Teva to recall certain blood pressure medicine in U.S
(Reuters) - Teva Pharmaceutical Industries Ltd is recalling certain combinations of blood pressure drug valsartan in the United States following the detection of a probable cancer-causing impurity, the latest global recall of the medicine.
The Israeli drugmaker will recall all lots of amlodipine-valsartan and amlodipine-valsartan-hydrochlorothiazide combination tablets due to an impurity in an ingredient made...
FDA overhauls approval process as medical devices come under fire
(CNN)As the US Food and Drug Administration publicizes its plans to overhaul the process for manufacturers that want to market medical devices in the United States, a year-long investigation by a nonprofit newsroom is reporting more than 80,000 deaths potentially linked to medical implants since 2008.
Despite the timing, the FDA denies any connection between...
FDA announces ‘modernized’ medical device clearance process
The U.S. Food and Drug Administration on Monday announced a new path for medical device manufacturers to receive product clearance, saying the “modern” framework will provide an alternative review procedure for a process frequently criticized as outdated and unsafe.
FDA Commissioner Scott Gottlieb’s long-awaited announcement marks an overhaul of the agency’s existing fast-track pathway, known...
Only romaine from certain parts of California should be avoided, FDA says
Only romaine lettuce from certain parts of California is unsafe to eat, federal health officials announced Monday.
The multi-state outbreak of E. coli infections has been traced to the Central Coast regions of California, according to a statement from Food and Drug Administration Commissioner Scott Gottlieb.
“Romaine lettuce that was harvested outside of the Central...
GM Trucks and SUVs Face Probe Over Brake Performance
The National Highway Traffic Safety Administration (NHTSA) has launched a probe involving 2.7 million pickup trucks and SUVs from General Motors over concerns that their braking ability may fade over time, increasing the risk of crashes.
According to NHTSA, 111 complaints have been filed with the agency about the problem, including nine reports of crashes....
Doctors, patients raise alarms about cancer linked to breast implants
When Michelle Forney’s breast started swelling and itching, doctors told her she had mastitis, a common infection, and treated her with antibiotics. When she discovered that she, in fact, had a rare form of lymphoma and that it was probably caused by her breast implant, she was both furious and frightened.
Forney is just one...
Mylan recalls batches of blood pressure medicine in U.S.
(Reuters) - Mylan NV said on Tuesday it would recall certain batches of blood pressure medicine valsartan in the United States after they were found to contain a probable cancer-causing impurity, the latest recall amid heightened safety concerns globally.
Shares of the company, which on Tuesday also disclosed a warning letter it received from the...
Romaine lettuce warning: CDC says E. coli outbreak has sickened 32 people in 11 states
Americans should not eat any romaine lettuce amid concerns over a new E. coli outbreak, the Centers for Disease Control and Prevention warned Tuesday.
Consumers should throw away any romaine lettuce, and retailers and restaurants should not sell or serve it, the CDC said.
At least 32 people in 11 states have gotten sick from...
Jeep Wrangler drivers report ‘death wobble’ on highways
Rich Person was satisfying a long-held desire in May when he bought a Jeep Wrangler Unlimited Sport with a 3.6-liter V6 engine.
In a picture taken by his salesman, Person is seen standing beside his new ride at a dealership in Massachusetts, grinning widely and flashing two thumbs up.
“I have wanted one forever and just...
Blood pressure drug recall expands again
(CNN)The US Food and Drug Administration says another heart medicine is being voluntarily recalled after tests showed that it was tainted with a potential cancer-causing chemical.
The recall includes one lot of Sandoz's losartan potassium hydrochlorothiazide 100 milligram/25 milligram tablets with the lot number JB8912. Patients use these drugs to keep their high blood pressure...