Blood Pressure Drug Recalled Over Hydrochlorothiazide Pill Mix-Up, Poses Potentially Life-Threatening Consequences

The Food and Drug Administration (FDA) announced this week that the healthcare company Accord was issuing a voluntary recall of its Hydrochlorothiazide tablets after a labeling mix up caused some customers to be given Spironolactone tablets instead.

In a statement released on Monday, the FDA explained that a product complaint reported at a pharmacy prompted an investigation that discovered a 100-count bottle of 12.5-milligram Hydrochlorothiazide tablets actually contained 100 25-milligram Spironolactone tablets.

Hydrochlorothiazide tablets are used to manage hypertension, either by itself or in conjunction with other antihypertensive drugs for people who have a more severe case of hypertension.

People who use Spironolactone tablets often take the medicine to help with hyperaldosteronism, congestive heart failure, cirrhosis of the liver, nephrotic syndrome, essential hypertension, hypokalemia or severe heart failure.

The FDA explained that taking Spironolactone instead of Hydrochlorothiazide poses the risk of contracting hyperkalemia, which is an increase in potassium levels, and consequences can range from being very limited to life-threatening. Fortunately, Accord hasn't received any reports of people having complications from the mix-up.

Hyperkalemia is commonly caused by acute kidney failure and chronic kidney disease, according to the Mayo Clinic, and in some cases, can require the need of dialysis. Other times, it can just be a matter of a doctor changing a patient's medication to something that doesn't affect potassium levels. In severe cases of Hyperkalemia, a person can experience muscle fatigue, weakness, paralysis and abnormal heart rhythms.

Hydrochlorothiazide tablets are light orange or peach colored, round, and debossed with an H on one side and the number one on the other. The FDA encouraged anyone in possession of Accord Hydrochlorothiazide to take a look at their tablets and return it to the pharmacy if it doesn't match the picture the FDA provided.

Accord's Hydrochlorothiazide tablets are a peach or light orange color with an H on one side and the number one on the other. Food and Drug Administration

In July, the FDA expressed concerns about valsartan, which is a drug used to treat high blood pressure and heart failure, leading the product to be recalled. Officials found trace components of the chemical compound N-nitrosodimethylamine (NDMA), a carcinogen that could cause cancer. FDA officials believe a change in how the active substance was made led to NDMA being found in the drug.

Despite the recall, the FDA advised people taking the drug for a serious medical condition to not stop taking it until they had a proper replacement and direct their concerns to the pharmacy where they purchased it. Recalls of the drug were also issued in over 20 other countries, including Canada, Sweden and Italy.

On Monday, Pfizer Consumer Healthcare announced it was recalling a specific lot of children's Advil that had been distributed with the incorrect dosage cup. Dosage cups were labeled in teaspoons but the medication is administered in millimeters.