Azithromycin (Zithromax or Zmax) – Risk of Potentially Fatal Heart Rhythms

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.

via Safety Alerts for Human Medical Products > Azithromycin (Zithromax or Zmax): Drug Safety Communication – Risk of Potentially Fatal Heart Rhythms.

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.

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.

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.

Safety Alerts for Human Medical Products > Chantix (Varenicline): Safety Communication – Updated Safety Review On The Risk of Cardiovascular Adverse Events.

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.