Asthmanefrin Safety Concerns

Asthmanefrine is liquid racepinephrine or racemic epinephrine which, when used with the EZ Breathe Atomizer, is turned into a continuous vapor that is inhaled into the lungs. The Food and Drug Administration (FDA) has raised Asthmanefrin safety concerns for the over the counter product used for temporary relief of mild asthma symptoms. In a letter sent to the company, FDA states the company must respond to the concerns and provide a plan on how it plans to address the concerns.

This creates a real tension for doctors, patients, and the FDA. Many patients do not have health insurance that allows them regular access to medical care and look to OTC drugs to meet a number of health needs. Given how common asthma is, a large portion of uninsured or underinsured patients will have asthma. The FDA is tasked with making sure that drugs are appropriately screened for safety and effectiveness. Doctors are then often placed in the middle having to address the care of individuals.

In addition to safety concerns, there are also concerns about whether the OTC products are as effective as the prescription options.

Safety Concerns

Asthmanefrin was released in September 2012 following a period where there were no available over the counter asthma products due to environmental concerns due to CFCs in older inhalers. In their statement, FDA cited multiple adverse events since Asthmanefrin has been released including:

• chest pain
• nausea (feeling sick at your stomach)
• vomiting
• elevated blood pressure
• increased heart rate
• hemoptysis (coughing up blood tinged red-colored sputum)

Additionally, there has recently been a recall due to a choking risk associated with the EZ Breathe Atomizers. There is concern that a washer can possibly become dislodged during use.

Safety concerns are not new for over the counter asthma products. Clinicians and concerned groups have pointed out over-the-counter medications are not sold for hypertension, heart disease or cholesterol problems so why should they exist for asthma?

Previous research has shown that OTC asthma products are relatively safe, but that at least one in five people using the otc drugs should not be. Additionally, products like Asthmanefrin have been associated with underutilization of physician services as well as drugs like inhaled steroids that can improve asthma control. In general, if you need any sort of over the counter product for the relief of asthma-like symptoms then you need to see a doctor or healthcare professional to have those symptoms evaluated.

FDA Warning Letter to Nephron Pharmaceuticals Corporation

The warning letter to the makers of Asthmanefrin focuses on several areas. First, the warning letter states that Asthmanefrin is essentially an unapproved “new drug” that has not been evaluated by FDA for safety and efficacy under the new drug application process. The FDA also states that the company is marketing its atomizer for uses “different from the intended use of a legally marketed device in the generic type of device.

” FDA also states the pharmaceutical company is making inappropriate claims in their advertising such as the claim that Asthmanefrin is an ”Alternative to Primatene Mist CFC Inhaler.” FDA states that the company does not have any data to support that the 2 drugs are comparable. Additionally, FDA is concerned that mislabeling may lead to inappropriate use by patients with asthma.

The FDA also expresses some of their safety concerns including a fatal asthma attack in a letter to the company. The concerns issues with the amount of active product can reliably be delivered to patients using the inhaler and the obvious outcomes this might lead to.

Similarly, if the patient receives too much medication there are concerns about potential cardiovascular side effects.

What Should I Do

If you need to use an over the counter product like Asthmanefrin you should see a doctor about your symptoms. Asthma is a condition where you can get worse quickly, and you shouldn't avoid the doctor because you're using an otc product and risk developing more serious symptoms.

If you need to regularly use an inhaler and you are using OTC products due to financial concerns, a patient assistance program sponsored by many drug companies may help you obtain your asthma medications free or at a significantly reduced cost. Qualification is usually based on financial need leaving some of my patients that feel in need like they are left out in the cold when they do not qualify. The programs can be difficult to manage and navigate so you may want to ask a social worker or case manager for help.

Sources:

FDA Warning to Nephron Pharmaceuticals Corp. 9/24/13.

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.