Thursday, July 28, 2011

Intercharm Inc. Issues A Recall Of Slim Forte Slimming Capsules

From the FDA:

 Intercharm Inc., is recalling Slimforte Slimming Capsules, Slimforte Slimming Coffee, and Botanical Slimming Soft Gel to the consumer/user level. FDA laboratory analyses found the products to contain Sibutramine an appetite suppressant. Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons.
  • Slim Forte Slimming Capsules is packaged in a green box with a picture of a woman on the front. The box has pink, blue, and green text. The box contains 30 capsules.
  • Slim Forte Slimming Coffee is packaged in a green box with a picture of a woman on the front. The box has pink, blue, and green text. The box contains 10 packets of instant coffee.
  • Meizitang Botanical Slimming Soft Gel is packaged in a green package/pouch with green background and a picture of a woman on front. The package has yellow, white, and black text. The pouch contains 3 blister packs of 12 each 650 mg softgel capsules.

Products containing Sibutramine pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. Intercharm Inc. has not received any reports of adverse events related to this recall.

These products are sold as dietary supplements and marketed for weight loss. Slim Forte Slimming Capsule, Batch No. 20100928, Best By 09.27.2012 and Batch No. 20100604, Best By 06.03.2012; Slim Forte Slimming Coffee, Batch No. 20100903, Best By 09.02.2012; and Meizitang Botanical Slimming Soft Gel, Lot Code 12.24.2009, Best By 12.23.2011 are included in this recall. Products were distributed through the internet nationwide and internationally to Ireland.

Consumers should stop using these products immediately and return to the place of purchase. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

Cetero Faked Documents, Claims the FDA

Drug companies that had medicines tested by  a company known as Cetero Research could face product reevaluation - that news according to the FDA after it found that Cetero was faking documents and manipulating samples.
The news is concerning. The FDA report states, "The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during a 5 year time frame (April 1, 2005 to June 15, 2010)." Source:

From the FDA:
The FDA has notified Cetero Research, Houston, Texas (Cetero) of significant violations of federal regulations relating to their conduct of analytical testing of drugs before they are marketed. Cetero is a contract research organization (CRO) that performs bioequivalence and pharmacokinetic testing for pharmaceutical companies; these data are included in New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
In addition, FDA is notifying pharmaceutical companies with applications pending before the Agency that testing conducted by Cetero’s Houston facility between April 2005 and June 2010 will need to be evaluated and possibly redone. Given the nature of Cetero’s violative practices, FDA has concerns that the bioequivalence and bioavailability data generated at the Cetero Houston facility from April 1, 2005 to June 15, 2010 may be unreliable. These data are included in New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) submitted to FDA.
It is unlikely that these concerns relating to data integrity will affect the overall safety and efficacy of drugs already on the market. FDA is taking this precautionary measure to make sure the data underlying the approval decision is completely reliable. At this time,  there is no evidence of problems with the safety, quality, purity or potency of drugs already approved and marketed.

Stay tuned to this story.

Wednesday, July 27, 2011

Meth users have greater risk of developing Parkinson’s

Meth addiction is a national problem.  Methamphetamine is a central nervous system stimulant drug that is similar in structure to amphetamine. Due to its high potential for abuse, methamphetamine is classified as a Schedule II drug and is available only through a prescription that cannot be refilled. Although methamphetamine can be prescribed by a doctor, its medical uses are limited, and the doses that are prescribed are much lower than those typically abused. Most of the methamphetamine abused in this country comes from foreign or domestic superlabs, although it can also be made in small, illegal laboratories, where its production endangers the people in the labs, neighbors, and the environment.

As if the known dangers are not enough, now there is this news:


Canadian scientists say there’s a link between the abuse of methamphetamines and the development of Parkinson’s disease.

Researchers at the Centre for Addiction and Mental Health in Toronto used medical records for more than 40,000 people in California who had been hospitalized for abusing meth- or amphetamine-like stimulants from 1990 to 2005.

They were compared to records for more than 200,000 people admitted for appendicitis, and more than 35,000 diagnosed with cocaine use disorders. A diagnosis of Parkinson’s was identified from hospital records or death certificates.

The study found that the methamphetamine group had a 76 per cent higher risk of developing Parkinson’s disease.

Here is the source:

Certain Antidepressants Linked to Falls in Nursing Homes

From Health Day:

In the days after they start taking non-SSRI (selective serotonin reuptake inhibitor) antidepressants, such as bupropion or venlafaxine, there is a new study suggesting that nursing home residents are at significantly greater risk for falls.

In conducting the study, recently published online in the Journal of Gerontology: Medical Sciences, researchers examined information on 1,181 nursing home residents who had fallen. Specifically, they compared changes in their antidepressant medication one week and two weeks before the fall.

Read more here: 

Pfizer’s Zyvox and Antidepressants: A Fatal Combination?

From Bloomberg and the FDA:

The drugZyvox - an antibiotic -- can cause potentially fatal central nervous system reactions in patients who also take antidepressants that increase levels of the brain chemical serotonin, so says the FDA.

The FDA site has this: Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox®) is given to patients taking certain psychiatric medications.

The U.S. Food and Drug Administration (FDA) has received reports of serious central nervous system (CNS) reactions when the antibacterial drug linezolid (marketed as Zyvox®) is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications).    

Although the exact mechanism of this drug interaction is unknown, linezolid inhibits the action of monoamine oxidase A—an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome—signs and symptoms include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.

Healthcare professionals and patients may not realize that linezolid has monoamine oxidase inhibitor (MAOI) properties. Linezolid should generally not be given to patients taking serotonergic drugs. However, there are some conditions that may be life-threatening or require urgent treatment with linezolid such as when:
  • Linezolid is used to treat vancomycin-resistant Enterococcus faecium (VRE) infections.
  • Linezolid is used to treat infections such as nosocomial pneumonia and complicated skin and skin structure infections, including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

Read more here:

Tuesday, July 26, 2011

July 27/11 News: FDA: Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

Last week I  wrote about the recent FDA report regarding TVM failures. Here is the information that has been available in 2008:

Dear Healthcare Practitioner:
This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.
Nature of the Problem
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

Physicians should:
  • Obtain specialized training for each mesh placement technique, and be aware of its risks.
  • Be vigilant for potential adverse events from the mesh, especially erosion and infection.
  • Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
  • Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
  • Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
  • Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

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Anti Clotting Drug -Severe Bleeding, No Benefit?

heart attack anatomyImage by gandhiji40 via FlickrAdding a new anti-clotting drug, Eliquis, to dual antiplatelet therapy may result in severe bleeding without reducing the risk of heart attack and stroke, according to a new report. 

 A trial evaluating the combination treatment was halted early when the risk of severe bleeding among those taking Eliquis (apixaban) became apparent.

 Link here.
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Thursday, July 21, 2011

Georgia: Transvaginal Mesh Patch Failure News

Transvaginal Mesh Patch Failure

A July 2011 FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA has received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch.
According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include serious issues such as:
  • Erosion of the vaginal tissue
  • Infection
  • Bleeding
  • Pain
  • Urinary problems such as incontinence
  • Pain during sexual intercourse (dyspareunia)
  • Organ perforation (puncturing) from surgical tools during mesh implantation
Less frequent problems included
  • Return of POP
  • Neuro-muscular problems
  • Vaginal scarring/shrinkage
  • Emotional problems

FDA Alerts and Research Find Transvaginal Patches Unsafe

2011 FDA Alert – Serious and painful complications are associated with the transvaginal placement of surgical mesh, and their occurrence is not rare. FDA also finds the risky surgical mesh treatment of POP to be no more effective than traditional treatment.

2011 Study Published – The New England Journal of Medicine published research showing an increased risk of complications associated with transvaginal mesh implants. Compared to colporrhaphy, a traditional treatment of POP, surgical mesh had a higher risk of defect including:
  • 7 times the risk of bladder perforation
  • Nearly twice the risk of urinary incontinence (loss of bladder control)
  • 3.2 percent of women required follow-up surgery to correct problems
2008 to 2010 – FDA received 2,874 more reports of adverse complications linked to transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the total adverse reports to over 3,800.

2010 Study Published – A study featured in the Obstetrics & Gynecology journal had to be terminated due to the extent of injuries to participants who received the transvaginal mesh patch. Of the women who were treated with the surgical mesh, 15 percent experienced erosions, and other complications included two cystotomies (bladder incision) and one blood transfusion.

2005 to 2008 – FDA received more than 1,000 reports from nine surgical mesh manufacturers about complications related to the device and its treatment of POP and SUI.
Over 200 Lawsuits Filed Already
More than 200 women across the United States have filed lawsuits against three of the makers of transvaginal mesh patches:
  • C.R. Bard
  • Johnson & Johnson’s Ethicon
  • American Medical Systems
Complications have been reported for several other manufacturers of surgical mesh as well including:
  • Boston Scientific Scimmed
  • Sofradim
  • Caldera
  • Mentor Corporation
What Should You Do?
If you have suffered complications due to the implantation of a transvaginal patch to treat POP, you are not alone, and you have a right to compensation. By filing a claim against the surgical mesh manufacturer, you could receive compensation for medical costs, other financial burdens and the pain and suffering caused by this defective medical device. You will also send a clear message to the manufacturer that it is unacceptable to sell medical devices that harm innocent people.

J and J must pay S.C. $327 million

A South Carolina judge has rules that Johnson & Johnson must pay $327 million for deceptive marketing of its Risperdal antipsychotic medication.

Judge Roger Couch chastised the company's management for allowing "the profit-at-all-costs mentality to cloud" their approach to marketing the drug. The letter to doctors, which eventually drew a warning from FDA for false and misleading claims, was a "clever effort" to "manipulate the message" about Risperdal, Couch ruled (as quoted by Bloomberg).

Wednesday, July 20, 2011

Las Vegas: Aria Hotel/Casino Guests & Legionnaires' Disease

Tests from the Centers for Disease Control and Prevention have determined that six former guests of the Aria hotel in Las Vegas' City Center have been diagnosed with Legionnaire's Disease, a form of pneumonia. All of the patrons have recovered, but the disease can sometimes be fatal. Aria officials are notifying guests who stayed at the hotel from June 21 to July 4 that they might have been exposed to the bacteria, and if they feel ill to quickly seek medical attention. 

According to the Las Vegas Review Journal, "Legionella, the bacterium that causes Legionnaires' disease, is often found in air-conditioning cooling towers, whirlpool spas, showers, faucets or other water sources. The bacterium can rapidly reproduce in warm, stagnant waters." The hotel received inspections that determined the bacteria was present in the showers and faucets of numerous rooms. 

From the Aria site:

A message from ARIA:
In cooperation with the Southern Nevada Health District, ARIA Resort is contacting guests who may have stayed with us from June 21 to July 4 at a time when water tests detected elevated levels of Legionella bacteria in several of our guest rooms.
Health officials have recently notified us of a few reported instances of guests who visited ARIA, were diagnosed with, treated for, and recovered from Legionnaires' disease (a form of pneumonia caused by Legionella bacteria). In an abundance of caution, we are attempting to notify guests who may have been exposed to these bacteria during this short period.
ARIA has in place a water treatment program and, once the initial tests were received, we immediately implemented a comprehensive abatement effort. All subsequent tests have come back with no detectable levels of active Legionella.

Seroquel: Label Change because of Heart Risks

From the FDA and other sources:

Seroquel is a drug that is widely prescribed. Also known as Quetiapine, it is used to treat either schizophrenia or bipolar disorder. In those with bipolar it is used for depressive episodes, acute manic episodes associated with bipolar I disorder, and maintenance treatment of bipolar I disorder (as adjunct therapy to lithium or divalproex). 

Last week, this label change:


Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of seventeen placebocontrolled trials (modal duration of 10 weeks) largely in patients taking
atypical antipsychotic drugs, revealed a risk of death in drug-treated
patients of between 1.6 to 1.7 times the risk of  death in placebo-treated
patients. Over the course of a typical  10-week controlled trial, the rate of
death in drug-treated patients was about 4.5%, compared to a rate of about
2.6% in the placebo group. Although the causes of death were varied, most
of the deaths appeared to be either cardiovascular (e.g., heart failure,
sudden death) or infectious (e.g., pneumonia) in nature.  Observational
studies suggest that, similar to atypical antipsychotic drugs, treatment with
conventional antipsychotic drugs may increase mortality. The extent to
which the findings of increased mortality in observational studies may be
attributed to the antipsychotic drug as opposed to some characteristic(s) of
the patients is not clear.  SEROQUEL (quetiapine) is not approved for the
treatment of patients with dementia-related psychosis [see  Warnings and
Precautions (5.1)]

Tuesday, July 19, 2011

Multaq on the FDA Watch List Again

The post below sets out the drugs on the FDA watch list. Making the list again is  Dronedarone or Multaq. 

Physicians should not stop prescribing these drugs, nor should patients stop taking them, according to the FDA.

In the case of dronedarone, reports of several potential signals of risk reported for 2010 were followed by regulatory action.
  • The AERS watch list for the first quarter of 2010 cited potential signals of congestive heart failure for the drug. On February 22, 2011, the FDA revised the warnings and precautions section of dronedarone's label regarding patients with new or worsening heart failure during treatment to state that postmarketing cases of such problems have been reported. The label had originally stated that there were limited data for patients with atrial fibrillation/atrial flutter who develop worsening heart failure during dronedarone therapy, but nevertheless advised clinicians to consider suspending or discontinuing the drug if heart failure commences or worsens.
  • In the second quarter, AERS identified potential signals of torsade de pointes, a rare kind of ventricular tachycardia.
  • The list for the third quarter of 2010 listed a potential signal for an interaction with warfarin that increases its anticoagulant effect. On March 21, 2011, the drug interactions section of dronedarone's label was changed to mention postmarketing cases of higher internal normalized ratio (INR) clotting times with or without bleeding events in patients taking warfarin. Physicians were advised to monitor INR in such individuals. The label had originally stated that in clinical trials, "there was no observed excess risk for bleeding compared to placebo" when dronedarone was coadministered with oral anticoagulants to patients with atrial fibrillation/atrial flutter, and that INR should be monitored according to the warfarin label.
  • Potential signals of liver failure for dronedarone appeared in the watch list for the last 3 months of 2010. On February 11, 2011, the FDA changed the warnings and precautions section of the label to mention postmarketing cases of hepatocellular liver injury and acute liver failure, and the need to promptly discontinue dronedarone if such an injury is suspected. Other parts of the label were revised accordingly.
For more information, please read the source of this post:
The FDA has published its latest quarterly list of drugs to monitor after having identified potential signs of serious risks or new safety information. The new watch list covers the first 3 months of 2011. Here's the list for 2011 so far: 

Potential Signals of Serious Risks/New Safety Information Identified by AERS, January to March 2011
Product Potential Signal of a Serious Risk/New Safety Information Additional Information (as of May 31, 2011)
Adalimumab (Humira, Abbot Laboratories) Hepatic dysfunction, hepatic failure  
Azathioprine (Imuran, Prometheus) Acute febrile neutrophilic dermatosis (Sweet's syndrome) The label's adverse reactions section was updated in May to include Sweet's syndrome
Cetuximab (Erbitux, Eli Lilly and Bristol-Myers Squibb) Corneal infection, ulcerative keratitis, skin necrosis  
Dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) Labeling for proper storage and handling to preserve potency The FDA issued a safety communication on March 29 reminding users and pharmacies about the correct handling and storage of the drug
Dronedarone HCl (Multaq, Sanofi-Aventis) Renal impairment, renal failure  
Fibrin Sealant (Tisseel VH, Baxter Healthcare; Evicel, Omrix Pharmaceuticals) Graft failure in ophthalmological procedures and lack of efficacy in neurosurgical procedures for repair of dural tears Tisseel VH and Evicel have been used off- label in ophthalmological and neurosurgical procedures as tissue adhesives
Immune Globulin Subcutaneous (Human) 6% Liquid (Vivaglobin, CSL Behring) Thromboembolic adverse events have been reported in association with numerous product lots The product was taken off the market on April 4
Iron sucrose injection (Venofer, Luitpold Pharmaceuticals) Anaphylactic reactions  
Quinolone products Pseudotumor cerebri  
Malathion (Ovide, Taro Pharmaceutical Industries) Burns and burning sensations  
Mercaptopurine (Purinethol, Teva Pharmaceuticals) Hepatosplenic T-cell lymphoma  
Prasugrel HCl (Effient, Eli Lilly) Hypersensitivity reactions  
Rituximab (Rituxan, Roche) Hypogammaglobulinemia  
Ropinirole HCl (Requip, GlaxoSmithKline) Medication errors resulting from similarities in product name and labeling to risperidone  

Lilly Says Alzheimer Patients Didn’t Improve

Eli Lilly & Co. said patients with Alzheimer’s disease whose conditions worsened upon taking the experimental drug semagacestat didn’t improve after dosing was halted.
Lilly stopped development of the pill in August after data showed it harmed patients instead of helping them.

Even seven months after patients ceased the use of semagacestat, they still had more trouble with thinking, remembering and mental functioning than those who didn’t receive the medication, the Indianapolis-based company said today.


Saturday, July 16, 2011

FDA Investigates Bracco Diagnostics & Excess Radiation in PET Scans

The FDA  has warned about the potential for excess radiation exposure in patients who underwent heart scans involving a radioactive drug called CardioGen-82.

Bracco Diagnostics Inc. is the maker of this drug. It has been is used in some positron emission tomography, or PET, scans involving the heart in order to diagnose heart disease. Bracco Diagnostics is part of Bracco SPA, a private firm based in Milan, Italy. A company spokeswoman said the firm was working with FDA and other regulatory authorities to investigate the problem.

The agency said it recently became aware of two patients who underwent PET imaging scans with CardioGen-82 and were later found to have detectable levels of radiation several months after their PET scans. Both patients were crossing the border to or from the United States when radiation detectors identified radiation originating from them.

The FDA said it believes "that the risk of harm from this exposure is minimal, although any unnecessary exposure to radiation is undesirable." The total number of patients who might have been exposed to excess radiation is currently unknown, but the FDA said the investigation into the problem is continuing.

Source here.

Friday, July 15, 2011

Antipsychotics Used for Parkinson's Despite Warning

From Web MD:

Doctors continue to prescribe antipsychotic drugs to their patients with Parkinson's disease and psychosis, despite "black box" warnings from the FDA linking them to increased risk of death among patients with dementia, a study shows. A black box warning is the strongest drug warning issued by the FDA.

The study is published in the Archives of Neurology.

The black box warning for antipsychotics says the drugs are associated with an increased risk of death for those with dementia, which is common among people diagnosed with Parkinson's. Some commonly prescribed antipsychotics also worsen symptoms of Parkinson's.

Spiriva Risks for Cardiovascular Problems?

This news from several sources, including Pharmalot and the British Medical Journal. The conclusion is troubling - the "meta-analysis explains safety concerns by regulatory agencies and indicates a 52% increased risk of mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease.

What is Spiriva? Tiotropium bromide is a long-acting, 24 hour, anticholinergic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD). Tiotropium bromide capsules for inhalation are co-promoted by Boehringer-Ingelheim and Pfizer under the trade name Spiriva. It is also manufactured and marketed by Cipla under trade name Tiova. Source.

The study is titled, "Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials."


Objective To systematically review the risk of mortality associated with long term use of tiotropium delivered using a mist inhaler for symptomatic improvement in chronic obstructive pulmonary disease.

Data sources Medline, Embase, the pharmaceutical company clinical trials register, the US Food and Drug Administration website, and for randomised controlled trials from inception to July 2010.

Study selection Trials were selected for inclusion if they were parallel group randomised controlled trials of tiotropium solution using a mist inhaler (Respimat Soft Mist Inhaler, Boehringer Ingelheim) versus placebo for chronic obstructive pulmonary disease; the treatment duration was more than 30 days, and they reported data on mortality. Relative risks of all cause mortality were estimated using a fixed effect meta-analysis, and heterogeneity was assessed with the I2 statistic.

Results Five randomised controlled trials were eligible for inclusion. Tiotropium mist inhaler was associated with a significantly increased risk of mortality (90/3686 v 47/2836; relative risk 1.52, 95% confidence interval, 1.06 to 2.16; P=0.02; I2=0%). Both 10 µg (2.15, 1.03 to 4.51; P=0.04; I2=9%) and 5 µg (1.46, 1.01 to 2.10; P=0.04; I2=0%) doses of tiotropium mist inhaler were associated with an increased risk of mortality. The overall estimates were not substantially changed by sensitivity analysis of the fixed effect analysis of the five trials combined using the random effects model (1.45, 1.02 to 2.07; P=0.04), limiting the analysis to three trials of one year’s duration each (1.50, 1.05 to 2.15), or the inclusion of additional data on tiotropium mist inhaler from another investigational drug programme (1.42, 1.01 to 2.00). The number needed to treat for a year with the 5 µg dose to see one additional death was estimated to be 124 (95% confidence interval 52 to 5682) based on the average control event rate from the long term trials. 

Conclusions This meta-analysis explains safety concerns by regulatory agencies and indicates a 52% increased risk of mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease.


From the FDA in 2008:

Update 10/07/2008:  FDA’s Early Communication About an Ongoing Safety Review issued on March 18, 2008 stated that Boehringer Ingelheim, the maker of Spiriva HandiHaler (tiotropium bromide), had conducted a pooled analysis of 29 trials that suggested a small excess risk of stroke (2 cases per 1000) with tiotropium bromide over placebo. FDA has now received preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease (COPD).  The preliminary results of UPLIFT reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide (Spiriva HandiHaler) compared to placebo.
Two recent publications1, 2 reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes. Singh et al.1 performed a systematic review and meta-analysis of 17 clinical trials enrolling 14,783 patients treated with inhaled anticholinergic drugs used for the treatment of chronic obstructive lung disease. Lee et al.2 performed a case-control study of 32,130 patients (320,501 controls) treated with inhaled medications, including an anticholinergic, for the treatment of chronic obstructive lung disease.
FDA expects to receive the complete report for UPLIFT in November 2008.  Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.

1. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease.  JAMA 2008; 300 (12): 1439-1450.

2. Lee TA, Pickard S, et al.  Risk of Death Associated with Medications for Recently Diagnosed Chronic Obstructive Pulmonary Disease.  Annals of Internal Medicine 2008; 149: 380-39

Thursday, July 14, 2011

Georgia News: Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

News on July 13th from the FDA on transvaginal mesh products.What you should know about the recall: 
  • From 2008 to 2010, the FDA received 2,874 injury reports resulting from TVM.
  • Of these reports, three involved patients who died from those complications.
  • Research estimates 10% of women with TVM implants suffer from erosion within a year of surgery.

Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.

Stress Urinary Incontinence

Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.


On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.

Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.
The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.

For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.

Summary of Problem and Scope:

In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.

From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.

In particular, the literature review revealed that:
  • Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
  • Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
  • There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
  • While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.

Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.

Recommendations for Health Care Providers:

As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should:
  • Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
  • Be vigilant for potential adverse events from the mesh, especially erosion and infection.
  • Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
  • Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
  • Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh.
  • Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available

Wednesday, July 13, 2011

Ultimate Sports Spray Lawsuit Verdict

St. Louis Rams linebacker David Vobora during ...Image via Wikipedia
A Federal Court Judge in Missouri granted a verdict for St. Louis Rams linebacker David Vobora in his lawsuit against the maker of a sports supplement called Ultimate Sports Spray. Vobora claimed that the product had been made with the NFL-banned substance methyltestosterone, and that his use of the product  triggered a  positive doping test that resulted in Vobora’s four-game suspension in 2009. Vobora won $5.4 million in the judgment, reflecting lost marketing opportunities and lost wages (during suspension), as well as damage to his reputation.

In issuing the ruling the judge said the company—inamed Anti-Steroid Program LLC (aka S.W.A.T.S.), a Key Largo, FL-based company—intentionally misrepresented the supplement. Vobora reportedly had the product tested, revealing it contained methyltestosterone but did not list the ingredient on the label.

While Vobora cleared the two supplements via the NFL Hotline, the league has stated its policy holds strict liability on each player for what they put in their bodies.
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FDA: CytoSport’s Milk Shakes Contain no Milk

Pesky things, words. Why, if it's called a "milk" shake, that is what is in it right? Wrong.

CytoSport Inc.’s nutritional shakes are misbranded, according to FDA, because their labels prominently feature the word “MILK," however these products contain no milk.

In an FDA warning letter sent to Michael Pickett, chief executive officer and president of the company, the agency said the labels for “Chocolate Muscle Milk Protein Nutrition Shake" (14 fl. oz.), “Vanilla Crème Muscle Milk Light Nutritional Shake" (4-8.25 oz. servings) and “Chocolate Peanut Caramel Muscle Milk" (5.57 oz.) are in violation of section 403(a)(1) of the Federal Food, Drug, and Cosmetic Ac [21 U.S.C. § 343(a)(1)].

FDA added the actual statements of identity on the “Protein Nutrition Shake" and “Nutritional Shake" products are in significantly smaller and less prominent type than the words “MUSCLE MILK" on these product labels. Further, while the product labels include the statement "Contains No Milk" on the principal display panel, the ingredient statements say these products contain milk-derived ingredients, such as  calcium and sodium caseinate, milk protein isolate and whey. The allergen statement printed on both of these products states, ''This product contains ingredients derived from milk . . . ."

The “Contains No Milk" statement could give consumers the impression that these products are free of milk-derived ingredients, according to FDA.

The “Chocolate Muscle Milk Protein Nutrition Shake" and “Vanilla Crème Muscle Milk Light Nutritional Shake" products are also misbranded, according to FDA because they purport to be milk (by prominently featuring the word “MILK" on the labels), but do not follow federal regulation of the definition and standard of identity for milk.  The standard of identity for milk (21 CFR 131.110) describes milk as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows," and it lists the vitamins and other ingredients that may be added. According to the ingredient list on product labels, CytoSport’s products contain no milk and contain numerous ingredients not permitted by the standard.

 Imagine that.
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