Just months after raising concerns to manufacturers, the U.S. Food and Drug Administration (FDA) will be holding a meeting to discuss whether or not non-prescription antiseptic products are safe and effective, RAPS reports.
Over-the-counter antiseptics are used to reduce the risk of infection during an injection. They are distributed in both single-use form and multiple-use packages; with the latter, the product is available in a package such as a tube that allows users to apply more antiseptic later. Continue reading
In a recent consumer warning, the Food and Drug Administration (FDA) said over-the-counter acne products that contain benzoyl peroxide or salicylic acid can cause serious and potentially life-threatening allergic reactions or severe irritation.
These products come in a variety of forms: gels, lotions, facial washes, cleansing pads, and facial scrubs. The FDA received 131 reports of serious allergic reactions from these products, according to Health Hub (of the Cleveland Clinic). Consumers and manufacturers made the reports between 1969 and January 2013. Those reports included such severe symptoms as
- Throat tightness
- Shortness of breath
- Low blood pressure
- Collapse Continue reading
Unique Pharmaceuticals, Ltd. just announced a nationwide recall of all of its sterile compounded preparations within those preparations’ expiry period over a potential lack of sterility assurance, the U.S. Food and Drug Administration (FDA) just revealed.
The sterile drug preparations compounded by the outsourcing facility have not reached the expiration date listed on the products. Unique Pharmaceuticals indicated that it initiated the recall following FDA concerns with Unique Pharmaceuticals’ compounding facilities and processes. According to the agency, the facilities and processes present a lack of sterility assurance and were also observed during recent inspections conducted by the FDA. Continue reading
A woman who had been taking a weight loss supplement suffered liver failure and needed a liver transplant, according to a recent report of her case.
The woman, 35, had taken three Saba Appetite Control and Energy (ACE) pills in a two-day period. Two weeks later, she developed jaundice, suffered from liver failure and required a liver transplant, according to Live Science, citing a report from researchers at the University of Kentucky in Lexington, who treated her. Continue reading
The United States Senate declared July 30, 2013 as “National Whistleblower Appreciation Day” in an effort to support and commend the actions of individuals refused to accept fraud, misconduct and other wrongdoing. According to National Whistleblowers Center, a non-profit organization, the decision to establish “National Whistleblower Appreciation Day” was a unanimous one made by the Senate on July 31, 2013. Continue reading
General Motors (GM) has recalled its 2014 Chevrolet Silverado and GMC Sierra six times this year so far, making them the most frequently recalled vehicles. And unfortunately for GM, that is not the end of the pickups’ recall history, they have been recalled a total of nine times since they were introduced one year ago, according to CNNMoney. Continue reading
The Food and Drug Administration (FDA) has decided not to institute a total ban on transvaginal mesh devices, despite a call to do so from the consumer advocacy group Public Citizen.
In a 2011 petition, Public Citizen asked the FDA to halt the marketing of surgical mesh products for pelvic organ prolapse repair, to recall devices currently in distribution, and to reclassify the products as Class III devices, Med Device Online reports. Class III devices, the highest risk devices, are subject to the greatest regulatory control and typically require approval they are marketed, according to the FDA. Continue reading
A newly published study shows that the power morcellator, a surgical device commonly used in hysterectomies, has greater potential to spread cancers in a woman’s body than previously thought.
The power morcellator, used in hysterectomies and fibroid removal, slices uterine tissue into pieces that can be removed through small laparoscopic incisions, The Wall Street Journal reports. In April, the Food and Drug Administration (FDA) advised doctors to stop using morcellators because of the risk of spreading previously undetected cancerous tissue inside the body, significantly worsening the patient’s odds of survival. The new report in the Journal of the American Medical Association reinforces the risks pointed put by the FDA. Continue reading
A testosterone lawsuit has been filed in Canada against the manufacturer of the testosterone injectable, Delatestryl (Testosterone Enanthate), over allegations that include that the consumers were not sufficiently advised of the risks associated with the so-called “Low T” medication. The lawsuit also alleges that use of Low T treatment is tied to the increased likelihood of cardiovascular reactions, such as heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism, and death.
The U.S. Food and Drug Administration (FDA) posted a notice on its website indicating that, on September 17, 2014, it would be convening a joint meeting with the Reproductive and Urologic Drugs Advisory and the Drug Safety and Risk Management Advisory committees. Recommendations regarding cardiac reactions tied to Low T drugs and what issues should be considered when prescribing low testosterone therapy are expected to be among the covered topics. Continue reading
A Philadelphia jury has awarded $55.3 million to a man who sued Honda over an allegedly defective seat belt after a car crash left him paralyzed. The Plaintiff, 57-year old Carlos Martinez, was driving his Acura Integra to work in 2010. Martinez lost control of the car when one of the tires blew out. As the car rolled over, his head hit the roof and he suffered injuries that permanently left him in a wheelchair. Continue reading