Product Safety


 






NDA-PVB-ISSUE-3

2018-03-19
RISK OF HYPERSENSITIVITY REACTION IN INFANTS AND CHILDREN FOLLOWING ADMINISTRATION OF NEVIRAPINE


This communication is to remind you about the risk of hypersensitivity reaction in infants and children receiving Nevirapine which may have fatal outcomes.

The National Pharmacovigilance Centre has received cases of preventable death as a result of septicaemia which was secondary to Nevirapine hypersensitivity. When children develop rash due to Nevirapine hypersensitivity and the care takers do not seek treatment or practice proper hygiene, the rash may become infected and the infection deteriorates into septicaemia.


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2018-02-15
INCREASED RISK OF OTOTOXICITY FOLLOWING CONCOMITANT ADMINISTRATION OF GENTAMICIN AND FUROSEMIDE



Dear Healthcare provider, This communication is to remind you about the increased risk of ototoxicity following concomitant administration of gentamicin and furosemide. Nephrotoxicity and ototoxicity are the most important side effects of aminoglycosides for example Gentamicin. Furosemide is a loop diuretic which is documented to cause hearing loss in some patients especially at a high dose.

When Furosemide and Gentamicin are administered concomitantly, Furosemide causes an increase in Gentamicin plasma and tissue concentration causing additive ototoxicity. The incidence of ototoxicity is increased when Furosemide is given in combination with Gentamicin compared to when Gentamicin is administered alone or when Furosemide is administered alone.


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2017-12-12
RISK OF ABORTION AND BIRTH DEFECTS WITH FLUCONAZOLE



Fluconazole is used in the treatment and prevention of specified fungal infections in adults and children. Management of opportunistic fungal infections among HIV infected mothers, and the inherent increased risk of fungal infections during pregnancy may call for Fluconazole use.

Review of current literature has shown evidence to suggest an increased risk of spontaneous abortion in women taking fluconazole in the first trimester of pregnancy. Previous studies have also linked high dose and long term treatment to birth defects.


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2017-11-29
PREVIOUSLY UNIDENTIFIED POTENTIAL RISK OF VISUAL COLOUR DISTORTIONS WITH PREGABALIN




Pregabalin is a gama aminobutyric acid (GABA) analogue used in the treatment of pain due to nerve injury, fibromyalgia, epilepsy, and anxiety disorders.
Pregabalin is registered in Uganda, and known to be prescribed in the management of neuropathic pain and anxiety disorders.

Case series reviewed from the WHO global database of individual case safety reports describe a relationship between pregabalin and changes in colour vision and chromatopsia occurring within hours to days and reversible on drug withdrawal.

Although pregabalin is associated with a number of adverse drug reactions affecting the eye, colour blindness and Chromatopsia (visual disorder where coloured objects appear unnaturally coloured, and uncoloured objects appear tinged with colour) have not been previously documented and are not labeled on the summary product characteristics
.
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2017-11-29