Fake drugs find leads to recall

The UK's medicines watchdog is recalling a batch of a cholesterol-lowering drug after fake tablets were discovered.

The Medicines and Healthcare products Regulatory Agency (MHRA), in conjunction with Pfizer, is recalling packs of Lipitor 20mg tablets.

Only those bearing the batch number 004405K1 are affected.

The MHRA said patients were not at any immediate risk from the fake drugs, which should be returned to chemists.

Patients will then be given new supplies of the prescription-only drug.

Fake tablets can be identified because they do not come in sealed packets in which the genuine drug is provided.

Tip-off

Pfizer said hundreds of batch numbers were released each year, and the recall only applied to this one.

There were around three million prescriptions for Lipitor issued in 2004.

Seventy-three packets of counterfeit Lipitor have so far been discovered after a tip-off from customs officers in Rotterdam, Holland.

It is the third time since the beginning of 2004 that fake drugs have entered the pharmaceutical supply chain in the UK.

Last year, counterfeit batches of Cialis, used to treat impotence, and Reductil, used to treat obesity, were discovered.

Nimo Ahmed, head of intelligence at the MHRA, said: "It is the vigilance of the MHRA that has led us to identify the counterfeit Lipitor and recall this product.

"Although the quality of counterfeit medicines cannot be guaranteed, our testing of the counterfeit product indicates that there is no immediate risk to patients. If patients have any concerns about possible side-effects they should discuss them with their doctor."

Pfizer called for more effort to be made by authorities in the UK and Europe to ensure the safety of medicines

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Kate Lloyd, medical director of Pfizer UK, said: "Patient safety is our top concern and we are seriously alarmed at the discovery of counterfeit medicine in the UK.

"Patient safety is at risk if counterfeit products can easily be introduced into the supply chain through cross-border trade, as patients will not gain the benefits their doctor intended when selecting their medicine."

She said measures including outlawing the repackaging of original manufacturers' medicines, supporting the introduction of tamper-resistant medicine packaging, and introducing a standardised European barcode for medicines could all help to protect medicine supplies.

However, Richard Freudenberg, of the British Association of European Pharmaceutical Distributors, told the BBC News website it was disingenuous of Pfizer to associate counterfeits with parallel distribution.

He said overlabelling or repackaging undertaken by parallel distributors was carried out under strict guidelines.

"The impression left by Pfizer UK's medical director is that parallel distribution of medicines in Europe is thoroughly flawed and a soft target for counterfeiters to introduce their illegal and dangerous products into the market.

"In fact, there has never been a single confirmed case in the UK of a counterfeit medicine reaching a patient as parallel distribution, ever.

Mr Freudenberg said the current fakes were a replica of the pack distributed by Pfizer in the UK.

"Counterfeit medicines in Europe remain remarkably rare.

"Parallel distributors, however, are concerned about the future possibility of their entering the supply chain, and would be pleased to discuss with manufacturers available means to prevent this happening."

Professor Peter Weissberg, Medical Director of the British Heart Foundation (BHF), said: "This is not an issue that should cause any worry for patients taking Lipitor.

"We would urge any patients who have this particular batch number on their packet to follow the MHRA's advice and return the product to where they obtained it and seek a replacement of the genuine drug."
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Diabetic Autonomic Neuropathy

Aaron I. Vinik, M.D., Ph.D.; Roy Freeman, M.B., Ch.B.; Tomris Erbas, M.D.

Abstract and Introduction

Abstract

Diabetic autonomic neuropathy is the most common and troublesome complication of diabetes mellitus. Although involvement of the autonomic nervous system is generally diffuse, symptoms may be confined to a single target organ or organ system. Complications of diabetic autonomic neuropathy contribute greatly to the morbidity, mortality, and reduced quality of life of the person with diabetes and are the major source of increased costs of caring for the diabetic patient. Factors in the pathogenesis of these complications are altered metabolism, vascular insufficiency, loss of growth factor trophism, and autoimmune destruction of nerves in a visceral and cutaneous distribution. The clinical manifestations and the complications of diabetic autonomic neuropathy are reviewed. Future therapeutic strategies that are developed from a better understanding of the pathogenetic processes underlying this disorder can be directed at the cause rather than the manifestations. There are studies in progress that suggest that autonomic nerves can be induced to regenerate, and the future for patients with diabetic autonomic neuropathy is brighter.Introduction

Diabetic neuropathy is a heterogeneous disorder that encompasses a wide range of abnormalities affecting both proximal and distal peripheral sensory and motor nerves, as well as the autonomic nervous system (ANS). Diabetic autonomic neuropathy is among the least recognized and understood complications of diabetes despite its significant negative impact on survival and quality of life in people with diabetes.[1-3] Many organs are dually innervated, receiving fibers from the parasympathetic and sympathetic divisions of the ANS. Diabetic autonomic neuropathy typically occurs as a systemwide disorder affecting all parts of the ANS. Diabetic autonomic neuropathy manifests first in longer nerves. The vagus nerve (the longest of the ANS nerves) accounts for ~75% of all parasympathetic activity; as such, even early affects of diabetic autonomic neuropathy are widespread. The organ systems that most often exhibit prominent clinical autonomic signs and symptoms in diabetes include the pupil, sweat glands, genitourinary system, gastrointestinal tract system, adrenal medullary system, and the cardiovascular system (Table 1).[4] The availability of sensitive, specific, and reproducible noninvasive tests of autonomic function has enhanced our understanding of the prevalence, pathophysiology, and clinical manifestations of this disorder.[1,5-6] Clinical symptoms of autonomic neuropathy generally do not occur until long after the onset of diabetes. Subclinical autonomic dysfunction, however, can occur within a year of diagnosis in type 2 diabetic patients and within 2 years in type 1 diabetic patients.[7]

Estimates of the prevalence of diabetic autonomic neuropathy are dependent on the criteria used for diagnosis and the specific population under study. The prevalence of symptoms of autonomic dysfunction and abnormal tests of autonomic nervous system function in diabetic clinic-based populations and tertiary referral centers is considerably higher than in general clinic-based populations. For example, symptomatic visceral autonomic neuropathy had a prevalence of 5.5% in a population-based study of diabetic patients in Rochester, Minnesota.[8] In a community-based population study of diabetic neuropathy in Oxford, England, the prevalence of autonomic neuropathy as defined by one or more abnormal heart rate variability (HRV) test results was 16.7%.[9] In a study that evaluated the prevalence of cardiovascular autonomic neuropathy in 1171 diabetic patients randomly recruited from 22 diabetic centers in Germany, Austria, and Switzerland, 25.3% of patients with type 1 diabetes and 34.3% of patients with type 2 diabetes had abnormal findings in more than two of six autonomic function tests.[10]

Section 1 of 9 Aaron I. Vinik, M.D., Ph.D.,1 Roy Freeman, M.B., Ch.B.,2 and Tomris Erbas, M.D.1

1Strelitz Diabetes Research Institutes, Eastern Virginia Medical School, Norfolk, Virginia; and 2Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
Semin Neurol 23(4):365-372, 2003. © 2003 Thieme Medical Publishers
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Eplerenone Reduces All-Cause Mortality After AMI in LVD Patients

Peggy Peck

March 31, 2003 (Chicago) — Eplerenone, a selective aldosterone blocker, significantly reduces morbidity and mortality when given on top of optimal medical therapy to patients who have left ventricular dysfunction after acute myocardial infarction (AMI), according to results released here at the 52nd annual scientific session of the American College of Cardiology.

The study, Epleronone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS), will also be published in the April 3 issue of the New England Journal of Medicine and was released early by the journal to coincide with the presentation here.

"This is very satisfying," said Bertram Pitt, MD, professor of medicine at the University of Michigan in Ann Arbor. "This study shows that on top of what we can do today for patients, we can still do better. This represents a new advance in to the treatment of heart attack and heart failure."

He added that patients who received the most aggressive treatment for their heart failure received the greatest benefit from eplerenone therapy.

"I wrote down home run when I heard the results," Jon Kobasigawa, MD, professor of medicine at the UCLA Medical Center in Los Angeles and moderator of a press briefing at which the eplerenone study was discussed, told Medscape. "I believe that the results of the study will impact how we practice medicine. We will see greater use of this drug in a broader group of patients, especially younger patients."

Dr. Kobasigawa said the increased use of the drug relates to its adverse-effect profile: there was no excess gynecomastia or impotence associated with the drug. "This is very different from what we observe with spironolactone," he said.

"Those side effects occur about 10% of the time," says Inder Anand, MD, professor of medicine at the University of Minnesota in Minneapolis. But because heart failure occurs in older men and women for whom menstrual cycles and impotence may be moot, about 6% to 7% of patients may require a drug like eplerenone. He told Medscape that spironolactone costs about two cents a tablet while eplerenone may cost as much as $3 a pill. Dr. Anand was not involved in the study.

Dr. Pitt agreed that eplerenone is more expensive then spironolactone, but he said it was "pennies compared to cost of an implantable defibrillator. I could throw pills at patients all day and it wouldn't add up to the cost of an ICD," he told Medscape.

The trial enrolled 6,632 patients within 3 to 14 days after AMI. Entry criteria included a left ventricular ejection fraction of 40% or lower and heart failure documented by the presence of pulmonary rales, chest radiography, or the presence of a third heart sound.

Patients were randomly assigned to receive best available medical care — angiotensin-converting enzyme inhibitor and β-blocker — and eplerenone or placebo. Initial eplerenone dose was 25 mg, titrated to 50 mg.

Eplerenone at a mean dose of 43 mg was associated with a 15% decrease in total mortality, a 17% decrease in cardiovascular mortality, and a 21% decrease in sudden cardiac death. Total hospitalizations were 8% lower in the active treatment arm and hospitalizations for heart failure decreased by 15%.

There was, however, excess hyperkalemia, 5.5% in the eplerenone group vs. 3.9% in the placebo group. "Hyperkalemia is a concern and there was one death among patients with hyperkalemia but that death was in the placebo arm," said Dr. Pitt. Conversely, eplerenone was associated with a lower rate of hypokalemia, 8.4% vs. 13.1%.

During a follow-up of 16 months, there were 478 deaths in the eplerenone arm and 554 deaths in the placebo arm.

The study was funded by Pharmacia Corporation and Dr. Pitt is a consultant to Pharmacia.

ACC 52nd Annual Scientific Session: Late Breaking Clinical Trials I. Presented March 31, 2003.

N Engl J Med. 2003;348:1309-1321, 1380-1383

Reviewed by Gary D. Vogin, MD
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