Current Events

The US Food and Drug Administration has ordered GlaxoSmithKline to review its manufacturing operations globally after finding that its Canadian subsidiary violated quality requirements during the manufacture of its flu vaccine FluLaval.

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(Reuters) - A GlaxoSmithKline Plc plant in Canada that makes the flu vaccine Flulaval has been cited by the U.S. Food and Drug Administration for failing to meet quality control standards. 

GSK said it is working to rectify the problems and does not expect a delay in distributing the vaccine for the 2014-2015 flu season. The company typically starts shipping the product at the end of July.

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General Motors Co. said Tuesday a Chinese auto supplier built the parts at issue in its recall of 3.4 million cars for ignition switch problems linked to eight crashes and six injuries.

The June 16 ignition recall of the Chevrolet Impala and Monte Carlo; Cadillac DTS and Deville; and Buick LaCrosse and Lucerne is similar to GM’s delayed recall of 2.6 million Cobalts, Ions and other cars linked to 13 deaths and 54 crashes due to faulty ignition switches.

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For years, Dr. Harry Lever, a cardiologist at the Cleveland Clinic, has been warning nearly anyone who would listen of his growing suspicions about generic versions of a widely used heart drug, Toprol XL.

Patient after patient, he said, would visit his office complaining of chest pains or other symptoms after switching from the brand-name version, made by AstraZeneca, to a generic product, often one made in India. When he switched them back to the brand — or to another generic — the symptoms disappeared, he said. Dr. Lever wrote a letter outlining his concerns to the Food and Drug Administration in 2012, and this year, he traveled to Washington to try to get the attention of Congress.

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U.S. auto-safety regulators are looking into complaints that exhaust fumes, which can contain potentially lethal carbon monoxide, may build up inside Ford Motor Co. (F) sport-utility vehicles.

The National Highway Traffic Safety Administration action on model year 2011-2014 Explorers follows reports filed by SUV owners and a lawsuit that contends Dearborn, Michigan-based Ford “knew or should have known” that hundreds of thousands of its vehicles are dangerous.

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A Louisiana federal judge said Friday that Takeda Pharmaceuticals Co. Ltd. intentionally destroyed evidence that would have helped the plaintiffs in a $9 billion bellwether lawsuit over claims the company hid the cancer risks of diabetes drug Actos to keep sales high.

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The US Food and Drug Administration has told manufacturers of prescription testosterone treatments for men that they need to add a warning on their drug label about an increased risk of blood clots in the veins.

Such clots can lead to complications such as deep vein thrombosis, which causes severe pain, or a life-threatening pulmonary embolism, which occurs when a clot breaks off and travels through the veins into the lungs.

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Mykia Jordan has no memory of the car accident that put her in a coma for three weeks, left a large scar across her jaw and caused the limp that forces her to walk with a cane at 23.

She only knows what the police and others told her — that in the middle of a Sunday afternoon, with her 3-month-old son strapped in a car seat, she lost control of her Chevrolet Cobalt on a freeway ramp in Detroit. It crashed into a cement barrier and overturned, crushing the roof around her. The air bags did not deploy.

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Government warnings a decade ago about the risks associated with children and adolescents taking antidepressants appear to have backfired, causing an increase in suicide attempts and discouraging many depressed young people from seeking treatment, according to a study published Wednesday in the academic journal BMJ.

Researchers said their findings underscore how even well-intentioned public health warnings can produce unintended conseque­n­c­­es, particularly when they involve widespread media attention and sensitive topics such as depression and suicide.

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Leann Darrow has been waiting on her General Motors dealership for more than a month to get the defective ignition switch on her 2005 Chevrolet Cobalt replaced. She has been nervous about driving the car, but as of last week, she was still waiting for an appointment to open.

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General Motors recalled some 3.16 million midsize and large car models in the USA on Monday for a defect similar to the deadly ignition switch flaw that led to a recall of 2.19 million Chevrolet Cobalts and other small cars in the USA this year.

This latest recall comes as CEO Mary Barra is to testify before a House subcommittee Wednesday about the initial switch defect.

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