Life-saving drug delivery system has “quality issues”
By Ilene Schneider
A company that bought out and took control of a life-saving medication and then drastically raised the price, claiming a need for greater “quality control,” has now issued an international recall for the product based on its failure.
Last week’s recall of EpiPens in countries such as Norway, Denmark, Japan, and Australia was a direct response to complaints from two consumers whose EpiPens failed to work during their allergic reactions. Both received medical attention and survived. Now Mylan has issued a new recall for products sold in the US.
Mylan, the maker of EpiPen and EpiPen Jr., has issued the recall for units distributed between December 2015 and July 2016. There were multiple cases of the units failing to work, due to defective parts, during severe allergy attacks. Generic EpiPen, a new product, is not involved. “The expanded voluntary recall is being initiated in the United States and also will be extended to additional markets,” Mylan said.
The EpiPen device contains epinephrine, a critical drug for reversing major allergic reactions. It is carried and self-injected by people who are at risk for such reactions.
According to Medical Daily, “EpiPen is an injection that contains epinephrine, a chemical that narrows blood vessels and opens airways in the lungs. EpiPens have become a necessity for families with children suffering from severe allergies to counter effects like wheezing, uneven breathing, increased or decreased heart rate, swelling and other potentially fatal reactions.”
Allergic reactions (anaphylaxis) treated by using EpiPen include those from insect stings or bites, food, drugs and other allergens. EpiPens are also used to treat exercise-induced anaphylaxis. EpiPen auto-injectors may beprescribed to people who have a history or recognized risk of going into anaphylactic shock because of a severe allergy. The effects of this medication are rapid but not long-lasting, so people are advised to immediately seek medical attention.
EpiPen and EpiPen Jr. auto-injectors contain adrenaline, a hormone produced naturally by the body released by the adrenal glands in times of stress. It helps the body to deal with life-threatening situations. Adrenaline, which is also sometimes called epinephrine, is released through the injection to treat fatal allergic reaction called anaphylactic shock. The injection rapidly controls the symptoms of an active allergic reaction, which includes wheezing, difficulty breathing or swallowing, fall in blood pressure causing dizziness or faintness, feeling sick, vomiting, fast heartbeat, weak pulse, tightening of the chest and itching. Reactions are reversed as the injection acts on alpha and beta adrenergic receptors in the body. While alpha receptors are found on the walls of blood vessels, beta receptors are found in the heart and lungs.
Mylan bought EpiPen in 2007 and began raising its price, nearly 600 percent in 10 years. CEO Heather Bresch was caught in lies about the company’s profits while testifying before Congress in 2016.
Mylan has paid $465 million to the federal government for Medicare and Medicaid abuses it has committed. Still, the company was not forced to admit any wrongdoing in that case.