Safety updates: Valproate – Tirzepatide - Glyceryl Trinitrate - Kisqali – Thiocolchicoside – Chlorhexidine containing products
Heba Mahmoud Fawzi
?????????????????????????????????? ??????????????. ???????? ?????????????????????? ???????????? ??????????????????????.
??????????????????: ???????????? ???? ?????? ?????????????????????? ???? ???????????????? ?????? ???????????????????? ?????????????????? ?????? ?????? ?????? ???????? ???????????????? ?????????????? ???????????? ?????????????????? - ????????
????????????????:
Valproate is an antiseizure medication used for epilepsy and bipolar disorder. It is available in various formulations, including sodium valproate, valproic acid, and valproate semisodium. While effective, valproate is associated with significant reproductive risks, particularly when used during pregnancy.
????????????:
A review by two specialists was required for initiating valproate in patients under 55 years old. However, this requirement does not apply now to men already taking valproate.
????????????????:
????????????????????:
Valproate remains an important treatment for epilepsy and bipolar disorder but must be prescribed with caution, particularly in individuals of reproductive age. The updated guidelines reinforce the necessity of specialist review before initiation, except for men already on the medication. Healthcare professionals should ensure appropriate patient counseling and adhere to safety measures to minimize reproductive risks.
?????????? ???????????????????????? ???????? ???????? ???????????????? ???????? ?????????????????? & ???????????????????? ?????????????? ???????????????????? ???????????? (????????) ???? ?????????????? ???? ?????????? ?????????????????? ?????? ???????????????????? ???????????? ?????? ???? ????????????????:
???????????????? ?????????????? ???????????????? ???????????????????? ???????? ?????? ???????????????????????????? ???? ?????????????????????? - ??????
????????????????:
Tirzepatide is a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It is indicated as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus. Tirzepatide has demonstrated superior glucose control and weight loss compared to selective GLP-1 receptor agonists in both preclinical and clinical trials.
????????????:
A potential safety signal has been identified regarding impaired gastric emptying (gastroparesis) associated with the administration of tirzepatide. This signal emerged following the review of a serious domestic case and further analysis of post-marketing data.
????????????????:
????????????????????:
The weighted available evidence from case series analysis and literature review suggests a potential risk of impaired gastric emptying with tirzepatide use. Given the plausibility of this mechanism and its occurrence in post-marketing settings, PVGA has agreed to consider it as a potential safety risk.
?????????? ???????? ???????????? ???????????????? ???????????????????? ???? ???????????????????????? ??????????????????????: ?? ???????? ???? ?????????? ?????????????? ???? ?????????? ???????????????? ?????????? ???? ?????????????????????????? ?????????????? ???????? -??????
????????????????:
Glyceryl trinitrate is an organic nitrate (vasodilator) used in cardiac diseases to reduce vascular smooth muscle tone. It decreases systemic vascular resistance, pulmonary vascular pressure, and arterial pressure, ultimately reducing both preload and afterload, thereby decreasing the workload on the heart. It improves oxygen supply by redistributing blood flow from epicardial to endocardial regions.
????????????:
A case report from the Egyptian Pharmaceutical Vigilance Centre highlighted a rapid and severe decline in blood pressure following the inappropriate administration of glyceryl trinitrate in a hypertensive emergency.
????????????????:
????????????????????:
This case highlights the importance of adhering to the recommended dosing guidelines for glyceryl trinitrate in hypertensive emergencies. Healthcare professionals should initiate treatment at the lowest recommended dose and gradually titrate upward to avoid complications such as severe hypotension and shock. Strict hemodynamic monitoring is essential to ensure patient safety.
???????????? ???????????????????? ???????????????????????? ?????????????????????????? (????????)
?????????????? - (????????) – ??????
Drug:
Kisqali (ribociclib)
Overview:
Kisqali (ribociclib) is used for treating hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant. It is also used in combination with an aromatase inhibitor for the adjuvant treatment of patients with HR-positive, HER2-negative early breast cancer at high risk of recurrence.
Update:
Findings:
The changes in storage conditions and shelf-life are aimed at maintaining the quality of Kisqali throughout its lifecycle, especially with its expanded indication for early breast cancer. These updates are applicable across all indications of the drug. Novartis has implemented a transition plan to manage existing stock and ensure a smooth shift to the revised storage guidelines.
Conclusion:
Healthcare professionals, including pharmacists and medical oncologists, should adhere to the new storage conditions to ensure the effectiveness and safety of Kisqali. The updated information has been approved by regulatory authorities and will be implemented at the national level in EU member states. Patients should be informed of the revised storage instructions upon dispensing to ensure proper handling of the medication.
???????????????????????????????? ???????????????????? ?????????????????? ?????? ???????????????? ??????: - ?????????????????? ?????????????????????? ???? ???????????????????????? ???????????????????? ???????? ?????? ???????? ???? ???????????????????????? - ???????? – ??????
?????? ??????????????????????????????????:
???????????????? ??????????????????????????????????:
???????????? ??????????????:
?????????????????? ?????????? ??????????????:
·???????? Teratogenicity, fetal toxicity, spontaneous abortion, reduced male fertility, and tumor development.
???????????????? ??????????????????????????????:
??????????????????????????-???????????????????? ????????????????: ?????????? ???? ???????????????????? ?????????????? ???????????? ?????? ?????????????????????? ???????????? ???????????????????? - ???????? – ??????
????????????????????:
???????????? ??????????????:
?????????????????????????????? ?????? ????????: