Potential side effects

As of the mid-1990s, use of MAOIs for the treatment of depression is severely restricted because of potential side effects, the most serious of which is hypertensive crisis, which results primarily from the presence of dietary tyramine. Tyramine, a naturally occurring amine present in cheese, beer, wine, and other foods, is an indirecdy acting sympathomimetic, that is, it potently causes the release of norepinephrine from sympathetic neurons. The norepinephrine that is released interacts with adrenoceptors and, by interacting with a-adrenoceptors, causes a marked increase in blood pressure the resultant hypertension may be so severe as to cause death. 

Although in many cases an enantiopure drug can be safer than the racemate, the advantages are clear. The final formulation of the drug product could be reduced inhalf, potential side effects could be minimized, and the resulting pharmokinetic and pharmacodynamic studies could clearly determine the efficacy of the active pharmaceutical ingredient (API) [21]. 

Before an antiviral agent becomes a drug, advanced toxicity testing, pharmacological combination, and drug-interaction studies are needed. The use of new cell-based assays that can predict mitochondrial toxicity, lactic acidosis, peripheral neuropathy, anemia, hypersensitivity, lipodystrophy, and other potential side effects can alleviate these issues (Stuyver et al. 2002). 

These so-called Pareto-based techniques do not force consolidation over multiple criteria in advance and aim to return a representation of the set of optimal compounds. They support discussion between team members who may have different views on the downstream impacts of different risk factors perhaps, for example, one team member may know that there is a reliable biomarker for one potential side-effect. This would then mean that assessing this risk need not consume much development time and cost, and the risk factor can have a reduced weighting within the target product profile being evolved by the team. 

Medication Half-Life (hour) Dose Range (mg/day)rf Potential Side Effect or Disadvantage... 

Evaluate potential side effects of therapy, including nausea, drowsiness, sleep attacks, and headaches for the DA agents. 

Which medications will facilitate adherence, minimize potential side effects, and offer an acceptable cost for AD s mother ... 

There are potential side effects of IUD use. The most common adverse effects are cramping, abnormal uterine bleeding, and expulsion of the device. Other side effects seen are ectopic pregnancy, sepsis, PID, embedment of the device, uterine or cervical perforation, and ovarian cysts.40,41... 

Available treatment options, including proper usage instructions and potential side effects. 

Potential side effects of drug therapy that may occur... 

Inadequate discussion about potential side effects, and duration of treatment Lacking in flexibility to change regimen in response to side effects Lack of contingency planning in case of non-compliance... 

Siems, W, Wiswedel, I, Salerno, C, Crifo, C, Augustin, W, Schild, L, Langhans, CD, and Sommerburg, O, 2005. Beta-carotene breakdown products may impair mitochondrial functions—Potential side effects of high-dose beta-carotene supplementation. J Nutr Biochem 16, 385-397. 

Figure 6.1 Anna Nicole Smith, a famous actress and model, reports that she used the dietary supplement TrimSpa to achieve her recent weight loss. Advertisements like these encourage consumers to believe they will achieve miraculous weight loss results, i.e., look like a runway model, if they use this product. These advertisements never even hint at the potential side effects associated with this diet pill.

Unlike with drugs, manufacturers of dietary supplements do not have to disclose potential side effects of their products to consumers. The label of the supplement may contain a cautionary statement, but the lack of such a statement does not mean that no adverse effects are associated with the product. Dietary supplements may also interfere with the activity of other medicines (drugs or other supplements) an individual is taking. Also unlike with drugs, the manufacturer is not required to disclose these interactions to the consumer. 

In February 2004, the FDA withdrew ephedra, one of the most popular dietary supplements, from the market because it finally had enough information to prove that ephedra presented an unreasonable risk of illness or injury under the conditions of use recommended on the product labeling. This withdrawal did not happen until many people suffered from the terrible potential side effects of this supplement (see Chapter 4). 

A corollary to the use of cBSA as a carrier protein is that its increased immune response often abrogates the use of complete Freund s adjuvant, which is a source of concern because of its potential side-effects in animals. A relatively innocuous mixture with alum is usually all that is required as adjuvant to result in good antibody production. 

The most common side effects noted included injection site reactions and flu-like symptoms with serious potential side effects including depression, as well as liver and blood abnormalities. Rebif is manufactured and marketed by Serono Inc. 

Minor side effects Serious potential side effects... 

Pivotal pre-approval safety and efficacy was assessed in a randomized, open label, multicentre study of infertile females undergoing in vitro fertilization and embryo transfer. The primary efficacy parameter was the mean number of oocytes retrieved, which (at 13.6) was similar to the number retrieved when urinary-derived hCG was used. Serious potential side effects can include ovarian over/hyper-stimulation, sometimes with pulmonary or vascular complications. The product is marketed by Serono Inc. 

The patient should be observed carefully for potential side effects of drug therapy. The specific side effects to be monitored and the method and frequency of monitoring should be documented. 

Pyrethroids are a class of synthetic chemicals that are similar in structure to natural pyrethrins. They have been used in field crops and urban pest management for nearly 30 years, and within the last 5 to 10 years new products have been registered for specific use against stored-product insects. Resmethrin is labeled for use as an aerosol in food plants, mills, and warehouse facilities, but could have potential side effects such as discoloration of surfaces and odor contamination and may be more appropriate for use in empty facilities. Labels generally state to cover any food prior to application. The pyrethroids esfenvalerate (Conquer) and prallethrin (Etoc) are also labeled for use in some situations as an aerosol space treatment in... 

Yet hands-on experience with 1 and other related compounds showed that free malonic acid groups on fullerenes are rather unstable even under physiological conditions and readily decarboxylate into side products, some of which may show toxicity under certain circumstances (Beuerle et al., 2007). To avoid these potential side effects new polar derivatives of 1 like 3, 4 and 5 have been synthesized (Beuerle et al., 2005 Witte et al., 2007). In these trisadducts the polar endgroups are attached via alkyl spacers to the fullerene core and thus no unwanted decarboxylation... 

No drug is completely safe or without potential side effects. Before a drug is approved for marketing, tests that show a drug is "safe" under the conditions on the proposed label. "Safety," therefore, is determined case-by-case and reflects the risk-benefit ratio. 

No serious side effects are reported by large clinical studies of ginkgo (Field and Vadnal 1998). Adverse effects resulting from improper dosage have also not been reported (Gruenwald et al. 1998). Mild gastrointestinal symptoms may occur or allergic skin reactions, albeit rarely. Other potential side effects are headaches, dizziness, and palpitations. However, some studies have reported adverse effects to be the same as that of... 

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