Sex, drugs and alcohol: drug interactions of concern to consumers

No Alcoholic Beverages (Photo credit: dualdflipflop)

Source: Australian Prescriber. April 2013.

Graeme M Vernon

Drug information pharmacist

Austin Health

Heidelberg

Victoria
Sex, drugs and alcohol Aust Prescr 2013;36:48
Summary PDF

People often have misconceptions about interactions between alcohol and commonly prescribed drugs. Often there is insufficient evidence to support prohibiting alcohol, but the overall risk needs
to be assessed for each individual.
Any drug which suppresses the central nervous system will exacerbate the immediate effects of alcohol and can be expected to increase the risk of alcohol-related harm. Alcohol should not be taken
with drugs that can cause a disulfiram-like effect.
Combined hormonal contraceptives are less reliable if taken with drugs which can increase the rate of metabolism of oestrogens and progestogens. The interacting drugs include some antiepileptic
drugs and the rifamycins, so action is required to maintain contraception.

Key words: antibiotics, contraception, drug abuse
Aust Prescr 2013;36:46-8
Introduction
Patients often express concerns about interactions between their medicines and alcohol and any illicit drugs that they may consume. Doctors and pharmacists are also often asked about interactions,
especially short courses of antibiotics, which might reduce the efficacy of oral contraceptives.
There are many misconceptions about which interactions are of clinical concern. While there is information about oral contraceptives and alcohol, it is not possible to predict the safety of
consuming any illicit drug. The outcomes of illicit drugs interacting with prescribed medicines cannot be quantified.
Alcohol
Current Australian guidelines do not define ‘social drinking’ but make recommendations that for healthy people daily alcohol consumption should be limited to two standard drinks* and a maximum of four on a single occasion.1 However, people asking about alcohol and medicines will generally have some level of ill
health. Questions of safety will therefore often need to be in the context of consuming a smaller volume of alcohol. A safer approach would be to think in terms of up to two standard drinks on one
occasion – typically, ‘Can I have a glass of wine (or beer) when I go out to dinner?’. This can often be addressed in terms of an individual’s risk of additive sedation and the circumstances of the
occasion, including the support available if the reaction to alcohol was more than expected.
The duration of additive sedation due to an alcohol– drug interaction will depend on the clearance rates of the two components. Blood alcohol concentrations will decline at a predictable rate, but
the rate of inactivation of the interacting drug must be considered, for example with long- and short-acting benzodiazepines.
Alcohol (ethanol) is principally metabolised to acetaldehyde by alcohol dehydrogenase in the liver. Other enzymes, including cytochrome P450 (CYP) 2E1, contribute to this conversion and become
more significant with higher concentrations of alcohol.2 Acetaldehyde causes unpleasant symptoms such as headache, flushing and vomiting. These
effects are more pronounced if the metabolism of acetaldehyde is inhibited by drugs such as disulfiram (which block aldehyde dehydrogenase). Regular alcohol consumption can induce elevated levels of
CYP 2E1, but fortunately this does not result in any clinically significant interactions with other drugs used at therapeutic doses. Consumers can also be assured that metabolic interactions do not
lead to elevated (or prolonged) blood alcohol concentrations.
The management of many chronic diseases will be assisted if patients limit their alcohol consumption, regardless of any additional risks from drug interactions. Regularly drinking alcohol may
increase the risks in people with chronic diseases, especially if they take drugs which, for example, increase the risk of liver disease, gastric bleeding or falls. A modest level of alcohol
consumption is safe in patients who take paracetamol. This is also the case with non-steroidal anti-inflammatory drugs, such as ibuprofen, however the overall long-term risk of gastric bleeding needs
to be considered. Regular or occasional consumption of small amounts of alcohol should not affect warfarin control in the absence of liver disease.
Antiepileptic drugs can increase sedation. Intoxication with alcohol can cause seizures, as can alcohol withdrawal syndrome.
The adverse effects of alcohol on illegal ‘recreational’ drugs only add to the hazards. Any attempt to advise a patient about the outcomes of an interaction between a medicine and an illicit drug
will be undermined by a lack of certainty about the actual content of the illicit substance consumed. The possibility of toxic ‘contaminants’ in an illicit product may be of more concern than a
possible pharmacological interaction.
Antimicrobials
Most antibiotics prescribed in general practice do not require abstinence from alcohol. Penicillins, cephalosporins, macrolides and tetracyclines do not present a hazard with alcohol, but the
condition being treated may warrant avoiding alcohol.
There are sufficient reports of disulfiram-like reactions with metronidazole to warrant abstinence during therapy. However, the actual danger of the alcohol contained in one or two standard drinks
is low. There is no direct evidence with tinidazole but, as with metronidazole, treatment courses are usually short and any risk of an interaction is easily avoided.
Griseofulvin is normally dispensed with an ancillary warning label for alcohol. This is based on a report of an adult who had a severe reaction after consuming a can of beer and one hour later
taking his regular dose of griseofulvin.3 Given the limited evidence and the extended periods of treatment required with griseofulvin, it would be
reasonable if patients wanted to test their tolerance to small amounts of alcohol rather than abstain.
Psychotropic drugs
Additional sedation can be anticipated when alcohol is consumed by patients taking benzodiazepines, antipsychotics, sedating antidepressants (especially tricyclics) and many antiepileptic drugs.
This potential may not preclude modest levels of alcohol consumption, however some patients who need these drugs may have a history of alcohol abuse. There is also a profound risk if patients
overdose with sedative drugs and alcohol. Beverages with a high tyramine content, including some beers and red wine, present an additional hazard with non-selective monoamine oxidase inhibitors
(phenelzine, tranylcypromine).
Hormonal contraceptives
Drugs which increase the metabolism of oestrogens and progestogens can reduce the efficacy of oral contraceptives. This occurs when the activity of metabolising enzymes (principally CYP 3A4) in
the liver and intestinal mucosa is increased by ‘inducing’ drugs. These include the complementary medicine St John’s wort which can potentially lead to a failure of oral contraception.4 Although not an enzyme inducer, griseofulvin can potentially reduce the efficacy of hormonal contraceptives. Examples of drugs which can reduce the
effectiveness of oral contraceptives are listed in the Box.
Women taking enzyme-inducing drugs may need to consider other methods of contraception, such as a levonorgestrel intrauterine device, depot medroxyprogesterone or a copper intrauterine device.
Depot medroxyprogesterone remains effective when used with enzyme-inducing drugs whereas etonogestrel implants are unreliable (based on reported failures over a shorter period of use).6 The efficacy of the levonorgestrel intrauterine device is due mainly to local release of progestogen and any increased metabolism in the liver would not be
expected to reduce its effectiveness. Vaginal rings (containing ethinyloestradiol and etonogestrel) depend on systemic release of oestrogen and progestogen and cannot be considered a safe option in
the presence of enzyme-inducing drugs.
After ceasing an enzyme-inducing drug it may take four weeks for enzyme activity to return to baseline and reliable methods of contraception should be used during this period.7
Contraceptive hormones can also affect the metabolism of other drugs. This can be clinically significant with antiepileptic drugs such as lamotrigine.






BoxDrugs which can reduce the effectiveness of oral contraceptives5



carbamazepine
griseofulvin
modafinil


oxcarbazepine
phenobarbitone
phenytoin


rifampicin
rifabutin
St John’s wort






Antimicrobials
Guidelines published in the UK and USA no longer recommend additional contraceptive precautions when non-enzyme inducing antibiotics are taken with oral contraceptives, regardless of the duration
of therapy. 7,8 This applies to commonly prescribed drugs such penicillins, cephalosporins, macrolides, tetracyclines,
trimethoprim and azole antifungals. These recommendations reflect the limited evidence of contraceptive failure associated with antibiotics which do not induce liver enzymes. The theory that oral
antibiotics could interrupt enterohepatic reabsorption of oestrogens has not been substantiated.
Additional contraceptive precautions may be warranted if the antibiotic or infection causes vomiting or diarrhoea. This is particularly important with progestogen-only oral contraceptives.
Enzyme-inducing antimicrobials include rifampicin, rifabutin, efavirenz, nevirapine, ritonavir and tipranavir. Women must use a reliable form of contraception with these drugs. There are no data
on the effects of short courses of rifampicin on hormonal contraceptives. Additional methods of contraception should be used if rifampicin is taken for prophylaxis of meningitis due to Neisseria
meningitidis or Haemophilus influenzae. Four weeks of additional cover will be required even after two days of exposure to rifampicin. Also, an active pill should be taken each day during
the course and for seven days after the last rifampicin dose.5
Enzyme-inhibiting antibiotics, such as erythromycin and fluconazole, can increase oestrogen and progestogen concentrations, but have limited potential to cause adverse effects. The duration of
antibiotic therapy will rarely warrant reducing the dose of oral contraceptive.
Antiepileptic and psychotropic drugs
Enzyme-inducing drugs such as phenytoin, carbamazepine, oxcarbazepine and phenobarbitone can cause failure of oral contraceptives. Topiramate is a weaker inducer and a change in contraception may
only be required with doses of more than 200 mg daily.7 Lamotrigine can cause slight reductions in progestogen concentrations, but this should not
lead to a reduction in the efficacy of combined oral contraceptives.7 However, ethinyloestradiol can increase the clearance of lamotrigine and reduce
control of seizures. Combined oral contraceptives may therefore be unsuitable for women taking lamotrigine for epilepsy.
Conclusion
The potential significance of interactions depends on both the drugs involved and an individual’s susceptibility to suffering an adverse outcome. Clinicians often appeal for drug interaction
alerts to define a severity rating. However, the severity of the outcome will usually depend as much on a patient’s medical risk as on the drugs in question. The best approach is to identify a
potential problem and then assess its significance for the patient. Practical advice on clinically significant interactions can be found in the Australian Medicines Handbook,5 and guidelines for managing interactions with contraceptives are provided in Contraception: an Australian clinical practice handbook9 . If in doubt seek advice from a pharmacist or a medicines information centre.
 * An Australian standard drink contains 10 g of ethanol, for example 375 mL of medium-strength (3.5%) beer or 100 mL of 12.5% wine
Conflict of interest: none declared
References

  National Health and Medical Research Council. Australian guidelines to reduce health risks
from drinking alcohol. Canberra: NHMRC; 2009.
  Jang GR, Harris RZ. Drug interactions involving ethanol and alcoholic beverages. Expert Opin Drug
Metab 2007;3:719-31.
  Fett DL, Vukov LF. An unusual case of severe griseofulvin-alcohol interaction. Ann Emerg Med
1994;24:95-7.
  Murphy PA, Kern SE, Stanczyk FZ, Westhoff CL. Interaction of St. John’s Wort with oral
contraceptives: effects on the pharmacokinetics of norethindrone and ethinyl estradiol, ovarian activity and breakthrough bleeding. Contraception 2005;71:402-8.
  Rossi S, editor. Australian Medicines Handbook 2013. Adelaide: Australian Medicines Handbook Pty Ltd; 2013.
  Implanon: interactions and failure of contraception.

Aust Adv Drug React Bull 2007;26:14-5.
  Faculty of Sexual and Reproductive Healthcare. Clinical Guidance: drug
interactions with hormonal contraception. London, UK: Royal College of Obstetricians and Gynaecologists; 2011 (updated 2012 Jan).
  Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for contraceptive
use, 2010. MMWR Morb Mortal Wkly Rep 2010;59:1-86.
  Sexual Health and Family Planning Australia.
Contraception: an Australian clinical practice handbook. 3rd ed. Family Planning New South Wales, Family Planning Queensland, Family Planning Victoria; 2012.

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Why Drug Safety Should Not Take a Back Seat to Efficacy

English: A Collection of Articles on Disease Mongering in PLoS Medicine Español: Portada del monográfico publicado en Public Library of Science - Medicine sobre promoción de enfermedades (Photo credit: Wikipedia)

Citation: The PLoS Medicine Editors (2011) Why Drug Safety Should Not Take a Back Seat to Efficacy. PLoS Med 8(9): e1001097. doi:10.1371/journal.pmed.1001097

Published: September 27, 2011

Copyright: © 2011 PLoS Medicine Editors. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: The authors are each paid a salary by the Public Library of Science, and they wrote this editorial during their salaried time.

Competing interests: The authors' individual competing interests are athttp://www.plosmedicine.org/static/edito​rsInterests.action. PLoS is funded partly through manuscript publication charges, but the PLoS Medicine Editors are paid a fixed salary (their salary is not linked to the number of papers published in the journal).

* E-mail: medicine_editors@plos.org

The PLoS Medicine Editors are Virginia Barbour, Jocalyn Clark, Susan Jones, Melissa Norton, Paul Simpson, and Emma Veitch.

Provenance: Written by editorial staff; not externally peer reviewed.

Historically, the evaluation of harmful effects resulting from prescription drug use has been considered less important than demonstrating drug efficacy, yet the harms caused by specific adverse drug reactions are a major, and avoidable, contributor to hospitalizations and deaths [1]. There are many reasons (both scientific and social) why reliable data on harmful effects may only emerge well after drug approval and marketing [2]. Some evidence suggests that drugs approved under a rapid regulatory review process may be more likely to show problems with safety post-marketing than drugs that go through a slower evaluation process [3]. And debates continue about the best ways to meaningfully synthesize and interpret data on the possible harmful effects of drugs—for example, how passive surveillance systems (spontaneous reports of suspected adverse reactions) should be improved, whether new drugs should go through a phased launch process with enhanced safety evaluations, and whether risk mitigation strategies are appropriate for drugs with safety concerns.

One such debate—whether systematic reviews estimating the risk of harmful effects should use evidence from randomized trials or observational studies—seems finally to have been laid to rest. In a systematic overview published earlier this year in PLoS Medicine [4], Su Golder, Yoon Loke, and Martin Bland demonstrate that, for 19 specific drug–harm relationships, the evidence on magnitude of risk for each particular harm discovered through systematic reviews of randomized trials was, on average, no different from the evidence assembled via systematic reviews of observational studies. This is an important finding, although perhaps counterintuitive: it is easy to imagine that observational studies would be so plagued by confounding that the estimates of risk of harm they generate could be biased away from true effects. The implications of this study for future evaluations of drug safety are clear: systematic reviewers should consider all types of evidence in trying to build a complete picture of harms associated with drug treatments.

In another study published this week in PLoS Medicine [5], Patricia McGettigan and David Henry report their re-evaluation of one specific and much-studied harmful effect—that of cardiovascular risk associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs). Many previous systematic reviews have been conducted, largely using evidence from randomized trials, but these trials have generally captured only small numbers of cardiovascular events and have focused mainly on a small range of specific NSAIDs. By revisiting observational data in their systematic review, Henry and colleagues were able to form a fuller profile of the cardiovascular risks associated with use of a much wider group of NSAIDs, across dose ranges and in population settings, than had previously been the case. Broadly, their findings correlate closely with those of systematic reviews of trial data, but also show that there seems to be no “safe” lower dose for cardiovascular risk associated with certain NSAIDs, such as rofecoxib and diclofenac.

These studies together highlight the importance of data from high-quality observational studies in enabling estimation of the risk of harms associated with specific drug treatments. Passive surveillance is still crucial for providing early warning signals and generating new hypotheses about possible harms associated with specific approved drugs. However, new hypotheses emerging from such surveillance must subsequently be explicitly tested, preferably using study designs that can incorporate data on the size of the exposed population (such as cohort or record linkage studies). Such studies can therefore estimate the relative increase in risk associated with exposure, which is difficult or impossible to calculate from passive surveillance data.

A new initiative established by the European Medicines Agency (ENCEPP, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [6],[7]) seeks to promote the conduct of such studies and establish standards for post-marketing safety evaluations. Given the diversity of designs and multiple possible sources of bias in pharmacoepidemiology, this will not be an easy job. But the initiative is already showing signs of setting high standards in some areas. Studies conducted solely by industry will not be eligible to qualify for ENCEPP approval; studies must be publicly registered before collection of data, and protocols and datasets must be released (with some restrictions relating to data privacy) in a timely way after completion. Some vague wording in the ENCEPP code of conduct remains, however: “datasets” can be interpreted to mean analyzed, not raw, data, meaning that other investigators may not be able to exploit the full potential of the data in conducting reanalyses. Critically, ENCEPP can still potentially approve studies funded by the pharmaceutical industry, with involvement of industry partners in design and analysis, providing the study's lead investigator is based within an ENCEPP-approved center. More worryingly, the code allows for industry sponsors to retain control of datasets; this, and other provisions, may enable conflicts of interest to creep in during study design or data analysis.

Clearly, for post-approval safety studies, one size will not fit all. Conduct and reporting are unlikely to be standardizable in the same way as has been possible for randomized trials, in which there is agreement on what information needs to be registered about the study and when [8], and specific standards for the reporting of studies, such as CONSORT [9], are widely accepted. The ENCEPP guidance avoids normative statements about study design, instead preferring to highlight the methodological challenges and multiple sources of bias that plague analysis and interpretation of data. However, these challenges should not discourage investigators, regulators, and patients from demanding a higher safety standard for approved drugs. Higher standards will require both greater transparency—in revealing what studies are being conducted and what data that have been generated—and greater willingness of funders to support new studies specifically addressing drug safety.

Author Contributions Top

Wrote the first draft: EV. Contributed to the writing of the paper: VB JC SJ MN PS.

References Top

1. Pirmohamed M, James S, Meakin S, Green C, Scott AK, et al. (2004) Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18,820 patients. BMJ 329: 15–19. FIND THIS ARTICLE ONLINE
2. Strom B (2004) Potential for conflict of interest in the evaluation of suspected adverse drug reactions. JAMA 292: 2643–2646. FIND THIS ARTICLE ONLINE
3. Carpenter D, Zucker EJ, Avorn J (2008) Drug-review deadlines and safety problems. N Engl J Med 358: 1354–1361. FIND THIS ARTICLE ONLINE
4. Golder S, Loke YK, Bland M (2011) Meta-analyses of adverse effects data derived from randomised controlled trials as compared to observational studies: Methodological overview. PLoS Med 8(5): e1001026. doi:10.1371/journal.pmed.1001026.
5. McGettigan P, Henry D (2011) Cardiovascular Risk with non-steroidal anti-inflammatory drugs: Systematic review of population-based controlled observational studies. PLoS Med 8(9): e1001098. doi:10.1371/journal.pmed.1001098.
6. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Home page. Available: http://www.encepp.eu/.
7. Schneeweiss S, Avorn J (2011) Postmarketing studies of drug safety. BMJ 342: d342. FIND THIS ARTICLE ONLINE
8. Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, et al. (2007) Clinical trial registration — Looking back and moving ahead. N Engl J Med 356: 2734–2736. FIND THIS ARTICLE ONLINE
9. CONSORT: Transparent Reporting of Trials. Home page. Available: http://www.consort-statement.org/.

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Safety Patients : Reumofan

MedWatch - The FDA Safety Information and Adverse Event Reporting Program Reumofan Plus: Recall - Undeclared Drug Ingredient AUDIENCE: Consumer, Health Professional, Emergency Medicine ISSUE: FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful. An FDA laboratory analysis of Reumofan Plus found that it contains Diclofenac Sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines, and Methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery. The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant. FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product. RECOMMENDATION: Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately. Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.

La FDA emite una nueva advertencia de seguridad sobre Reumofan Plus y Reumofan Plus Premium

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA en inglés) emitió hoy una nueva advertencia a los consumidores sobre los posibles riesgos de dos productos etiquetados como complementos alimentarios naturales para tratar la artritis, el dolor muscular, la osteoporosis, el cáncer de los huesos y otras afecciones. Los productos, Reumofan Plus y Reumofan Plus Premium, contienen varios ingredientes farmacéuticos activos potencialmente peligrosos que no están indicados en las etiquetas de los productos.
La FDA ha recibido docenas de reportes de eventos adversos, incluyendo muerte y derrames cerebrales asociados con el uso de Reumofan Plus desde que la agencia emitió su primera advertencia sobre el producto el 1 de junio de 2012. Otros reportes incluyen daños al hígado, sangrado grave, empeoramiento repentino del control de la glucosa (azúcar), aumento de peso, hinchazón, calambres en las piernas y síndrome de abstinencia de los corticosteroides, así como supresión adrenal.
Los consumidores que estén tomando estos productos o que hayan dejado recientemente de tomar Reumofan Plus o Reumofan Plus Premium deben consultar inmediatamente a un profesional del cuidado de la salud. Los consumidores no deben comprar ni comenzar a usar estos productos.
Los análisis de laboratorios continuos de la FDA de Reumofan Plus han encontrado que este producto contiene ingredientes que se usan en medicamentos recetados:
dexametasona – un corticosteroide, usado comúnmente para tratar las afecciones inflamatorias, que pueden afectar la capacidad natural del cuerpo para combatir infecciones y causar niveles altos de azúcar en la sangre, lesiones de los huesos y músculos y problemas psiquiátricos. La dexametasona también puede causar supresión adrenal cuando se toma durante un período de tiempo prolongado o en dosis altas. La descontinuación repentinamente de los corticosteroides después de haber sido usados por un largo período de tiempo o en altas dosis puede resultar en el síndrome de abstinencia de los corticosteroides que incluye cansancio, náuseas, presión arterial baja, niveles bajos de azúcar en la sangre, fiebre, mareos y dolor muscular y en las coyunturas.
diclofenaco de sodio - un medicamento antiinflamatorio no esteroide (NSAID, por su sigla en inglés) que puede causar un riesgo mayor de eventos cardiovasculares, tales como ataques al corazón y derrames cerebrales, así como complicaciones gastrointestinales graves adversas que incluyen sangrado, ulceración y perforación fatal del estómago y los intestinos.
metocarbamol - un relajante muscular que puede causar adormecimiento, mareos, baja presión arterial y afectar las habilidades mentales o físicas para realizar actividades, tales como conducir un automóvil u operar maquinaria.
Un análisis aparte de laboratorio de la FDA del Reumofan Plus Premium encontró que contiene dos de los ingredientes indicados arriba, diclofenaco de sodio y metocarbamol.
Reumofan Plus y Reumofan Plus Premium están etiquetados en español. Sin embargo, también pudieran existir versiones de estos productos con etiquetas en inglés.
Los productos son fabricados en México por Riger Naturals y se venden en los EE.UU. en algunas tiendas, mercados de pulgas y en varios sitios Web populares.
Los ingredientes ocultos de la droga Reumofan Plus y Reumofan Plus Premium pueden causar reacciones adversas graves al ser combinados con otros medicamentos. Se les exhorta a los profesionales del cuidado de la salud a que les pregunten a sus pacientes sobre el uso del Reumofan Plus, Reumofan Plus Premium y otros productos similares etiquetados como complementos alimentarios naturales cuando los pacientes presentan síntomas sin explicación que indican toxicidad con un medicamento antiinflamatorio no esteroide o NSAID, cambios psiquiátricos o el uso o descontinuación abrupta de los corticosteroides.

 

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Reumofan Plus: Recall - Undeclared Drug Ingredient

English: Logo of the . (Photo credit: Wikipedia)

Reumofan Plus: Recall - Undeclared Drug IngredientAUDIENCE: Consumer, Health Professional, Emergency Medicine

ISSUE: FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful. An FDA laboratory analysis of Reumofan Plus found that it contains Diclofenac Sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines, and Methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. 

BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product. 

RECOMMENDATION: Consumers who are currently taking or who recently stopped taking Reumofan Plus are urged to consult a healthcare professional immediately. Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids. Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.

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Taking painkillers increases death risk, second heart attacks in survivors / American Heart Association salud equitativa at CIENCIASMEDICASNEWS - 2 hours ago Taking painkillers increases death risk, second heart attacks in survivors / American Heart Association Taking painkillers increases death risk, second heart attacks in survivors

Taking painkillers increases death risk, second heart attacks in survivors / American Heart Association

salud equitativa at CIENCIASMEDICASNEWS - 2 hours ago

Taking painkillers increases death risk, second heart attacks in survivors / American Heart Association Taking painkillers increases death risk, second heart attacks in survivors September 10, 2012 *Study Highlights:* - Heart attack survivors using common painkillers such as ibuprofen face a higher long-term risk of death or second heart attack. - The higher risk persists for at least five years. *EMBARGOED UNTIL 3 pm CT/4 pm ET, Monday, September 10, 2012* DALLAS, Sept. 10, 2012 — Heart attack survivors who take common painkillers after a heart attack [image: External li... more »

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