The oral hepatitis C drug telaprevir (Incivek) will now carry a boxed warning about potentially fatal skin reactions in the wake of multiple deaths, its manufacturer said Wednesday.
via Hep C Drug Linked to Fatal Skin Reactions.
Oops.
Pharma
FDA Warns Against Combining Alcohol, Other CNS Depressants With Xyrem – AAFP News
According to the Dec. 17 statement, the FDA recently evaluated reports of patients who died while taking Xyrem — which is used to reduce instances of cataplexy and to manage other symptoms of narcolepsy — along with alcohol or other central nervous system (CNS) depressants. Although the precise cause of the deaths remains uncertain — the reports contained incomplete information and did not adequately address confounding factors, such as pre-existing sleep apnea and/or chronic obstructive pulmonary disease — given some of the circumstances noted in the deaths, the FDA determined that the recommendations in the Xyrem drug label should be strengthened to highlight the risks of using the drug in conjunction with CNS depressant drugs or alcohol.
via FDA Warns Against Combining Alcohol, Other CNS Depressants With Xyrem — AAFP News Now — AAFP.
Oops.
CHOP to be Chopped?
Once the most common treatment for indolent non-Hodgkin’s Lymphoma, the combination chemotherapy known as CHOP is rapidly falling to the wayside in Germany – replaced by bendamustine (Treanda), frequently combined with rituximab (Rituxan), researchers reported here.
via New Combo Replaces CHOP for Lymphoma.
NOTE the commercial interests disclosures at the end of the original article.
FDA Warns Chantix May Up Heart Risk
A meta-analysis ordered by the agency and conducted by drugmaker Pfizer found a higher occurrence of major adverse cardiovascular events — including death, MI, and stroke — with the drug than with placebo.
The FDA noted, however, that such events were uncommon in both groups, and the increased risk wasn’t statistically significant.
via Chantix May Up Heart Risk, FDA Warns.
Quitting smoking is good. Maybe quitting smoking without a pharmaceutical assist is better. Additional link to the FDA release follows.
Off Label Drug Use – DrPullen.com
When the Patient Is ‘Noncompliant’ – NYTimes.com
Despite efforts to change the term to the slightly more accurate “nonadherent,” the word “noncompliant” remains firmly entrenched in the medical lexicon. No matter what it’s called, however, it’s an enormous problem. Experts estimate that some 50 percent of patients do not take their medicines as prescribed or follow doctors’ recommendations.
via When the Patient Is ‘Noncompliant’ – NYTimes.com.
Underwriting and mortality issue? I think so.
AHA: No Excess Bleeding Risk with Dabigatran (Pradaxa)
Although the FDA review discounted an excess bleeding risk with dabigatran, it did not address another potential concern — the ability to reverse the anticoagulant effect acutely in cases of emergency.
Antman acknowledged that there is no specific, approved antidote for dabigatran or any of the novel anticoagulants, although it is an area of active investigation and the topic of several studies that will be presented at the AHA meeting in the coming days.
He said it’s not true, however, that clinicians don’t have any options. Intravenous administration of blood coagulation factors — prothrombin complex concentrates that are available in every hospital — can help to reverse the effect, though not completely.
In comparison, the effects of warfarin can be reversed with the administration of vitamin K. Antman noted. But that that doesn’t always work either, and patients can die because of it, he added.
Linzess – Think IBS with Constipation
Linzess is felt to act as a guanylate cyclase-C agonist. An agonist increases the activity of a process, the opposite of an antagonist. Linzess seems to act locally on the surface of the inside of the intestinal lining cells and by activation of guanylate cyclase-C increases levels of intracellular cGMP (cyclic guanosine monophosphate) which results in increased levels of chloride and bicarbonate in the intestinal lumen and speeds up gastrointestinal transit.
Mirapex (pramipexole) Possible Risk of Heart Failure
ISSUE: FDA notified healthcare profesionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether Mirapex increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with Mirapex and will update the public when more information is available.
ADHD drug from Targacept Phase 2 Clinical Trial Failure
The drug known as TC-5619 failed to show enough evidence of effectiveness against inattentive-predominant ADHD. The Winston-Salem-based company said it will have to reduce its employee count to save money, but it did not announce how many jobs will be affected.
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