APPROVAL DATE EFFECTIVE DATE REVISION 05/01/11 INTRODUCTION Prior to commencing work involving carcinogens, chemotherapeutics or other hazardous drugs, the Principal Investigator must perform a hazard assessment in order to identify the proper personal protective equipment (PPE) and engineering requirements for handling hazardous compounds. A key element of the risk
- A |
J |K |
U |V |
Japi.orgSubarachnoid Haemorrhage : Possibly Caused by the Illegitimate Use of Sildenafil CitrateMala V Kaneria*, S Pagar#, H Samant#, S Yeole#, Shilpa Patil** AbstractSildenafil (Viagra) has been developed as a drug to treat male impotence. It has also been used to reduce symptoms (e.g. improved exercise capacity) in patients with pulmonary arterial hypertension. A case of subarachnoid haemorrhage (SAH) following the illicit use of sildenafil is reported. systems were unremarkable on examination. Fundoscopy Sildenafil is used orally as a vasoactive agent to showed no papilloedema or changes s/o HT. An urgent facilitate attainment of a sexual y functional erection noncontrast CT Brain was done which showed diffuse subarachnoid haemorrhage in the cisterns, sylvian fissures with headache, flushing, dizziness, visual disturbance and and parieto-occipital sulci (Fig. 1). Mild hydrocephalus was hypotension (especially in cardiac patients who are on noted. Biochemical parameters were normal except for serum cholesterol (221 mg%) and serum triglyceride (181 1 There are a few anecdotal reports of patients suffering from myocardial infarction with the use of mg%), which were on the higher side. Electrocardiogram and Chest radiograph were normal. 2D Echocardiography 1 Product information also mentions Subarachnoid haemorrhage (SAH) and intracerebral haemorrhage (ICH) was within normal limits. A four vessel digital subtraction in the adverse effects, but these are seen in less than 2% of angiography (DSA) and a CT Angiography were within 1 Besides, these serious adverse effects are usually seen in patients with cardiac disease and other comorbid The patient was started on cerebral dehydrants and illnesses.1 We report a healthy male who presented with oral Nimodipine every 4th hourly. His BP was monitored subarachnoid haemorrhage after the illicit usage of and maintained > 100 systolic and < 140 diastolic. The A 48 year old male patient presented with h/o sudden onset severe generalized headache on waking up one morning. There was no h/o fever, vomiting, convulsions, photophobia or focal neurological deficit. He described it as the worst headache of his life. There was no similar past history or h/s/o migraine. There was no h/o hypertension (HT), diabetes mellitus (DM) or ischaemic heart disease (IHD) and this was his first hospital admission. The patient was a labourer by occupation and was a non-addict. He was married and had two grown-up sons. On examination, he was agitated and in severe discomfort due to the headache. He was conscious, oriented with a blood pressure (BP) of 140/80 mm of Hg. There was no focal neurological deficit, neck rigidity and plantars were bilaterally flexors. All other *Associate Professor; #Resident; **Lecturer; Department of Medicine, T. N. Medical College and B. Y. L. Nair Ch. Hospital, Mumbai.
Received : 8.12.2007; Revised : 27.3.2008; Fig. 1 : Non contrast CT Brain showing diffuse subarachnoid Re-revised : 16.7.2008; Accepted : 22.7.2008 haemorrhage in the cisterns, sylvian fissures and parieto-occipital sulci.
Fig. 2 : Normal Digital Subtraction Angiography.
electrolytes were monitored to detect hyponatremia. Tab Naproxen was given for his persistent headache which was final y relieved on day 6. On recovering, the patient volunteered information that he had taken tablets of sildenafil citrate (Viagra) in a dose of 1 bid for 4 days (total 8 tablets of 50 mg each) just prior to the episode, with the last dose being approximately 6-8 hours prior to the episode. He had purchased these from a local chemist without a Although it has many side effects related to its vascular prescription. There was no h/o sexual intercourse during properties (headache, flushing, dizziness, nasal congestion), this period as his spouse was not willing. He firmly denied SAH has not been commonly reported.2 Angina pectoris, a history of erectile dysfunction. The patient recovered AV block, myocardial infarction, chest pain, cerebral completely and he was discharged on day 15. His BP was thrombosis, cerebrovascular haemorrhage (e.g. SAH, ICH), always within normal limits in the wards and he was asked TIA, stroke, coronary artery disease have occurred in less to continue Nimodipine for 2 weeks more and get a repeat than 2% of patients with erectile dysfunction in controlled DSA done at the end of 2 weeks which was normal.
clinical trials and in postmarketing surveillance, but have not been directly attributed to the drug.1 Majority of these patients had preexisting cardiovascular risk factors and The possible association of Subarachnoid haemorrhage many of these adverse effects were reported to occur (SAH) with sildenafil in a patient with no known cardiac shortly after taking sildenafil, either with or without sexual risk factors is a cause of enormous concern. Whilst other activity.1 Though phosphodiesterase 5 (PDE5) inhibitors are drugs, that are known to raise blood pressure, such as widely used for the treatment of erectile dysfunction, the amphetamine or cocaine, or reduce clotting capabilities results on the cerebral vasculature are unknown.4 Various such as warfarin or aspirin, are well established in their studies have indicated a similar nitric oxide-cGMP pathway association with ICH and SAH, sildenafil is not.2 responsible for cerebral vasodilatation and inhibition of One of the major advances in the treatment of male platelet activation and aggregation.2 The vascular relaxation impotence has been the serendipitous discovery of effects of sildenafil, whilst designed to only affect the vessels sildenafil. Although the drug has a good safety profile, of the corpus cavernosum, may have an effect on cerebral certain admonitions should be kept in mind while using vasculature as flushing, headache and dizziness are well Sildenafil is indicated in the treatment of erectile Several cases of intraparenchymal haemorrhage in dysfunction.2 It produces a selective vasodilatation of the setting of PDE5 inhibitors use have been reported.4 the corpus cavernosum (CC), mediated by the inhibition Spontaneous intracerebral haemorrhage which did of phosphodiesterase 5, an enzyme that degrades cyclic not affect the visual function has been reported more guanosine monophosphate (cGMP).2 Its therapeutic efficacy commonly.2,5-7 McGee et al have reported left homonymous has been demonstrated in organic as well as psychogenic hemianopia secondary to right parietal lobe haemorrhage after ingestion of 20 mg of vardenafil in a 66 year old healthy male8 while Mehdizadeh et al have reported the same due to right occipital lobe haemorrhage after ingestion of 50 Sildenafil, whilst fil ing an apparently huge untapped market, is not without risks. This case illustrates the risk of arteriovenous malformation (AVM) is speculative and association of SAH with its use in a healthy patient with no Steeves et al have reported a case of coital haemorrhage of cardiac risk factors. The il icit acquisition of such a potential y an AVM after premedication with Tadalafil.
dangerous drug is of enormous concern. The potential for the risk of devastating neurovascular complications related The dose recommended is initially 50 mg, to be to phosphodiesterase inhibitors should be monitored.
subsequently titrated upwards to 100 mg according to the desired response, the maximum single dose being 100 mg Cheitkin MD, Hutter AM, Brindis RG. ACC/AHA expert consensus There are many recognized adverse health events document : Use of sildenafil (viagra) in patients with cardiovascular disease. American Col ege of Cardiology/American Heart Association. associated with sexual intercourse.2 Whilst the link between sexual intercourse and SAH is wel established, that between Buxton N, Flannery T, Wild D, Bassi S. Sildenafil induced spontaneous SAH and sildenafil is not.2 At least 39 sildenafil –related intracerebral haemorrhage. British Journal of Neurosurgery deaths have been reported in men who had a history of heart disease, were taking nitrates or who were in poor Goldstein J. Sexual aspects of headache : how sexual function health. Many of the men who experienced serious adverse relates to headaches and their causes and treatment. Postgrad Med effects or death had a variety of concomitant diseases and Steeves T, Jones L, Ecker R, et al. Coital haemorrhage of an Arteriovenous Malformation after premedication with Tadalafil Because of the potential effects on sexual performance, (Cialis). Journal of Stroke and Cerebrovascular diseases 2005;14:179- sildenafil has been misused and abused for enhancing erection by men who do not have documented erectile Mehdizadeh M, Hosseini H, Yazdchi T, et al. Visual field defect as a presenting sign of hemorrhagic stroke caused by sildenafil. Indian J Our patient was a healthy male with no premorbid il ness. Monastero R, Pipia C, Camarda LK, et al. Intracerebral hemorrhage He was a non-hypertensive, non-diabetic, non-addict and associated with sildenafil citrate. J Neurol 2001;248:141-2.
was not on any prescription medications. He firmly denied Marti I, Marti JF. Hemiballismus due to sildenafil use. Neurology sexual intercourse in the week preceding the episode and while he was taking Viagra. He also strongly denied having McGee HT, Egan RA, Clark WM. Visual field defect and intracerebral erectile dysfunction. In view of this, it is most likely that the hemorrhage associated with use of Vardenafil (Levitra). Neurology illegal ingestion of sildenafil by an individual who lacked a legitimate medical need for phosphodiesterase 5 inhibition Armstrong K, Asch DA, deKieffer DE, Shuron JE, Henney JE. Direct sale of sildenafil (Viagra) to consumers over the internet. N Engl J Med caused the subarachnoid haemorrhage.
As the safety and efficacy, particularly with frequent and long term use in individuals not suffering from erectile dysfunction has not been established, sildenafil is currently not recommended for simply enhancing erections in such Sildenafil is readily available, not only over the counter (OTC), but also via the internet, wherein there is little or no physician/pharmacist intervention.9 This is particularly alarming due to the drug’s potential appeal to consumers and its medical risks. It raises concern for the implications of sildenafil acquisition and use without VIIIth Annual Conference API Tripura State Branch on 20th and 21st December 2008 (Saturday and Sunday) at Agartala, Tripura.
For further details contact : Dr. Saumen Chaudhuri, Organizing Secretary, TAPICON - 2008, N.S. Road Extension, Near MBB Club, P.O: Agartala College, West Tripura, Pin - 79.
Mobile No. 09436120497; Email : [email protected]
RENEWAL MINISTRIES REPORT ON HAITI 2009 Renewal Ministries was invited by Haiti Missions to add a “spiritual dimension” to their humanitarian work in Haiti—a kind of melting together of proclamation and demonstration of the Gospel. We flew from Texas to Miami and met the team who were mainly from Louisiana. We were here with a pharmacist, Deacon Lloyd Duplantis and his wife Faie who are