Hearing Loss is one of the bodily changes that Happeh Theory claims are caused by Masturbation.
The news story reproduced below discusses a study that found Viagra usage is associated with hearing loss. The study indirectly corroborates the claim by Happeh Theory that masturbation causes hearing loss.
It is not the drug Viagra itself that is causing the hearing loss. The hearing loss is being caused by the Excessive Sexual Activity, Masturbation being one of those activities, that Viagra enables the people to engage in.
This study supports the claim that Scientists R Stoopid. They are so focused on miniscule objects like the chemicals in Viagra, it will never occur to them to consider the possibility it could be the sex acts that Viagra is allowing the people to engage in that could be causing the hearing loss.
The original news story is reprinted below
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Patients taking Cialis, Levitra or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention, the FDA said in a statement issued late Thursday. The agency said people using Revatio should not stop taking the drug without talking to their doctors because the product is used to treat a life-threatening condition. The companies all said they agreed to the labeling changes. “We feel this is in the overall interest of patients,” said Keri McGrath, an Eli Lilly spokeswoman who noted that the reported instances of hearing loss “are low.” [1] Reuters says the FDA found 29 cases in which men taking the drug suffered sudden hearing loss. “Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention,” the FDA says on its website. “Those using Revatio should continue taking their medication but should contact their health care provider for further 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 consult their physician if they experience sudden problems with their hearing.”[2]
Label information for Viagra, Levitra, and Cialis, drugs used to treat male erectile dysfunction, have been modified to include warnings about sudden hearing loss associated with use of these medications. The Food & Drug Administration (FDA) announced the labeling changes after it had received more than two dozen reports of sudden hearing loss occurring among patients taking these drugs.[3] New warnings about the potential risk of sudden hearing loss will be added to the labels of Viagra and other drugs to treat erectile dysfunction, the U.S. Food and Drug Administration says. While it’s not clear whether the drugs actually do cause hearing loss, the FDA said that since 1996 there have been 29 reports of hearing problems among users of these kinds of drugs, the Associated Press reported.[4]
The FDA said it found a total of 29 reports of sudden hearing loss among patients taking the erectile dysfunction drugs. The agency said the search of its adverse-events database was prompted by a case report in medical literature of a patient with sudden hearing loss who was taking Viagra. Such adverse-event reports, which are filed to the FDA by drug companies, doctors and patients, does not mean a particular drug has caused a problem. The FDA said hearing loss was also reported in a few patients in clinical trials of these drugs.[1] The FDA on Thursday asked manufacturers of Viagra, Cialis and Levitra to revise product labelling after a very small number of patients taking the drugs reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness. It’s not clear”if the drugs”actually trigger hearing loss, but the agency decided to act after counting 29 reports of hearing problems since 1996 among users. Dr. Robert Boucher, an agency ear, nose and throat specialist, said in reviewing the reports he noticed that the hearing loss occurred within hours to two days of taking one of the drugs. “We don’t know enough to say that it’s ironclad caused by the drugs, but we see enough to say we can’t ignore it either,” he said.[5]
FDA noted that while decreased hearing is common among elders, sudden hearing loss is highly unusual. Agency officials said they have received 29 reports of sudden hearing loss since Pfizer’s Viagra, the first impotence drug, was approved in 1998. FDA said men taking the drugs who experience hearing problems should stop taking them immediately and seek medical attention.[6] The reports involved hearing loss in one ear, which in a third of cases was temporary. The FDA has urged patients who experience any hearing problems, loss or ringing in the ears to promptly call their doctors and stop taking the impotence drugs. Because some level of hearing loss is usually associated with the aging process, patients taking these drugs (phosphodiesterase type 5 inhibitors) may not think to talk to their doctor about it, said Dr. Janet Woodcock, the FDA’s chief medical officer.[5]
The FDA says all manufacturers have agreed to the change their labels. “This is basically a public health announcement to let people decide if they want to take the drug,” Dr. Robert Boucher said. Boucher is an ear, nose and throat specialist for the FDA who reviewed reports of sudden hearing loss in patients taking these drugs.[7] Viagra’s label already mentioned hearing loss as a possibility, because a few cases were reported during initial testing of that drug. Given that hearing loss is a risk of advancing age and certain conditions, such as diabetes and heart disease, that can lead to impotence, it wasn’t clear if the link was real. That still isn’t clear, said FDA ear nose and throat specialist Dr. Robert Boucher. In poring over FDA’s database of possible drug reactions, what struck him was these 29 reports said the hearing loss occurred without hours to two days of taking one of the drugs. “We don’t know enough to say that it’s ironclad caused by the drugs, but we see enough to say we can’t ignore it either,” he said.[8]
WASHINGTON (AP) — Viagra and other impotence drugs are about to bear new warnings that users may experience sudden hearing loss. It’s not clear that the drugs truly trigger hearing loss, but the Food and Drug Administration decided Thursday to add a warning about the possible risk after counting 29 reports of the problem since 1996 among users of this family of medicines.[8] The impotence drugs Viagra, Cialis and Levitra will get more prominent warnings on the risk of sudden hearing loss, U.S. regulators said. The enhanced warnings for the drugs, made by Pfizer Inc., Eli Lilly & Co. and Bayer AG, will be in prescribing information, the Food and Drug Administration said Thursday in a statement on its website.[9] WASHINGTON (CNN) — Men taking any of three erectile dysfunction drugs — Viagra, Levitra or Cialis — may be at increased risk for sudden hearing loss, prompting Food and Drug Administration officials to require label changes for the medications.[7] The Food and Drug Administration (FDA) informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors, Viagra, Levitra, Cialis for the treatment of erectile dysfunction and Revatio for the treatment of pulmonary arterial hypertension.[10]
The FDA has sent alerts out to healthcare professionals, and the Administration has updated the labels and product information for Viagra, Cialis and Levitra, which are all phosphodiesterase Type 5 (PDE5) inhibitors. The same hearing loss is being linked to the drug, Revatio, which is used for pulmonary hypertension and also a PDE5 inhibitor.[11]
The FDA asked the manufacturers of Viagra, Levitra and Cialis to update the drugs”’ labeling to include warnings on sudden hearing loss. The previous Viagra labeling did mention that deafness was a possible side effect of the drug, because a few cases were reported during its initial testing.[3] WASHINGTON, Oct 18 (Reuters) – U.S. regulators on Thursday added new warnings about the potential risk of sudden hearing loss to best-selling impotence drugs Viagra, Cialis, and Levitra, used by millions of men.[12]
The U.S. Food and Drug Administration has approved labelling changes for three kinds of”erectile dysfunction drugs to display more prominently the potential risk of sudden hearing loss.[5] The U.S. Food and Drug Administration said a published report of a man taking Pfizer Inc’s (PFE.N: Quote, Profile, Research ) Viagra, who suffered from sudden hearing loss, prompted it to explore a possible association.[12] WASHINGTON (AP) – The Food and Drug Administration alerted physicians Thursday to rare reports of sudden hearing loss in men taking popular impotence drugs from Pfizer (NYSE:PFE), Eli Lilly (NYSE:LLY) and Bayer.[6]
Washington, DC (AHN) – The Food and Drug Administration alerted doctors Thursday that Viagra and other drugs used to treat impotence have been linked to sudden hearing loss.[13]
The news was published by the Food and Drug Administration (FDA), which has ordered producing companies to change the labels after recording at least twenty-nine cases of hearing loss among its consumers since 1996.[14] The FDA is requiring label changes for drugs that may increase the risk of sudden hearing loss.[7]
All of the drugs fall into a category of drugs known as PDE5 inhibitors. “Though no causal relationship has been demonstrated, FDA believed that the strong temporal relationship between the use of PDE5 inhibitors and sudden hearing loss in these cases warranted revisions to the product labeling for the drug class,” the FDA said in a statement posted on its Web site.[1] In the 10 years since Viagra was approved, the FDA has received reports of sudden hearing loss in 29 patients taking PDE5 Inhibitors.[3] The study reported on a man taking Viagra who had experienced sudden hearing loss. This prompted the FDA to look for other reports of sudden hearing loss. The FDA found a total of 29 reports, which involved patients experiencing ringing in their ears, vertigo and/or dizziness.[7] In the 29 reports noted by the FDA, hearing loss occurred within hours to two days after patients took one of the drugs, said FDA ear-and-nose specialist Dr. Robert Boucher. “We don’t know enough to say that it’s ironclad caused by the drugs, but we see enough to say we can’t ignore it either,” he told the AP. People who take the drugs and experience hearing loss or ringing in the ears should stop the medications and contact their doctor, the FDA said.[4] The FDA found 29 reports of sudden hearing loss in people who took the erectile dysfunction drugs since 1996.[9] The FDA also expects to adopt the same measures with regard to a drug against pulmonary arterial hypertension, Revatio. This drug, along with those against erectile dysfunctions, belong to the inhibitor class phosphodiesterase type 5. ‘Since loss of hearing is often associated with aging, patients should not immediately alert their doctors,’ FDA’s Janet Woodcock said. ‘We do not have the necessary information to ascertain that the loss of hearing is indeed linked to the use of these drugs,’ said Robert Boucher, the FDA’s otolaryngologist.[14] Due to the age of many of the drugs’ users, hearing loss may be hard to properly correlate with the drugs. Other conditions that the ED drug users suffer from may also be factors. The FDA however is releasing the information about the hearing loss in order to better inform health professionals and their patients as to the possible effects from use of the drugs.[11]
Patients taking the impotence drugs who experience hearing loss should discontinue use, Boucher said. Those taking Revatio should immediately consult a doctor if they suffer the side effect, he said.[9] Patients taking Revatio and experiencing hearing loss should not discontinue taking the drug because it is used to treat a potentially life-threatening condition, the FDA said. Those patients are urged to see their physicians immediately.[7] Labeling must also be changed for the blood pressure medication Revatio, which has the same active ingredient as the other drugs. Men taking any of the ED drugs and experiencing hearing loss should immediately stop taking the drug and see their physician, the FDA said.[7]
In an informational “question and answer” page on the FDA MedWatch website, the FDA explains that a single case of hearing loss prompted the FDA to explore other reports of hearing loss in men using the ED drugs.[11]
The hearing loss was temporary in about one-third of the cases, according to the FDA. After reviewing results of studies and harmful side effects, New York-based Pfizer concluded its drugs didn’t cause hearing loss, said Ponni Subbiah, the company’s vice-president of medical, in an interview.[9] A further review of the FDA’s side effect data found 29 cases of sudden hearing loss with a relationship to the three drugs.[15]
The FDA has decided to put warning on drugs designed for ED concerning sudden hearing loss.[16] The drugs are not definitely linked to hearing loss, but the FDA decided on the warnings after 29 cases since 1996.[16]
More than 40 million people worldwide have used the medications, said Robert Boucher, an FDA medical officer, in an interview. The agency isn’t sure whether the drugs caused the hearing loss and is continuing to investigate, he said.[9] The FDA began investigating the possible link between hearing loss and ED drugs after the publication of an article for ear, nose and throat specialists in last April’s Journal of Laryntology and Otology, according to FDA spokeswoman Rita Chappelle.[7] The FDA said in most cases the sudden hearing loss occurred in one ear and in about one-third of the cases the hearing loss was temporary.[1] All of the reports involved the loss of hearing in one ear, and in a third of the cases the hearing loss was temporary. Many men who use Viagra, Levitra and Cialis are elderly, and gradual hearing loss is not uncommon in this group of patients.[3] Cialis and Levitra are also among the drugs to bear the warning, as will the hypertension drug Revatio. Hearing loss reportedly occurred within hours to two days of taking the drugs, though it’s unclear what causes it. A third of the cases were temporary and reports also involve hearing loss in one ear.[13]
The new labeling on Viagra, Levitra and Cialis will include much more information. The warning on sudden hearing loss will be included in both the ”’Precautions”’ and ”’Adverse Reactions”’ sections of the label.[3] In the ”’Adverse Reactions”’ section, the label now warns of ”’sudden decrease or loss of hearing”’, whereas the previous label simply stated ”’deafness”’ as a possible side effect. This is not the first time that the Viagra, Levitra and Cialis labels were modified due to a serious side effect.[3]
In the ”’Precautions”’ area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of PDE5 Inhibitors. It also says that patients should seek immediate medical attention if they experience a sudden loss or decrease in hearing or dizziness.[3] Anti-impotence drugs linked to hearing loss Viagra and other anti-impotence drugs will be labelled with new warnings that users may experience sudden hearing loss.[5]
In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors.[10] Lee A. Davies, a Schering-Plough spokesman said about 1 million men in the U.S. have used Levitra, which has also been on the market since 2003, and said reports of sudden hearing loss associated with the product were temporary.[1] Ponni Subbiah, Pfizer’s vice president of medical affairs, said Viagra has been used by more than 30 million men world-wide since 1998. She said the product is safe and effective and that the company doesn’t believe Viagra is the cause of hearing loss.[1] Pfizer scientists stressed that the problems reported in connection to Viagra are extremely rare, with just 11 cases reported in 16,000 patients studied. ‘Based on this data we don’t think there’s any causal relationship between Viagra and hearing loss,’ said Pfizer’s Vice President of Medical Affairs Dr. Ponni Subbiah.[6]
The agency noted that hearing loss is commonly reported in an aging population, especially in patients with risk factors for erectile dysfunction[1] The US Food and Drug Administration announced today that users of erectile dysfunction medication are reporting sudden decreases in and/or loss of hearing.[11] Pfizer Inc. announced Thursday that it was halting production of its inhaled insulin product Exubera, which was touted as a major advance for diabetes patients when the U.S. Food and Drug Administration approved it in January 2006.[4]
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Levitra, developed by GlaxoSmithKline and Bayer HealthCare, is jointly promoted in the United States by GSK and Schering-Plough Corporation. Representatives from Pfizer and Eli Lilly stressed that this is a “class label change” for all such drugs. In separate statements, Pfizer and Lilly representatives said “the FDA is making this change in the interests of patients so that patients can make informed decisions regarding PD-5 medications.” CNN’s Amy Burkholder and Ben Leach contributed to this report. [7] FDA said it is unclear whether the hearing problems are directly related to drugs like Viagra, Cialis and Levitra.[6] The FDA found that nearly 30 other cases had been noted, and that some hearing loss was reported in clinical trials of the drugs as well.[11] The change was prompted after the FDA reviewed 29 reports of sudden hearing loss.[1] The FDA said manufacturers must change the labels “to display more prominently the potential risk of sudden hearing loss,” according to the agency’s Web site.[7] The FDA stated that a notification of the risk of hearing loss should be added in the documentation.[14]
In most cases, the hearing loss only occurred in one ear, and for about one third of patients, the hearing loss was temporary. “So, we’re only talking about a couple cases per year,” he said. He said 40 million prescriptions of all four drugs have been filled worldwide so far. “This is a very small number of cases, but because we’re talking about a person’s ability to hear, we thought it was important to make the label clear that this is a possible event,” Chappelle said.[7] At the agency’s request the drug makers added more prominent precautions about hearing loss to product labels.[6]
In most of the 29 cases, the sudden hearing loss occurred within hours to two days of taking one of the drugs.[3] Since hearing loss is associated with older age, diabetes and heart disease, which cause impotence to begin with, there isn’t a clear link. The 29 reports said hearing loss happened within hours to days of taking one of them.[16] In one third of the cases the hearing loss was temporary, the agency said, the remaining cases were described as ongoing at the time of the report or the outcome was not described.[12] The reports cited hearing loss in one ear, of which 1/3 cases were temporary only.[16]
The Administration does write that the effect seems to be temporary in a third of the cases reported, and there are no warning signs linked with the hearing loss.[11] Cases of hearing loss involving Levitra were temporary, Davies said in an interview.[9]
Subbiah said there were 11 reports of hearing loss out of 16,000 patients in clinical studies, but the figure wasn’t statistically significant compared with patients in control groups.[1] In some of the cases, the sudden hearing loss was accompanied by tinnitus ”’ ringing in the ears ”’ and dizziness.[3] ” However, sudden hearing loss is an uncommon event at any age,” the agency said.[1]
Unfortunately, the follow up studies to determine the correlation between the drugs and the hearing loss are not easy and turning up little results as of today.[11] Even though the relationship between use of the drugs and the loss of hearing has not yet been clarified, the U.S. authority has immediately called for the change in labelling.[14] In most cases, the loss of hearing only concerned one ear and about a third of the patients recovered the use of the ear with time.[14]
Prior labeling for the pills mentioned that hearing problems occured in rare cases among patients tested with the drugs.[6] Tinnitus (ringing in the ear) and dizziness are also being reported in addition to the hearing problems.[11]
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Hearing loss can be caused by blood flow blockage as a result of diabetes or other illness, smoking, age and antibiotics. [7]
In 2005, the labels were changed to include warnings about vision loss associated with the drugs. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve. This entry was posted on Thursday, October 18th, 2007 at 8:24 pm and is filed under Legal News, Drug Side Effects, Health Concerns.[3] The erectile dysfunction drugs already carry prescribing information that warns of rare instances of sudden vision loss.[9] Pfizer’s Revatio, a version of Viagra used for a lung condition, will also carry a new warning. Erectile dysfunction drugs are a huge business, with Pfizer reporting Viagra sales of $450 million in its most recent quarter. The drugmakers are all cooperating with the FDA and defended the safety of their drugs.[12] The FDA also is negotiating with Pfizer about cautionary language for Revatio, a drug that uses Viagra’s active ingredient to treat high blood pressure in the pulmonary artery.[9]
The agency said the change will also apply to Pfizer’s Revatio, a drug with the same active ingredient as Viagra that’s used to treat pulmonary arterial hypertension.[1]
Viagra, the most well-known of the PDE5 Inhibitors on the market, was approved in 1998 to treat male erectile dysfunction. Another PDE5 Inhibitor, Revatio, is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.[3]
The new warnings will be carried by the impotence drugs Viagra, Cialis and Levitra, as well as the pulmonary hypertension drug Revatio, which contains the same ingredient as Viagra.[4] The precaution and updated Adverse Reactions Sections of the approved product labeling for Viagra, Levitra, and Cialis were revised.[10]
McGrath said 11.5 million people have used Cialis world-wide since the product’s U.S. launch in 2003.[1]
The report, by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), is based on national surveys conducted and analyzed by the agency’s Office of Applied Studies. “While other studies have shown that significant progress has been made in lowering the levels of substance abuse among young people in the last few years, this report shows many young people are still engaging in risky behavior,” SAMHSA Administrator Terry Cline said in a prepared statement. “By breaking the data down and analyzing on a day-to-day basis, we gain fresh perspective on how deeply substance abuse pervades the lives of many young people and their families,” Cline said.[4] Following a bone-healthy lifestyle — including eating a nutritious diet, getting regular exercise, and avoiding smoking and excess alcohol consumption — can help build strong bones and prevent fractures, the IOF said. By 2050, it’s estimated that the incidence of hip fracture (a major consequence of osteoporosis) will increase by 310 percent in men and 240 percent in women, according to IOF Chief Executive Officer Daniel Navid. Report author and IOF board member Professor Cyrus Cooper said if “people recognize osteoporosis risk factors when they are young and take appropriate action, it can have enormous positive impact on their bone health in later years.”[4] The study of 1,788 breast cancer patients and 2,129 women who didn’t have the disease found that women with high sun exposure had half the risk of developing advanced breast cancer than women with low sun exposure. This effect was noted only in women with naturally light skin color.[4] “We believe that sunlight helps to reduce women’s risk of breast cancer because the body manufactures the active form of vitamin D from exposure to sunlight,” lead researcher Esther John, of the Northern California Cancer Center, said in a statement. “It is possible that these effects were observed only among light-skinned women because sun exposure produces less vitamin D among women with naturally darker pigmentation.” John and her colleagues emphasized that women should not sunbathe in an attempt to reduce their breast cancer risk.[4]
Increased sun exposure halves risk of advanced breast cancer: study U.S. researchers have found that the more sun exposure that light-skinned women receive, the lower their risk of advanced breast cancer.[5]