. Although definitive data are lacking, certain factors appear to predispose individuals to NAION. It has been implied, both from studies and anecdotal data that pre-existing hypertension, diabetes, elevated cholesterol, and/or an arteriosclerotic risk profile put patients at risk. [6],[7] However, people taking Lipitor and Zocor fall into a group likely to have these risk factors, yet we find a much lower percentage of cases of ION with Lipitor and Zocor (Table 1).

Tip	Explanation	Source of Verification	Importance
Only buy from licensed pharmacies	Ensures product safety and authenticity	FDA, EMA	High
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Diabetes emerged as a risk factor in two studies undertaken before Viagra approval. One case-control study looked at diabetes, hypertension, high cholesterol, coronary artery disease, tobacco use, and body mass index as risk factors for NAION and found that only diabetes was statistically significant. [8] In a larger study (n=326 cases) of people each of whom already had NAION in one eye and was being followed to determine risk factors for NAION in the unaffected eye, 15% developed NAION in the other eye over a 5 year period. Diabetes was the only factor reaching statistical significance (p=0.02)[9] (“Vascular condition” did not quite reach statistical significance with p=0.06.) The potential risk factors of smoking, hypertension, myocardial infarction, cerebrovascular accident, transient ischemic attack, and aspirin use were not statistically significant in this study. In a review of NAION pathogenesis, Arnold stated that, “diabetes is the most consistently identified vasculopathic risk factor”.

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Although definitive data are lacking, certain factors appear to predispose individuals to NAION. It has been implied, both from studies and anecdotal data that pre-existing hypertension, diabetes, elevated cholesterol, and/or an arteriosclerotic risk profile put patients at risk. [6],[7] However, people taking Lipitor and Zocor fall into a group likely to have these risk factors, yet we find a much lower percentage of cases of ION with Lipitor and Zocor (Table 1). Diabetes emerged as a risk factor in two studies undertaken before Viagra approval. One case-control study looked at diabetes, hypertension, high cholesterol, coronary artery disease, tobacco use, and body mass index as risk factors for NAION and found that only diabetes was statistically significant.

Public Citizen’s Analysis

[8] In a larger study (n=326 cases) of people each of whom already had NAION in one eye and was being followed to determine risk factors for NAION in the unaffected eye, 15% developed NAION in the other eye over a 5 year period. Diabetes was the only factor reaching statistical significance (p=0.02)[9] (“Vascular condition” did not quite reach statistical significance with p=0.06.) The potential risk factors of smoking, hypertension, myocardial infarction, cerebrovascular accident, transient ischemic attack, and aspirin use were not statistically significant in this study. In a review of NAION pathogenesis, Arnold stated that, “diabetes is the most consistently identified vasculopathic risk factor”. Nocturnal hypotension may also play an important role: in a study of 544 episodes of NAION, 73% were presented as visual loss upon first awakening. The anatomic configuration around the optic disc appears to be of great importance in NAION. Nocturnal hypotension may also play an important role: in a study of 544 episodes of NAION, 73% were presented as visual loss upon first awakening. The anatomic configuration around the optic disc appears to be of great importance in NAION. Many studies have measured the optic cup and optic disc in the unaffected eye in patients with viagra jellys NAION (the optic disc is measured in the non-affected eye because it is obscured by swelling in the affected eye). The optic disc is where the optic nerve enters the back of the eye; the optic cup is where the central retinal artery and vein emerge from within the optic nerve.

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Measurements from the unaffected eye often showed a relatively small optic nerve head (disc) and a small to absent cup resulting in a cup-to-disc ratio of 0.1 to 0.2[12] (see Figure). “postulate that the pathogenesis of n-AION [NAION] is multifactorial with the size of optic disc as one important factor”, and Bollinger and Lee state that, “Nearly all patients with NAION have a small, crowded optic nerve head (“disk at risk”) . Back of eye showing optic disc and cup where arteries and veins enter the eye. The disc represents the optic nerve and the cup the region within the optic nerve where the central retinal artery and vein emerge. Because of so many occurrences of NAION within hours after dosing with PDE5 inhibitors, most authors find it hard not to strongly suspect a cause-and-effect relationship. [14],[15],[16],[17],[18],[19],[20],[21],[22],[23] One case in the literature is especially compelling: a patient suffered somewhat reversible visual field defects within 2 hours of taking each of four doses of Cialis with permanent loss of vision shortly after the fifth dose. Although the manufacturers deny any causal effect, Cunningham and Smith state that, “The temporal relationship between the doses of sildenafil citrate [Viagra] and the onset of visual loss make it difficult to accept the notion that these were unrelated coincidental events.”[25] Now that sildenafil is also available under the brand name Revatio as long-term therapy for pulmonary arterial hypertension (PAH) with dosing of 20 mg three times a day[26] (on a par with the 25, 50, or 100 mg doses of Viagra), it is even more urgent to determine whether a link exists between these drugs and the development of NAION.

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We tabulated the number of cases of ION for the three PDE5 inhibitors as well as for two statin drugs, since the statins would be given to a similar group of people, i.e., older men more likely to have heart disease and/or diabetes. By dividing the number of cases by the total number of prescriptions filled, we were able to estimate the ION reporting rate for each drug (Table 3). The rate of ION with Viagra was 18 times higher than that with Lipitor, the largest-selling statin drug; Cialis was 25 times higher, but the number of Cialis cases in the database, thus far, is small. Even though the number of cases of ION is still very small with Cialis, the numbers of prescriptions is very low compared with Viagra (Cialis was approved in November 2003, Levitra in August 2003, and Viagra in March 1998). It is clear, however, looking at the vision-related non-ION terms, that all of these drugs clearly have an adverse effect on the eye.

Is Black Viagra different from regular Viagra?

It could be that there were many more cases of ION not reported to the FDA as such, since the numbers of non-ION cases (corrected for the number of prescriptions) are an order of magnitude higher with all three PDE5 inhibitors compared with the two statins. * visual field defect, blindness, blindness unilateral, scotoma, or optic nerve infarction Patient information leaflets are provided by private companies, not the FDA, and so are not regulated. Some of the current patient information leaflets contain no clear warnings, lump serious and less serious adverse events together, and bury information in large amounts of other material. Readability varies greatly, with small font-sizes and single-spacing being common (see Attachment). Two general types of risk factors for NAION have been studied: disease/lifestyle factors and those relating to the anatomy around the optic disc. Revatio (sildenafil) for PAH is used as long-term daily therapy compared to the sporadic use of Viagra (sildenafil) when indicated for erectile dysfunction. 1) FDA should immediately require a black box warning for NAION for the entire PDE5 inhibitor drug class (Viagra, Cialis, Levitra, and Revatio) since the current labeling is inadequate.

Risk	Description	Potential Outcomes	Preventive Measures
Heart issues	Increased cardiac workload due to vasodilation	Heart attack, stroke	Get medical clearance beforehand
Allergic reactions	Unpredictable hypersensitivity to ingredients	Rashes, swelling	Allergy testing if possible
Priapism	Prolonged erection	Tissue damage	Seek immediate medical help if prolonged

Although the FDA’s safety evaluator recommended NAION be added to both the Precautions and Warnings sections of the Viagra label,[27] at present, there are only two inconspicuous paragraphs (one in Information for Patients under Precautions and one in Post-marketing Experience under Adverse Reactions) for Viagra, Cialis, and Levitra.

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These sections have neither titles nor bolding to call attention to this serious adverse event; instead, everything imaginable has been done to detract from its relevance and prominence. The Revatio label has no information at all. Our model black box warning for NAION — for doctors and patients — would be: There have been a significant number of patients taking PDE5 inhibitors (Viagra, Cialis, and Levitra) who have developed non-arteritic anterior ischemic optic neuropathy (NAION), a sudden loss of vision, usually in one eye, that can lead to permanent blindness. Patients should be told to report to their physicians any loss of vision, particularly that occurring upon waking up, not to take any more doses of drug, and to have an immediate eye exam. All physicians are encouraged to question patients appearing with NAION as to their use of these drugs and provide information on its symptoms. Patients who have experienced NAION in one eye are likely at increased risk for a second event, especially if they have other risk factors such as diabetes and hypertension and should not take these drugs. 2) In order to insure that patients receive the needed information, FDA needs to write a Medication Guide for consumers. 3) Because there is still much debate as to the causes, incidence, and risk factors for NAION, we recommend that the FDA have manufacturers establish a registry of patients taking PDE5 inhibitors who develop NAION. This will help clarify the nature of the relationship between drug use and NAION.

Warnings & Precautions

This will help clarify the nature of the relationship between drug use and NAION. 4) The manufacturers should immediately send a letter to all Health Care Professionals with all the new information. Health Care Professionals should be encouraged to report to the FDA all cases of adverse events related to the eye. Nothing requested in this petition will have an impact on the environment. We certify that, to the best of our knowledge and belief, this petition includes all information and views on which this petition relies, and that it includes representative data and information known to the petitioners which are unfavorable to the petition.

Genuine Medicines

Peter Lurie, M.D., M.P.H.Deputy Director Sidney M. Wolfe, M.D.DirectorPublic Citizen’s Health Research Group *Howard D. Pomeranz, MD, PhD is a neuro-ophthalmologist who recently joined the Department of Ophthalmology at North Shore Long Island Jewish Health System in Great Neck, NY. 4) The manufacturers should immediately send a letter to all Health Care Professionals with all the new information. Health Care Professionals should be encouraged to report to the FDA all cases of adverse events related to the eye. Nothing requested in this petition will have an impact on the environment.

Fact Box

1) FDA should immediately require a black box warning for NAION for the entire PDE5 inhibitor drug class (Viagra, Cialis, Levitra, and Revatio) since the current labeling is inadequate. Although the FDA’s safety evaluator recommended NAION be added to both the Precautions and Warnings sections of the Viagra label,[27] at present, there are only two inconspicuous paragraphs (one in Information for Patients under Precautions and one in Post-marketing Experience under Adverse Reactions) for Viagra, Cialis, and Levitra. These sections have neither titles nor bolding to call attention to this serious adverse event; instead, everything imaginable has been done to detract from its relevance and prominence. The Revatio label has no information at all. Our model black box warning for NAION — for doctors and patients — would be: There have been a significant number of patients taking PDE5 inhibitors (Viagra, Cialis, and Levitra) who have developed non-arteritic anterior ischemic optic neuropathy (NAION), a sudden loss of vision, usually in one eye, that can lead to permanent blindness.

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Patients should be told to report to their physicians any loss of vision, particularly that occurring upon waking up, not to take any more doses of drug, and to have an immediate eye exam. All physicians are encouraged to question patients appearing with NAION as to their use of these drugs and provide information on its symptoms. Patients who have experienced NAION in one eye are likely at increased risk for a second event, especially if they have other risk factors such as diabetes and hypertension and should not take these drugs. 2) In order to insure that patients receive the needed information, FDA needs to write a Medication Guide for consumers. 3) Because there is still much debate as to the causes, incidence, and risk factors for NAION, we recommend that the FDA have manufacturers establish a registry of patients taking PDE5 inhibitors who develop NAION. We certify that, to the best of our knowledge and belief, this petition includes all information and views on which this petition relies, and that it includes representative data and information known to the petitioners which are unfavorable to the petition. Peter Lurie, M.D., M.P.H.Deputy Director Sidney M. Wolfe, M.D.DirectorPublic Citizen’s Health Research Group *Howard D. Pomeranz, MD, PhD is a neuro-ophthalmologist who recently joined the Department of Ophthalmology at North Shore Long Island Jewish Health System in Great Neck, NY.