Posts tagged as:

FDA

Meet the New Commissioner of the FDA

by pharmacy on April 20, 2016

Food and Drug AdministrationIn February, the Senate overwhelmingly voted to confirm the new commissioner of the FDA, Robert Califf. Califf was nominated by President Obama in September of 2015 for the position. Over the past few months, the nomination was contested for a variety of reasons before finally satisfying the Senate review. [click to continue…]

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FDA Opioid Action Plan

by pharmacy on April 13, 2016

opioid regulation pharmacyOver the past several years, there has been a great deal of attention focused on the increasing number of individuals addicted to and abusing opioids. State legislatures, healthcare providers, and the federal government have all been looking at ways to reduce dependency. [click to continue…]

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FDA Warning: High Doses of Celexa May Be Dangerous

by pharmacy on September 21, 2011

The FDA has issued a warning about new dosage recommendations for the antidepressant Celexa (citalopram). Aftermarket testing found that dosages higher than 40mg per day can result in dangerous changes to heart rhythm. Celexa is a selective serotonin reuptake inhibitor (SSRI) that’s been marketed in the U.S. since 1988. [click to continue…]

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New Sunscreen Rules: No More Over-the-Top Claims

by pharmacy on September 14, 2011

After four years of development, the FDA has finally published the new rules about sunscreen labels, and that’s good news for consumers. [click to continue…]

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FDA Extends Trials for Cladribine

by pharmacy on December 21, 2010

Cladribine is a new oral medication, manufactured by Merck KGaA, designed to treat patients with multiple sclerosis. This medication has been under intense scrutiny in both the United States and in Europe. The European regulators recently advised against approving the medication but the FDA feels the drug deserves a closer examination. This is significant because it was once thought to be a huge breakthrough for patients with multiple sclerosis, along with a rival medication Novartis which won approval from the FDA in September of 2010. [click to continue…]

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Government Report Suggest Avandia be Removed from Market

by Toby Roberts on February 24, 2010

The New York Times reported recently that a government report has suggested a link between Avandia and an increased risk of heart attacks and heart failure. Avandia, used to treat type 2 diabetes, was linked to just over 300 deaths during the third quarter of 2009 alone.

GlaxoSmithKline, who makes Avandia, has stated that they have done extensive research on the drug and have reached the conclusion that it does not damage the heart or lead to any increase in heart attacks. Sales of the drug have decreased since 2007 when an independent panel suggested the possibility that it might contribute to heart damage. Despite those findings, the FDA decided to allow the drug to remain on the market.

The authors of the current government study have suggested that the drug be removed from the market. The FDA also cites several conflicting studies that make conclusions about any possible link between Avandia and heart trouble difficult to discern. The main concern of the government will remain whether or not GlaxoSmightKline has been up front with the possible dangers of the drug. No word has yet been issued about the future of the drug and its availability.

http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?pagewanted=1&th&emc=th

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