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Side Effects and Safety

Side Effects and Safety

• Millions of patients in the U.S. have been prescribed TAMIFLU ¹²
• Generally well tolerated in children (≥1 year of age), adults, and the elderly (>65 years of age) ¹
• In vitro studies showed no interference with the cytochrome P450 pathway ¹
• Co-administration with amoxicillin does not alter plasma levels of either drug ¹

Safety Information

There is no evidence for efficacy against any illness caused by agents other than influenza types A and B.

Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population.

No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization.

Efficacy of TAMIFLU has not been established in immunocompromised patients.

Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving TAMIFLU. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on TAMIFLU usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of TAMIFLU to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with TAMIFLU.

The most common adverse events reported >1% of patients treated with TAMIFLU and more commonly than in patients treated with placebo are:

• Treatment of adult and pediatric patients – nausea, vomiting.
• Prophylaxis of adult and pediatric patients – nausea, vomiting, abdominal pain.

Vaccination is considered the first line of defense against influenza.

Adverse Events Reported in Treatment and Prophylaxis Studies in Adults

In treatment studies in adult patients, the most frequently reported adverse events (incidence ≥1%) were nausea and vomiting. In prophylaxis studies in adult patients, adverse events were similar. ¹

Most Frequent Adverse Events in Studies in Naturally Acquired Influenza in Patients 13 Years of Age and Older ¹

		Treatment		Postexposure Prophylaxis
	Adverse Event	TAMIFLU 2 mg/kg bid n=515	Placebo n=517	TAMIFLU qd n=99	No prophylaxis n=87
	Vomiting	15%	9%	10%	2%
	Diarrhea	10%	11%	1%	–
	Otitis media	9%	11%	2%	2%
	Abdominal pain	5%	4%	3%	–
	Asthma (including aggravated)	3%	4%	1%	1%
	Nausea	3%	4%	4%	1%

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Adverse Events Reported in Treatment and Prophylaxis Studies in Children Aged 1 to 12 Years

In treatment studies in patients 1 to 12 years old, the most frequently reported adverse event (incidence ≥1%) was vomiting (15%). In a household prevention trial that included patients 1 to 12 years old, adverse events were similar to those observed in pediatric treatment studies, with GI events being the most common. ¹

Most Frequent Adverse Events Occurring in Children Aged 1 to 12 Years in Clinical Trials ¹

		Treatment		Prophylaxis
	Adverse Event	TAMIFLU 75 mg bid n=724	Placebo n=716	TAMIFLU 75 mg bid n=1790	Placebo n=1688
	Nausea (w/o vomiting)	10%	6%	7%	3%
	Vomiting	9%	3%	2%	1%
	Diarrhea	7%	10%	3%	2%
	Bronchitis	2%	2%	1%	1%
	Abdominal pain	2%	2%	2%	1%
	Dizziness	2%	3%	1%	1%
	Headache	2%	2%	18%	18%
	Cough	1%	2%	5%	7%
	Insomnia	1%	1%	1%	1%
	Vertigo	1%	1%	≤1%	≤1%
	Fatigue	1%	1%	8%	10%

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