Friday, December 09, 2005

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There Have Been Inadequate Warnings That...

Erectile Dysfunction (ED) Drugs Can Cause Blindness

Posted 12/05/2005

Fifty reports of ischemic optic neuropathy (ION), usually resulting in irreversible unilateral blindness, in men using the erectile dysfunction (ED) drugs Viagra, Cialis, or Levitra had been received by the US Food and Drug Administration (FDA) by March 2005. But the FDA and the companies have downplayed the link between these drugs and ION, stating, correctly, that the disease also occurs in men with cardiovascular risk factors who do not take erectile dysfunction drugs, but implying that the cause is cardiovascular risk, not the drugs. To test this, we compared the rate of reports of ION, per million prescriptions filled, in those using ED drugs with the rate in those using Lipitor -- both groups having presumed increased cardiovascular risk.

For Viagra, there were 18 times more reports of ION per million prescriptions than for Lipitor and, for Cialis, 25 times more reports. Thus, it is very likely that the drugs can actually cause blindness in some people. Further evidence of causation can be seen in a case report in which one patient using Cialis suffered reversible visual field defects each time within 2 hours after taking 4 sequential doses of Cialis and suffered permanent partial loss of vision shortly after the fifth dose.[1] Our organization has thus petitioned the Food and Drug Administration to immediately require a black box warning on the labels for all 3 drugs, to require an FDA-approved Medication Guide for patients that contains the black box warning, and to begin a registry of all cases of ION following the taking of ED drugs. The full petition is at www.worstpills.org. Dr. Howard Pomeranz, the neuroophthalmologist who first published a report of ION in a man using an ED drug,[2] and has added 13 further cases, has joined us in the petition.[3] A rapid response from the FDA is mandatory.

That's my opinion. I'm Dr. Sidney Wolfe, Director, Public Citizen's Health Research Group.

References

  1. Bollinger K, Lee MS. Recurrent visual field defect and ischemic optic neuropathy associated with tadalafil rechallenge. Arch Ophthalmol. 2005;123:400-401.
  2. Egan R, Pomeranz H. Sildenafil (Viagra) associated anterior ischemic optic neuropathy. Arch Ophthalmol. 2000;118:291-292.
  3. Pomeranz HD, Bhavsar AR. Nonarteritic ischemic optic neuropathy developing soon after use of sildenafil (Viagra): a report of seven new cases. J Neuroophthalmol. 2005;25:9-13.

9 Comments:

Blogger FDF said...

If you are over 65 years of age, you may be more likely to experience side effects from Skelaxin. Your doctor may prescribe a lower dose of the medication.

7:15 PM  
Blogger FDF said...

It is not known whether Didrex passes into breast milk. Do not take Didrex without first talking to your doctor if you are breast-feeding a baby

6:47 AM  
Blogger FDF said...

Remember, keep this Zydone and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

12:51 PM  
Blogger Dr.Chatwin said...

All the ED drugs are strictly prescribed. Having them without prescription can lead to fatal consequences. Among all the ED drugs levitra has the least restrictions. It can be had in a full stomach and it can be had whenever a person feels like making love. However, by no means should a person have levitra twice in the span of 24 hours. Regarding the levitra dosages one should always follow the physician’s directions.

11:49 PM  
Blogger Dr.Shirley said...

One big black spot that still tarnishes the image of the ED drugs like viagra is the illegal sale of these drugs. The illegal sale or smuggling of the drugs like viagra is very rampant and still beyond the clutches of the respective authorities. In countries like South Korea the illegal sale of viagra is fetching double the money that is fetched from its legal sale. http://www.viagracare.com

10:21 PM  
Blogger goooooood girl said...

Very good......

7:30 PM  
Blogger kevin said...

Just after its launch in the market, viagra has created a niche for itself as the most effective medication for treating male erectile dysfunction across the world but alongside, the effectives of herbal Viagra products in dealing with male sexual problems cannot be ignored. Herbs and plants are, however, extensively used as sex stimulants worldwide and details present at http://www.pill-care.com inform you that the highly utilized sex boosters collectively known as herbal Viagra are namely, gingko biloba, yohimbe, horny goat weed and muira puama.

10:54 PM  
Blogger viagra said...

Before the arrival of viagra in the pharmaceutical market, people were thoroughly scared of male erectile dysfunction as no effective treatment of the disorder was available at that time. However, as soon as the medicine was released in the market, it unleashed a revolutionary change in the lives of men by rescuing millions of men from the grip of erectile dysfunction. To known more on the effects of Viagra against erectile dysfunction, log in to the website http://www.viagraforce.com.

8:42 PM  
Blogger Dr.Puttlitz said...

Viagra, the FDA (Food and Drugs Administration) approved anti-impotence drug is composed of specific inactive ingredients such as anhydrous dibasic calcium phosphate, microcrystalline cellulose, magnesium stearate et al and altogether the medicine contains sildenafil as the chief component. But the erectile dysfunction medicine viagra would yield effective results only when taken in accordance with the instructions of the doctor.

10:41 PM  

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