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Two female patients aged 45 and 51 years experienced curling of hair during treatment with alitretinoin (Toctino ® ). For one patient, the indication for use was severe chronic hand eczema, but for the second patient the indication was not reported. After 5 and 9 months, respectively, the patients developed hair texture changes and their straight hair began to curl. The dose of alitretinoin was reduced in both cases, but the patients' hair had not straightened at the time of reporting (9 months and 2 years after onset of the event). Based on the described reports received by the Netherlands Pharmacovigilance Centre Lareb, the case reports in the literature, and the possible mechanisms, we suggest a causal relationship between curling of the hair and the use of alitretinoin. Using the World Health Organization Uppsala Monitoring Centre (WHO-UMC) system for standardized case causality assessment, the association in our cases can be assessed as likely.

A 38-year-old male and a 36-year-old female experienced red-brown urine discolouration after 2 and 3 days, respectively, during the use of mesalamine for inflammatory bowel disease. Both patients mentioned that the urine discoloured after contact with sodium hypochlorite detergent in toilet water. Mesalamine and the inactive metabolite N-acetyl-5-aminosalicylic acid are primarily excreted in the urine. We hypothesised a possible reaction with sodium hypochlorite and/or light. Naranjo assessment scores of 9 and 6 were obtained for the reports, indicating a certain and probable relationship, respectively, between the red-brown urine discolouration and the use of the suspect drug mesalamine. Knowledge of this harmless reaction is desirable to avoid unnecessary physical examination and worry., Competing Interests: Compliance with Ethical Standards Written informed consent was obtained from both patients for the publication of these case reports. Copies of the consents may be requested for review from the corresponding author. Competing interests/funding Tim Smeets and Florence van Hunsel declare that they have no conflicts of interest. No financial support was received for the conduct of this study or preparation of this manuscript.

Twelve cases of unbearable pruritus several days after withdrawal of (levo)cetirizine were reported to the Netherlands Pharmacovigilance Centre Lareb. Eleven reports concerned women and one report concerned a man, aged 19-58 years. These patients had been using these antihistamines continuously for months or years. They had tried to stop using antihistamines on several occasions but felt unable to withdraw the drug because of the unbearable maddening itch. Finally, slowly tapering the drug or using a short course of corticosteroids helped to withdraw (levo)cetirizine. The Naranjo assessment score ranged from two to four for all the cases, indicating a possible relationship., Competing Interests: Compliance with Ethical StandardsFundingNo financial support was received for the conduct of this study or preparation of this article.Conflict of interestCorine Ekhart, Petra van der Horst and Florence van Hunsel declare that they have no conflicts of interest.Consent for publicationWritten informed consent was obtained from the patient in the detailed case description (case 11 in Table 1) for the publication of the case report. A copy of the consent may be requested for review from the corresponding author.

Two 54-year-old women developed abdominal cramps and vaginal hemorrhage as a result of endometrial hyperplasia during treatment with a hop-containing phytotherapeutic product (MenoCool ® ) for post-menopausal complaints. The women used the hop-containing phytotherapeutic product (418 mg of hop per tablet) twice daily (1 and 0.5 tablets by both patient A and B). Patient A developed abdominal cramps and vaginal hemorrhage after 2 months of use. After gynecological examination, she was diagnosed with endometrial hyperplasia. The patient was treated with a curettage. The hop-containing phytotherapeutic product was discontinued, and the patient recovered. Patient B developed abdominal pain/cramps and vaginal hemorrhage after 5 months of use. A cervix smear, internal examination, and ultrasound were performed. Due to the thickness of the endometrium, a pipelle endometrial biopsy was performed. Results showed no indication for cervix cancer. The use of MenoCool ® was ceased; follow-up information received from the patient shortly thereafter indicated that she had almost entirely recovered from the abdominal pain/cramps and vaginal hemorrhage. Hop (Humulus lupulus) has phytoestrogenic properties that may be the cause of endometrial hyperplasia and subsequent vaginal hemorrhage. A Naranjo assessment score of 5 was obtained for both cases, indicating a probable relationship between the patient's endometrial proliferation and subsequent vaginal hemorrhage and their use of the suspect drug.