The FDA approved Primatene Mist last week for over-the-counter (OTC) status. It was taken off the market in 2011 because of its CFC propellants, which have been shown to damage the ozone layer. It is now being reintroduced with an ozone-safe HFA propellant, the same one used in all prescription metered-dose inhalers for asthma and COPD.
Dr. Steven shares the concerns about this development that have been expressed by the President of the ACAAI, Dr. Bradley Chipps. Not only does the medication in Primatene Mist have more potential side effects than the asthma rescue medications available by prescription, but allergists should be involved in supervising the...
From the FDA:
FDA is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.
In a letter to health care professionals from Pfizer, the manufacturer of the Mylan EpiPen, the label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove...
