Publications serious adverse effects

Weekly dosing with mefloquine for chemoprophylaxis may cause nausea, vomiting, dizziness, sleep and behavioral disturbances, epigastric pain, diarrhea, abdominal pain, headache, rash, and dizziness. Neuropsychiatric toxicities have received a good deal of publicity, but despite frequent anecdotal reports of seizures and psychosis, a number of controlled studies have found the frequency of serious adverse effects from mefloquine to be no higher than that with other common antimalarial chemoprophylactic regimens. Leukocytosis, thrombocytopenia, and aminotransferase elevations have been reported. 

Naturally fluoridated foods and water have been ingested for decades with no serious side effects. In addition, public fluoridation has been widespread in this country for over 30 years without serious adverse effects. The incidence of mottled enamel, one of the earliest and most sensitive signs of fluoride toxicity, has not increased significantly in the past 15 years of water fluoridation. The safety and efficacy of fluoride has definitely been established, with no scientific evidence against fluoridation. 

In the USA, following public discussions on the safety of hepatitis B vaccine, health officials, testifying in 1999 before the Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources, said that use of the vaccine has been monitored for 15 years, that it has not been proven to be the cause of deaths, and is only rarely linked to serious adverse effects (31). 

The purpose of a facility hazard analysis is to identify and evaluate hazards and make recommendations for the elimination and control of hazards. The major safety concerns that facility managers should address are loss of life or serious injury to personnel, reportable (to the Enviromnental Protection Agency and/or state and local agencies) hazardous materials discharge to the environment, serious damage to facilities or equipment resulting in large dollar loss, and hazards that could have serious adverse effects on the plant or company mission capability, operability, or public opinion. 

The significance of the exposure levels shown in the tables and figures may differ depending on the user s perspective. For example, physicians concerned with the interpretation of clinical findings in exposed persons may be interested in levels of exposure associated with "serious" effects. Public health officials and project managers concerned with appropriate actions to take at hazardous waste sites may want information on levels of exposure associated with more subtle effects in humans or animals (LOAEL) or exposure levels below which no adverse effects (NOAEL) have been observed. Estimates... 

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. 

Currently, MRLs for the dermal route of exposure are not derived because ATSDR has not yet identified a method suitable for this route of exposure. MRLs are generally based on the most sensitive chemical-induced end point considered to be of relevance to humans. Serious health effects (such as irreparable damage to the liver or kidneys, or birth defects) are not used as a basis for establishing MRLs. Exposure to a level above the MRL does not mean that adverse health effects will occur. MRLs are intended only to serve as a screening tool to help public health professionals decide where to look more closely. They... 

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