-

Posts Tagged ‘FDA’

RSS

June 19th, 2013

FDA, IND, FMT: Nine Letters, Some Common Sense, and a Real Video Link

Good news here — the FDA has reconsidered their requirement for an IND for fecal microbiota transplantation (FMT) for C diff: Some health care providers have stated that applying IND requirements will make FMT unavailable and have suggested that an alternative regulatory approach is needed to ensure the widespread availability of FMT for individuals with [...]


August 28th, 2012

“Quad” Approved by FDA

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 [...]


April 28th, 2011

Hepatitis C Week is Upon Us

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 [...]


December 22nd, 2010

Holiday Hafnias

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 [...]


February 11th, 2010

Ritonavir Tablet Approved

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 [...]


February 4th, 2010

Non-Cirrhotic Portal Hypertension: A Rare but Serious Side Effect of ddI

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 [...]


December 2nd, 2009

So Much in Less than a Week!

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 [...]


September 2nd, 2009

Etravirine Warning

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 [...]


April 18th, 2009

Ceftriaxone and Calcium — OK Again in Adults!

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 [...]


April 11th, 2009

Another Drug Linked to PML — Law Firms Waiting for Your Call

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 [...]


HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Editor-in-Chief

NEJM Journal Watch HIV/Aids Clinical Care

Biography | Disclosures | Summaries

Learn more about HIV and ID Observations.