ISSUE: FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. FDA has issued a Drug Safety Communication today as a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.
Pharma
Diabetes: Drugs only work if you take them – MayoClinic.com
It’s a common problem. According to an April 2011 Mayo Clinic Proceedings article, only about half of those who are prescribed medication take it exactly as prescribed.
via Diabetes: Drugs only work if you take them – MayoClinic.com.
Read in between the lines when reviewing medical records. Adjust your risk assessments accordingly. Decline if warranted.
France confirms Diane-35 drug deaths
French medical authorities made headlines recently over Mediator, a diabetes drug widely prescribed by doctors as an appetite suppressant, which is believed to have killed at least 500 people. The head of the French pharmaceutical firm Servier, maker of Mediator, is under formal investigation for manslaughter, and the head of France’s public health agency has resigned. The row has highlighted the links between drug regulators and lobbying drug companies in France, which has one of the world’s highest levels of consumption of prescription drugs.
via France confirms Diane-35 drug deaths | World news | The Guardian.
Hep C Drug Linked to Fatal Skin Reactions
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.
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.
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