Archive for October, 2012

Report finds state oversight of compounding pharmacies lax

The Massachusetts Department of Health said over the weekend that it had closed a second compounding pharmacy, Infusion Resource, after a state inspection found unsanitary conditions. Released by Massachusetts Rep. Edward J. Markey, the report stems from the national fungal meningitis outbreak linked to a steroid from the New England Compounding Center that has
sickened 354 people in 19 states and killed 25.

Read more about compounding pharmacy regulations…

International health agencies criticized for response to faulty hip implants

A joint investigation by the British Medical Journal (BMJ) and the Daily Telegraph revealed several international health agencies may be more interested in products than safety when it comes to faulty metal-on-metal hip implants. The investigation occurred as a response to the 2012 recall of the DePuy ASR hip replacement, which was found to fail at a rate much higher than expected.

Read more about the metal-on-metal hip implant investigation…

Watson Can Sell Generic Actos Now, U.S. Judge Rules

Watson Pharmaceuticals Inc. may begin immediately marketing a generic version of Takeda (4502) Pharmaceutical Inc.’s diabetes drug Actos, a federal judge ruled, handing the U.S. Food and Drug Administration a defeat. U.S. District Judge Amy Berman Jackson in Washington today overturned an FDA decision that kept Watson from joining a period of shared exclusivity granted to the companies that are first to file for the right to market generic versions of branded drugs.

Read more about the new generic version of Actos…

Study reveals statins may have fewer benefits than previously thought

A new study published in the PLOS Medicine medical journal indicates that statins such as Crestor may have fewer benefits than previously thought. Most notably, results of the study contradict previous findings that drugs like Crestor have a substantial effect on lowering the risks of veinous thrombosis.

Read more about the findings from the PLOS Medicine statin study…

Health officials warning state officials and doctors to check company’s other drug shipments

The Food and Drug Administration has warned state officials and doctors to check hundreds of thousands of other shipments of drugs from the company responsible for the recent fungal meningitis outbreak. The health agency compiled a list of more than 130,000 drug shipments from the New England Compounding Center (NECC), whose steroid injection drug was found to be contaminated and the cause of at least 23 deaths and over 300 additional cases of illness.

Read more about the NECC fungal meningitis outbreak…

Firm linked to meningitis outbreak will likely file bankruptcy

The New England Compounding Center (NECC) will likely file for bankruptcy protection after distributing a steroid that has caused a nationwide meningitis outbreak. Currently the pharmacy faces at least 10 lawsuits filed in state and federal courts, with predictions that hundreds more will be filed in the near future.

Read more about the nationwide meningitis outbreak…

FDA sends criminal investigators to compounding center responsible for meningitis

The Food and Drug Administration sent criminal investigators to the New England Compounding Center (NECC) in Massachusetts linked to the deadly fungal meningitis outbreak sweeping the nation. The investigation could possibly be an indication of pending federal action against the company, whose drug has killed 16 people and sickened more than 200.

Read more about the FDA investigation…

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