Posts Tagged ‘FDA’
Paul Sax • August 28th, 2012
We now have a third single-pill treatment available for HIV treatment, co-formulated tenofovir/emtricitabine/elvitegravir/cobicistat. From the FDA announcement: The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection. Stribild contains two previously approved [...]
Paul Sax • April 28th, 2011
After many — and I mean many — years of telling patients that new hepatitis C drugs were “coming soon,” that time has finally come. An FDA Advisory Panel yesterday favorably reviewed the HCV protease inhibitor boceprevir; today telaprevir got the same unanimous report. The FDA will certainly follow with approval for both drugs, and [...]
Paul Sax • December 22nd, 2010
Some items to consider in HIV/ID world as you dig into your salmonella-free holiday bird: Drug label change for stavudine (d4T): The label no longer has recommendations for dose-reduction in case of peripheral neuropathy, and cites data more strongly linking d4T use to lipoatrophy. The strategy of decreasing the dose to reduce d4T toxicity hasn’t [...]
Paul Sax • February 11th, 2010
It’s not on Abbott’s web site yet (update: now it’s here), but the FDA has approved a new formulation of ritonavir — a heat-stable 100 mg tablet. From an e-mail release by the FDA: On February 10, 2010, FDA approved Norvir (ritonavir) 100 mg Tablets. These tablets do not require refrigeration. Unlike the capsule formulation [...]
Paul Sax • February 4th, 2010
The FDA has issued a warning about an association between use of ddI (didanosine) and the development of non-cirrhotic portal hypertension: Non-cirrhotic portal hypertension (portal hypertension that is not caused by cirrhosis of the liver) is rare in the United States. It occurs when blood flow in the major vein in the liver (the portal [...]
Paul Sax • December 2nd, 2009
First the updated WHO Guidelines. Then the following: Updated DHHS Guidelines. Agree? Disagree? Sensible or crazy? Practical or ivory-tower academic? South Africa does the right thing. Yes, it’s about time, but good news nonetheless. 2012 International AIDS Meeting in Washington, D.C. First time in USA in a long, long time — 1990, to be exact [...]
Paul Sax • September 2nd, 2009
From the FDA Advisory: There have been postmarketing reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, as well as hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. Intelence therapy should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop. These [...]
Paul Sax • April 18th, 2009
As every house officer, hospitalist, intensivist, and ID doc knows, ceftriaxone and calcium have been contraindicated since 2007 due to fears of a potentially fatal precipitation of the two that led to the death of 5 neonates. Pediatricians are fond of saying “kids are not small adults” (I should know), and if that’s true, it’s [...]
Paul Sax • April 11th, 2009
The psoriasis drug Raptiva (efalizumab) has been linked to progressive multifocal leukoencephalopathy: On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients [...]
Paul Sax • January 17th, 2009
Today’s ID/HIV Link-o-Rama is being brought to you from the frozen tundra of Boston, MA: This past summer’s salmonella outbreak that sickened more than 1000 people was linked to raw jalapeno and serrano peppers. In the current one, the suspected culprit is contaminated peanut butter. Aside from the fact that raw hot peppers and peanut butter [...]