Offer a second adult Epinephrine auto-injector choice with a longer needle and possibly a larger dosage since dosage appears to be based on body size.

The Issue

Imagine, if you will, that you have a severe allergy to a particular food and you find that you have accidentally ingested that food and could go into anaphylactic shock. What would you do? Hopefully, you’d have a way to immediately get life-saving medication into your system to counteract the allergic reaction. But what if you found that administering that medication wouldn’t work as it should because the needle is too short? This is a very real possibility.

There are two main prescription epinephrine auto-injectors for anaphylaxis treatment, EpiPen and Auvi-Q. The way to apply the treatment is to inject it into the thigh muscle. If you have a large body (over a body mass index of 30) or a lot of fat on your thighs, the needles may not be long enough to reach the muscle and you may be at risk for injection failure with dire consequences.

As many as 50 million Americans may be at risk for anaphylaxis.  Approximately 82,000 episodes of anaphylaxis occur each year in the US*. There have been three studies conducted, as far back as 2005, that have shown the needle length of these devices to be problematic. However, Mylan and Sanofi U.S. (the makers of the treatments) have done NOTHING to address this problem.

We are asking these companies to act responsibly and offer a second adult injector choice with a longer needle and possibly a larger dosage since dosage appears to be based on body size.

References:

* http://www.allergy911.com/allergy911-statistics.html

Adequacy of the epinephrine autoinjector needle length in delivering epinephrine to the intramuscular tissues, TT Song, et al., 2005

Predictors of epinephrine autoinjector needle length inadequacy, MC Bhalla, et al., 2013

Auto-injector needle length may be inadequate to deliver epinephrine intramuscularly in women with confirmed food allergy, G Tsai, et al., 2014

This petition had 440 supporters

The Issue

Imagine, if you will, that you have a severe allergy to a particular food and you find that you have accidentally ingested that food and could go into anaphylactic shock. What would you do? Hopefully, you’d have a way to immediately get life-saving medication into your system to counteract the allergic reaction. But what if you found that administering that medication wouldn’t work as it should because the needle is too short? This is a very real possibility.

There are two main prescription epinephrine auto-injectors for anaphylaxis treatment, EpiPen and Auvi-Q. The way to apply the treatment is to inject it into the thigh muscle. If you have a large body (over a body mass index of 30) or a lot of fat on your thighs, the needles may not be long enough to reach the muscle and you may be at risk for injection failure with dire consequences.

As many as 50 million Americans may be at risk for anaphylaxis.  Approximately 82,000 episodes of anaphylaxis occur each year in the US*. There have been three studies conducted, as far back as 2005, that have shown the needle length of these devices to be problematic. However, Mylan and Sanofi U.S. (the makers of the treatments) have done NOTHING to address this problem.

We are asking these companies to act responsibly and offer a second adult injector choice with a longer needle and possibly a larger dosage since dosage appears to be based on body size.

References:

* http://www.allergy911.com/allergy911-statistics.html

Adequacy of the epinephrine autoinjector needle length in delivering epinephrine to the intramuscular tissues, TT Song, et al., 2005

Predictors of epinephrine autoinjector needle length inadequacy, MC Bhalla, et al., 2013

Auto-injector needle length may be inadequate to deliver epinephrine intramuscularly in women with confirmed food allergy, G Tsai, et al., 2014

The Decision Makers

Mylan
Mylan
Sanofi US
Sanofi US
Sanofi Media Relations
United States Federal Drug Administration
United States Federal Drug Administration

Petition Updates