FDA orders withdrawal of injectable drug

The Food and Drug Administration (FDA) has ordered the recall from the market of a batch of an injectable diuretic used in the treatment of congestive heart failure and kidney disease due to the potential risk of broken ampules.

In an advisory, the FDA expressed concern that patients given the problematic batch of Furosemide 10mg/ml (20mg/ml) solution for injection with brand name Lasix may suffer from possible “thromboembolic events” due to unseen glass particles in the ampules if not thoroughly examined prior to administration.

Thromboembolic events refer to the formation of a clot in a blood vessel that may later plug a vessel in the lungs, brain, gastrointestinal tract or kidneys.

FDA’s recall order was directed at Batch Number 4F202A of Lasix, manufactured by Aventis Pharma Deutschland and GmbH in Frankfurt, Germany, and distributed by Sanofi-Aventis Philippines Inc. The affected batch was manufactured in March 2014 and has an expiration date of February 2019.

Furosemide is used to treat fluid buildup and swelling caused by cardiac and hepatic disease, renal disease and pulmonary edema.

“The affected product batch presents safety risk and potential adverse health consequences. Therefore, distributors, hospitals, retailers or pharmacies that have the affected batch [of the product] are instructed to discontinue its distribution, sale and use,” Health Secretary Janette Garin, also acting FDA director general, said in her directive.