Primatene Mist inhalers are back, but not approved for children under 12

Primatene Mist inhalers are back, but not approved for children under 12

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Firstly, if your child is younger than 12 years old, no. Although the old version of Primatene Mist was approved for children ages 4 and up, the contents and design of the new inhaler are different. Now, the Food and Drug Administration (FDA) says only children ages 12 and older can use it. That's because researchers haven't tested whether the new version is safe for children younger than that.

Secondly, if your child is old enough to use Primatene Mist, talk with his or her pediatrician or allergist first. And never stop any medications your child is already taking for asthma without your pediatrician's approval. The inhaler doesn't treat the underlying disease, it simply masks mild symptoms, so it's not a substitute for prescription asthma medications and regular medical care.

Primatene Mist was pulled from the market in 2011 because it contained chemicals that damage the ozone layer. The new inhaler has been reformulated to make it less harmful to the environment.

Parents should know that, although the FDA says Primatene Mist is safe when used as directed, several asthma and allergy-related organizations are strongly opposed to it. The American Lung Association, American College of Chest Physicians, and American Association of Respiratory Care, among others, recently issued a joint statement condemning the FDA's decision allowing Primatene Mist to be sold again.

These organizations are concerned that people with asthma will use the inhaler to medicate themselves, rather than going to a doctor. This could put them at risk of severe complications and even death. They also say the active ingredient in Primatene Mist – racemic epinephrine – only works to mask the symptoms caused by asthma, rather than treat the actual disease.

Amphastar Pharmaceuticals, the company that makes Primatene Mist, says it's proud to bring the inhaler back and that the product will improve people's lives. The company says it expects Primatene Mist will be available in major drug stores in early 2019.

If you ever find yourself considering in using Primatene Mist for your child, keep this additional guidance from the FDA in mind:

  • Only use it for mild, intermittent asthma, such as wheezing, tightness in the chest, and shortness of breath. If symptoms aren't better within 20 minutes of using the inhaler, or your child needs more than eight inhalations in 24 hours, or has more than two asthma attacks in a week, see a doctor right away.
  • Only use Primatene Mist if your child has been diagnosed with asthma. The inhaler can't be used for coughs, respiratory infections, or other non-asthma conditions.
  • Read the updated instructions and learn how to use the new inhaler properly. For example, you'll need to clean the inhaler every day it's used, and shake and spray it once into the air before using.

Asthma is a serious, chronic disease affecting 6.5 million children in the U.S. If you have a child under 12 who is coping with this condition, check out BabyCenter's resources on asthma in babies, asthma in toddlers, and asthma in children ages 5 to 8.

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