Folks who regularly take Excedrin, Bufferin and other over-the- counter preparations, such as Gas-X and No-Doz, will want to check their medicine cabinets for these products as Novartis AG is voluntarily recalling the over-the-counter drugs due to possible contamination. Broken or chipped tablets from other Novartis products occurring in the wrong bottles are the pesky problem. The company’s concern is that mixing different products in the same bottle might cause an individual taking a preparation to receive an incorrect product, a higher or lower strength preparation than intended, or to receive an unintended ingredient, which might result in overdose or an allergic reaction experienced by the person taking the product.
Operations and shipments from its Lincoln, Nebraska, plant have been stopped until the problems with the packaging Novartis’ products are cleared up. Novartis estimates that the recall and improvements to the Lincoln facility may cost up to $120 million, and has informed the U.S. Food and Drug Administration of the recall. The recall involves bottled packages of Excedrin and NoDoz with expiration dates of December 20, 2014, or earlier, and of Bufferin and Gas-X products with expiration dates of December 20, 2013, or earlier. We commend Novartis AG for being pro-active in the recall, however, Novartis appears to have another headache!
According to The Los Angeles Health Examiner’s January 9, 2012, article by Dr. Robin Wulffson, Novartis’ hypertension remedy, Aliskiren, is causing the company some lost revenue. Poor showing in a major clinical trial involving 8,600 patients with type-2 diabetes and poor kidney function linked the drug to possible risks of nonfatal stroke and renal problems. The company subsequently decided to halt promotion of Aliskiren for use in combination with ACE-inhibitors and angiotensin receptor blockers “until regulators decide whether the drug’s marketing license needs to be changed.” The European Medicines Agency (EMA) also has advised physicians to stop prescribing the drug to diabetic patients who are also taking the older hypertension drugs known as ACE inhibitors or angiotensin receptor blockers.