07.11.12

FYI on Pain Med Methadone aka Dolophine Hydrochloride

Posted in Medication at 11:58 AM by Dr. Greathouse

Evidence Mounts: Methadone Risky in Chronic Pain

The opioid-treatment drug methadone is culprit in almost one in three prescription painkiller overdose deaths, even though it only accounts for a fraction of scripts for pain, CDC researchers said.
About 5,000 patients died from methadone overdose in 2009, about six times more than 10 years earlier, Thomas Frieden, MD, PhD, director of the CDC, and colleagues said in a Vital Signs report.
“Methadone is riskier than other prescription painkillers … and we don’t think it has a role in the treatment of acute pain,” Frieden said during a call with reporters.
He emphasized that most of these accidental deaths are tied to the drug’s use in chronic pain — a condition for which there is little evidence of its benefit, he noted — and are not associated with its indication for the treatment of substance abuse.

The opioid-treatment drug methadone is culprit in almost one in three prescription painkiller overdose deaths, even though it only accounts for a fraction of scripts for pain, CDC researchers said.
About 5,000 patients died from methadone overdose in 2009, about six times more than 10 years earlier, Thomas Frieden, MD, PhD, director of the CDC, and colleagues said in a Vital Signs report.
“Methadone is riskier than other prescription painkillers … and we don’t think it has a role in the treatment of acute pain,” Frieden said during a call with reporters.
He emphasized that most of these accidental deaths are tied to the drug’s use in chronic pain — a condition for which there is little evidence of its benefit, he noted — and are not associated with its indication for the treatment of substance abuse.

08.25.11

Autism Not Caused by Vaccines, IOM Report Concludes

Posted in Medication at 4:22 PM by Dr. Greathouse

Autism Not Caused by Vaccines, IOM Report Concludes

By Michael Smith, North American Correspondent, MedPage Today
Published: August 25, 2011
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There’s convincing evidence that some vaccines can cause some adverse effects, including seizures, brain inflammation, and fainting, according to a new report from the Institute of Medicine.

But the evidence also favors rejecting the idea that some vaccines cause type 1 diabetes or autism, the institute said.

The 647-page report was commissioned in 2009 by the Health Resources and Services Administration, which administers the Vaccine Injury Compensation Program. The agency asked the institute to review the evidence linking eight vaccines and a suite of possible adverse effects that have been the subject of compensation claims.

All told, an expert panel convened by the institute found “convincing evidence” that 14 adverse effects can be caused by eight vaccines — those against varicella zoster, influenza, hepatitis B, hepatitis A, human papillomavirus (HPV), measles/mumps/rubella (MMR), and meningococcus, as well as tetanus-containing vaccines that do not carry the whole-cell pertussis component.

Evidence “favors” the idea that vaccines can cause another four adverse effects and favors rejection of the causal link with five others, including autism and diabetes, the expert panel reported.

Finally, evidence is inadequate to accept or reject a causal link in another 135 possible associations.

“The findings should be reassuring to parents that few health problems are clearly connected to immunizations, and these effects occur relatively rarely,” said the panel’s chair, Ellen Wright Clayton, MD, JD, of Vanderbilt University in Nashville, Tenn.

“And repeated study has made clear that some health problems are not caused by vaccines,” Clayton said in a statement.

The panel established four categories of causation, based on evidence that:

  • “Convincingly supports” a causal relationship, usually on the basis of good epidemiological data and a clear mechanism of action.
  • “Favors acceptance” of a causal relationship, but is not firm enough to be convincing.
  • Is “inadequate to accept or reject” a causal relationship.
  • “Favors rejection” of a causal relationship. Because it’s impossible to prove a negative, the committee did not have a category of evidence that “convincingly” rejects a causal relationship.

The panel was not asked to say how rare potential various adverse effects might be. But, they reported, “many of the adverse events we examined are exceedingly rare in the population overall, and in most instances any particular adverse event, be it arthritis, meningitis, or any of the other vaccine-adverse events that the committee considered, are not preceded by immunization.”

The committee reported convincing evidence that:

  • Because of infection by the vaccine virus strain, the varicella zoster vaccine can cause four specific adverse events — disseminated varicella infection, disseminated varicella infection with subsequent infection resulting in pneumonia, meningitis, or hepatitis in people with immunodeficiencies, vaccine strain viral reactivation, and vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis.
  • The MMR vaccine can cause measles inclusion body encephalitis in people with compromised immune systems.
  • The MMR vaccine also is linked to febrile seizures in infants and young children.
  • Six types of vaccines — MMR, varicella zoster, influenza, hepatitis B, meningococcal, and tetanus-containing vaccines — can cause anaphylaxis.
  • Any of the vaccines can cause syncope and deltoid bursitis.

The experts found evidence “favoring” a causal link between HPV vaccine and anaphylaxis, as well as between the MMR vaccine and transient arthralgia in women and in children.

Also, the committee said, there’s evidence that favors a causal link between some trivalent inactivated influenza vaccines used in Canada recently and a mild and temporary syndrome, characterized by conjunctivitis, facial swelling, and upper respiratory symptoms.

Evidence favored rejection of a causal link in five cases:

  • The MMR vaccine and autism.
  • The MMR vaccine and type 1 diabetes.
  • The tetanus component of the Dtap vaccine and type 1 diabetes.
  • Inactivated influenza vaccine and Bell’s palsy.
  • Inactivated influenza vaccine and exacerbation of asthma or reactive airway disease episodes in children and adults.

The panel cautioned that the “inadequate evidence” category might lead some people to conclude that, “because the committee did not find convincing evidence that the vaccine does cause the adverse event, the vaccine is safe.”

Others, they said, might take the opposite tack: because the committee did not find convincing evidence that the vaccine does not cause the adverse event, the vaccine is unsafe.

“Neither of these interpretations is correct,” the report concludes. “‘Inadequate to accept or reject’ means just that – inadequate.”

07.12.11

Cholesterol Drug Warning

Posted in Medication at 6:40 AM by Dr. Greathouse

http://www.medscape.com/viewarticle/744242?src=top10

http://www.greenliveforever.com/general-health/blood-pressure-and-cholesterol-problem/warning-cholesterol-control-drug-simvastatin-zocor-merck-risk-myopathy-rhabdomyolysis

Simvastatin that marketed as Zocor from Merck pharmaceutical company is statin drug to control elevating cholesterol levels.

Million of people has prescribed with this drug without ‘respecting’ to the side effects, both in due to the doses and combination with other drugs.

As growing evidence has linked to this drug with the development of myopathy and rhabdomyolysis, now the U.S. Food and Drug Administration (FDA) just start to warns and recommends for simvastatin use.

Although this decision seem ‘late respond’ as some of previous study has suggested this relationship, however it still useful for remain or candidate patients due to use of simvastatin drug.

The agency recommend to the physicians to limit the use of simvastatin 80 mg and warning in combination with other drugs.

The agency states, “Simvastatin 80 mg should not be started in new patient, including patient already taking lower doses of drugs.”

However, for patients who already taking the drug for 12 months and no indication linking to myopathy, then the drug may prescribed with precautions.

Also, the FDA request to the pharmaceutical company to change drug’s label as above mention including the warning for drug combination with other medications.

This warning and recommendation based on the Study of the Effectiveness of Additional Reductons in Cholesterol and Homocysteine (SEARCH).

Based on SEARCH study results, there were myopathy development in 52 patients taking simvastatin 80 mg and 1 patient taking simvastatin 20 mg.

Also, compared with patients whose taking 20 mg dose of simvastatin, rhabdomyolysis also occurred in patients taking 80 mg dose.

Both of risks at higher rate in the first year, and older people and female are at significant risk.

According to the FDA, the drug should not combined with;
- itraconazole (Sporanox, Jannsen Pharmaceutica),
- ketoconazole (Nizoral from Ortho-McNeil Pharmaceutical),
- posaconazole (Noxafil from Merck),
- erythromycin,
- claritomycin,
- telithromycin (Ketek from Sanofi-Aventis),
- HIV protease inhibitors,
- nefazodone,
- gemfibrozil,
- cyclosporine, and
- danazol.

05.18.11

Painful Side Effects of Antibiotics

Posted in Medication at 8:03 AM by Dr. Greathouse

Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population

Hall MM, Finnoff JT, Smith J
PMR.2011:3:132-142

Article Summary

Adverse musculoskeletal side effects have been well documented with the use of fluoroquinolone antiobiotics. In 2008, the US Food and Drug Administration (FDA) placed a black box warning, as well as further medication recommendations, on all fluoroquinolones due to the increased risk of developing tendinitis and/or tendon rupture.[1] A review of the current literature by Dr. Hall and colleagues discusses potential mechanisms of pathology, identifies risk factors, and proposes updated guidelines in the athletic population, which include:

Avoid fluoroquinolone use unless there is no alternative.

The coaching and athletic training staff should be made aware of the use.

Corticosteroids should not be utilized in conjunction with fluoroquinolones.

Consider concomitant magnesium and/or antioxidant use.

Training routines should be reduced in intensity and volume once antibiotics are started. A graduated return to full activity should be implemented so long as the patient remains asymptomatic after the antibiotic course is finished.

All athletic activity should be stopped if any adverse reactions are experienced.

The patient should be monitored for 1 month after completion of antibiotics.

The quinolones are a family of synthetic broad-spectrum antibiotics. The term quinolone(s) refers to potent synthetic chemotherapeutic antibacterials.[1][2]

Quinolones, in comparison to other antibiotic classes, have the highest risk of causing colonization with MRSA and Clostridium difficile. For this reason, a general avoidance of fluoroquinolones is recommended based on the available evidence and clinical guidelines.[6][7][8] The majority of quinolones in clinical use belong to the subset fluoroquinolones, which have a fluorine atom attached to the central ring system, typically at the 6-position or C-7 position.

01.28.11

Pain Medication Safety Considerations

Posted in Medication at 12:32 PM by Dr. Greathouse

From British Medical Journal

Cardiovascular Safety of Non-Steroidal Anti-Inflammatory Drugs

Network Meta-Analysis

Sven Trelle; Stephan Reichenbach; Simon Wandel; Pius Hildebrand; Beatrice Tschannen; Peter M Villiger; Matthias Egger; Peter Jüni

Posted: 01/27/2011; BMJ © 2011 BMJ Publishing Group

Abstract

Objective To analyse the available evidence on cardiovascular safety of non-steroidal anti-inflammatory drugs.

Design Network meta-analysis. 
Data sources Bibliographic databases, conference proceedings, study registers, the Food and Drug Administration website, reference lists of relevant articles, and reports citing relevant articles through the Science Citation Index (last update July 2009). Manufacturers of celecoxib and lumiracoxib provided additional data.

Study selection All large scale randomised controlled trials comparing any non-steroidal anti-inflammatory drug with other non-steroidal anti-inflammatory drugs or placebo. Two investigators independently assessed eligibility.

Data extraction The primary outcome was myocardial infarction. Secondary outcomes included stroke, death from cardiovascular disease, and death from any cause. Two investigators independently extracted data.

Data synthesis 31 trials in 116 429 patients with more than 115 000 patient years of follow-up were included. Patients were allocated to naproxen, ibuprofen, diclofenac, celecoxib, etoricoxib, rofecoxib, lumiracoxib, or placebo. Compared with placebo, rofecoxib was associated with the highest risk of myocardial infarction (rate ratio 2.12, 95% credibility interval 1.26 to 3.56), followed by lumiracoxib (2.00, 0.71 to 6.21). Ibuprofen was associated with the highest risk of stroke (3.36, 1.00 to 11.6), followed by diclofenac (2.86, 1.09 to 8.36). Etoricoxib (4.07, 1.23 to 15.7) and diclofenac (3.98, 1.48 to 12.7) were associated with the highest risk of cardiovascular death.

Conclusions Although uncertainty remains, little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms. Naproxen seemed least harmful. Cardiovascular risk needs to be taken into account when prescribing any non-steroidal anti-inflammatory drug.