Flu-Stricken Babies Have Options

Tamiflu approved by FDA to treat babies two weeks old and older

(RxWiki News) When one family member gets the flu, it often means the rest are likely to catch it. Now there's a new option for treatment for the youngest members of the family who get the flu.

Tamiflu (oseltamivir) is a drug used to treat the flu and to prevent it in some individuals. The US Food and Drug Administration just approved Tamiflu for young babies.

"Get your flu shot."

Now infants 2 weeks old and older who have flu symptoms for two days or less can be prescribed Tamiflu by a doctor. Tamiflu is now the only medication that the FDA has approved to treat influenza in children under 1 year old.

The flu is rough on nearly everyone's body, but it can be even more dangerous for young babies. Children under 6 months old are especially more likely to be hospitalized for influenza infections.

All babies aged 6 months old and older should be given the yearly flu vaccine if they do not have any medical indications against it.

Tamiflu has already been approved to treat influenza for adults and children 1 year old and older as long as they have not had symptoms of flu for more than two days. If symptoms have gone on for more than two days, the medicine is unlikely to help.

Tamiflu has also already been approved to prevent the flu in adults and children (1 year and older) when they have been known to be exposed to the flu.

However, babies under 1 year old are still not approved to receive Tamiflu for prevention if they have been exposed to it. The FDA approval only applies to using Tamiflu as treatment for babies with symptoms of the flu.

The best way to prevent the flu is to get the annual flu shot and regularly wash your hands.

For adults and children aged 1 and older, Tamiflu is given according to specific dosing categories based on the range of a person's weight.

For babies between 2 weeks old and 1 year old, the dose should be determined based on a child's exact weight. Tamiflu should be given at 3 milligrams for every 2.2 pounds that a child weighs. The dose is given twice a day for five days.

Tamiflu has not been tested on large numbers of babies under 1 year old. Instead, the initial safety data for the medication was based on looking at the results of studies from Tamiflu's use in adults and older children.

Then additional studies sponsored by the National Institutes of Health and the manufacturer of Tamiflu (Roche Group) provided further safety information about the drug.

The information regarding the dosage for young babies (3 mg per 1 kilogram, or 2.2 pounds, of a child's weight) is based on the information the researchers learned about how the body processes Tamiflu.

Finally, 135 children were involved in two safety studies on Tamiflu. Almost all the children had a confirmed diagnosis of flu.

The study results showed Tamiflu to be just as safe in babies as it is in adults and children aged 1 and older. The most common side effects reported among babies included vomiting and diarrhea.

In past studies, some side effects associated with Tamiflu include severe rash, skin reactions, hallucinations, delirium and abnormal behavior. None of these were seen in the two most recent safety studies with childcare.

If any parent notices any condition in their child which could be a side effect after the child receives Tamiflu, the parent should report the possible side effect to the FDA's MedWatch program.

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Review Date: 
December 30, 2012