The First Generic EpiPen Just Received FDA Approval

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iStock

For people with severe allergies, having an EpiPen on hand could mean the difference between life and death. But that safety net comes at a high price: In the past decade, the cost of the brand-name drug has risen by more than 400 percent, with a set of two pens selling for $600. Now, CNBC reports that patients can finally get the treatment they need for a more reasonable amount of cash: The FDA has approved a generic version of Mylan's EpiPen, making it the first direct generic competitor to the brand-name medication.

Teva Pharmaceutical's versions of both the EpiPen and EpiPen Jr. will work like the originals, with an injector delivering epinephrine, a chemical that opens the airways, into the bloodstream of someone suffering an allergic reaction. Similar generics have been made commercially available in the past: In 2016, Mylan introduced a cheaper version of its own product at $300 for a two-pack, and in 2017 CVS started selling an EpiPen alternative for $110. Teva's drug is different, though. It's a direct generic copy of the EpiPen, which means pharmacists will be free to offer it to patients who have been prescribed Mylan's product. A price hasn't been announced, but Teva's EpiPen could end up being significantly cheaper than Mylan's generic EpiPen, which could in turn bring down prices of the injector drug across the board.

The exorbitant price of the EpiPen has hit patients hard in recent years. Some EMTs have even started loading epinephrine into syringes manually rather than paying for the drug-injector combo. Though the drug itself isn't protected by a patent, the design of the EpiPen device is difficult for competing pharmaceutical companies to replicate, which has allowed Mylan to charge whatever it can for the product.

In 2017, the FDA tweaked its guidelines to make it easier for generic EpiPen competitors to receive market approval, even if the design of the new injector differed slightly from the original. With the approval of Teva's auto-injector made official, more EpiPen generics could soon start appearing behind pharmacy counters.

[h/t CNBC]

What You Should Know About Necrotizing Fasciitis, the 'Flesh-Eating' Infection

DragonImages/iStock via Getty Images
DragonImages/iStock via Getty Images

You’ve likely stumbled across one of several recent news stories describing cases of necrotizing fasciitis, or “flesh-eating bacteria.” The condition can follow exposure to certain bacteria in public beaches, pools, or rivers. This July, a man in Okaloosa County, Florida with a compromised immune system died after going into local waters. Just two weeks before, a 12-year-old girl was diagnosed with necrotizing fasciitis after scraping her foot in Pompano Beach, Florida. The stories and their disturbing imagery spread on social media, inviting questions over the condition and how it can be avoided.

According to the Centers for Disease Control and Prevention, necrotizing fasciitis can be caused by different strains of bacteria, with group A Streptococcus (strep) being the most common. When group A strep enters the body through a break in the skin like a cut or burn, a serious and rapidly spreading infection can develop. People will have a high fever, severe pain at the site of exposure, and eventual tissue destruction, which gives the condition its name. Necrotizing is to cause the death of tissue, while fasciitis is inflammation of the fascia, or tissue under the skin.

Because necrotizing fasciitis spreads so quickly, it’s crucial for people to seek medical attention immediately if they see early symptoms: rapid swelling and redness that spreads from a cut or burn, fever, and severe pain. Doctors can diagnose the infection using tissue biopsies, blood work, or imaging of the infected site, though they’ll almost always initiate treatment immediately. IV antibiotics, surgery to excise dead tissue, and blood transfusions are all used in an attempt to resolve the infection.

Even with care, necrotizing fasciitis can lead to complications like organ failure or sepsis. An estimated one in three people who are diagnosed with the condition die.

Fortunately, the condition is extremely rare in the United States, with an estimated 700 to 1200 cases confirmed each year. The CDC acknowledges, however, that the number is likely an low estimate.

Because group A strep can be found in water, the CDC advises people to avoid going into public waters with any kind of open wound. This applies to both public beaches and rivers as well as swimming pools or hot tubs. Chlorination is no guarantee against group A strep. Any cut or other wound should always be cleaned with soap and water. It’s especially important that people with compromised immune systems from illness, diabetes, cancer, or another conditions be exceedingly careful.

Rising ocean temperatures may make necrotizing fasciitis more common, unfortunately. A recent study in the Annals of Internal Medicine suggested that warmer water temperatures in Delaware Bay has allowed another kind of bacteria, Vibrio vulnificus, to flourish, resulting in five cases of necrotizing fasciitis in 2017 and 2018. Previously, only one case had been confirmed since 2008. Florida is also known to harbor group A strep in seawater.

But, owing to its rarity, necrotizing fasciitis should not overly concern people with healthy immune systems and unbroken skin. If you suffer a cut with a reddened area accompanied by severe pain and fever, however, seek medical evaluation right away.

Pioneering Heart Surgeon René Favaloro Is Being Honored With a Google Doodle

Dr. René Favaloro (left) pictured with colleague Dr. Mason Sones.
Dr. René Favaloro (left) pictured with colleague Dr. Mason Sones.
The Cleveland Clinic Center for Medical Art & Photography, Wikimedia Commons // CC BY 4.0

Argentinian heart surgeon René Favaloro is the subject of today’s Google Doodle, which features a sketched portrait of the doctor along with an anatomical heart and several medical tools, The Independent reports.

The renowned doctor was born on this day in 1923 in La Plata, the capital of Argentina’s Buenos Aires province, and pursued a degree in medicine at La Plata University. After 12 years as a doctor in La Pampa, where he established the area’s first mobile blood bank, trained nurses, and built his own operating room, Favaloro relocated to the U.S. to specialize in thoracic surgery at the Cleveland Clinic.

In 1967, Favaloro performed coronary bypass surgery on a 51-year-old woman whose right coronary artery was blocked, restricting blood flow to her heart. Coronary bypass surgery involves taking a healthy vein from elsewhere in the body (in this case, Favaloro borrowed from the patient’s leg, but you can also use a vein from the arm or chest), and using it to channel the blood from the artery to the heart, bypassing the blockage. According to the Mayo Clinic, it doesn’t cure whatever heart disease that caused the blocked artery, but it can relieve symptoms like chest pain and shortness of breath, and it gives patients time to make other lifestyle changes to further manage their disease.

Favaloro wasn’t keen on being called the “father” of coronary bypass surgery, but his work brought the procedure to the forefront of the clinical field. He moved back to Argentina in 1971 and launched the Favaloro Foundation to train surgeons and treat a variety of patients from diverse economic backgrounds.

Favaloro died by suicide on July 29, 2000, at the age of 77, by a gunshot wound to the chest. His wife had died several years prior, and his foundation had fallen deeply into debt, which Argentinian hospitals and medical centers declined to help pay, The New York Times reported at the time.

“As a surgeon, Dr. Favaloro will be remembered for his ingenuity and imagination,” his colleague Dr. Denton A. Cooley wrote in a tribute shortly after Favaloro’s death. “But as a man ... he will be remembered for his compassion and selflessness.” Today would have been his 96th birthday.

[h/t The Independent]

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