Friday, February 15, 2008

Food and Drug Administration (FDA) ALERT Viagra, Cialis, Levitra

FDAA small number of men have lost eyesight in one eye some time after taking Viagra, Cialis, or Levitra. This type of vision loss is called non-arteritic anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow is blocked to the optic nerve.


We do not know at this time if Viagra, Cialis, or Levitra causes NAION. NAION also happens in men who do not take these medicines. People who have a higher chance for NAION include those who:




  • have heart disease


  • are over 50 years old


  • have diabetes


  • have high blood pressure


  • have high cholesterol


  • smoke


  • have certain eye problems

FDA has approved new labels for Viagra, Cialis, and Levitra to include information on possible eyesight loss (NAION).


Stop using Viagra, Cialis, or Levitra if you have a loss in your eyesight. Get medical help right away.


This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.


What is Viagra?


Viagra is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. Viagra may help a man with ED get and keep an erection when he is sexually excited. Viagra must be used only under a doctor's care.


Viagra does not:




  • cure ED


  • increase a man's sexual desire


  • protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare professional about ways to guard against sexually transmitted diseases.


  • serve as a male form of birth control

Viagra is only for men with ED. Viagra is not for women or children. Viagra must be used only under a healthcare professional's care.


Who Should Not Take Viagra?


Do not take Viagra if you:




  • take any medicines called "nitrates"


  • use recreational drugs called "poppers" like amyl nitrate and butyl nitrate


  • have been told by your healthcare professional to not have sexual activity because of health problems

What are The Risks?


The following are the major possible risks and side effects of Viagra therapy. This list is not complete.


Viagra can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines such as nitrates and alpha-blockers, and recreational drugs that contain nitrates called "poppers". A sudden drop in your blood pressure could cause you to become dizzy, faint, or have a heart attack or stroke.


Tell all your healthcare professionals that you take Viagra. If you need emergency medical care for a heart problem, it will be important for your healthcare professionals to know when you last took Viagra.


Viagra may uncommonly cause:




  • an erection that won't go away (priapism)


  • vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green

Some common side effects with Viagra include:




  • headache


  • flushing


  • upset stomach


  • stuffy or runny nose


  • urinary tract infection


  • diarrhea

What Should I Tell My Healthcare Professional?


Tell your healthcare professional if you:




  • have or had heart problems


  • have low blood pressure or have high blood pressure that is not controlled


  • have had a stroke


  • have liver problems


  • have ever had severe vision loss


  • have kidney problems or require dialysis


  • have retinitis pigmentosa, a rare genetic (runs in families) eye disease


  • have stomach ulcers


  • have a bleeding problem


  • have a deformed penis shape or Peyronie's disease


  • have had an erection that lasted more than 4 hours


  • have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia


  • are taking a medicine called a protease inhibitor for the treatment of HIV


  • are taking medicines called alpha blockers (alpha blockers are sometimes prescribed for prostate problems or high blood pressure)

Can Other Medicines or Food Affect Viagra?


Viagra and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your healthcare professional.


Date created: July 8, 2005, updated October 2, 2007


Thyroid eye disease: an unusual presentation British Journal of Ophthalmology J Shankar,1 C P Noonan,2 P Mathew,2 and S Hanif2 1Royal Liverpool University Hospital, Prescot Street, Liverpool L7 8XP, UK 2Warrington General Hospital, Warrington, UK Correspondence to: Jai Shankar, Royal Liverpool University Hospital, Prescot Street, Liverpool L7 8XP, UK;
Accepted December 9, 2002. Keywords: Viagra, proptosis, sildenafil, thyroid.


Viagra (Sildenafil) is an oral preparation for the treatment of male erectile dysfunction. Although the drug is marketed solely for its therapeutic purposes, it has high potential for abuse owing to its ability to intensify and prolong erectile response. We describe here an ocular side effect following its use as a recreational drug, which led to the diagnosis of thyroid eye disease.


Side Effects Of Cialis?


The most common side effects found in the clinical trial of Cialis were headache, muscle pain( myalgia ), upset stomach ( dyspepsia ) and back pain. Lower doses produced correspondingly reduced side effects.


Who should Not Take Cialis?


Cialis® is only for patients with ED. Cialis® is not for newborns, children, or women. Do not let anyone else take your Cialis® . Cialis® must be used only under a health care providers supervision. Before you start any treatment of Cialis®, be sure to ask your Health Care Provider if your heart is healthy enough. If youre a man who uses nitrate drugs, like nitroglycerine, never take Cialis®. The combination of Cialis® and nitrates can make your blood pressure suddenly drop to unsafe levels. You could get dizzy, faint, or even have a heart attack or stroke. Nitrates are found in many prescription medications that are used to treat angina (chest pain due to heart disease) such as: Nitroglycerin (sprays, ointments, skin patches or pastes, and tablets that are swallowed or dissolved in the mouth) Isosorbide mononitrate and isosorbide dinitrate (tablets that are swallowed, chewed, or dissolved in the mouth) Nitrates are also found in recreational drugs such as amyl nitrate or nitrite ("poppers"). If you are not sure if any of your medications contain nitrates, or if you do not understand what nitrates are, ask your health care provider or pharmacist.






Case report


A 30 year old white man was referred to the eye clinic, with a history of waking up one morning with a left proptosis, having had no ocular signs or symptoms the previous day. The patient did not have any subjective symptoms of pain, redness, change in visual acuity, double vision, or of hearing any sounds. There was no history of direct or indirect trauma. He gave a history of having acquired a tablet of Viagra from a friend at a Christmas party. He ingested half and gave half to his partner. The exact dosage strength was unknown. His partner noticed increased visibility of the white of the eye under the left upper lid. He was otherwise healthy and was taking no medication.


Visual acuity was 6/5 unaided in each eye. Ocular examination showed a 3 mm axial non-pulsatile left proptosis. He was orthophoric and ocular movements were unrestricted. Anterior segment examination showed generalised conjunctival engorgement on both sides, more on the left than the right. Pupils were normally reacting and fundus examination was unremarkable. Intraocular pressure was normal with no significant difference between straight gaze and up gaze. Auscultation over the globe revealed no bruit.


The clinical findings along with the acute onset history led us to suspect superior ophthalmic vein thrombosis as a possible cause. An magnetic resonance imaging (MRI) scan was ordered with a specific request to comment on the calibre of the superior ophthalmic veins. The MRI scans showed normal superior ophthalmic veins bilaterally but thickening of all extraocular muscles, particularly the inferior recti on both sides. The inferior rectus was intensely white on T2 weighted scans. Biochemical tests for thyroid function showed him to have high T3 and T4 levels and very low TSH levels.


Comment


Sildenafil citrate has been in use since early 1998 for the treatment of male erectile dysfunction. It is a selective cyclic guanosine monophosphate dependent phosphodiesterase type 5 (PDE5) inhibitor. It potentiates the smooth muscle relaxant effect of nitric oxide and leads to engorgement of the sinusoids of the corpus cavernosa with a resultant penile erection. At the time of orgasm, emission, and ejaculation sympathomimetic substances-adrenaline (epinephrine) and noradrenaline (norepinephrine)-are released with consequent sinusoidal smooth muscle contraction and rapid loss of penile rigidity.


As with any new drug, clinical information and known side effects with regard to sildenafil are limited. Ocular side effects are few. Although sildenafil was developed as a selective PDE5 inhibitor, it has about 10% effect against PDE6-an enzyme localised in retinal photoreceptors. This results in various visual symptoms like a blue tinge to vision, impaired colour vision, increased light sensitivity, and blurred vision. Symptoms are transient and occur between 2-4 hours after ingestion. Results of ocular electrophysiological tests have been variable.2,3 A recent study showed no effect of sildenafil on mean blood pressure, intraocular pressure, perfusion pressure, or choroidal and optic nerve head blood flow,4 but there have been isolated reports of anterior ischaemic optic neuropathy,5 vascular third nerve palsy,6 and retinal vascular occlusions.


Lid retraction following ingestion of Viagra has not been reported before. We believe that the release of sympathomimetic substances may have produced a supranormal response in the form of noticeable lid retraction in a sensitised individual with thyroid dysfunction. We speculate, based on the close temporal relation between ingestion of this recreational drug and the presentation to our department, that Viagra therapy was responsible for the unmasking of latent thyroid eye disease in a sensitised individual.


Success comes in cans, not cant's


Young


It also comes in bottles.

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