FDA investigating nonprescription cough and cold products

Respiratory symptoms, such as congestion and cough, commonly accompany respiratory tract conditions. Various medications, such as antitussives, expectorants, and mucolytics, play crucial roles in providing relief.
Antitussives include codeine, dextromethorphan (Robitussin), and benzonatate (Tessalon). Codeine and dextromethorphan exert their effects centrally by suppressing the cough reflex center in the medulla.  Benzonatate operates peripherally within the respiratory tract by anesthetizing...

Decongestants are a class of medications used primarily to alleviate nasal congestion, a common symptom resulting from allergies, colds, sinusitis, and other upper respiratory tract infections. These drugs work by activating α-adrenergic receptors, constricting small blood vessels in the nasal membranes. This action results in the opening of clogged nasal passages, thereby facilitating sinus drainage and relieving congestion.
Most decongestants are readily available over-the-counter in various...

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Upper respiratory tract disorders, including viral infections and allergic rhinitis, cause significant discomfort and disrupt daily life. Managing these conditions involves a variety of drugs, such as antihistamines, intranasal steroids, decongestants, antitussives, expectorants, and mucolytics. Specific examples of drugs in each category are provided.
Antihistamines (e.g., Benadryl) block histamines from binding. Histamines are chemicals released during an allergic reaction in the body. As a...

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...