Sunday Digest: 7/10/2011

So I've found lately that the FDA updates haven't had a lot of interesting material in them lately, but I do get interesting updates all week about all kinds of things, so I'm going to start including some of that in here. The end result (I hope) is that there will be more diversity, interesting and relevant material in the Sunday updates.

Sunday Digest: 7/03/2011

So I've found lately that the FDA updates haven't had a lot of interesting material in them lately, but I do get interesting updates all week about all kinds of things, so I'm going to start including some of that in here. The end result (I hope) is that there will be more diversity, interesting and relevant material in the Sunday updates.

FDA Update: 6/26/2011

There isn't a lotout of the FDA to note today, but there were a couple of things worth noting. First...

Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor

Ortho-McNeil-Janssen Pharmaceuticals is recalling a lot of Risperidal 3mg tablets and a lot of risperidone 2mg tablets due to potential contamination causing an uncharacteristic odor. The risperidone 2mg tablets are packaged under the manufacturer Patriot. The odor could be caused by 2,4,6 tribromoanisole (TBA). TBA is a fungus which causes a foul. Ortho-McNeil-Janssen is a subsidiary of Johnson & Johnson and has seen a number of recalls related to TBA (including of many of their over the counter products such as Tylenol and Motrin).

FDA Update 5/29/2011

The FDA has approved a couple new drugs this week. You can expect more information on them when and if I get more. 

FDA Approves Edurant (rilpivirine) in combination with other anti-retrovirals to treat HIV

Rilpivirine has been shown to effectively decrease viral load when combined with peginterferon alpha and ribavirin. It is contraindicated in pregnancy (of patient or patient's sexual parter), previous adverse reaction, history of anemia. Common side effects are anemia (regular CBCs should be performed), birth defects (two non-hormonal contraceptive forms should be used), itching, nausea, tiredness, anal problems, and taste changes. It may cause interactions with a number of HMG CoA Reductase Inhibitors (-statins), as well as a few other medications. More information is available in the medication guide.

A Couple of the Bigger Stories out of the FDA this Week

Here's a couple of the bigger stories out of the FDA this week.... and my personal commentary on one...

Class I Recall of Coumadin 5mg Tablets

Bristol-Meyers Squibb is recalling a single lot of brand name Coumadin (warfarin sodium) 5mg tablets because a tablet was found to be a higher potency than expected. Warfarin is a high alert drug, even small amounts can cause significant inhibition of clotting.