Current Events

(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 its communications and the report from the International Consortium of Investigative Journalists.
"We didn't even know about what the ICIJ was doing until early October," FDA spokeswoman Deborah Kotz said Tuesday. She added that the agency issued its Medical Device Safety Action Plan in April, laying out what it has done and what new steps it plans to take to enhance device safety.

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(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 by an India-based unit of Mylan, the U.S. Food and Drug Administration (FDA) said on Tuesday.

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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 of hundreds of breast-implant recipients who have developed a rare blood cancer called anaplastic large cell lymphoma (ALCL). The Food and Drug Administration has been investigating reports linking breast implants with the cancer, and now has more than 400 reports about patients who developed ALCL after having a breast implant, including nine who died.

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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. In addition, there have been two reports of injuries resulting from two of those crashes. No fatalities have been reported, NHTSA says. The probe may lead to a recall, but for now, it is considered an investigation.

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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 Coast growing regions of northern and central California does not appear to be related to the current outbreak,” Gottlieb said. “There is no recommendation for consumers or retailers to avoid using romaine harvested from these sources.”

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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 as the 510(k) clearance process.

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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 never pulled the trigger. My wife has always wanted a convertible. This year was our 20th anniversary, and with the oldest going to college next year we figured it was now or a long time from now,” Person wrote in an email to the Free Press.

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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 the same strain of E. coli in the outbreak. The illnesses started in October and have hospitalized at least 13 people, including one with a kind of kidney failure, the CDC said. No deaths have been reported, and no recalls have been issued.

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(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 FDA earlier this month, fell nearly 2 percent to $33.91 after the bell.

The news comes a day after the European Union authorities stepped in to effectively ban sales of valsartan made by an India-based Mylan unit after some batches were found to contain the same impurity, N-nitrosodiethylamine (NDEA).

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Quick quiz: which of the following 8 active Salmonella outbreaks listed on the Centers for Disease Control and Prevention (CDC) website do you think will most affect Thanksgiving?

• Salmonella Infantis linked to raw chicken products
• Salmonella Newport linked to ground beef
• Salmonella Enteritidis linked to Gravel Ridge Farms shell eggs
• Salmonella I 4,[5]],12:i:- linked to chicken
• Salmonella Reading linked to raw turkey products
• Salmonella Enteritidis linked to pet guinea pigs
• Salmonella Agbeni with investigations into Duncan Hines cake mix
• Salmonella Typhimurium linked to clinical and teaching microbiology laboratory exposure

If you answered number 6, the one linked to guinea pigs, you may have very interesting Thanksgiving traditions.

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(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 in check.

The drug is being recalled because the active ingredient has tested positive for N-Nitrosodiethylamine or NDEA, a suspected human and animal carcinogen that is used in gasoline as a stabilizer for industry materials and as a lubricant additive, according to the National Institutes of Health.

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