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serious injury 98 articles

Consumer groups question safety of expedited medical device approvals

Medical device manufacturers spent more than $33 million last year and used 225 lobbyists to pressure lawmakers to support the Food and Drug Administration’s current practice of allowing moderate-risk devices to be approved without thorough testing for safety and efficacy. The practice has come under fire in recent months, in particular by consumer groups who argue that the agency’s expedited approval process puts patients at risk for serious injury or death. This debate is currently being weighed by members of congress, who will also consider the FDA’s proposal to remedy the situation. The agency is proposing a fee increase for ... Read More

Generic Yaz will include same blood clot warnings

Watson Pharmaceuticals has launched Vestura, a generic version of Bayer’s blockbuster birth control pill Yaz. Like their brand-name counterpart, these pills will also carry a safety announcement on their packaging, warning users that studies suggest the drospirenone-containing pills may put users at greater risk for developing life threatening blood clots. Yaz, as well as the brands Yasmin, Beyaz, Safyral, and other generic varieties, combine the hormones drospirenone and ethinyl estradiol. Yaz and its generic versions had sales of about $510 million last year alone. Watson hopes to take a bite out of those profits. However, just as Watson was vying ... Read More

FDA wants more data on safety of transvaginal mesh

Manufacturers of surgical mesh used to repair pelvic floor disorders including pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are being asked by the Food and Drug Administration (FDA) to conduct new studies on the safety of the products. The review is in response to mounting complaints associated with the transvaginal use of the mesh. Inserted through the vagina to shore up organs that have slumped from childbirth or obesity, the mesh offers an attractive non-invasive alternative to surgical repair. However, complaints show that the mesh often over time begins to erode into the vaginal wall. This causes pain, ... Read More

FDA rejects type 2 diabetes drug based on bladder, breast cancer risks

The Food and Drug Administration (FDA) has rejected the experimental type 2 diabetes drug Dapagliflozin because it poses a risk for bladder and breast cancers. Drug makers Bristol-Myers Squibb and AstraZeneca must provide more data on the drug’s risks and benefits before the FDA would be willing to consider approving the drug for use in the United States. Dapagliflozin works by increasing renal glucose elimination, thereby allowing more sugar to be excreted in the urine. An FDA advisory panel voted in July to recommend the approval for the drug, but raised concerns over the cancer risks that rose out of ... Read More

Hospital, home ventilators recalled due to manufacturing defect

Respironics Trilogy 100 ventilators, used to provide breathing support for infants and adults, is being recalled because of a defect that can cause the machine to stop working. This recall is listed as a Class 1, which is the most serious type of recall issued by the Food and Drug Administration (FDA) and involves situations in which there is a reasonable probability that use of these products will cause serious injury or death. ... Read More

Defective ventilators recalled

Leading global medical device company, CareFusion, is recalling its AVEA Ventilator because of a defect that could cause it to stop ventilating, which if left undetected could be deadly for patients. This is the second Class 1 recall of a CareFusion ventilator. The company recalled lots of its EnVe Ventilators for a defect that affected ventilation. A Class 1 recall is the most serious type of recall issued by the Food and Drug Administration (FDA) and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. The AVEA ... Read More

FDA undertaking priority review of new anti-clotting drug

The Food and Drug Administration (FDA) is undertaking a priority review for an experimental anti-clotting drug for the prevention of strokes and systemic embolism in patients with atrial fibrillation, an irregular heartbeat that raises the risk for serious blood clots. Eliquis, made by Pfizer and Bristol-Myers, was recently approved in the European Union (EU) for prevention blood clots in patients who have had knee or hip replacement surgery. The EU is currently reviewing the possibility of approving the drug for use with atrial fibrillation patients as well. Anti-clotting agents, also known as coagulants or blood thinners, include medications such as ... Read More

Pelvic floor muscle exercises help prevent, improve SUI, POP

A recent study by the Norwegian School of Sport Sciences showed that pelvic floor muscle exercises were an effective treatment for stress urinary incontinence, or SUI, with short-term cure rates varying between 35 and 80 percent. The exercises also proved beneficial in patients who suffered from pelvic organ prolapse, or POP. SUI and POP are often treated with surgery in which surgical mesh is implanted transvaginally to hold up the dropping organs. However, the transvaginal mesh used in these types of surgery is currently under a review by the Food and Drug Administration (FDA) for possibly causing serious injuries. In ... Read More