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Are Primatene Mist And Generic Epinephrine Inhalers Safe?

What You Need To Know About Primatene Mist

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Updated April 05, 2010

Written or reviewed by a board-certified physician. See About.com's Medical Review Board.

Primatene Mist, as well as ther generic epinephrine inhalers, are the only non-prescription inhalers currently available for the treatment of asthma in the United States.

In 2009, federal laws mandated that inhaler propellants (the substance that causes the medicine from your inhaler to enter into your lungs when pressed) change from chlorofluorocarbons (CFCs) to hydroflouroalkane (HFA) in order to decrease ozone levels and protect the environment. This allowed pharmaceutical companies to start increasing costs, as the new propellants were considered a "new drug." As a result, many patients began turning to Primatene Mist as an over-the-counter alternative.

Makers of over-the-counter epinephrine CFC inhalers appealed the FDA ban, claiming that many patients could not afford the new inhalers. However, the drug companies subsequently lost their appeal. As a result, Primatene Mist and other generic epinephrine CFC inhalers cannot be made or sold in the U.S. after December 31, 2011.

Is There A Difference Between Primatene Mist and Albuterol Inhalers?

Albuterol inhalers can only be bought after you have received a prescription from your doctor. Primatene Mist is available over the counter without a doctor's prescription until December 31, 2011.

Primatene mist CFC inhalers may taste different than HFA albuterol inhalers. Also, many patients say CFC inhalers like Primatene Mist feel different when inhaled, compared to the albuterol HFA inhalers.

Albuterol HFA inhalers also cost significantly more than Primatene Mist CFC inhalers.

Is Primatene Mist Safe?

Many healthcare providers have concerns about whether it is safe to sell over-the-counter asthma medications. We do not currently sell over-the-counter medications for hypertension, heart disease or cholesterol problems -- so many ask, why for asthma? As a result, a number of researchers have studied whether or not this practice is safe.

In general, Primatene Mist appears safe if used appropriately. An article in Chest, the journal of the American College of Chest Physicians, concluded that "the occasional use of OTC epinephrine inhalers appears to be safe and effective when used according to labeled instruction by individuals with only mild, intermittent disease." However, the authors went on to point out that 20% of people using OTC epinephrine inhalers like Primatene Mist should not be using them, and should actually be on other asthma medication and under the care of a physician.

Additionally, use of drugs like Primatene Mist has been been associated with decreased use of inhaled steroids and under-utilization of physician services.

Who Should Use Primatene Mist?

As a physician, I would recommend that anyone who feels they need to use Primatene Mist see a doctor, as asthma is a serious disease that can get worse quickly. I am concerned that patients with a serious problem will use this over-the-counter medication to avoid seeking medical care.

According to its packaging information, Primatene Mist can be used "for temporary relief of occasional symptoms of mild asthma," such as:

The packaging specifically tells you:

  • Not to use unless you have been diagnosed by a physician.
  • Not to use if you have certain other problems, like heart disease.
  • Not to exceed the recommended dose.

Check out the Primatene Mist website for the complete labeling and other specific instructions and warnings before using Primatene Mist.

Primatene Mist Side Effects

Common side effects of Primatene Mist include:

  • Appetite changes
  • Dizziness
  • Headache
  • Hyperactivity
  • Nausea
  • Nervousness
  • Shakiness
  • Sinus pain
  • Sore throat
  • Tremor
  • Trouble sleeping
  • Vomiting

More Serious Side Effects of Primatene Mist

Some Primatene Mist side effects require you to see a healthcare provider immediately. These would include:

  • Allergic reactions, like rash, hives, difficulty breathing, and swelling of the mouth, face, lips, or tongue
  • Chest pain
  • Ear pain
  • Fast or irregular heartbeat
  • Hoarseness
  • Pounding in the chest
  • Red, swollen, blistered, or peeling skin
  • Severe headache or dizziness
  • Trouble breathing

Is It Safe To Buy Primatene Mist & Other Asthma Medications Over The Internet?

I am commonly asked by patients if it is safe to purchase OTC medications, like Primatene Mist, and prescription medications over the Internet. The short answer is that if you use a reputable company and follow a few steps, it is probably just as safe as your local pharmacy. Reputable companies:

  • Are located in the U.S. and licensed by the National Association of Boards of Pharmacy (NABP)

  • Have a licensed pharmacist available to you to address any concerns you have about your asthma medication, just as the pharmacy down the street would

  • Only fill prescriptions for appropriately licensed healthcare providers

  • Do not sell products not approved by the FDA

  • Participate in the Verified Internet Pharmacy Practice Sites (VIPPS) certification program

  • Protect your privacy and keep your personal information safe

More Need-To-Know Information About Buying Medications Online

Financial Help for Asthma Medications

The are a number of patient assistance programs that can help you obtain free or low-cost asthma medications. The programs are all very different and will have different rules and qualification standards.

Sources:

Armstrong Pharmaceuticals. Accessed January 31, 2010. Primatene Mist

FDA. Accessed January 31, 2010. Epinephrine CFC Metered-dose Inhalers - Questions and Answers

Kuschner WG, Hankinson TC, Wong HC and Blanc PD. Nonprescription Bronchodilator Medication Use in Asthma. Chest 1997;112;987-993.

Dickinson BD, Altman RD, Deitchman SD and Champion HC. Safety of Over-the-Counter Inhalers for Asthma. Chest 2000;118;522-526.

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