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States, Counties and Cities are Suing Big Pharma Over America’s Opioid Crisis

In this month’s edition of the PKSD Newsletter, You Should Know, we cover the opioid epidemic and the lawsuits being filed by state, county and city governments to try to hold drug companies accountable. This month’s newsletter also explains what you can do to fight the opioid epidemic and avoid…

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FDA Lists Several Recalls

The following products have been recalled by the FDA for various reasons. For more information, please go to www.fda.gov. Rushing Waters Fisheries, Palmyra, is recalling about 225 pounds of smoked trout and smoked salmon spreads, because the products may be contaminated with Listeria monocytogenes. (FDA) Frontier Natural Products Co-op nutmeg…

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Government Watchdog Reports Gaps in FDA Drug Safety Oversight

A new report released by the Government Accountability Office (GAO) reveals disturbing gaps in the the Food and Drug Administrations (FDA) tracking of drug safety issues, putting patients across the nation at risk. The January 2016 report details numerous flaws in the system used by the FDA to track safety…

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First Jury Verdict in Risperdal Case Awards Plaintiff $2.5 Million

Pharmaceutical giant Johnson & Johnson has been ordered to pay a 20-year-old Alabama man $2.5 million for injuries related to Risperdal, the popular antipsychotic drug linked to the development of breasts in young male patients. This trial marks the first verdict in thousands of lawsuits filed against Johnson & Johnson and…

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Actos Manufacturer Takeda Ordered to Pay $155k for Destruction of Evidence

On Nov. 17, a West Virginia jury decided that Takeda Pharmaceutical Co. would pay $155,000 for destroying information on its diabetes drug, Actos, after jurors concluded that this action prevented plaintiff Richard Myers from proving his claim that the medication caused his cancer. The panel reached a decision after only…

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Generic Drug Maker Pays $500 Million in Fines

Ranbaxy, a generic drug maker, pleaded guilty to federal drug safety violations on Monday and agreed to pay $500 million in fines to resolve claims that it sold subpar drugs and made false statements to the Food and Drug Administration regarding its manufacturing processes. Ranbaxy acknowledged that it failed to…

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FDA Pulls Approval on Breast Cancer Drug Avastin

The FDA’s withdrawing it approval of Avastin (bevacizumab) to treat breast cancer received major media coverage, including front-page articles in major papers and a lead story on a network newscast. ABC World News (11/18, story 5, 0:35, Muir) reported, “The FDA revoked its approval” of Avastin “as a treatment for…

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Wisconsin Receives Settlement in Off-label Marketing Lawsuit

The State of Wisconsin, through the Attorney Generals Office, announced settlements with two pharmaceutical companies over off-label marketing and kickback violations. Off-label marketing involves marketing drugs for uses not approved by the Food and Drug Administration. The FDA prohibits drug manufacturers from marketing or promoting a drug for a use…

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FDA Says Heartburn Medications May Lead to Fracture Risk

The Food and Drug Administration warned yesterday that some heartburn medications could increase the risk of hip, wrist and spine fractures in high doses or with long-term use. The FDA’s decision came after it’s review of several studies that reported an increased risk of hip, wrist and spine fractures after…

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Evidence Links Fosamax to Femur Fractures

An ABC investigation found growing evidence between long-term use of osteoporosis drugs such as Fosamax and spontaneous fractures of the thigh bone (the femur). The investigation gave several examples of women who suffered femur fractures after prolonged use of bisphosphonates such as Fosamax. Doctors are concerned that the prolonged use…

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