Frågedatum: 2004-02-27
RELIS database 2004; id.nr. 20503, DRUGLINE
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Is there an increased risk of developing an ischemic stroke after taking tadalafil (Cialis)?/nThe q



Fråga: Is there an increased risk of developing an ischemic stroke after taking tadalafil (Cialis)? The question concerns a 39-year-old man who had a cerebral haemorrhage ten years ago. He did at that time abuse some drug, but has been free of drug abuse for some years. He is taking lamotrigine (Lamictal) 200 mg x 2 and was prescribed tadalafil in an unknown dose by an urologist. Sildenafil had not been effective, but he got a good effect from his first dose tadalafil. Two days later he had left side weakness and a CT the day after indicated an ischemic stroke. The patient is normotensive.

Sammanfattning: No reports of tadalafil-induced strokes have been found in the literature. For the other PDE5-inhibitor sildenafil, a few reports have been found. The sexual activity and the pre-existing disease have to be remembered as confounding factors.

Svar: Tadalafil is a relatively new substance used for erectile dysfunction, belonging to the same group of drugs as sildenafil. These drugs are phosphodiesterase 5 (PDE5) inhibitors, which inhibit the degradation of cGMP, thus leading to smooth muscle relaxation and increased blood flow in the corpus cavernosum. However, the pharmacokintetics differ between tadalafil and sildenafil. The longer half life of tadalafil makes it possible to take the dose up to 12 hours before sexual intercourse (1). Since tadalafil only has been on the market for a year, limited information is available.

A thorough literature search has been done in available databases and no reports of ischemic strokes have been found. According to a cross-over study the frequency of ischemic strokes after tadalafil use was 0.27 per 100 patient years, which is comparable with the number expected in this patient group (2).

Only a total of five reports of adverse effects for tadalafil have yet been registered in the files of SADRAC (the Swedish Adverse Drug Reactions Advisory Committee) (3). None of these were any cerebral or ischemic incidents.

A similar question concerning sildenafil and the risk of stroke has previously been answered in Drugline (4). A few reports of cerebral incidents, both haemorrhagic and ischemic, were found in the literature. One report of a cerebral infarction was found in the files of SADRAC. An important consideration is the fact that the sexual activity is a risk factor itself and that the patient group with erectile dysfunction may be predisposed for cerebrovascular incidents.

We recommend this case be reported to the regional centre of SADRAC.

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