The Food & Drug Administration occasionally discovers an ingredient or bacteria in a drug or product that wasn’t labeled for, or supposed to contain, the ingredient or bacteria. For instance, microbial contamination was recently discovered in sterile medications manufactured by Specialty Compounds, reportedly causing 15 patients to develop severe bacterial infections. Like the presence of a bacteria, undeclared material present in a medication could be harmful to a user of the drug. Jack Rabbit Inc., a Melbourne, Fla.-based company, recently recalled one lot of its dietary supplement Jack Rabbit due to the presence of undeclared drug ingredients.
The FDA discovered that the Jack Rabbit supplements, which are marketed as dietary supplements for sexual enhancement, contain Sildenafil and Tadalafil. Sildenafil, found in Viagra, and Tadalafil, found in Cialis, are used for erectile dysfunction and symptoms of benign prostatic hyperplasia. The presence of these ingredients makes Jack Rabbit an unapproved drug.
According to the FDA, the ingredients found in Jack Rabbit supplements “may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.” Nitrates are often consumed by patients with diabetes, high blood pressure, high cholesterol and heart disease. Additional side effects caused by the undeclared ingredients include headaches and flushing.
The recalled supplements were distributed through various websites and retail stores. They were packaged in blister packs of four pills. According to Jack Rabbit’s website, the product can allegedly help with erectile dysfunction, loss of sex drive, stamina and sexual performance. The website also claims that the supplements can be taken if the user has had too much to drink, but it states that the supplements can cause a drop in blood pressure.
The FDA recommends that consumers who own the product should immediately stop using it, and contact their physicians if any adverse reactions have occurred due to the use of the product. Consumers can return the product to the original location of purchase or contact Jack Rabbit Inc.