The FDA issued a new blood pressure medication recall due to a potentially life-threatening labeling mixup.
According to a report from USA Today, the Food and Drug Administration issued the recall due to mislabeled bottles of Hydrochlorothiazide. Bottles that were supposed to contain the blood pressure medication Hydrochlorothiazide Tablets USP 12.5 mg contained Spironolactone Tablets USP 25 mg. The Spironolactone medication is used to treat high blood pressure as well as conditions like congestive heart failure, cirrhosis of the liver among other things.
Meanwhile, Hydrochlorothiazide is used “as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.”
For some, the medication mixup could be “life-threatening,” according to the FDA’s recall notice. The notice said, “Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increase potassium levels) in certain individuals, resulting in adverse events that range from limited health consequences to life-threatening situations in certain individuals.”
Because of the mixup, Accord Healthcare Inc. voluntarily recalled lot PW05264 of the drug involved in the mislabeling. The Hydrochlorothiazide Tablets USP 12.5 mg should be round with a light orange or peach color. One side of the pill has an “H,” and the other side has a “1.” Patients who have tablets that don’t match the description should call their doctor or pharmacy for further instructions.
So far, Accord Healthcare has not received any reports of adverse outcomes as a result of the labeling mixup. Anybody who experiences adverse reactions should report them to the FDA’s MedWatch Adverse Event Reporting program, which can be accessed online, sent by regular mail, or by fax.
Earlier this month, the FDA expanded a blood pressure medication recall that started in July, according to a report from the Inquisitr. Drugs containing valsartan experienced a recall over concerns over the drug being tainted with a compound that potentially increases cancer risks. The affected drugs in that recall may have been contaminated with N-nitrosodimethylamine or NDMA, which the U.S. Environmental Protection Agency considers a possible carcinogen.
All the drugs in the valsartan recall were linked to Zhejiang Huahai Pharmaceuticals, in Linhai, China, which is where authorities believe the possible contamination may have taken place.
Close to one in every three adults experience high blood pressure in the United States, according to a CDC report. Altogether, about 75 million people likely take some type of medication to control hypertension.