Ibuprofen, the grandfather of all non-steroidal anti-inflammatory drugs (NSAIDs), was considered so safe that it was made an over-the-counter drug. This class of drugs (Nurofen, Brufen, Motrin, Rufen, Advil, Nuprin, Medipren) is used to treat fever and pain of every variety, but particularly joint pain.
Ever since it was divested of prescription status, drug companies have pursued any and all markets for this drug, including the lucrative kiddy market for painkillers - so much so that, in many instances, ibuprofen has replaced paracetamol as the first port of call for juvenile pain of any variety. Even the US Health Research Group, ordinarily so cautious about recommending drugs, has considered ibuprofen the second-safest drug after aspirin for arthritic pain, largely because it has been studied the longest.
Such cautious endorsements could be set to change with the recent lawsuits in the US on behalf of children who developed the rare and potentially fatal skin condition Stevens-Johnson syndrome (SJS) after taking children's ibuprofen.
The cases concern a nine-year-old California girl, who died 20 months after taking children's Motrin, a seven-year-old who went blind two months after taking the same drug and a three-year-old who died a week after taking just a few doses of kiddy Advil. In the case of Kaitlyn Langstaff, who died after battling the disease for 20 months, her deteriorating condition left her unable to speak, or even breathe or eat without assistance.
At the moment, the US Food and Drug Administration is not requiring drug-makers to put a warning on their products, largely because SJS is so rare. The official position is that labels should only mention the more common side-effects such as gastrointestinal bleeding. At the moment, the agency does not even require cases of SJS to be reported.
Stevens-Johnson syndrome supposedly affects one to six people per million in the US. The syndrome causes painful blistering of the skin. The biggest concern is that it will progress to the more serious form of the illness, toxic epidermal necrolysis, or TEN, when the outermost layer of skin peels off. TEN is fatal in about a third of cases. The syndrome can also cause blisters, and even erosion and perforation of the cornea of the eye. Most cases are drug reactions, and virtually any drug can cause SJS.
According to the Stevens-Johnson Syndrome Foundation in Westminster, Colorado, cases of SJS have risen in the past year to the point where the Foundation now receives one or two reports of new cases a month. The FDA claims it has received, thus far, some 150 reports of SJS in patients who'd taken ibuprofen.
The Stevens-Johnson Syndrome Foundation has warned parents to stop giving their children ibuprofen the moment they come up in a rash, an early sign of SJS, or in blisters on the ears, nose and genitals, or have sores inside the mouth. Caught this early, SJS won't progress to the more serious TEN.
At the moment, no drugs warn of SJS on the label. Nevertheless, Pfizer is now adding a black-box warning on its painkiller Bextra, after receiving reports of 87 people developing severe skin reactions, including SJS and TEN, four of whom died. Bextra is one of the more specific NSAIDs known as the COX-2 inhibitors.
Other side-effects from ibuprofen include heartburn, abdominal pain, nausea, ulcers and gastrointestinal bleeding, increased problems in patients with ulcers, mental depression, ringing in the ears (tinnitus), weight gain, swelling in the lower extremities, vomiting, changes in eyesight or hearing, nosebleeds, drowsiness, confusion and constipation.