Non-prescription Drug Manufacturers

The pharmaceutical industry is represented by several organizations. Examples are the Pharmaceutical Research and Manufacturers of America, the Non-Prescription Drug Manufacturers Association, and the National Pharmaceutical Council, The schools and colleges of pharmacy are organized as the American Association of Colleges of Pharmacy, representing both schools and colleges, and faculty members. 

Non-Prescription Drug Manufacturers Association Label Readability Guidelines NMDA Washington, DC, 1991 20036. 

Table 1 indicates our survey of prescription and non-prescription drugs. We have investigated only a single manufacturer s product for each item. Contaminants in three presciption and two over-the-counter formulations were shown to give a positive TEA response. Subsequent chemical tests showed that for the prescription drugs, the impurities were probably N-nitroso compounds, although this has not been confirmed by mass spectrometry. Several other drugs which contained TEA positive materials were demonstrated not to contain N-nitroso compounds by a series of chemical tests used in conjunction with HPLC-TEA. 

Because of the problems that resulted from self-regulation, another law, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was approved in 2006. This law requires manufacturers, packers, or distributors of supplements to submit reports of serious adverse events to the FDA. Serious adverse events are defined as death, a life-threatening event, hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or an adverse event that requires medical or surgical intervention to prevent such outcomes based on reasonable medical judgment. If this requirement were enforced, and consumers cooperated, these reports would make it possible to identify trends in adverse effects and would help to alert the public to safety issues. 

Physicians Desk Reference Compendium of FDA approved pharmaceutical products details formulation, pack, administration and use identification guide Published by Medical Economics Co., N.J., USA, in participation with individual manufacturers also PDRs for ophthalmology and non-prescription drugs CD-ROM or hard copy... 

Recently, many health advocates have become concerned with a prescription drug called OxyContin. Manufactured by Purdue Pharma, OxyContin is the brand name for the drug oxycodone hydrochloride. Concern about this drug is a result of its increasing non-medical abuse. In 2003, for example, the National Survey on Drug Use and Health found that about 2.8 million people older than 12 years of age had used OxyContin at least once non-medically. The problem, perhaps, is that OxyContin is extremely good at doing its job—pain relief. OxyContin is a powerful prescription medication used by millions of people annually to treat severe pain. 

There appear to be no reports of an interaction between miconazole and sirolimus. However, a large proportion of miconazole oral gel (both prescription and non-prescription doses) may be swallowed and therefore adequate systemic absorption may occur to produce an interaction. The manufacturers of miconazole oral gel recommend close monitoring and possible dose reduction of sirolimus if both drugs are given. An interaction with intravaginal miconazole would not normally be expected because its systemic absorption is usually very low (less than 2%). 

Recent data suggest that COX-2 inhibitors, including rofe-coxib, valdecoxib, and celecoxib, may increase the risk for MI and stroke.47 There is also some evidence that the non-selective NSAIDs may increase the risk for cardiovascular events.47,48 Rofecoxib was withdrawn from the market in late 2004 because of safety concerns. The FDA requested the withdrawal of valdecoxib from the market in 2005. The FDA also asked the manufacturers of celecoxib and non-selective NSAIDs (prescription and over-the-counter) to include information about the potential adverse cardiovascular effects of these drugs in their product labeling. The cardiovascular risk with COX-2 inhibitors and NSAIDs may be greatest in patients with a history of, or with risk factors for, cardiovascular disease. The American Heart Association recommends that the use of COX-2 inhibitors be limited to low-dose, short-term therapy in patients for whom there is no appropriate alternative.48 Patients with cardiovascular disease should consult a clinician before using over-the-counter NSAIDs. 

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