Assessment of the nevirapine safety signal using data from the national antiretroviral dispensing database: a retrospective study

Table 5 Number of adverse reactions related to antiretrovirals, nevirapine, and other medicines in 2011 and in the Previous Years (2008 - 2010)

Adverse Reaction Reports	2011	2008–2010 (previous years)	RR
Adverse Reaction Reports	n = 481	n = 593	RR
Adverse reaction related to antiretroviral medicines	389 (80.9 %)	482 (81.3 %)	1
Total NVP reactions (related to skin and liver)
Adverse reactions attributed to NVP	208 (43.2 %)	99 (16.7 %)	2.6
NVP skin reactions
All skin reactions	150 (31.2 %)	70 (11.8 %)	2.6
Severe	109 (22.7 %)	33 (5.6 %)	4.1
Mild/moderate	41 (8.5 %)	37 (6.2 %)	1.4
NVP-liver reactions
All liver reactions	58 (12.1 %)	29 (4.9 %)	2.5
Severe	41 (8.5 %)	13 (2.2 %)	3.9
Mild/moderate	13 (2.7 %)	14 (2.4 %)	1.1
Unknown grade	4 (0.83 %)	2 (0.34 %)	-
Other antiretroviral medicine reactions
Adverse reactions attributed to other medicines	273 (56.8 %)	494 (83.3 %)	0.7

The severe skin reaction reports in 2011 included: Stevens-Johnson Syndrome (n = 54), Toxic Epidermal Necrolysis (n = 3), Erythema Multiforme Major (n = 1), Skin reactions with conjunctivitis and oral lesions (51). In the Previous Years the severe reactions included the same reactions but much fewer reports. Note: The adverse reaction reports that never provided any form of description of the type of reaction – e.g., skin rash, were regarded as mild or moderate. The severe liver reaction reports in 2011 included: High alanine aminotransferase i.e., above 5× the upper limit of normal (many were far above this), hyperbilirubinaemia, and some were reported as severe hepatotoxicity. Reports that never provided description of the liver reaction were considered to be mild or moderate

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