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PubMed1961

Drug dangers and reactions.

The protection of the consumer against dangerous, adulterated, and misbranded drugs provided by the Federal Food, Drug, and Cosmetic Act has failed in some instances. A general program of reporting adverse drug reactions has been initiated on a pilot basis. Arrangements are being made to extend this program into larger hospitals. Better and more complete reporting of adverse drug reactions together with tightening of the Food and Drug law regarding new drugs will improve this situation. Recently the president of the National Academy of Sciences appointed a committee at the request of the Secretary of Health, Education, and Welfare to review the policies and procedures used by the Food and Drug Administration in reaching decisions and to present recommendations. This committee has completed its work and has made specific recommendations that would give the Food and Drug Administration authority to require proof of efficacy as well as safety of all new drugs, and would provide it with sufficient resources to meet the responsibilities assigned to it.

Drug-Related Side Effects and Adverse Reactions↗
PubMed2004

Comparison of spot tests with AdultaCheck 6 and Intect 7 urine test strips for detecting the presence of adulterants in urine specimens.

BACKGROUND: Several adulterants are used to mask tests for abused drugs in urine. Adulterants such as "Klear" and "Whizzies" contain potassium nitrite while "Urine Luck" contains pyridinium chlorochromate (PCC). The presence of these adulterants cannot be detected by routine specimen integrity check (pH, specific gravity, creatinine and temperature). We previously reported the development of rapid spot tests to detect the presence of these adulterants. AdultaCheck 6 and Intect 7 urine test strips are commercially available for detecting the presence of these adulterants along with specific gravity, creatinine and pH in urine. METHODS: The performance of these two test strips for detecting adulterants was compared with the results obtained by spot tests. RESULTS: Both AdultaCheck 6 and Intect 7 effectively detected the presence of nitrite and pyridinium chlorochromate in urine. Moreover, both test strips successfully detected the presence of glutaraldehyde, for which no spot test is currently available. High amount of glucose and ascorbic acid did not cause any false positive result with AdultaCheck 6 or Intect 7. CONCLUSIONS: Both AdultaCheck 6 and Intect 7 can be used for checking the integrity of a urine specimen submitted for drugs of abuse testing.

Ascorbic Acid↗
PubMed1989

Interference of common household chemicals in immunoassay methods for drugs of abuse.

I report how some adulterants affect results for drugs of abuse in urine as measured by Roche RIA, Syva emit d.a.u., and Abbott TDx fpia (fluorescence polarization immunoassay) for the following drugs: amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, and phencyclidine (PCP). Sodium chloride interfered negatively with all of these drugs when assayed by emit and caused a slight decrease in measured benzodiazepine concentration by fpia. Drug concentrations were also decreased by added H2O2 (emit: benzodiazepine), Joy detergent (emit: cannabinoid, benzodiazepines, PCP), NaHCO3 (emit: opiate; fpia: PCP), or NaClO [corrected] (emit, RIA, fpia: amphetamines, opiates, PCP; emit, fpia: cannabinoid; emit: benzodiazepines). False-positive results were caused by H2O2 (fpia: benzodiazepines) and Joy (RIA, fpia: benzodiazepine, cannabinoid; fpia: barbiturate, amphetamine). Sodium bicarbonate causes a suspiciously high pH in the urine, NaClO [corrected] an apparently low pH (using pH paper).

Amphetamines↗
PubMed2005

Heroin-associated nephropathy.

Since the first reports in the late 1960s and early 1970s there have been numerous studies describing the clinical and pathological features of renal diseases associated with chronic parenteral abuse of heroin, cocaine, morphine, amphetamine, and other narcotic and hallucinogenic drugs, including several adulterants. The past 35 years have witnessed an explosive growth in illicit drug use in many parts of the world. Meanwhile, drug addict nephropathy constitutes an important cause of end-stage renal disease. The term heroin-associated nephropathy' includes different morphological findings following chronic drug abuse. Up to now it still remains ambiguous as to whether or not heroin/morphine itself, adulterants, other diseases like hepatitis B and C infection, or HIV, lead to a spectrum of morphologically described heroin-associated' findings in the kidneys. As a measure of prevention it appears that the purity of heroin plays an important role.

HIV Infections↗
PubMed2006

Traditional Chinese medicine in the treatment of diabetes.

This review focuses on the efficacy and safety of Chinese medicine in the treatment of type-2 diabetes. Included were 84 controlled clinical studies of type-2 diabetes treated with Chinese medicine for at least 1 month. Reported outcomes were: symptom relief; improvement in glycemia, insulin resistance and secondary failure, and adverse events. Symptom relief was achieved in most (>80%) of the patients receiving Chinese medicine. Compared with orthodox drugs, Chinese medicine had a 1.2-fold (95% CI 1.2-1.3) increase in symptom relief. The relative risk of achieving a fasting blood glucose of <7.3 mmol/l or a postprandial blood glucose of <8.2 mmol/l was: 3.0 (95% CI 1.4-6.5) for Chinese medicine plus diet versus diet; 2.0 (95% CI 1.4-3.0) for Chinese medicine versus placebo; 1.8 (95% CI 1.4-2.3) for combined Chinese medicine and orthodox drugs versus Yuquan Wan (a classic Chinese herbal formula for diabetes), 1.5 (95% CI 1.4-1.7) for combined Chinese medicine and orthodox drugs vs. orthodox drugs, and 1.3 (95% CI 1.2-1.5) for Chinese medicine versus orthodox drugs. A fasting blood glucose of <8.2 mmol/l plus symptom relief was observed in 71-100% of the patients with secondary failure to oral anti-diabetic drugs. Serious adverse events including hypoglycemic coma and death were caused by adulteration with orthodox drugs, erroneous substitution, self-meditation, overdoses, and improper preparation. Chinese herbal medicine should be used cautiously with doctors' prescription and follow-up. Long-term clinical studies may disclose the effectiveness of Chinese medicine in reducing the mortality and morbidity of diabetic complications.

Blood Glucose↗
PubMedDate not supplied

The effects of adulterating agents on FPIA analysis of urine for drugs of abuse.

A variety of chemical agents were evaluated to determine their effects on fluorescence polarization immunoassays for drugs of abuse. Sixteen different agents, at concentrations up to 10%, were tested against urine assays for cannabinoids, cocaine (metabolite), amphetamines, opiates, phencyclidine (PCP), and barbiturates. The potential to cause both false positive and false negative results was evaluated, and assays were performed one and seven days after sample adulteration to simulate different collection/testing formats. All six drug assays were susceptible to one or more adulterating agents, but the degree varied considerably between assays. The cannabinoid assay was most susceptible to adulterant-induced false negative results, and the barbiturate assay was most susceptible to false positive results. The remaining assays demonstrated relatively few, but characteristic effects, some of which were attributable to drug degradation and others to assay interference. Although the results of pH measurement on adulterated samples verified its utility in identifying some samples adulterated with interfering agents, other adulterants that cause substantial effects would not be identified by pH measurements alone.

Amphetamines↗
PubMed2002

Therapeutic ineffectiveness: heads or tails?

Reporting of therapeutic ineffectiveness through adverse drug reaction spontaneous reporting systems has been proposed by some authors. In the WHO Adverse Reactions Terminology (WHO-ART) and Medical Dictionary for Regulatory Activities (MedDRA) terminology, the term therapeutic ineffectiveness includes drug interactions, resistance, tolerance and tachyphylaxis, as well as pharmaceutical defects such as substandard, adulterated, and counterfeit drugs. Under certain circumstances, reporting therapeutic ineffectiveness may contribute to identifying pharmaceutical defects. However, the best approach to avoid their occurrence would be implementing good manufacturing practices and strengthening quality control activities. This would prevent the misuse of spontaneous reporting of adverse drug reactions (e.g. when reporting of therapeutic ineffectiveness is 'suggested' by interested parties, especially when a generic product has been substituted for a branded original product).

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Long-term voluntary consumption of MDMA and THC in rats is modified by individual and situational factors.

Factors influencing long-term voluntary intake of 3,4-methylenedioxymethamphetamine (MDMA; ecstasy) and Delta9-tetrahydrocannabinol (THC; cannabis) were studied in a rat model. Sixty-four male Wistar rats were given free choice for 49 weeks between (1) water and MDMA solution, (2) water and THC solution or (3) water, MDMA solution and THC solution. After the first experiences with the drugs, animals of both monodrug and polydrug group developed an individually stable pattern of MDMA consumption, whereas the individual predictability of THC consumption remained poor. While THC consumption was maintained for the whole experimental period, MDMA consumption decreased with time and was nearly ceased after 3-7 months. Intake of both drugs was adapted to social changes, with THC consumption being more sensitive to social changes than MDMA consumption. In the re-test after 4 months of abstinence, all animals ceased drug consumption when the drug solutions were adulterated with bitter tasting quinine. The results show that the rats had maintained a flexible mode of drug consumption and had not become addicted. Response to novelty of the rats in test trials before the start of drug supply correlated with later MDMA intake. In conclusion, although very low amounts of MDMA and/or THC were consumed, the findings that drug-experienced animals responded differentially to a stressor and that housing conditions influenced drug intake suggests that MDMA and THC can induce psychopharmacological effects in our long-term voluntary consumption paradigm.

Animals↗
PubMed2004

Analysis of street drugs in seized material without primary reference standards.

A novel approach was used to analyze street drugs in seized material without primary reference standards. Identification was performed by liquid chromatography/time-of-flight mass spectrometry (LC/TOFMS), essentially based on accurate mass determination using a target library of 735 exact monoisotopic masses. Quantification was carried out by liquid chromatography/chemiluminescence nitrogen detection (LC/CLND) with a single secondary standard (caffeine), utilizing the detector's equimolar response to nitrogen. Sample preparation comprised dilution, first with methanol and further with the LC mobile phase. Altogether 21 seized drug samples were analyzed blind by the present method, and results were compared to accredited reference methods utilizing identification by gas chromatography/mass spectrometry and quantification by gas chromatography or liquid chromatography. The 31 drug findings by LC/TOFMS comprised 19 different drugs-of-abuse, byproducts, and adulterants, including amphetamine and tryptamine designer drugs, with one unresolved pair of compounds having an identical mass. By the reference methods, 27 findings could be confirmed, and among the four unconfirmed findings, only 1 apparent false positive was found. In the quantitative analysis of 11 amphetamine, heroin, and cocaine findings, mean relative difference between the results of LC/CLND and the reference methods was 11% (range 4.2-21%), without any observable bias. Mean relative standard deviation for three parallel LC/CLND results was 6%. Results suggest that the present combination of LC/TOFMS and LC/CLND offers a simple solution for the analysis of scheduled and designer drugs in seized material, independent of the availability of primary reference standards.

Amphetamines↗
PubMed2005

Comparative study between capillary electrophoresis and high performance liquid chromatography in 'guarana' based phytopharmaceuticals.

The last years have seen a significant increase in the use of herbal medicines and their preparations all over the world. Adulterations with synthetic drugs are common problems with phytopharmaceutical products and this can potentially cause adverse effects. In consequence, it is important to determine the presence of synthetic drugs in herbal medicines to ensure their efficacy and safety. In this study, guarana derivatives were analyzed by capillary electrophoresis (CE), and the results were compared with those obtained by the HPLC technique. In order to obtain adequate fingerprints, and search for adulterants, caffeine was used as the marker compound. This separation method was applied to analyze the seed powder and commercial tablets of Paulinia cupana Mart. The methodology performance was evaluated in terms of specificity, sensitivity and precision. The results are in agreement with those obtained by the HPLC method. Furthermore, the analysis time of the CE method is up to two times shorter than the respective parameter in HPLC and solvent consumption is more than 100-fold less.

Chromatography, High Pressure Liquid↗
PubMed2005

Atypical reactions associated with heroin use--five states, January-April 2005.

Heroin use typically produces a well-recognized syndrome of euphoria, miosis, and respiratory and central nervous system depression; cardiovascular effects are not a common finding. In January 2005, a man aged 21 years in New Jersey was hospitalized with an atypical reaction (e.g., tachycardia and palpitations) after reported heroin use. During the next 3 months, 25 additional persons in five states were reported to poison control centers (PCCs) and local public health agencies with a similar reaction after reported heroin use; in all, 24 of 26 patients were hospitalized. Analysis of drug specimens or testing of urine was performed in certain cases; in eight patients, the veterinary pharmaceutical clenbuterol was detected. This report describes four representative cases and summarizes the investigation by state and local health and law enforcement authorities and CDC into the 26 cases of atypical reactions after heroin use reported in five states (Connecticut, New Jersey, New York, North Carolina, and South Carolina) during January 28-April 17, 2005. Unintentional or intentional adulteration of illicit drugs such as cocaine or heroin is an additional potential hazard associated with their use.

Adrenergic beta-Agonists↗