Every year, millions of women undergo breast augmentation surgery. Most of these surgeries include installing breast implants - medical devices regulated by the U.S. Food and Drug Administration (FDA). Now, concerns about breast implant illness are causing many women to weigh the risks of implants and make difficult choices about...
Medication Safety Questioned as FDA Investigates More NDMA Claims
With Valsartan and Zantac still making headlines due to possible carcinogenic contamination, it is no surprise that medication safety is being questioned by the masses. But it is also being questioned by agencies like the U.S. Food and Drug Administration (FDA). As the investigation into Zantac continues, the FDA is...
Secret Cache of Medical Device Complaints Spurs Lawsuits and Research
In June, we told you about the U.S. Food and Drug Administration’s (FDA) secret database that effectively hid millions of medical device injury complaints. In our post titled “The FDA Comes Clean About Millions of Injuries Caused by Medical Devices,” we touched on the fact that six million reports of...
Patients Experiencing Hardship Amid Hypoparathyroid Drug Recall
In September 2019, Takeda Pharmaceutical Company Limited issued a drug recall of all doses of Natpara, a parathyroid hormone injection. The recall is due to safety concerns about rubber particulate contaminating the drug. While the focus of the medication recall is patient safety, the result is hardship for the more...
Zimmer Biomet Recalls ROSA Brain Surgical Robot Due to Software Problem
The U.S. Food and Drug Administration (FDA) has announced that Zimmer Biomet is recalling ROSA Brain 3.0 surgical robots due to a possible software defect. According to the recall announcement, there is a software problem that could cause the robotic arm to position itself incorrectly. The incorrect positioning of the...
Medtronic Device Recall of 106,000 Potentially Defective Heart Catheters
The U.S. Food and Drug Administration (FDA) has announced a recall of more than 106,000 Medtronic heart catheters. According to the FDA announcement, the device recall follows numerous complaints about the devices not performing as expected. The FDA classifies this recall as a Class I. Class I medical device recalls...
Medication Recall Alert: Mylan Pharmaceuticals Recalls Xanax
Mylan Pharmaceuticals has issued a medication recall for one batch of Xanax (alprazolam). According to the recall notice posted by the U.S. Food and Drug Administration (FDA), the affected lot may contain a foreign substance. Read on to learn more about the recall and what you can do to stay...
How Does Vaping Affect Your Body?
E-cigarettes are incredibly popular, especially with teenagers and young adults. While it is touted as being a safer alternative to traditional cigarettes, e-cigarette use, or vaping, is not without risk. According to the Centers for Disease Control and Prevention (CDC), e-cigarette use may actually be more dangerous than other tobacco products. ...
FDA Answers Questions about Ranitidine (Zantac) Recall
News sources across the United States have reported on the recall of popular antacid medication Zantac (ranitidine). The U.S. Food and Drug Administration’s (FDA) recall notice warns patients and healthcare providers that certain Zantac and ranitidine products manufactured by Apotex Corp. may be contaminated with N-nitrosodimethylamine (NDMA). Consequently, the FDA...
FDA Issues Multiple Safety Alerts for Medical Devices
The U.S. Food and Drug Administration (FDA) issues recalls and safety alerts to keep consumers and the healthcare community informed. Safety alerts often involve drugs, medical devices, supplements and cosmetics. In September, the FDA issued multiple new safety alerts for medical devices and drugs. Several of the safety alerts involve...
Blood Pressure Medication Recall Expands Yet Again
In September 2019, the ongoing blood pressure medication recall that has made headlines this year expanded once again. The U.S. Food and Drug Administration (FDA) announced that Torrent Pharmaceuticals Limited is expanding the recall of blood pressure medications at the consumer level. According to the FDA, several batches of Losartan...
News Update: JUUL CEO Steps Down, Ends Merger Talks with Philip Morris
At Drug and Device Watch, we continue to follow reports of illness and addiction related to JUUL brand e-cigarettes. Most recently in the news is the fact that JUUL’s CEO has stepped down. The new CEO is an executive at Altria Group Inc., the company that owns 35 percent of...