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[2] Grassley’s staff interviewed the safety evaluator from the FDA Office of Drug Safety (ODS), who had produced the original analysis of NAION in Viagra users. By monitoring adverse event reports submitted to the FDA, the safety evaluator had concluded, as early as January 2004, that NAION was an important safety issue for Viagra users. Her review had been sufficient to convince the deputy director of the Division of Anti-inflammatory, Analgesic, and Ophthalmic Drug Products that the potential for NAION should be added to the Viagra label. The NAION report was finalized in April 2004 and sent to the Office of New Drugs (OND), the final arbiter of label changes. Nevertheless, it wasn’t until July 8, 2005, 13 months after the Office of New Drugs received documents from the safety evaluator, that the FDA finally published safety alerts for patients and healthcare professionals on its web site. There is now mention of NAION in the Precautions and Adverse Reactions sections of the professional labels for Viagra, Cialis, and Levitra (but no mention anywhere in the label for Revatio). However, the wording is ambiguous and the location of this information is buried: under Information for Patients in the Precautions section (information that usually is not given to patients), there is one untitled paragraph. In the Adverse Reactions section under Post-marketing Experience, one of several paragraphs discusses NAION.

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However, after the publicity in May 2005 about NAION, we began reading the literature reports and decided to undertake our own analysis using the FDA Adverse Event Reports (AERS) database. We searched the entire FDA database from 1/1/98 to 12/31/04 for all reports of ION that showed up for any drug (combining brand and generic names). We found 258 reports in which a drug was listed as the primary suspect for this adverse event. The three drugs with the highest percentage of reports of ION in the FDA’s AERS database were Viagra, interferon, and amiodarone (Table 1). These three drugs (of thousands in the data set) accounted for 42% of all reported ION cases.

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Viagra had the highest percentage by a factor of more than 2-fold in spite of the fact that during this time period there was no mention of NAION in the label, whereas the labels for both interferon and amiodarone had prominent Warnings and amiodarone had a statement in the Precautions section as well. [5] The fact that Viagra’s large numbers of adverse reaction reports occurred without any warnings to the medical profession strongly suggests that Viagra is an important factor in causing ION (all of these cases accrued before the Viagra-NAION association first came to public attention in May 2005). All reports are for Viagra, since Revatio had not been approved during the time period we searched. *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 generic viagra sildenafil citrate 50 mg 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).

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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”. *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. In the case of Viagra, NAION is discussed in one of two paragraphs under Adverse Reactions subheaded “Special Senses” which gives no indication as to what is discussed (the other two drugs have paragraphs that are at least titled “Ophthalmologic”). Emphasis in the label is on the word “rarely”, downplaying the importance of NAION and is coupled with the caveat that, “It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient’s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors”. It is probably true that many factors are involved, but one factor clearly seems to be the drug (see below). The current label has a paragraph titled “Effects of VIAGRA on Vision” which includes no reference to NAION.

Public Citizen has been concerned about a number of safety issues with Viagra’s use since its approval in 1998 when we asked the FDA to include stronger warnings concerning adverse effects. [4] Public Citizen had, at that time, only looked at the FDA reviews since no postmarketing adverse event data were available. Our concerns relating to the eye were limited to color aberrations, increased sensitivity to light, and blurred vision. However, after the publicity in May 2005 about NAION, we began reading the literature reports and decided to undertake our own analysis using the FDA Adverse Event Reports (AERS) database. We searched the entire FDA database from 1/1/98 to 12/31/04 for all reports of ION that showed up for any drug (combining brand and generic names). We found 258 reports in which a drug was listed as the primary suspect for this adverse event.

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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. 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).

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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. 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.

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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 liquid viagra 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. 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. The three drugs with the highest percentage of reports of ION in the FDA’s AERS database were Viagra, interferon, and amiodarone (Table 1). These three drugs (of thousands in the data set) accounted for 42% of all reported ION cases. Viagra had the highest percentage by a factor of more than 2-fold in spite of the fact that during this time period there was no mention of NAION in the label, whereas the labels for both interferon and amiodarone had prominent Warnings and amiodarone had a statement in the Precautions section as well. [5] The fact that Viagra’s large numbers of adverse reaction reports occurred without any warnings to the medical profession strongly suggests that Viagra is an important factor in causing ION (all of these cases accrued before the Viagra-NAION association first came to public attention in May 2005). All reports are for Viagra, since Revatio had not been approved during the time period we searched. *1/1/98 to 12/31/04; total number of reports was 258.

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To put into context and further understand the relevance of the disproportionate percentage of cases of ION in which Viagra was the primary generic viagra sildenafil citrate 50 mg 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).

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[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. [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.

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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. Many studies have measured the optic cup and optic disc in the unaffected eye in patients with 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. 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”. *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. 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.

• Black Viagra might be sought for its supposed faster or more intense effect.
• It is critical to avoid buying from unverified sources to reduce health risks.
• Long-term effects of black Viagra are unknown due to lack of clinical studies.
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• Always consider consulting a healthcare provider before using any erectile dysfunction medication.

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. 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 liquid viagra common (see Attachment).

• Black Viagra is sometimes available on the black market, risking legal issues.
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• Use of black Viagra can lead to unexpected side effects or health complications.
• Education on the risks associated with black-market pills is essential for safety.

Two general types of risk factors for NAION have been studied: disease/lifestyle factors and those relating to the anatomy around the optic disc. 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.

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[2] Grassley’s staff interviewed the safety evaluator from the FDA Office of Drug Safety (ODS), who had produced the original analysis of NAION in Viagra users. By monitoring adverse event reports submitted to the FDA, the safety evaluator had concluded, as early as January 2004, that NAION was an important safety issue for Viagra users. Her review had been sufficient to convince the deputy director of the Division of Anti-inflammatory, Analgesic, and Ophthalmic Drug Products that the potential for NAION should be added to the Viagra label. The NAION report was finalized in April 2004 and sent to the Office of New Drugs (OND), the final arbiter of label changes. Nevertheless, it wasn’t until July 8, 2005, 13 months after the Office of New Drugs received documents from the safety evaluator, that the FDA finally published safety alerts for patients and healthcare professionals on its web site.

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There is now mention of NAION in the Precautions and Adverse Reactions sections of the professional labels for Viagra, Cialis, and Levitra (but no mention anywhere in the label for Revatio). However, the wording is ambiguous and the location of this information is buried: under Information for Patients in the Precautions section (information that usually is not given to patients), there is one untitled paragraph. In the Adverse Reactions section under Post-marketing Experience, one of several paragraphs discusses NAION. In the case of Viagra, NAION is discussed in one of two paragraphs under Adverse Reactions subheaded “Special Senses” which gives no indication as to what is discussed (the other two drugs have paragraphs that are at least titled “Ophthalmologic”). Emphasis in the label is on the word “rarely”, downplaying the importance of NAION and is coupled with the caveat that, “It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient’s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors”.

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It is probably true that many factors are involved, but one factor clearly seems to be the drug (see below). The current label has a paragraph titled “Effects of VIAGRA on Vision” which includes no reference to NAION. Public Citizen has been concerned about a number of safety issues with Viagra’s use since its approval in 1998 when we asked the FDA to include stronger warnings concerning adverse effects. [4] Public Citizen had, at that time, only looked at the FDA reviews since no postmarketing adverse event data were available. Our concerns relating to the eye were limited to color aberrations, increased sensitivity to light, and blurred vision. [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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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 NAION (the optic disc is measured in the non-affected eye because it is obscured by swelling in the affected eye).

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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. 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. The disc represents the optic nerve and the cup the region within the optic nerve where the central retinal artery and vein emerge.