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Rare cases of anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Steven-Johnsons Syndrome and erythema multiforme have been reported in post marketing experience with Tamiflu. Tamiflu should be stopped if an allergic like reaction occurs.
There have been post marketing reports of delirium and abnormal behaviour leading to injury and in some cases resulting in fatal outcomes.

Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made.

I.e, because reporting of adverse reactions is voluntary, they don’t know how many people could suffer these reactions.

These events primarily happened in pediatric patients. The contribution of Tamiflu to these events has not yet been established.

If neuro-psychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

Nausea and vomiting were the most commonly reported side-effects.

There was an increase in nausea, vomiting, bronchitis, insomnia,and vertigo were more commonly reported in the Tamiflu group than the placebo group. Also more commonly reported in the Tamiflu group were aches and pains, rhinorrhea, dyspepsia, and upper respiratory tract infections.

Additional adverse events associated with Tamiflu that occured in less than 1% of patients were unstable angina, anemia, pseudomembranous colitis, humerus fracture, pneumonia, pyrexia, and peritonsillar abscess.

The most commonly reported adverse effects in pediatric patients aged 1 to 12 years, was vomiting, abdominal pain, epistaxis, ear disorder and conjunctivitis.

Side-effects observed during clinical practice are swelling of the face or tongue, allergy, anaphylactic reactions, dermatitis, rash, eczema, urticaria, erythemia multiforme, Steven-Johnsons Syndrome, Toxic Epidermal necrolysis, hepatitis, abnormal liver function tests, heart arrhythmias, gastrointestinal bleeding, hemorrhagic colitis, seizures, aggravation of diabetes, delirium, altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares.

ANIMAL TOXICOLOGY

In a 2 week study, a single dose of 1000mgs of oseltamivir to 7 day old unweaned rats, resulted in DEATHS.

However, in 14 day old unweaned rats, there were no deaths.

Source: August 2008 Roche Pharmaceuticals data sheet for Tamiflu:

http://www.rocheusa.com/products/tamiflu/pi.pdf

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