Part I of II EPVC Newsletter Egyptian Pharmaceutical Vigilance Center (EPVC) Pharmacovigilance Department Inside this issue: Epidemiology Training organized by EPVC 1 Solgar ABC Dophi- lus Powder: Recall - Risk of Infection 1 Nitrofurantoin - Case Of Abortion Due To Maternal Exposure During Pregnancy In Cairo 2 Levoxin - Case of QT Prolongation with a History of Hypokalemia in Cairo 3 Ziprasidone Drug safety communica- tion-Rare but po- tentially fatal skin Reactions 5 Volume 6, Issue 2 February 2015 Epidemiology Training organized by EPVC Kindly note that ABC Dophilus is not registered in Egypt, however; because some batches are illegally imported and distributed against law, the Pharmacovigilance department recom- mended informing the public with this safety information through this news- letter. This recommendation is based on the FDA announcement on 11/17/2014 that Solgar, Inc. is vol- untarily recalling Solgar ABC Doph- ilus Powder. Testing conducted by the Centers for Disease Control re- vealed the presence of Rhizopus oryzae in 50 g containers of Solgar ABC Dophilus Powder, which may cause Mucormycosis. This is a rare infection that may cause health prob- lems to consumers, particularly pre- mature infants/infants, children, and those with weakened immune systems. It may also occur rarely in people who are otherwise healthy. Mucormycosis is any fungal infec- tion caused by fungi in the or- der Mucorales. Generally, species in the Mucor, Rhizopus,Absidia, and Cunninghamella genera are most often implicated. This disease is often characterized Solgar ABC Dophilus Powder: Recall - Risk of Infection At the interval from 20 to 22 Janu- ary, the Egyptian Pharmaceutical vigilance center (EPVC) conducted an epidemiology training under the umbrella of AUPAM (Arab Union of the Manufacturers of Pharmaceu- ticals and Medical Appliances) and Arab League and was attended by 48 attendees. The covered topics in this workshop were: • Principles of Pharmacoepidemiolo- gy • Appropriate Literature Review • Systematic Review and Meta- analysis • Evidence Based Medicine • Study designs • Essential Statistics for the Pharma- ceutical Sciences • Evidence Based Medicine in Phar- macy Practice
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Part I of II
EPVC Newsletter Egyptian
Pharmaceutical
Vigilance Center
(EPVC)
Pharmacovigilance
Department
Inside this issue:
E p i d e m i o l o g y
Training organized
by EPVC
1
Solgar ABC Dophi-
lus Powder: Recall -
Risk of Infection
1
Nitrofurantoin -
Case Of Abortion
Due To Maternal
Exposure During
Pregnancy In Cairo
2
Levoxin - Case of
QT Prolongation
with a History of
Hypokalemia in
Cairo
3
Ziprasidone Drug
safety communica-
tion-Rare but po-
tentially fatal skin
Reactions
5
Volume 6, Issue 2 February 2015
Epidemiology Training organized by EPVC
Kindly note that ABC Dophilus is not
registered in Egypt, however; because
some batches are illegally imported
and distributed against law, the
Pharmacovigilance department recom-
mended informing the public with this
safety information through this news-
letter.
This recommendation is based on
the FDA announcement on
11/17/2014 that Solgar, Inc. is vol-
untarily recalling Solgar ABC Doph-
ilus Powder. Testing conducted by
the Centers for Disease Control re-
vealed the presence of Rhizopus
oryzae in 50 g containers of Solgar
ABC Dophilus Powder, which may
cause Mucormycosis. This is a rare
infection that may cause health prob-
lems to consumers, particularly pre-
mature infants/infants, children,
and those with weakened immune
systems. It may also occur rarely in
people who are otherwise healthy.
Mucormycosis is any fungal infec-tion caused by fungi in the or-
der Mucorales. Generally, species in the Mucor, Rhizopus,Absidia,
and Cunninghamella genera are most often implicated.
This disease is often characterized
Solgar ABC Dophilus Powder: Recall - Risk of
Infection
At the interval from 20 to 22 Janu-ary, the Egyptian Pharmaceutical
vigilance center (EPVC) conducted an epidemiology training under the umbrella of AUPAM (Arab Union
of the Manufacturers of Pharmaceu-ticals and Medical Appliances) and
Elderly patients may be more susceptible to drug-associated effects on the QT interval. (1)
The QT interval is the time between onset of ventricular depolarization and end of ventricular repolari-
zation. (2)
Other possible causes of prolonged QT interval include: MI, myocarditis, hypocalcemia, hypokalemia, hypomagnesemia, hypothyroidism, subarachnoid or intracerebral hemorrhage, stroke, congenital long
QT syndrome, antiarrhythmics, tricyclic antidepressants, phenothiazines, other drugs. (2)
Labeled information:
According to Levofloxacin Summary of product Characteristics (SmPC) (3) it was stated under section (4.4
Special warnings and precautions for use) that: Caution should be taken when using fluoroquinolones,
including levofloxacin in patients with known risk factors for prolongation of the QT interval such as, for
example:
congenital long QT syndrome
concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhyth-
Hypokalemia must be corrected first. Monitor potassium level to avoid such serious Medication Error that led to
QT prolongation in this case. N.B: Normal adult serum potassium level is (3.5 - 5.2 mmol/L). (3, 4)
Cardiac disease (e.g. heart failure, myocardial infarction, bradycardia), or cardiac disorder (e.g. congenital long QT syndrome).(3, 5)
Certain type of irregular heartbeat (QT prolongation, long QT syndrome) or low blood potassium levels. (5)
History of myasthenia gravis. (5)
Elderly patients and women may be more sensitive to fluoroquinolones related QTc-prolongation. (3)
Patients receiving drugs known to prolong the QT interval (e.g class IA and III antiarrhythmics, tricyclic antide-pressants, macrolides, antipsychotics). (3)
Allergy to any ingredient in levofloxacin or to any other quinolone antibiotic (e.g., ciprofloxacin). (5)
References:
1. Drugs.com. Levofloxacin (Click Here)
2. Merckmanuals.com. [cited 28 January 2015]. (Click Here)
3. Medicines.org.uk. [cited 28 January 2015]. (Click Here)
4. Webmd.com. [cited 28 January 2015]. (Click Here)
5. Drugs.com. [cited 28 January 2015]. (Click Here)