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FDA Changes Labels for Cialis, Levitra, Viagra Due To Hearing Loss ...

Potential side effects of sudden hearing loss with erectile dysfunction drugs such as Viagra. Levitra and Cialis to be displayed more prominently. The U. S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis. Levitra and Viagra to display more prominently the potential risk of sudden hearing loss and to guide consumers on what to do if they experience sudden problems with their hearing. In addition the FDA plans to require the same changes in labeling for the drug Revatio also a member of this medicate class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to alter heart failure and death. The FDA asked manufacturers of Cialis. Levitra and Viagra to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss sometimes accompanied by ringing in the ears and dizziness. 揃ecause some level of hearing loss is usually associated with the aging process patients on these drugs may not think to communicate to their doctor about it,?said Janet Woodcock. M. D.. FDA抯 deputy commissioner for scientific and medical programs chief medical officer and acting director of its Center for Drug Evaluation and Research. Patients taking Cialis. Levitra or Viagra who experience sudden hearing loss should immediately forbid taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for advance evaluation. Because Revatio is used to treat a potentially life-threatening condition the FDA does not recommend patients abruptly stop taking this medication but should ask their physician if they experience sudden problems with their hearing. A inspect report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA抯 Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a be of 29 postmarketing reports of sudden hearing loss both with and without accompanying ringing in the ears vertigo or dizziness. In most of the cases the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual.

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No evidence of increased risk of blindness among patients taking ...

“There is no evidence that Viagra causes blindness or any other serious ocular condition,” said Dr. Joseph Feczko. Pfizer’s chief medical command. “Men taking Viagra are at no greater assay for blindness - including vision loss from NAION - than men of similar age and health not taking the care for.” Pfizer said discussions are progressing with the U. S. Food and Drug Administration to update the Viagra label to reflect rare reports of non-arteritic anterior ischemic optic neuropathy (NAION) in some men who have used the care for. While the FDA concluded that no causal relationship between Viagra and NAION has been established. Pfizer has agreed with the agency to consider the fact of these reports in the Viagra label to help communicate physicians and patients. It is Pfizer’s understanding that the FDA has asked that similar information be included in the labels of all oral ED medicines. NAION among the most common acute optic nerve diseases in older adults shares a number of common assay factors with erectile dysfunction: over 50 years of age high daub pressure high cholesterol and diabetes. Since Viagra was introduced in 1998. Pfizer and regulatory authorities around the world have regularly reviewed all reported adverse events including those involving the eye. No regulatory authority has concluded that Viagra use is associated with an increased assay for blindness. Most of the reported NAION cases occurred in Viagra users with underlying anatomic or vascular risk factors associated with the development of NAION. Pfizer has shared this information with CBS News which plans to air a story tonight highlighting reports of blindness with Viagra. Pfizer said it is concerned that such news reports unnecessarily alarm patients.

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More young men turning to viagra

The study is the first to profile trends in the use of Viagra using prescription affirm information from a random nationwide sample. The chew over by Express Scripts examined Viagra use among more than 5 million commercially insured adult beneficiaries 18 years and older from 1998 to 2002. The fastest growing segments of users were open to be men 18 to 45 years and 46 to 55 years who experienced increases in use of 312% and 216% respectively over the study period. In addition use for an underlying medical reason declined in all age groups over the five years. These findings declare increased use of Viagra as an enhancement or recreational agent. Overall use increased from 0.8% of the consume population in 1998 to 1.4% in 2002 an 84% increase. Men 56 years and older continued to receive the majority of Viagra prescriptions. In contrast with greater use among younger men growth in use slowed among women and older men. With healthcare resources becoming more scarce debate continues over the coverage of lifestyle medications such as Viagra. “Already concerned with the impact Viagra has had on their pharmacy budgets health plan sponsors now face the prospect of increased use among a younger healthier generation of patients,” said Tom Delate. Ph. D. bring about compose of the study. “In addition marketing approval of other erectile dysfunction drugs such as Levitra(R) and Cialis(R) ordain likely change magnitude utilization of such drugs.” The coverage of erectile dysfunction (ED) drugs by prescription acquire plans varies widely with some plans having no restrictions on coverage others requiring prior authorization for medical necessity or placing quantity limits and others offering no coverage. In one finding the use of quantity limits by intend sponsors can mitigate the effects of increased bespeak for ED drugs.

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Viagra helps children with heart-lung condition achieve improved ...

Researchers in a small chew over involving the drug known generically as sildenafil say the study needs to be repeated in a larger assort to be accepted as credible but sign results suggest a daily pill could be an alternative to current cumbersome treatments. Ian Adatia an associate professor of pediatrics at the University of California. San Francisco Children’s Hospital who led the chew over says that sildenafil compared favorably to drugs currently being used and had far fewer align effects. Adatia says left untreated these children usually die within one year of diagnosis. Apparently change surface with the beat therapy which entails continual intravenous infusion of the drug prostacyclin that helps displace the compel in the pulmonary arteries few patients be five years past diagnosis. In childhood pulmonary arterial hypertension the daub pressure in the arteries that supply the lungs is extremely high and as a prove the small blood vessels in the lungs steadily narrow and their walls thicken so they displace less blood. This causes compel to build as the blood backs up and the heart works overtime to cope properly. This then becomes a chronic condition known as heart failure which causes patients to feel tired alter and bunco of breath. Prostacyclin treatment involves patients always carrying an infusion handle and their parents must mix the medicate daily. Sildenafil works by relaxing the smooth muscle of daub vessels expanding them and increasing the blood move. When it was being tested on young men for development as a heart medicate doctors noticed the side-effect that the drug is now used for it caused erections. In the chew over varying doses of Viagra were given to 14 children aged 5 to 18 with pulmonary arterial hypertension for one year by Adatia’s aggroup. After a year the children could go considerably advance blood resistance dropped and the patients reported they could exist more easily. Most importantly says Adatia the align effects were minimal the drug was very easy to take and there were no changes in liver or kidney answer.

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The Viagra of heart drugs now available in the UK

medicate affiliate Pfizer has launched Revatio for use in patients with this instruct which produces abnormal pressure levels in the daub vessel that leads from the heart to the lungs. Sufferers experience breathlessness fainting chest pains and tiredness. The condition affects about 100,000 people worldwide and is most commonly seen in women between the ages of 20 and 40. Revatio has the same active ingredient as the anti-impotence medicate Viagra. A clinical trial by the medicate affiliate open the medicate reduced the daub pressure in the artery and improved the ability of PAH patients to exercise. The launch of the new treatment follows a series of research findings showing Viagra could be effective for other medical problems in addition to impotence. Recent research showed Viagra was beneficial in treating the inflammatory bowel disorder Crohn’s disease. Research has also shown that the drug reduces the harmful effect of stress on the heart and could be used to treat people with hypertrophy (enlarged heart). Britain is the back up major European merchandise to have the product after Germany where it went on sale in January. The world’s biggest drug maker launched Revatio in the United States measure August.

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