실데나필 복용 후 발생한 유리체출혈과 절반망막정맥폐쇄

황영훈,정원도,김재석 인제대학교 2007 仁濟醫學 Vol.28 No.-

Objective : To report two cases of vitreous hemorrhage and hemiretinal vein occlusion associated with sildenafil (Viagra^(R)) in patients with diabetic retinopathy. Methods and Materials : A 38-year-old man (case 1) and a 43-year-old man (case 2) with diabetes visited eye clinic due to sudden visual disturbance after Viagra medication. Results : In case 1, best corrected visual acuity was hand movement and vitreous hemorrhage was revealed in the right eye. Regular follow up with medication was scheduled. In case 2, superior hemiretinal vein occlusion was found with best corrected visual acuity of 0.3 in the left eye. Regular ocular exams and laser photocoagulation were performed because of non-perfusion areas in fluorescein angiography. Conclusion : In cases of diabetic retinopathy, Viagra^(R) should be taken carefully because of the possiblity of Viagra^(R) related complications including vitreous hemorrhage and retinal vein occlusion.

실데나필 복용 후 발생한 유리체출혈과 절반망막정맥폐쇄

이성우(Seong Woo Lee),김재석(Jae Suk Kim) 대한검안학회 2015 Annals of optometry and contact lens Vol.14 No.2

Purpose: To report two cases of vitreous hemorrhage and hemiretinal vein occlusion after taking sildenafil (Viagra??) in patients with diabetic retinopathy. Case summary: A 38-year-old man (case 1) and a 43-year-old man (case 2) with diabetes visited eye clinic due to sudden visual disturbance after Viagra?? medication. In case 1, best corrected visual acuity was hand movement and vitreous hemorrhage was revealed in the right eye. Regular follow up with medication was scheduled. In case 2, superior hemiretinal vein occlusion was found with best corrected visual acuity of 0.3 in the left eye. Regular ocular exams and laser photocoagulation were performed because of non-perfusion areas in fluorescein angiography. Conclusions: In cases of diabetic retinopathy, Viagra?? should be taken carefully because of the possiblity of Viagra?? related complications including vitreous hemorrhage and retinal vein occlusion.

비아그라??복용 후 발생한 급성 심근경색증

유지영,왕순주,조성훈 대한응급의학회 2001 대한응급의학회지 Vol.12 No.2

Erectile dysfunction(ED) is defined as the inability to achieve and/or maintain an erection which is sufficient for satisfactory sexual activity. Risk factors for ED include many of the same risk factors for cardiovascular disease: hypertension; lipid abnormalities, including low high-density lipoprotein cholesterol; diabetes; and smoking. Therefore, some patients with ED will have ischemic heart disease. Viagra□, an oral therapy for ED, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate(cOMP)-specific phosphodiesterase 5(PDE5). The adverse effects of sildenafil include headache, flushing, dyspepsia, nasal congestion, visual disturbance, and cardiovascular complications. A general impression exists that cardiovascular complications of sildenafil occur mainly when the drug is taken concomitantly with nitrate. We report the case of a 52-year-old man who developed an acute myocardial infarction shortly after taking one tablet of sildenafil without sexual activity. The patient had not been using nitrates. Physicians treating patients with chest pain should be aware of the potential consequences of giving nitrates to patients taking sildenafil. We suggest that before initiating therapy, the history of sildenafil ingestion be obtained from patients with suspected myocardial infarction.

Sildenafil Citrate의 복용 후 발생한 양안의 안압 상승과 단안의 비동맥염성 앞허혈시신경병증 1예

이동익(Dong Ik Lee),이미연(Mee Yon Lee),문남주(Nam Ju Moon) 대한검안학회 2013 Annals of optometry and contact lens Vol.13 No.2

목적: Sildenafil citrate (Viagra??)의 복용 후 양안의 안압 상승 및 단안의 비동맥염성 앞허혈시신경병증이 동시에 발생한 증례 1예를 보고하고자 한다. 증례요약: 62세 남자 환자가 2개월 전 발생한 좌안의 시력저하로 타 병원에서 전원되었다. 환자는 증상 발생 하루 전 Sildenafil citrate 50 mg을 복용하였으며 아침에 일어난 직후 좌안의 통증과 시력저하를 느꼈다. 타병원에서의 안압은 우안 48 mmHg, 좌안50 mmHg였다. 안압 하강제를 사용하여 안압조절을 시행하였으며, 치료 후에도 시야협착이 호전되지 않아 본원으로 의뢰되었다. 본원에 첫 방문 시의 안압은 정상이었으나 좌측 시야의 전반적 결손 및 좌안 시신경유두의 창백 소견을 보였다. 좌안의 비동맥염성 앞허혈시신경병증 의심하 시력과 안압에 대한 정기적 추적관찰을 시행하였다. 3개월의 추적관찰기간 동안 안압은 안정적이었으나 시야의 호전은 없었다. 결론: Sildenafil의 복용이 안압상승 및 시신경병증의 발생에 영향을 미친다는 여러 보고들이 있다. 본 증례는 Sildenafil의 복용 후 안압상승과 그에 의한 것으로 추정되는 시신경병증이 발생한 국내의 첫 보고로, 상기 질환들의 위험인자가 있는 환자에게서 Sildenafil citrate의 복용을 주의해야 할 것이다. Purpose: To report a patient who simultaneously developed bilateral increased intraocular pressure and unilateral non-arteritic anterior ischemic optic neuropathy (NAION) after Sildenafil citrate (Viagra??) use. Case summary: 60-year-old male was referred from other hospital by decreased vision of his left eye. 2 month ago, he visited other hospital’s ophthalmologic department by pain and sudden decrease of vision in left eye and. He had taken Sildenafil citrate 50 mg one day before, and symptom was first recognized after wake up in the morning. At that hospital, intraocular pressure (IOP) was 48 mm Hg and 50 mm Hg in his right and left eye. IOP was controlled by topical IOP-lowering agent. However, visual field constriction was not improved after treatment, the patient was referred to our ophthalmologic clinic. IOP was normal at the first visit, but diffuse constriction of visual field and pale optic disk was observed in his left eye. With the impression of NAION, regular outpatient follow up was done. During 3 months follow up period, IOP was stable but visual field was not improved. Conclusions: There are several reports about increased intraocular pressure or development of NAION after Sildenafil use. To our best knowledge, this is the first case of developed increased intraocular pressure and unilateral NAION after Sildenafil use in Korea. Those who predisposed towards these diseases, special concern should be taken in using Sildenafil citrate.

제품의 형태와 색채 모방행위와 부정경쟁행위에 대한 소고 - 비아그라 판결¹⁾ 과 세레타이드 판결²⁾을 중심으로 -

최승재 ( Choi Sung Jai ) 한국상사판례학회 2017 상사판례연구 Vol.30 No.2

본고에서는 부정경쟁방지법 제2조 제1호 (가), (다), (차)목에서 문제가 되는 쟁점들을 살펴보았다. 부정경쟁방지법 제2조 제1호 (가)목의 혼동가능성 판단주체로서의 수요자의 판단기준은 전문의약품인지 여부에 의해서 결정되어야 할 것이 아니라 당해 의약품의 구체적인 구매 행태 등을 고려하여 판단되어야 하며 도식적으로 전문의약품이므로 의사에 국한되어야 한다는 식으로 판단해서는 안된다. 전문의 약품이라고 하더라도 수요자는 환자도 포함될 수 있다. 이런 점에서 세레타이드 판결은 비아그라 판결에 비해서는 진일보 한 면이 있다고 본다. 부정경쟁방지법 제2조 제1호 (다)목의 저명성 판단기준으로서의 일반공중의 의미는 관련시장을 염두에 두고 판단되어야 한다. 관련시장을 고려하지 않고 우리나라 국민 대다수라는 식으로 판단을 하게 되면 세레타이드와 같은 천식치료제는 저명성 요건을 충족하지 못해서 (다)목에 의한 보호를 불가능하게 되는 상황이 된다. 이와 같은 해석은 희석화 중에서 특히 명성손상행위(tarrnishment)에서 분명하게 드러난다. 명성손상행위는 관련시장에서의 명성손상을 의미하는 것이지 대한민국 국민 대다수를 상대로 하는 것이 아니다. 이점에서 세레타이드 판결은 재고되어야 한다. 부정경쟁방지법 제2조 제1호 (차)목의 적용에 있어서 유사성 판단과 성과의 이용의 문제를 연결하여 유사하지 않으므로 이용조차도 없다고 하는 것은 부정경쟁방지법 제2조 제1호 (차)목의 입법경위, 문언내용, 비교법적 지위 등을 고려하면 다시 검토하여야 할 부분이다. 이 쟁점은 비아그라판결에는 없고 세레타이드 판결에만 있는 쟁점이다. 그리고 이들 쟁점과 관련된 소극적 요건으로서의 기능성 원칙의 적용에 해서는 여러 판결들을 통해서 판례가 축적되고 있다. 기능성 원칙은 실제 사안에서는 논의가 어려운 국면이 있으므로 비아그라와 세레타이드 판결에서의 기능성에 대한 판단은 향후 판례축적에 기여할 것으로 본다. In this article, Article 2 paragraph 1, subparagraph (a), (c) and (j) of the Unfair Competition Act were to be reviewed. Re Article 2 paragraph 1, subparagraph (a)(the Confusion clause), the customers as a standard observer of the likelihood of confusion have to be the doctors and pharmacists including but without limitation to the patients and their relatives. In Viagra case(2015), Korean Supreme Court decided that the standard observers of the likelihood of confusion are to be limited to the doctors and pharmacist because the drugs to be discussed are the special drugs not the general drugs. However that sort of understanding is not the right way in terms of the he likelihood of confusion when the special drug is concerned. Re Article 2 paragraph 1, subparagraph (c)(the Dilution clause), the well-known to the general public requirement has to be decided after the relevant market is to be defined in the very first place. In Viagra and Seretide case92016), the general public in that requirement is to be understood as the whole Koreans in its wordings by the Korean Supreme Court. But that is the wrong standard in reading the general public either the case law or the black letter law. Especially where the tarnishment matters, the general public has to the customer of the relevant market. In the Seretide case, those customers in the relevant market would be the patient plus the doctors and pharmacist not the general public as a whole. Re Article 2 paragraph 1, subparagraph (j), in Seretide case the Seoul High Court decided that lack of similarity would make no merit under the Article 2 paragraph 1, subparagraph (j). However considering the legislation history, the context of the subparagraph (j) in relation to the other subparagraph of the Article 2 paragraph 1 of the Unfair Competition Act and so forth, this approach has to be reconsidered. This point was discussed only in the case of Seretide not in the Viagra case. Finally Functionality Doctrine works as a negative rule in the case of Trade Dress protection. Case laws in the Viagra case and the Seretide case will be marked as referenced of their own.

A Rare Case of Viagra Induced Toxic Encephalopathy

Jeong, Soo Yeon,Jeon, Se Jeong,Kim, Youe Ree,Choi, See-Sung,Kwak, Hyo Sung Korean Society of Magnetic Resonance in Medicine 2016 Investigative Magnetic Resonance Imaging Vol.20 No.3

Viagra has been prescribed worldwide to treat men with erectile dysfunction. Clinical trials have shown that Viagra may cause various kinds of adverse effects include some central nervous system (CNS) adverse effects. Although extremely rare, toxic encephalopathy also can be one of those effects. This report presents a case of encephalopathy caused by Viagra in correlation with its radiologic findings. Its pharmacologic mechanism and potential effects on the biochemistry of the CNS are reviewed.

연구논문 : 발기부전 환자와 비아그라를 통해 본 한국 남성의 남성성: 비아그라 효과에 대한 비판적 논점을 중심으로

채수홍 ( Su Hong Chae ) 한국문화인류학회 2006 韓國文化人類學 Vol.39 No.1

A Rare Case of Viagra Induced Toxic Encephalopathy

정수연,전세정,김유리,최시성,곽효성 대한자기공명의과학회 2016 Investigative Magnetic Resonance Imaging Vol.20 No.3

Viagra has been prescribed worldwide to treat men with erectile dysfunction. Clinical trials have shown that Viagra may cause various kinds of adverse effects include some central nervous system (CNS) adverse effects. Although extremely rare, toxic encephalopathy also can be one of those effects. This report presents a case of encephalopathy caused by Viagra in correlation with its radiologic findings. Its pharmacologic mechanism and potential effects on the biochemistry of the CNS are reviewed.

Comparison on physical property, dissolution and disintegration of four launched orally disintegration film (ODF) products for erectile dysfunction

권민주,강한,안준현,조원경,선보경,황성주 한국약제학회 2014 Journal of Pharmaceutical Investigation Vol.44 No.4

Commercially available orally disintegrationfilms (ODF) for erectile dysfunction were Viagra L 50 and100 mg by Pfizer Pharmaceuticals Korea Ltd., and Mvix S50 and 100 mg by SK Chemicals Co. The comparativestudies of physical property, disintegration and dissolutiontime of four ODFs were carried out to evaluate film formulation. For film physical property, thickness and weightuniformity, tensile strength, dissolving pH, hygroscopicity,morphology, flexibility and polymeric characteristics wereinvestigated. In vitro disintegration studies were implementedby six methods. Conventional disintegration methodwas carried out using USP disintegration apparatus. One sidedisintegration method and both side disintegration methodwere performed by using shaking water bath. Slide framedisintegration method was conducted by contact anglemeasurement. Mouth disintegration method was performedby using two different mediums. One medium was a-amylasefree medium, another was add a-amylase. In vitro dissolutionstudies were carried out using pH 2.0 HCl and pH6.8 PBS. The results were validated statistically. Filmthickness of Mvix S 50 and 100 mg was thinner than that ofViagra L 50 and 100 mg, respectively. Film tensile strengthof Mvix S 50 mg and 100 mg was much higher than that ofViagra L 50 and 100 mg. However, Viagra L 50 and100 mg were more flexible so that it is easier to carry andstore. High hygroscopicity and high porosity in Viagra Lcould contribute to disintegrate film quickly. In six kinds ofdisintegration studies, both Viagra L 50 and 100 mgshowed not only muche faster disintegration time but alsomuch faster dissolution rate.

의약품 디자인 분쟁사례를 통한 시사점 도출 및 보호방안 연구

박해림 ( Hae Rim Park ) 한국기초조형학회 2013 기초조형학연구 Vol.14 No.3

각국 정부가 의약품 지출에 대한 정부 예산을 절감하기 위한 방안으로 Generic 의약품 사용을 장려하고 이로 인해 후발업체인 Generic 의약품 제조사들은 치열한 경쟁에서 시장을 선점하기 위하여 기존 Original 의약품의 명성과 인기에 편승하려는 의도적인 알약디자인 모방을 계속적으로 시도하고 있다. 한미제약과 화이자의 한국 분쟁에서 한미제약의``팔팔정``은비아그라가 곡선 중심의 마름모 인데 반해 ‘팔팔정’은 직선 중심의 육각형이고 특허청에 디자인 등록까지 돼 있다고 반박했지만 비아그라의 고유한 디자인을 베낀 것은 명확한 사실이며 다이아몬드형의 파란 알약 다자인을 모방했다고 판결되었다. 삼성과 애플의 미국 분쟁사례의 경우도 주관적이고 감성적인 부문인 애플의 디자인 특허(트레이드 드레스)가 공식적인 법적 권리로 인정되었다. 알약 디자인의 경우 그 용도상 목넘김을 쉽게하는 원형이거나 마름모 형태 등일 수밖에 없다는 점에서 이러한 형태에 독점권을 줄 수 없지만 최근에는 첨단기술과 문화의 발달로 지식재산권도 점차 다양해지고 지식재산권(특허법·저작권법· 실용신안법·디자인법·상표법·발명보호법)의 권리 보호범위가 중첩되거나 경계가 모호해지면서 디자인과 지식재산권의 패러다임도 변화하고 있다. 이에 대해 우리나라는 블록버스터의 약품에 대한 특허정보 및 국내외 특허분쟁자료를 지속적으로 분석?제공함으로써, 국내 제약사가 제품 개발 시 초기단계부터 디자인전문가와 협업하여 적절한 지식재산권 대응전략을 수립할 수 있도록 지원해야 할 것이다. To reduce the government budget for medical supplies, each government tries to promote Generic produced by developing countries. Many companies made Generic enter into competition with each other to gather a larger share of the nascent market. They have tried to ride on the famous and popular of existing medical supplies by imitating pill`s design consistently. In Korea, The Hanmi Co. vs Hwaiza Co. dispute has had an important point of the lawsuit, that is a dissimilarity between a strighted-center-hexagon of PalPalJeong made by Hanmi and a curved-center-diamond shape of Viagra made by Hwaiza in pill`s design part. Hanmi Co. insisted that a pill`s design of theirs be registrated on the office of Patent Administration. However, the case was decided to imitate the traditional shape of Viagra, a diamond shape and blue pill`s design. In another case, Apple Co vs Samsung Co , the Apple design had recognized as the right reasons in its subjective and sensitive part of design patent, especilly the trade dress. In pill`s design case, there is no exclusive representation in a circle shape or a diamond shape for swallowing easily. But the more develop technology skills and cultures, the more variety intellectual property rights - the patent, the copyright, the practical new device, the design, the trademark, and the invention preserve. As the boundary of the intellectual property rights is ambiguous, between the design and the intellectual property right have changed the paradigm. So the government should give cosistantly patent information about blockbuster medical supplies and analytical criticism about world`s patent dispute. Also, the government should support medical companies are prepared to cope with any situation.