Warning on label

Neotame is an artificial sweetener designed to overcome some of the problems with aspartame. The dimethylbutyl part of the molecule was added to block the action of peptidases, enzymes that break the peptide bond between the two amino acids aspartic acid and phenylalanine. This reduces the availability of phenylalanine, eliminating the need for a warning on labels directed at people who cannot properly metabolize phenylalanine. 

The prevention plan, and in particular symbols and warnings on labels and packaging of a substance, will depend on this risk level. In order to make sense, the risk classification has to take into account the inflammability level of a substance, to be on a coherent risk scale and not the mere result of more or less unpredictable fluctuations, particularly those due to the choice of apparatus or working method. The aim of estimation is to be able to identify substances on a scale where their position directly indicates their level of inflammability risk. 

FDA requires warnings on labels of potentially hazardous household chemicals. 

The Food and Drug Administration (FDA) mandates warnings on labels for foods, personal care, and cosmetic products. These are specifically exempt from regulation by other federal government agencies. 

Some of the elements of the NDA are of particular significance to the pharmacist. For example, in the statement on labeling it is necessary for manufacturers to abstract from their clinical summaries that which is both recommended for the description of the use of the drugs and that which is necessary for the warning or... 

Boxed warnings" on medicine labels are described in the Code of Federal Regulations as follows ... 

The Commission and the CSM also made recommendations on the introduction of many other broad safety measures. These included the Phen-acetin Prohibition Order (SI 1974/1082), presentation of medicines in relation to child safety (SI 1975/2000), and declaration of alcohol in medicinal products on their package as active ingredient where this is likely to be pharmacologically active. Other labelling issues culminated in an Order (SI 1976/1726) that set out the standard particulars that must be shown on the containers and packaging of medicinal products. Consultations on other generally applicable warnings on the labels of certain medicines to protect children and to ensure that... 

Saccharin is noncaloric and noncariogenic (2,3). The safety of saccharin for public health has been the center of several controversies. In 1970, saccharin at high dietary levels was observed to increase the incidence of urinary bladder cancer in experimental rats (1,59). However, extensive human epidemiological investigations showed that use of saccharin does not significantly increase the risk of bladder cancer (5,7,11,59). Saccharin is approved for use in several countries. Its use is not permitted in Canada, and a health warning on the label of saccharin-containing foods is required in the United States (7,8,10). 

In addition, the purveyors of thousands of patent medicines—containing drugs such as opium, morphine, heroin, and cocaine—sold them without restriction. The makers of these medicines, who regularly made false claims about their therapeutic value, did not even list ingredients or warnings on the labels. 

Risperdal was first marketed in 1994 as an atypical neuroleptic. The clinical trials, most of which lasted a few weeks, were too short to determine the rate of tardive dyskinesia and many other adverse effects. Indeed, the brief controlled clinical trials used for the approval of both clozapine and risperidone do not provide sufficient information to determine either efficacy or safety since the drugs would be used for months and years in individual patients, rather than for a few weeks (see chapter 13). Patients taking the medications over the coming years will provide the experimental data. However, since Risperdal is a potent dopamine blocker, it should have been anticipated that it would cause similar adverse reactions as the older neuroleptics. In my own experience, I have evaluated many cases of tardive dyskinesia caused by Risperdal, Zyprexa, and Geodon. Meanwhile, the Food and Drug Administration (FDA) has required the same tardive dyskinesia and neuroleptic malignant syndrome warnings on the labels of clozapine and risperidone as on the labels of the older neuroleptics. 

As already described, the FDA now requires a broad range of warnings on antidepressant labels. There should no longer be any scientific doubt about the range and frequency of abnormal reactions in children... 

One particular study in the American Journal of Psychiatry made an unusually low estimate for stimulant prescriptions to children and claimed, against all other estimates, that there had been no increase in rates over the past decade (Zuvekas et al., 2006). I puzzled over what had motivated publication of the study. Then, some time later, I came on an unashamed, boastful explanation by editor Robert Freedman (2006) about how the Zuvekas article was rushed to print to discourage the Food and Drug Administration from placing additional warnings on stimulant labels. The following is taken from an annual review by the editors of especially memorable events and achievements (Zuvekas et al., 2006) ... 

All of the DEA s observations run contrary to the Ritalin label as found in the Physicians Desk Reference (2007), which continues to identify this potent, highly addictive drug as a mild central nervous system (CNS) stimulant (p. 2269), misleading doctors and consumers alike. Although the DEA and all responsible pharmacologists view Ritalin as essentially similar to amphetamine, the dependence warnings on the Ritalin label remain extremely weak in comparison to those on the Dexedrine and Adderall (amphetamine) labels. 

Following is the new warning on the Halcion label as found, for example, in the 1995 Physicians Desk Reference ... 

Ultimately, some patients was also dropped. The warning on the current neuroleptic label states that TD may develop in patients treated with neuroleptics—not even a hint of a serious risk, let alone an astronomical one, with millions of victims. In the critical arena of TD rates, the class warning label is possibly weaker, although more detailed, than the old one. 

The letter goes on to describe details of which particular false claims were made and, for example, alleges that representatives belittled the warnings on the label. It continues ... 

Some formulations may cause severe reversible eye irritation and have a signal word, Warning, on the label (ProShear). See Table 5.28 for a listing of commercial prodncts. 

Most of the organotin salts are moderately toxic, and some are labeled Poison (triphenyltin chloride). They have a low oral LD50 and require the signal word Warning on the label. 

In a related action, Health Canada first issued a warning on aristolochic acid in November 1999 that this ingredient posed a Class I Health Hazard with a potential to cause serious health effects or death (2) and warned consumers not to use the pediatric product Tao Chih Pien. This Chinese product, sold in the form of tablets, is said to be a diuretic and a laxative. It is not labeled to contain aristolochic acid. However, the Chinese labeling says that it contains Mu Tong, a traditional term used to... 

For years efforts to pass legislation to require alcohol warning labels had been unsuccessful, despite the endorsement of approximately a hundred health and public interest groups. However, such legislation became law in 1989. A bill passed by Congress now requires this warning on all alcohol beverage containers ... 

Regulatory requirements the world over dictate that hazardous chemicals and chemical products carry warning labels on them that convey health hazard information about such chemicals and products. Well-communicated warnings are instrumental in saving lives and protecting the health of people who use or are incidentally exposed to hazardous chemicals. Chemical product warnings that fail to warn, on the other hand, are often responsible for serious injuries and even death. 

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