Erectile dysfunction drugs linked to eye conditions

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People who use phosphodiesterase type 5 (PDE5I) inhibitors, a class of drugs most often prescribed for erectile dysfunctionmay be at increased risk for vision-threatening eye disorders, researchers say.

Patients in an insurance database who have been prescribed sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), or avanafil (Stendra) were almost twice as likely as patients who received no drug to have ischemic optic neuropathy, retinal vascular occlusion, or serous retinal detachment.

In 2020, doctors wrote about 20 million monthly prescriptions for PDE5I in the United States alone, said Mahyar Etminan, PharmD, associate professor of ophthalmology at the University of British Columbia.

“We don’t want to alarm people who take them, but generally speaking, if they are experiencing visual problems or vision changes, then these drugs may be the culprit, and they should check it out,” he said. -he declares. Medscape Medical News.

The study was published in JAMA Ophthalmology.

Previous reports, including post-marketing studies by drug manufacturers, have documented ocular events. Monographs for sildenafil, tadalafil, vardenafil and avanafil warn users of ischemic optic neuropathy, the researchers found.

The monographs for sildenafil, tadalafil, and vardenafil list retinal vascular occlusion as a potential adverse event, but do not quantify risk. None of the drug monographs mention serous retinal detachment.

Previous research has linked PDE5Is to compromised optic nerve perfusion. Some researchers have hypothesized that choroidal blood vessels may undergo smooth muscle relaxation through a cyclic guanosine monophosphate pathway that can lead to choroidal congestion.

To better understand the ocular risks of PDE51, Etminan and colleagues analyzed health insurance claim records from the PharMetrics Plus database of 213,033 men who had not experienced any of the three eye conditions during the year. preceding their regular drug use. .

They identified 1,146 patients who had been diagnosed with at least one of the three conditions.

The total number of conditions diagnosed was small relative to the size of the population, 15.5 cases per 10,000 person-years. “So it’s still relatively rare, but the problem is that these are very widely used drugs,” Etminan said.

For each man diagnosed with one of the eye conditions, the researchers matched four control people who were the same age and could be followed for the same length of time. There were a total of 4584 witnesses.

The researchers compared regular users of PDE5I (those who had received at least one prescription for a PDE5I every 3 months in the year prior to ocular diagnosis) with non-users (those who had not received a prescription for PDE5I during this period).

Patients with eye disorders were more likely than those in the control group to have hypertension, diabetes, cardiovascular disease or sleep apnea. After controlling for these covariates, the researchers found that users were 85% more likely overall to be diagnosed with one or more of them (incidence rate ratio [IRR]1.85).

Table. Risk of eye conditions

Eye condition Total number of cases SORT of users
Serous retinal detachment 278 2.58
Retinal vascular occlusion 628 1.44
Ischemic optic neuropathy 240 2.02
Composite 1146 1.85

The researchers also found that the risk was even greater for patients who received five or more prescriptions of PDE5I, compared to those who received less than five prescriptions, suggesting a dose response.

Based on these findings, Etminan thinks drug companies should add warnings about serous retinal detachment and retinal vascular occlusion to drug monographs.

Asked to comment, Pfizer, which developed Viagra, posed questions to its spin-off company, Viatris, which did not respond. Eli Lilly, which makes Cialis, also did not respond to a request for comment. Vivus, which makes Stendra, could not be reached by press time.

Bayer, which makes Levitra, declined to provide anyone who could answer questions, but did provide a statement noting that the occurrence of ocular adverse events is already known among PDE5I users and that retinal vascular occlusion and optic neuropathy ischemic are mentioned in the product information.

“For example, non-arteritic anterior ischemic optic neuropathy (NAION) is a very rare condition that occurs with a higher overall risk in the general population with erectile dysfunction (ED) – i.e. older men with co-occurring conditions such as diabetes, dyslipidemia and hypertension – compared to the general population,” the statement said.

Due to the retrospective nature of the analysis, Etminan acknowledged that the researchers could not prove that the increased risk of eye disease was associated with the use of the drugs rather than an underlying condition. But in addition to adjusting for known risk factors, they also separately analyzed men without hypertension, diabetes, or coronary artery disease and still found that the risk of eye disorders was about double for men who received PDE5I prescriptions.

Howard Pomeranz, MD, PhD, professor of ophthalmology at Northwell Health in Great Neck, New York, who was not involved in this study, said his results confirmed similar research he had done on ischemic optic neuropathy. .

He said Medscape Medical News that people taking PDE5Is should weigh the risk against the benefit, but added that the math might be different for people using them to treat pulmonary hypertension rather than erectile dysfunction.

While people taking the drugs should discuss any changes in their vision with their practitioners, he said they shouldn’t be concerned about a “type of bluish tint to vision that can transiently occur during a few minutes up to 40 or 45 minutes.”

Pharmaceutical companies and regulators should consider modifying monographs in light of this new evidence, Pomeranz said. “Perhaps these data could lead to the warning being maybe a bit stronger, now that there is more data to suggest maybe a bit stronger association and not just a chance association between the use of these medications and visual events.”

The study was funded by the University of British Columbia. Etminan and Pomeranz have not disclosed any relevant financial interests.

JAMA Ophthalmol. Published online April 7, 2022. Abstract

Laird Harrison writes about science, health and culture. His work has appeared in magazines, newspapers, on public radio and on websites. He is working on a novel about alternate realities in physics. Harrison teaches writing at Writers Grotto. Visit him at lairdharson.com or follow him on Twitter: @LairdH.

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