4 Drug Safety Warnings We Should Have Seen Coming


The FDA issued a number of drug safety warnings in 2015, but pharmacists shouldn't be surprised by some of them.

The FDA issued a number of drug safety warnings last year, but pharmacists shouldn't be surprised by these:

1. SGLT2 Inhibitors: Glucose in the Bladder Isn’t a Good Thing

The FDA issued new safety warnings for an entire class of antidiabetic drugs: the sodium-glucose co-transporter 2 (SGLT2) inhibitors.

The use of these drugs has been linked to an increased incidence of ketoacidosis and urosepsis in patients. The FDA felt that the severity of these effects and the incidence were concerning enough to levy the class warning.

It is recommended that patients currently taking SGLT2 inhibitors receive education on the signs and symptoms of urinary tract infection, diabetic ketoacidosis, and/or hyperglycemic hyperosmolar non-ketotic acidosis, which is more common in type 2 diabetics. It isn’t clear whether stable patients should stop taking this drug class altogether, but if other agents are safer and just as effective, a change may be reasonable.

2. Codeine Raises Risk of Respiratory Depression in Children

I once heard that a given dose of codeine is an unknown dose of morphine. With genetic variations in cytochrome P450 2D6 activity, children can be exposed to a range of morphine, which is codeine’s active metabolite.

In some children, there may be little to no morphine produced, leading to an absent analgesic effect. In others, however, excessive morphine production could cause opioid toxicity, which is primarily concerning for respiratory depression.

The FDA advises against the use of codeine or codeine-containing cough and cold products in children aged younger than 18 years.

3. NSAIDs Still Increase Risk of Heart Attack and Stroke

Most pharmacists are already aware of this, but the FDA is strengthening its warnings to inform prescribers. In short, nonsteroidal anti-inflammatory drug (NSAID) labels will now reflect specific risks and how they pertain to the drugs’ use.

For instance, the drug labels will detail how the risk of heart attack and stroke can occur within the first weeks of NSAID use, even if patients don’t have heart disease or even risk factors. This risk increases by dose, and all NSAIDs carry similar risk.

4. Name Confusion Between Brintellix and Brilinta

Brintellix and Brilinta is yet another sound-alike combination to add to your hospital’s high alert list.

These are 2 very different drugs approved within a short period of time that sound remarkably alike. Brintellix is used to treat depression, while Brilinta is used to treat myocardial infarction.

If one were to be substituted for the other, the effects could be catastrophic.

Let’s hope for a safe and effective 2016.

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