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Weekly Drug News Round-Up: June 14, 2017

FDA Requests Removal of Opana ER From U.S. Market Due to Abuse

This is the first time FDA has requested removal of an opioid product due to abuse Read More...

The FDA has requested that Endo Pharmaceuticals voluntarily remove reformulated Opana ER (oxymorphone hydrochloride), an opioid pain drug, from the U.S. market. The Opana ER reformulation was approved in 2012 with the intent of becoming more abuse-deterrent. However, postmarketing data has shown a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). If Endo does not voluntarily remove the product from the market, FDA will take steps to retract approval of the drug.

Types 2 Diabetes Drug Linked to Serious Side Effect

Experts state the rate of diabetic ketoacidosis is still very low and should not stop use of these medications Read More...

A common class of type 2 diabetes medications called SGLT2 inhibitors can increase the risk of a serious, possibly fatal complication known as ketoacidosis. SGLT2 inhibitors include prescription medications such as canagliflozin, dapagliflozin and empagliflozin. Brand names are Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi. Clinicians had already suspected this uncommon risk, and a new study published in the New England Journal of Medicine adds further evidence. Ketoacidosis can cause vomiting, abdominal pain, shortness of breath and swelling in the brain. However, among patients taking an SGLT2 inhibitor, only about 1 in every 1,000 patients would develop ketoacidosis, according to researchers.

New Drug Class to Prevent Migraines is Under Study

Migraine is a disabling disease affecting more than 36 million men, women and children in the United States Read More...

The first migraine-specific preventive drug class is inching closer to FDA approval. Most drugs used today to prevent migraines have been repurposed from other classes, such as blood pressure drugs, antidepressants, or seizure medications. Triptans like sumatriptan (Imitrex) are used to treat ongoing migraines. However, the mechanism of action of the new preventive class works by blocking a migraine-related protein called the calcitonin gene-related peptide (CGRP), a pain molecule, or the receptor it acts on. One investigational agent is erenumab, in Phase 3 studies from Amgen. Results demonstrated that 50% of patients receiving monthly injections lowered their number of migraines per month by half. So far, the only side effect is temporary injection site irritation.

Nasal Glucagon More Convenient Way to Treat Low Blood Sugar

Eli Lilly hopes to submit nasal glucagon to the U.S. Food and Drug Administration sometime in 2018 Read More...

Researchers report that a new nasal powder containing the hormone glucagon quickly reverses the effects of hypoglycemia (low blood sugar) in diabetes. Symptoms of low blood sugar include dizziness, hunger, confusion, blurred vision, sweating, slurred speech and irritability. Continued lack of blood sugar may cause disorientation, seizures, unconsciousness and even death. Currently, glucagon (Glucagen) is only available in an injectable form. In the research study, 96% of 157 low blood sugar levels returned to normal within 30 minutes. Side effects were similar to injectable glucagon, including nausea and vomiting. The nasal powder also caused some nasal irritation and headache.

Flu Shot Not Always Effective for Obese People: Study

Experts state alternative options may be needed to protect obese adults from influenza virus infection Read More…

New research from Gillings School of Public Health at UNC-Chapel Hill reveals the influenza vaccine doesn't work as well for people who are obese. While the flu vaccine is still the best way to prevent the flu, obese people who got a flu shot were twice as likely as their normal-weight peers to still get sick. Their study showed that about 10% of the vaccinated obese group still came down with flu, compared to roughly 5% of healthy weight participants. Their work suggests T-cells, infection-fighting white cells, don’t function as well in the obese. T-cells help guard against the flu and aid in recovery.