6 Recent FDA Drug Warnings Pharmacy Techs Should Know

JUNE 24, 2016
Ryan Marotta, Assistant Editor
Although medications are tested for potential adverse events before they’re approved, some side effects may not be evident until after a drug enters the market.
As some of the last health care team members to handle prescription drugs before they reach patients, pharmacy technicians should familiarize themselves with new FDA warnings for the following products:
1. Aripiprazole
The FDA added a new warning to the label of drugs containing the antipsychotic aripiprazole (Abilify, Abilify Maintena, Aristada) that alerted patients and providers to an associated risk of impulsive behavior.
The warning was issued on May 3, 2016, after the FDA identified a total of 167 US cases where the use of aripiprazole was linked with impulse-control problems in adults and children. The majority of these cases involved pathological gambling, but instances of compulsive eating, spending, and sexual behaviors were also reported.
Although these side effects were reported to occur after the medication was discontinued or the dose was reduced, patients treated with aripiprazole should first consult a health care professional before changing their therapy.
2. Antacids Containing Aspirin
On June 6, 2016, the FDA reiterated that OTC antacid products containing aspirin carry a risk of serious bleeding. Some of the products associated with this risk include Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, Zee-Seltzer Antacid and Pain Reliever, and their generic equivalents.
Although the labels of aspirin-containing antacid products have included a warning about serious bleeding since 2009, recent cases of serious bleeding linked to the use of these drugs prompted the FDA to remind patients and providers about the risk.
Risk factors for serious bleeding include age 60 years or older, history of stomach ulcers or bleeding, use of a blood-thinning or steroid medicine, use of other medications containing nonsteroidal anti-inflammatory drugs (NSAIDs), or an intake of 3 or more alcoholic drinks every day. Patients can also increase their risk for serious bleeding by taking a higher dose of aspirin-containing antacids than recommended, or by taking these medications for a longer time period than recommended.
The FDA will continue to evaluate this issue to determine whether further action is required.
3. Canagliflozin and Dapagliflozin
The FDA strengthened its existing warnings concerning the risk of acute kidney injury associated with the diabetes medications canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) on June 14, 2016.
Following the identification of 101 cases of acute kidney injury linked with the use of canagliflozin and dapagliflozin, the FDA decided to revise the drugs’ label to include further information about potential kidney problems, as well as recommendations to minimize the risks.
Some of the risk factors of acute kidney injury include decreased blood volume, chronic kidney insufficiency, congestive heart failure, and the use of other medications such as diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and NSAIDs.
Patients who experience signs or symptoms of acute kidney injury, such as decreased urine or swelling in the legs or feet, should seek immediate medical attention. However, those who are treated with canagliflozin or dapagliflozin should consult their health care provider before stopping the medications, as doing so could lead to uncontrolled blood sugar levels.

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