The EPVC Newsletter (Volume 19, Issue 10- October 2025)

This document is the October 2025 newsletter (Volume 19, Issue 10) from the Egyptian Pharmacovigilance Center (EPVC). It is a detailed bulletin focused on drug safety monitoring and public health in Egypt.

Here is a detailed breakdown of its contents:

1. Drug Safety Alert: Systemic Fluoroquinolone Antibiotics

• Purpose: To issue a strong warning about a class of antibiotics, including ciprofloxacin and moxifloxacin.
• Key Message: These antibiotics are associated with disabling and potentially irreversible side effects.
• Details:
  • It lists serious adverse reactions affecting multiple body systems, such as tendon rupture, peripheral neuropathy, psychiatric effects (which may include suicidal thoughts), heart problems, and severe skin reactions.
  • It emphasizes that these reactions can occur in anyone, at any age, and sometimes months after stopping the treatment.
  • Clinical Advice: These drugs should only be used when there is no suitable alternative. Doctors are advised to monitor patients closely and discontinue the drug at the first sign of a serious reaction.

2. Local Case Safety Report: A Drug Combination in Pregnancy

• Purpose: To present and analyze two serious case reports from Cairo involving pregnant women.
• The Cases: Two pregnant women took a combination drug containing Caffeine, Drotaverine, and Paracetamol for uterine spasms.
  • Case 1: A 19-year-old experienced Premature Rupture of Membranes (PROM) at 37 weeks.
  • Case 2: A 24-year-old developed Oligohydramnios (low amniotic fluid) at 33 weeks, and her baby required NICU care.
• In-Depth Analysis:
  • Background: Explains what PROM and Oligohydramnios are.
  • Mechanism of Action: Describes how the drugs work.
  • Pregnancy & Lactation: Highlights that Drotaverine is not recommended in pregnancy, and while Paracetamol is generally safe, the caffeine in this combination is a concern.
  • Maternal and Fetal Kinetics: Provides a scientific explanation of how caffeine accumulates in the fetus because the fetus cannot metabolize it effectively, leading to prolonged exposure.
• Recommendations for Healthcare Professionals:
  • Avoid prescribing this specific combination to pregnant women.
  • Educate patients against self-medicating with such products during pregnancy.
  • If pain relief is needed, recommend Paracetamol alone, at the lowest effective dose for the shortest duration.
  • Report any suspected adverse drug reactions in pregnant women to the PV center.

3. EPVC News & Initiatives

This section provides updates on the EPVC’s ongoing programs to promote drug safety:

• BE-Vigilant Initiative:
  • Welcomes a new participant, the General Organization for Teaching Hospitals and Institutions (GOTHI), with 54 new focal points.
  • Highlights awareness campaigns conducted by various hospitals for “World Patient Safety Day” and “World Pharmacist Day,” reaching thousands of beneficiaries.
• Together for Safer Medicine Initiative:
  • Announces that the 7th wave of participants successfully entered 128 Adverse Drug Reaction (ADR) reports into the national database.
• VigiTest Competition:
  • Announces the 5th round of the monthly pharmacovigilance knowledge competition.
  • Publishes the answers and winners from the previous round, recognizing top-performing PV specialists from various hospitals.
  • The answers serve as a mini-educational section on key PV concepts (e.g., Phase IV trials, the WHO Uppsala Monitoring Centre).

4. EPVC Tips: Cosmetovigilance

• Purpose: To raise public awareness about the safety of cosmetic products.
• Key Message: “Cosmetovigilance” is the monitoring of cosmetic product safety after they are sold.
• What to Do: If you experience a reaction (redness, itching, etc.):
  1. Stop using the product.
  2. Take photos and note details (batch number, when it started).
  3. Seek medical help if severe.
  4. Report the reaction to the Egyptian Drug Authority via email, hotline, or through the pharmacy.

5. Call to Action & Contact Information

• Reiterates the definition and importance of Pharmacovigilance.
• Encourages everyone to report any side effects or drug safety concerns.
• Provides all necessary contact details: Hotline (15301), Email, Website, and Address.

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Summary

In essence, this newsletter is a comprehensive drug safety update that:

• Warns about the serious risks of specific antibiotics (Fluoroquinolones).
• Educates through a detailed analysis of real-life cases, specifically cautioning against the use of a certain drug combination in pregnancy.
• Engages the healthcare community through updates on initiatives and a knowledge competition.
• Informs the public about monitoring cosmetic product safety (Cosmetovigilance).
• Promotes a reporting culture by providing clear channels for healthcare professionals and the public to submit safety reports.

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