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Does Off-Label Promotion Settlement Signal Change in FDA Policy?

Science & Medicine
Reuters |
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Analyst Claims FDA May Have ‘Greatly Underestimated’ Essure Fetal Deaths

The U.S. Food and Drug Administration may have greatly underestimated the number of fetal deaths among women who became pregnant after using Bayer AG's Essure contraceptive device, according to a private analyst who combed through the agency's public database.


Madris Tomes, founder and chief executive officer of Device Events, said her analysis of thousands of adverse events from the agency's website shows 303 fetal deaths were linked to Essure


The agency is expected this month to decide whether to restrict use of the device, change the product's label or recommend additional clinical trials. The FDA also cited four adult deaths for reasons such as infection and uterine perforation.

Science & Medicine
Fierce Pharma |

Pfizer Pulls Over 10,000 Children’s Advil Bottles in Canada

Parents needing to treat their children during this cold season are facing another hurdle after Pfizer ($PFE) pulled 126 lots of children's and infants' Advil products from retailer shelves in Canada over dosing concerns.


Drugmakers hold back product that they periodically test to see how it is holding through its expiry dates. Pfizer Consumer Healthcare said that during that routine testing, it discovered "clumps" of the active ingredient ibuprofen may form in the bottle and that could lead to higher or lower doses that are given to infants and children if it is not shaken well before each use.

Science & Medicine
Fierce Pharma |

Drug Companies Defend Ad Despite Criticism That it ‘Fuels Opioid Addiction’

A Super Bowl commercial paid for by AstraZeneca and Daiichi Sankyo to stimulate awareness of opioid-induced constipation (OIC) continues to draw controversy, including from the White House, days after the big game. Since Sunday, a parade of politicians, physicians and pundits have criticized the ad, linking the campaign to the opioid prescription drug addiction problem in the U.S. and forcing AZ and Daiichi, which market the OIC relief drug Movantik, to defend it.

Science & Medicine
STAT |

Do Narration ‘Tricks’ Underplay Side Effect Warnings in Drug Ads?

Drug makers are legally required to spend money telling you their products might lead to a series of horrifying side effects, up to and including death.


Nearly two decades after television ads for prescription drugs began flooding American homes, drug makers have also perfected their delivery — allowing them to include the information they are obligated to provide while minimizing how scary it might sound.

Science & Medicine
Bloomberg |

Report: Drug Makers Keep Clinical Trial Results Secret

Pharmaceutical companies including Gilead Sciences Inc. and Sanofi kept secret more than a third of all clinical trial results for 15 drugs approved in 2012, according to a study, failing to publish data that could tip off doctors and patients to potentially dangerous side effects.

Science & Medicine
Reuters |
Paha_L-Istock-Thinkstock

26,000 Traffic Deaths in the First 9 Months of 2015

Traffic deaths in the United States rose about 9 percent in the first nine months of 2015 compared to same period a year earlier, according to the U.S. Transportation Department.


The department's National Highway Traffic Safety Administration did not offer an explanation for the increase in traffic deaths to an estimated 26,000 in the first nine months of 2015, the highest level since the same period in 2008.
The northwestern United States reported a 20 percent increase in road deaths, higher than any other region.

Science & Medicine
Courthouse News Service |

Report: 20% of Lawyers are Problem Drinkers

Lawyers are three times more likely to become problem drinkers than the rest of the population, a joint study by the American Bar Association and Hazelden Betty Ford Foundation found.


Published in the Journal of Addiction Medicine, the study says one in every five practicing attorneys qualifies as a problem drinker. While 28 percent of attorneys struggle with depression, 19 percent show signs of anxiety, the study found.