A case report of seizure and renal failure after taking a not approved tablet used for management of premature ejaculation

Premature ejaculation (PE) is a common sexual complaint and systemic drug treatment is usually applied for its management. Drugs such as serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants and phosphodiesterase type 5 inhibitors are commonly used for management of PE. Unfortunately, most of the drugs used for management of PE are not prescribed by the physicians and are provided from black markets which increase the risk of adulteration in pharmaceutical ingredients. The case is a 36-year-old man consumed two identical tablets under the brand name of Papely in order to manage the PE problem. The tablets were purchased from black market and the stated active ingredients were labeled as combination of clomipramine and tadalafil. After consumption, the patient experienced tonic clonic seizure which caused a head injury. The patient had no history of seizures. In the evaluation, the brain computed tomography (CT) scan was normal, the primary creatine phosphokinase (CPK) and creatinine (Cr) were 27500 and 1.2, respectively. The amount of Cr was increased to 7.1 and the patient underwent hemodialysis treatment with the diagnosis of interstitial nephritis. The urine screening was positive for tramadol and marijuana. The tablets were analyzed by HPLC and a high dose of tramadol was reported while tadalafil and clomipramine which were stated on the drug label were not detected. Considering the obtained results the drugs which are provided without the physician’s prescription and are purchased from black market and invalid drug stores are usually adulterated with ingredients other than the stated labels which could cause dangerous side effects.