Sodium Bicarbonate

So far this year, drugmakers have been forced to yank their products over labeling issues, potency issues, contamination scares and more. So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels.While neither recall has resulted in any safety flags or side effect reports so far, the issues stemming from the faulty products could be severe, the drugmakers have warned.First up, German drug and devicemaker B. Braun Medical is yanking two lots of injectable 0.9% sodium chloride to the consumer level in the U.S. The company blamed the product pull on the potential for particulate matter and fluid leakage from the product’s “E3 containers.” The solution is used in both kids and adults as a source of electrolytes and water for hydration. The product is specifically approved for extracellular fluid replacement, treatment of metabolic alkalosis with fluid loss and mild sodium depletion. The product is also used as a priming solution for hemodialysis procedures and may be used to kick-start and terminate blood transfusions without hemolyzing red blood cells.The German firm says it mistakenly released the affected batches to domestic distributors across the U.S. before completing required acceptance activities for embedded particulate matter.While the company hadn’t received any safety reports as of Aug. 8, there is a risk of patients suffering embolic issues like stroke or ischemia/infarction to other organs, plus possible infection, if the particulates in the product aren’t sterile, B. Braun warned.Separately, Baxter International is voluntarily withdrawing a single lot of heparin sodium in 0.9% sodium chloride injection due to the potential for elevated endotoxin levels.The injection is used as an anticoagulant to maintain catheter patency—or the state of being open or unobstructed. Baxter says it shipped the suspect batch to U.S. healthcare facilities, wholesalers and distributors between March 12 and Aug. 24.Using heparin with excess endotoxin levels could lead to serious health consequences for patients such as toxic shock, organ failure and death, the company warned.As of Aug. 6, the company hadn’t received any adverse event reports tied to the product pull.Over the last year, drugmakers have been forced to yank their products over labeling issues, potency issues, contamination scares and more. Most recently, Endo USA—a unit of Endo Pharmaceuticals—recalled a single lot of clonazepam tablets in July thanks to a labeling issue that resulted in an incorrect strength being printed on the product cartons.Endo blamed the issue on a third-party packager.As for the risk of particulate matter turning up in drugs, Pfizer’s Hospira in October recalled three lots of sodium bicarbonate and lidocaine HCI injectables due to the possible presence of glass particles in vials. 

MONDAY, Aug. 12, 2024 -- An apple a day, along with a healthy serving of vegetables, could become a first line of treatment for hypertension, new research suggests. Diet plays a large role in overall health, and the study confirmed that a diet high in fruits and vegetables lowers blood pressure while improving both heart and kidney health. And although most modern diets include animal products, which produce high levels of unhealthy acid in the body, fruits and vegetables can help neutralize that acid. “It's important for us to remember that the usual diets that we eat in modern societies contain much more animal products like meats than fruits and vegetables,” said lead study author Dr. Donald Wesson , a professor of internal medicine at the University of Texas at Austin's Medical School. “So, when we eat a diet like we do in modern societies, more animal products like meat than fruits and vegetables, we have an acid-producing diet.” In the study, published Aug. 6 in the American Journal of Medicine , 153 patients with primary hypertension who also had very high levels of blood acid were divided into three groups: those who added 2 to 4 cups of fruits and vegetables to their daily diet; those who took sodium bicarbonate (baking soda) tablets; or those who received standard blood pressure treatment and medications. The patients were followed for five years. What did the researchers find? Both the patients who ate more fruits and vegetables or took baking soda tablets had improved kidney health. However, only the high fruit and vegetable diet improved both kidney health and heart health. “That's why our conclusion from the study is that diets high in fruits and vegetables should be foundational,” Wesson said. “That should be the baseline, the first thing that we do in treating individuals with high blood pressure. So, our thought is we should start with diet and then add medication as necessary.” Fruits such as apples, oranges, peaches and raisins were provided to patients in the study. Vegetables including carrots, cauliflower, eggplant and lettuce were also given to participants. It was found that raisins were the most effective at neutralizing acid in the body. People who don't have access to fresh fruits and veggies should probably not turn to baking soda tablets instead, Wesson said. “I would not suggest that you take those sodium bicarbonate or baking soda type pills on your own. But if you think that you can be benefited by taking those baking soda-like tablets, I would talk with your physician first before doing it on your own,” he advised. Adding more fruits and vegetables may seem like a daunting task to some, so Amy Kimberlain , a nutritionist and spokesperson for the Academy of Nutrition and Dietetics offered some advice. “I always tell patients that fruits and vegetables while they provide fiber, they also can provide flavor,” Kimberlain said. “Eat the ones they enjoy [don’t eat something you don’t like], but also experiment with different ways of preparing the fruits and vegetables. If you don’t like raw carrots, try them cooked. Like beets, if you don’t love them as is, maybe add them to a hummus and now have a flavored hummus. Experiment, get creative and keep trying!” Kimberlain offered some additional tips to make this transition in your diet easier: Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.