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Archive for January, 2009

Levitra

Saturday, January 31st, 2009

The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED,buy levitra online) 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 drug class known as phosphodiesterase type 5 (PDE5,buy levitra online) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH,buy levitra online). 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 right heart failure and death.The FDA asked manufacturers of these drugs 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.(buy levitra online) “Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.(buy levitra online)

Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. 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 (buy levitra online) sudden problems with their hearing. A case 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’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total 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 hearing. In approximately one third of cases (buy levitra online), the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.

Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.

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Sunday, January 18th, 2009

For example, within two months of Viagra’s approval in the United States, The Lancet published a news feature entitled ‘Is the honeymoon over for Viagra?’, in which the author paints a frightening image of Viagra as having already been confirmed by the FDA as being linked to the deaths of six men in the United States, leaving three men in Egypt in need of intensive care after its use, and causing the Israeli health ministry to prohibit its physicians from prescribing the drug. The same journal published an editorial in September of 1998 in which the relatively easy availability of the drug is criticized. The editorial states that “the speed of transfer of this agent from an FDA license to a drug of misuse has been remarkable but that is no reason to give up on attempts to control distribution”. It continues to state that the manufacturer will want to cooperate with drug regulators in bringing illicit sources and distribution networks under control, however difficult this might be, and concerns about the impact on health services indicate that restriction, for the time being, to hospital prescription only would be sensible for Europe. Two months later, The Lancet published another article cautioning physicians of potential issues with the drug. The article states that “sildenafil is no panacea” and that not all patients with erectile dysfunction will benefit from it (Chan-Tack, 1998). It continues that there is substantial risk that many patients will receive little or no evaluation before treatment, the potential for ill-informed and inappropriate prescribing is high, that sildenafil is not an aphrodisiac, does not increase sexual desire or libido and has a high potential for abuse by thrill-seekers. The article also notes that the known side-effects may not be transient, “as current data suggest” (Chan-Tack, 1998). It continues that, “sildenafil may also have other, as-yet-unknown, adverse effects that will become evident only over time” (Chan-Tack, 1998). The Journal of the American Medical Association, although not as unenthusiastic of sildenafil therapy as The Lancet, in its commentaries, editorials and news features also tends to advise physicians to prescribe sildenafil cautiously. In various issues, physicians are advised to exercise extreme caution when prescribing sildenafil to men with diabetes, or those with coronary artery disease. Physicians are also made aware of the possibility of hypotensive reactions in patients taking antihypertensive drugs and sildenafil and are instructed to alert their patients about this potential adverse effect. So, if the core medical journals were not publishing articles on sildenafil, then who was? In our database, The International Journal of Impotence Research is the most common journal title, having published 53, or 7.1% of the 745 articles. These findings are also supported by those from the Science Citation Index. The International Journal of Impotence Research was established eighteen years ago as an offshoot of the Nature publishing group, and lists no official sponsors on its website. However, the editor-in-chief, as well as the remainder of the editorial board have overwhelming financial relationships with Pfizer. Of the nine members, seven serve as speakers, consultants, scholars, researchers or recipients of research funding from Pfizer, all in multiple categories. A qualitative exploration of the articles published by the journal reveals a decidedly positive view of the drug, with minimal mention of side effects or unfavorable research results. This may stem from the fact that investigators and consultants for Pfizer must generally sign nondisclosure agreements that prevent them from divulging data that might conflict with the company’s reports (Loe, 2004). An examination of the top 100 most common authors publishing on sildenafil indicates a similar level of sponsorship. Of the top ten authors, eight openly receive research support from Pfizer, including all of those in the top six. The most common author within these 500 articles is Dr. R. Kloner, a urologist who serves on the International Journal of Impotence Research editorial board, as a speaker and consultant for Pfizer, and who also co-authored the book entitled Viagra: How the Miracle Drug Happened and What it Can Do for You! (1998). The second most common author is Dr. I Goldstein. As a Boston University urologist who also serves as consultant and spokesperson for Pfizer, Dr. Goldstein was “solely entrusted with the ‘branding’ of ED and teaching doctors and the public at large about ED” from the 1990s onwards, largely constructing and revealing the necessity for an impotence drug such as oral sildenafil (Loe, 2004).

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    For example, within two months of Viagra’s approval in the United States, The Lancet published a news feature entitled ‘Is the honeymoon over for Viagra?’,...