Which of the following complaints by a man taking gentamycin would be most indicative that he is experiencing ototoxicity?

A. Bacteriostatics are narrow spectrum drugs, and bactericidal drugs are broad spectrum:

This statement is incorrect. The spectrum of activity (narrow vs. broad) of an antibiotic refers to the range of bacterial species that it can target, not whether it is bacteriostatic or bactericidal.

B. Bacteriostatic drugs inhibit bacterial growth, and bactericidal drugs actually kill bacteria:

This statement is correct. Bacteriostatic drugs work by inhibiting the growth and reproduction of bacteria without directly killing them, whereas bactericidal drugs directly kill bacteria.

C. Bacteriostatics work by inhibiting protein synthesis, and bactericidal drugs work by inhibiting nucleic acid synthesis:

This statement is incorrect. Both bacteriostatic and bactericidal drugs can target various bacterial cellular processes, including protein synthesis, nucleic acid synthesis, cell wall synthesis, and others. The mechanism of action is not a definitive factor in distinguishing between bacteriostatic and bactericidal drugs.

D. Bacteriostatic drugs actually kill bacteria, and bactericidal drugs inhibit bacterial growth:

This statement is incorrect. It contradicts the established definitions of bacteriostatic and bactericidal drugs. Bacteriostatic drugs inhibit bacterial growth without killing the bacteria, while bactericidal drugs directly kill bacteria.

1. Do not have to demonstrate effectiveness:

This statement is generally true under DSHEA regulations. Unlike pharmaceutical drugs, dietary supplements are not required to undergo rigorous testing to demonstrate their effectiveness in treating, preventing, or curing specific health conditions before they are marketed. However, manufacturers are prohibited from making unsubstantiated claims about the effectiveness of their products.

B. Are determined to be safe before being placed on the market:

Under DSHEA regulations, dietary supplement manufacturers are responsible for ensuring the safety of their products before they are marketed. However, unlike pharmaceutical drugs, dietary supplements do not undergo premarket approval by the Food and Drug Administration (FDA) to verify their safety and efficacy. Instead, manufacturers are required to notify the FDA of their intent to market a new dietary ingredient (NDI) and provide evidence of the ingredient’s safety.

C. Are checked for label accuracy:

The FDA regulates dietary supplements to ensure that their labels are accurate and truthful. However, the extent of label accuracy checking varies, and the FDA does not routinely test every dietary supplement product on the market. Instead, the FDA relies on postmarket surveillance, consumer complaints, and other mechanisms to identify and address inaccuracies or violations of labeling regulations.

D. Are tested prior to marketing:

Unlike pharmaceutical drugs, dietary supplements are not required to undergo premarket testing to demonstrate their safety or efficacy before they are marketed. While manufacturers are responsible for ensuring the safety of their products, there is no formal premarket testing requirement under DSHEA regulations.