The FDA has issued safety alerts concerning the antibiotic azithromycin, which is marketed under the brand names Zithromax and Zmax, and a dietary supplement, Night Bullet. The FDA warned that azithromycin can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. In addition, Green Planet, Inc. issued a voluntary recall of one lot of Night Bullet, which is marketed as a supplement to support male sexual performance, because it was found to contain trace amounts of an analogue of an FDA-approved drug.
Patients at particular risk for developing abnormal heart rhythms as a result of taking azithromycin include those with known risk factors, including 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. In a Drug Safety Communication, the FDA recommended that health care professionals consider the risk of torsades de pointes and fatal arrhythmia when considering treatment options with antibiotics, particularly for those patients with risk factors.
In May 2012, the FDA released a statement regarding a study that found a small increase in cardiovascular deaths, and in the risk of death from any cause, in people treated with a five-day course of azithromycin compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
The FDA also reported that azithromycin drug labels have been updated to strengthen the Warnings and Precautions section with information on the risk of developing abnormal heart rhythms.
Tests conducted by the FDA concluded that Night Bullet contained trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil, which are analogues of sildenafil. Sildenafil is an FDA-approved drug used for erectile dysfunction, which makes Night Bullet an unapproved drug. The undeclared ingredients pose a health hazard to consumers because sildenafil can interact with nitrates, usually taken by people with diabetes, high blood pressure, high cholesterol or heart disease.
Night Bullet is in capsule form and packaged in one-count blister packs. The recalled lot number is B43N032, with an expiration date of October 2015. Customers should stop using the product, contact their doctors if they have experienced any problems related to taking Night Bullet, and return the product to the place of purchase or to Green Planet.