January 15, 2014

Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing

On January 14, 2014, FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

We recommend that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. We also recommend that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.

In January 2011 we asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. We requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.

For more information please visit: Acetaminophen

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Source FDA

Benitec cleared for first-in-man hep C trial

By Dylan Bushell-Embling   |   Posted in Autoimmune on 15 January, 2014

Benitec Biopharma (ASX:BLT) has been granted approval to proceed with a first-in-man trial of its single-injection hepatitis C treatment candidate TT-034.

The US FDA has advised Benitec that it can conduct the trial, after reviewing the Investigational New Drug (IND) application the company filed in early December.

“We are very pleased with this outcome, which establishes Benitec as a clinical-stage company,” Benitec Biopharma CEO Peter French said.

TT-034 is a therapeutic designed to treat hepatitis C with a single injection. It is based on gene-silencing technology known as DNA-directed RNA interference (ddRNAi), originally developed at the CSIRO and then exclusively licensed to Benitec.

The treatment itself was developed by US-based Tacere Therapeutics, which took out a licence to the ddRNAi technology from Benitec in 2006.

Benitec acquired Tacere and TT-034 in 2012 through an all-stock deal worth around $1.5 million before licensing fees

The global market for hepatitis-based treatments is estimated at $6.5 billion, and is expected to more than double in value by 2015.

Benitec Biopharma (ASX:BLT) shares were trading 8.7% higher at $0.75 as of around 12.30 pm on Wednesday


Cost-effectiveness of Sofosbuvir-based triple therapy for untreated patients with genotype 1 chronic hepatitis C


Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

Viral Hepatitis

Salvatore Petta1, Giuseppe Cabibbo1,  Marco Enea2, Fabio Salvatore Macaluso1,  Antonella Plaia2, Raffaele Bruno3, Antonio Gasbarrini4, Antonio Craxì1, Calogero CammĂ 1, on behalf of the WEF study group

DOI: 10.1002/hep.27010

Copyright © 2014 American Association for the Study of Liver Diseases

Publication History
Accepted manuscript online: 13 JAN 2014 01:48PM EST
Manuscript Accepted: 4 DEC 2013
Manuscript Revised: 19 NOV 2013
Manuscript Received: 9 AUG 2013


Background and aims: We assess the cost-effectiveness of sofosbuvir (SOF)-based triple therapy(TT) compared with boceprevir(BOC)- and telaprevir(TVR)-based TT in untreated G1CHC patients discriminated according to IL28B genotype, severity of liver fibrosis and genotype1(G1) subtype.

Methods: The available published literature provided the data source. The target population was made up of untreated Caucasian patients, aged 50 years, with G1CHC and these were evaluated over a lifetime horizon by Markov model. The study was carried out from the perspective of the Italian National Health Service. Outcomes included discounted costs(in euro at 2013 value), life-years gained(LYG), quality adjusted life year(QALY), and incremental cost-effectiveness ratio(ICER). Cost of SOF was assumed to be € 3,500 for week, i.e. the price generating a willingness-to-pay threshold of €25,000 per LYG compared with TVR in the entire population of untreated G1 patients. The robustness of the results was evaluated by one-way deterministic and multivariable probabilistic sensitivity analyses.

Results: SOF was cost-effective compared with BOC in all strategies with the exception of cirrhotic and IL28B CC patients. In comparison with TVR-based strategies, SOF was cost-effective in IL28B CT/TT(ICER per LYG €22,229) and G1a(€19,359) patients, not cost-effective in IL28B CC(€45,330), fibrosis F0-F3(€26,444) and in cirrhotic(€34,906) patients, and dominated in G1b patients. The models were sensitive to SOF prices and to likelihood of sustained virological response.

Conclusions: In untreated G1 CHC patients, SOF-based TT may be a cost-effective alternative to first-generation Protease Inhibitors depending on pricing. The cost-effectiveness of SOF improved in IL28B CT/TT and G1a patients. SOF was dominated by TVR in G1b patients even if, in clinical practice, this issue could be counterbalanced by the good tolerability profile of SOF and by the shorter treatment duration. (Hepatology 2014;)