Drug Safety Developments

U.S. FDA warns on newer class of type 2 diabetes drugs

Quoted from http://www.reuters.com/article/2015/05/15/fda-diabetes-idUSL1N0Y615520150515

U.S. FDA warns on newer class of type 2 diabetes drugs

By Bill Berkrot
May 15, 2015

May 15 (Reuters) - The U.S. Food and Drug Administration on Friday warned that a widely used newer class of type 2 diabetes drugs sold by AstraZeneca, Johnson & Johnson and Eli Lilly in partnership with Boehringer Ingleheim may cause dangerously high levels of blood acids that could require hospitalization.

The oral drugs belong to a class known as SGLT2 inhibitors that work by causing blood sugar to be secreted in the urine. They include AstraZeneca's Farxiga (dapagliflozin), J&J's Invokana (canagliflozin) and Jardiance (embagliflozin) from Lilly and Boehringer.

The FDA, in a warning on its website, said the medicines may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones.

The FDA said its Adverse Event Reporting System database identified 20 cases of acidosis reported as diabetic ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors between March 2013 to June 6, 2014. It said all the affected patients required emergency room visits or hospitalization to treat the condition.

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More articles on this topic:

• Health Canada Warns About Link Between DKA & Popular Diabetes Drugs
• Canagliflozin Also Causes DKA in Those With Type 1 Diabetes
• EMA Advises How to Reduce DKA Risk While Taking SGLT2 Inhibitors

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200-Year-Old Heart Drug Linked To Increased Risk Of Death

Quoted from http://www.forbes.com/sites/larryhusten/2015/05/05/200-year-old-heart-drug-linked-to-increased-risk-of-death/

200-Year-Old Heart Drug Linked To Increased Risk Of Death

Larry Husten
Forbes

May 5, 2015

For more than 200 years physicians have been trying to figure out how and when to use the heart drug digoxin. Although it has a narrow therapeutic window and potentially dangerous interactions with other drugs, it is endorsed by current guidelines and widely given to patients with heart failure (HF) and atrial fibrillation (AF). However, there have been no randomized trials in AF and only one trial, the famous DIG trial, in HF. In that trial digoxin had no impact on mortality but was found to help reduce the rate of hospitalization for HF.

Now researchers led by Stefan Hohnloser have performed a meta-analysis, published in the European Heart Journal,of 19 studies of digoxin, including more than 235,000 AF patients and 91,000 HF patients. With the exception of the randomized, placebo-controlled DIG study, all the studies were observational.

Overall, there was a 21% increase in the relative risk of death in people taking digoxin (HR 1.21, CI 1.07 – 1.38, p= 0.01). Separately, the increased risk was 29% in the AF population and 14% in the HF population. There were three studies that included both AF and HF patients. In these trials there was a 28% increase in mortality in the AF group but no significant effect in the HF group.

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