Ibuprofen makers to add adverse reaction Stevenson Johnson Syndrome in package insert: CDSCO panel

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has recommended that CDSCO may request the State Drugs Controllers to direct the manufacturers of Ibuprofen to include adverse reaction Stevenson Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN) in the package insert of the product.

This came in line with the recommendation of signal review panel, Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) which was placed before the committee.

Sold under top brand names such as Abbott's Brufen and Cipla's Ibugesic, Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) and non-selective COX inhibitor used to treat mild-moderate pain, fever, and inflammation.

Ibuprofen has multiple actions in different inflammatory pathways involved in acute and chronic inflammation. The main effects reported in ibuprofen are related to the control of pain, fever and acute inflammation by the inhibition of the synthesis of prostanoids by COX-1 and COX-2. Pain relief is attributed to peripheral affected regions and central nervous system effects in the pain transmission mediated by the dorsal horn and higher spinothalamic tract.

Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) is a severe skin reaction most often triggered by particular medications.

Fever and flu-like symptoms are common signs of SJS/TEN. The skin blisters and peels within a few days, producing very painful raw areas called erosions that resemble a severe hot-water burn. Skin erosions commonly begin on the face and chest and extend to other regions of the body. The illness also destroys mucous membranes, such as the lining of the mouth and the airways, in the majority of people who are affected, which can make swallowing and breathing difficult.

At recent SEC meeting for Analgesic & Rheumatology, the recommendation of signal review panel, PVPI, IPC was placed before the committee regarding the adverse reaction related to non-steroidal anti-inflammatory drug (NSAID), Ibuprofen.

In view of the above, after detailed deliberation, the committee recommended,

"CDSCO may request the State Drugs Controllers to direct the manufacturers of the drug ibuprofen to include adverse reaction Stevenson Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN) in the package insert of the product."