Tysabri causes Liver Problems
February 29, 2008
Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.
Popularity: 54% [?]
Statins Harm Mitochrondria
February 27, 2008
Statins, the wildly popular cholesterol-lowering drugs, may interact with at least one blood pressure drug to damage the mitochondria, the powerhouses of cells, the researchers reported in the journal Nature Biotechnology.
The mitochondria are structures in cells that make adenosine triphosphate, or ATP, which helps power cells. Mootha’s team tested more than 2,000 drugs on cells to see how they might interfere with this process. Their test looks at gene function, ATP levels and other measures of how well the mitochondria are working.
Many patients who take statins have reported side-effects that include muscle pain and weakness. The cause is not well understood but Mootha has long suspected the mitochondria are involved.
The effects have been hard to pin down because studies of different groups have produced conflicting results. Mootha’s team said their findings showed some statins lower ATP levels and interfere with the mitochondria.
“Of the six statins present in our screening collection, three (fluvastatin, lovastatin and simvastatin) produced strong decreases in cellular ATP levels and (mitochondrial) activity,” they wrote. Fluvastatin is sold by Novartis under the brand name Lescol, lovastatin is sold under the brand name Mevacor and simvaststin is sold as Zocor.
Three others —atorvastatin, made by Pfizer under the brand name Lipitor, pravastatin or Pravachol, made by Bristol Myers Squibb and rosuvastatin, sold under the Crestor brand name by AstraZeneca —had little effect, they said.
Popularity: 48% [?]
New Supreme Court Bends to Big Business - Leaves Consumers Out in the Cold
February 27, 2008
Donna Riegel filed suit against Medtronic after a Medtronic catheter burst inside the artery of her husband Charles causing him to undergo emergency bypass surgery in 1996. Although Charles Riegel survived the surgery, he passed since, and Donna carried the fight all the way to the Supreme Court.
On
The catheter that caused Charles Riegel’s injuries was approved by the FDA through pre-market approval (PMA). PMA is the most stringent type of review required by the FDA. The main difference between 510K and PMA is that 510K focuses on substantial equivalency to a product already approved to go to market whereas PMA focuses on the safety of a previously unapproved product.
In simple terms: you can no longer sue a company for putting out a bad medical device if it goes through the PMA process.
What does this mean to you?
The Supreme Court dealt the American public a tremendous blow. No longer are you safe from desperate companies looking for patents to please shareholders. The Court wrongly relies on the supposed “scientific prowess” of an inept and dysfunctional federal Food and Drug Agency.
What can you do?
Popularity: 43% [?]
Nanotech - a possible danger to the public’s health?
February 27, 2008
The Project on Emerging Nanotechnologies (PEN) has released a first-time legal analysis that finds a key federal toxics reporting statute could be applied to production and commercialization of nanotechnology, providing the public with more information about these revolutionary – yet still potentially risky – technologies.But before the Toxics Release Inventory (TRI) authorities can be applied to nanomaterials, in most cases more toxicological data must be developed to better understand the potential human health and environmental impacts of these cutting-edge technologies. The analysis, conducted by two noted environmental law experts, finds that federal authorities may need to be amended to address reporting thresholds that may not apply effectively to nanomaterials because of their unique characteristics.
“There needs to be development of additional toxicological data on nanomaterials, but in theory TRI could be applied to nanomaterials. The key question is whether EPA will make any determinations about whether particular nanomaterials constitute toxic chemicals,” says Linda Breggin, one the authors of the analysis and Senior Attorney at the Environmental Law Institute.
The landmark analysis comes as over 40 environmental, consumer, labor and other groups are calling for regulation and disclosure of products containing nanomaterials, and as congressional lawmakers are considering legislation to expand reporting requirements for environmental pollutants under TRI. Although currently proposed legislation does not specifically address nanomaterials, a public dialogue about the benefits and costs of TRI is underway that could include discussion of the program’s application to nanomaterials, the new PEN analysis says.
At the local level, in 2006 the City of Berkeley, Calif., adopted a disclosure ordinance that requires nanomaterial manufacturers to disclose the known risks of their products. Now Cambridge, Mass., is considering a similar ordinance, and other local governments may follow suit.
“If Cambridge passes an ordinance similar to Berkeley’s, who knows how many other cities or other municipalities will follow?” says PEN Director David Rejeski. “Soon we could have a patchwork of cities across the country with nanotech disclosure ordinances, which is why environmental law experts should take the time now to make the decision as to whether TRI is a tool that can be used at the federal level to disclose nanomaterials’ potential risks.”
The report also emphasizes the importance of recognizing that several additional right-to-know or disclosure-related laws and initiatives should be explored as possible disclosure vehicles for environmental, health, and safety risks that could be associated with nanomaterials. The report also highlights the fact that additional research is required to determine whether application of TRI to nanomaterials should be pursued as a policy priority in the near term.
Popularity: 59% [?]
Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches Recalled
February 27, 2008
PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by ALZA Corporation.
Popularity: 44% [?]
Chantix Label Revision
February 27, 2008
FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.
Popularity: 57% [?]
Leukine (sargramostim)
February 27, 2008
Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer.
Popularity: 53% [?]
Hormone Therapy Linked to Abnormal Test Results
February 26, 2008
Combined hormone replacement therapy may affect the effectiveness and accuracy of breast screening mammograms and tissue sample tests, called biopsies, study results show.
Lead researcher Dr Rowan Chlebowski, from Harbor-University of
Dr Chlebowski and team analysed data from a study of more than 16,600 postmenopausal women who took either a combination of oestrogen and progesterone or a dummy hormonal treatment for around 5 years.
In total, 199 of the women taking combined hormone therapy and 150 of those taking the dummy treatment developed breast cancer over the course of the study.
Abnormal mammogram results were significantly more common among women taking combined hormone treatment (35%) than among those taking the dummy treatment (23%). Indeed, women taking combined hormone therapy had a 4% greater risk of having a mammogram with abnormalities after 1 year and an 11% greater risk after 5 years compared with those taking the dummy treatment.
Learn More: Archives of Internal Medicine
Popularity: 43% [?]
Trasylol Increases the Risk of Death
February 26, 2008
Use of the blood-saving drug aprotinin (Trasylol) during coronary bypass surgery significantly increases the risk of death, according to data from two large studies.
Patients treated with aprotinin had an almost a two-fold greater mortality compared with patients given aminocaproic acid during heart surgery, Sebastian Schneeweiss, M.D., Sc.D., of Harvard, and colleagues, reported in the Feb. 21 issue of The New England Journal of Medicine.
A second study in the NEJM by a Duke-led group revealed about a 30% higher mortality risk with aprotinin versus aminocaproic acid (Amicar) or no antifibrinolytic therapy.
“Characteristics of neither the patients nor the surgeons explain the [mortality] difference, which persisted through several approaches to control confounding,” Dr. Schneeweiss and co-authors concluded.
Evidence of an increased mortality hazard adds to adverse effects documented in a report two weeks ago in The Lancet that implicated aprotinin in renal dysfunction among patients undergoing cardiac surgery.
Popularity: 49% [?]
Denture Cleanser Allergic Reactions and Misuse
February 26, 2008
FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdominal pain, vomiting, seizures, hypotension and difficulty breathing, have occurred both when the product has been used properly as well as from improper use. These events can occur soon after first use or after years of use. FDA believes that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers to help clean and bleach the dentures. FDA has provided specific recommendations for dental healthcare professionals and an ‘Advice for Patients’ document that can be accessed at the links below.
FDA is recommending that all manufacturers of denture cleansers modify their labeling to include warning information that the product contains persulfates and recommends improving the directions for use on their labeling in order to reduce misuse.
Popularity: 50% [?]
Pfizer Pulls Doctor Ad for Lipitor
February 25, 2008
Pfizer said today that it was pulling the plug on advertising that features Robert Jarvik, M.D., promoting the benefit of atorvastatin (Lipitor).
The Pfizer decision was included in a letter to Reps. John D. Dingell (D-Mich.), chairman of the Committee on Energy and Commerce, and Bart Stupak (D-Mich.) chairman of the Subcommittee on Oversight and Investigations. Last month, Dingell and Stupak launched an investigation into th