Current Events

Johnson & Johnson has begun settling consumers’ claims that it sold artificial hips knowing they were defective, marking the first settlements in the seven-year-old litigation.

A federal judge in Texas overseeing the cases said about 3,300 of 10,000 “have settled or are in the process of settling,’’ according to a Dec. 9 court filing. Terms of the accords weren’t made public.

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Infant ibuprofen destined to be sold at several national retailers might contain a higher concentration of ibuprofen, leading to potential risks in infants, according to a Wednesday voluntary recall notice.

New Jersey-based Tris Pharma, Inc. said lots sold under Walmart, CVS Pharmacy and Family Dollar brands are impacted by the recall. The products were labeled to contain 50 mg of Ibuprofen per 1.25 mL.

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The Food and Drug Administration has issued a recall for the blood pressure medication Valsartan because it has the possibility to cause cancer.

However, the FDA advises people to continue use of the medication until they can talk with their doctor, saying the risk of immediately stopping the pills is greater than the possibility of developing cancer.

The recall is for Teva Pharmaceuticals Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets. The pills were found to have the chemical N-nitroso-diethylamine (NDEA), classified as a carcinogen.

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Doctors say patients with high blood pressure should pay attention to and be ready to act on the trickle of drug recalls involving a commonly prescribed type of blood pressure medication – but warned against dropping a medicine without consulting a physician or pharmacist.

The Food and Drug Administration announced the recall of several versions of the valsartan in July over concerns that the drugs contained a possible cancer-causing impurity.

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More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The U.S. Food and Drug Administration’s decision to restore silicone implants to the market in 2006 followed an earlier decision to approve the less-commonly-used saline-filled implants. It came after a furious lobbying campaign by leading manufacturers Allergan and Mentor, which convinced regulators that frequent ruptures and leaks, and an array of other ailments reported by breast implant patients, were concerns of the past.

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(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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