Generally, drugs are OTC because they are safe and non habit forming. Epinephrine has a very narrow therapeutic index (read generally not safe except at low levels) and it's not really a good idea to hand it out to people without explaining its uses. It's not like an Advil or Tylenol where you can just pop one or two without fearing some kind of adverse effect. Very small overdoses can cause irreversible heart damage or death.
Without educating the general public about it, there isn't much use for epinephrine apart from anaphylaxis. If that's the case, they should see a doctor anyway to have allergy tests to find out what foods to look out for.
I'm sure you've heard of an adrenaline junky. Epinephrine is essentially adrenaline, so there is abuse potential with it also as it can activate the reward center in the brain.
In all, it's not a strategy for pharma to make more money. The FDA doesn't want it to be easily accessible as there is only really one use for the average person and they should see a doctor about it to get educated anyway.
Disinformation and a completely ridiculous bunch of statements you have posted.
Since you want to not only post disinformation, but defend the FDA and obviously Mylan, I'll be happy to address your claims.
• From the FDA
—FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death. Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs.
—"There is no period of use shown to be without risk,” says Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.
—But the risk is also present in people without cardiovascular disease. “Everyone may be at risk – even people without an underlying risk for cardiovascular disease,” Racoosin adds.
www.fda.gov/ForConsumers/ConsumerUpdates/ucm453610.htm• The FDA has sent out numerous alerts to healthcare providers and patients, to acknowledge and adhere to the alarming and even often deadly consequences of acetaminophen
www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm• From the FDA
1. How Does Liver Injury Occur?
—The mechanism of liver injury is related to the fact that small amounts of acetaminophen are converted to a toxic metabolite. The toxic metabolite binds with liver proteins to cause cellular injury. The amount of toxic metabolite produced and the ability of the liver to remove this metabolite before it binds to liver protein influence the extent of liver injury.
2. How Common is Liver Injury Due to Acetaminophen Overdose?
—A number of studies have tried to answer this question. However, many questions remain about the full scope of the problem. Nonetheless, what is known about the extent of liver failure cases reported in the medical literature clearly indicates a reason for concern.
3. Liver Injury, Population Overall
— From 1998 to 2003, acetaminophen was the leading cause of acute liver failure in the United States, with 48% of acetaminophen-related cases (131 of 275) associated with accidental overdose.
— A 2007 CDC population-based report estimates that, nationally, there are 1600 cases of ALF each year (all causes). Acetaminophen-related ALF was the most common etiology.
—Summarizing data from five different surveillance systems, there were an estimated 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths related to acetaminophen-associated overdoses per year during the 1990-1998 period.
4. Why Do Acetaminophen Overdoses Occur?
—In some individuals, taking just a small amount more than the recommended total daily dose of acetaminophen (4 grams per day) may lead to liver injury
—Some individuals may be especially prone to liver injury from acetaminophen
—It can be difficult to recognize the onset of liver injury. The onset of symptoms associated with acetaminophen liver injury can take several days, even in severe cases. In addition, symptoms may be non-specific and mimic flu symptoms, resulting in the individual continuing to use acetaminophen
—There are many different types of OTC and Rx acetaminophen products and a range of doses for a variety of different indications. Acetaminophen can be found in many widely used OTC single ingredient products (e.g., to treat headaches) and in multiple ingredient (combination) products (e.g., in products to treat symptoms of the common cold). Acetaminophen is also a component in a number of Rx drug products in combination with narcotic pain medicines. Consumers may attempt to treat different conditions or symptoms at the same time with more than one product containing acetaminophen. They may not realize that acetaminophen is in each of those products and that they are at risk of acetaminophen overdose.
—Many consumers do not know that acetaminophen overdoses can cause serious liver injury
—It can be difficult to identify acetaminophen as an ingredient in Rx products
—Liquid products for children are available in different concentrations...It is possible to mistakenly overdose an older child by giving him or her a product intended for an infant.
• The remainder of the exhausting list concerning Tylenol (acetaminophen) from just this one report by the FDA can be found here:
www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf
• More thanks to the FDA (2006)
—The FDA's spontaneous reporting system was searched to identify possible root causes for overdoses. Analysis of national databases show that acetaminophen-associated overdoses account for about 56,000 emergency room visits and 26,000 hospitalizations yearly. Analysis of national mortality files shows 458 deaths occur each year from acetaminophen-associated overdoses; 100 of these are unintentional.
www.researchgate.net/publication/7474986_Estimates_of_Acetaminophen-Associated_overdoses_in_the_United_States• Toxic epidermal necrolysis caused by acetaminophen featuring almost 100% skin detachment: Acetaminophen is associated with a risk of severe cutaneous adverse reactions
onlinelibrary.wiley.com/store/10.1111/1346-8138.13073/asset/jde13073.pdf?v=1&t=iyjsy2ng&s=8e05d020517f8749db4721dcb5d6ab17818dd470&systemMessage=WOL+Usage+report+download+page+will+be+That is all the effort I am willing to put forth concerning your first paragraph. More later. Stay tuned.
