News and Events - 21 Feb 2012

New Diet Pill Side-Effects Under Scrutiny By FDA Regulators

2012-02-20 09:36:10

A weight-loss drug currently under a second review from the Food and Drug Administration (FDA is causing concerns that it may be responsible for birth defects and heart problems, according to documents released by the agency on Friday. The drug, developed by Vivus, was rejected by the agency in 2010, largely because of those risks. A committee of outside advisers to the FDA will meet this week to reconsider whether the drug, called Qnexa, should move forward in the approval process, reports Andrew Pollack for the NY Times. Obesity specialists and patient advocates agree there is a huge need for obesity drugs to bridge a treatment gap between diet and exercise, which do not work for many people, and bariatric surgery, which is expensive and not suitable for those with specialized medical conditions. The FDA, however, has been cautious with approving diet drugs, in part because with two-thirds of American adults overweight or obese, such drugs might be used for a long time by millions of people. There is an FDA Advisory Panel meeting this month that is tasked with combing through 2-years’ worth of clinical data. When Qnexa was last reviewed, the Agency only had 1-year’s worth to examine. The Advisory Panel will have to discuss and vote on whether to recommend supporting or declining the obesity drug after carrying out an overall benefit-risk assessment, reports Christian Nordqvist for Medical News Today. The FDA can choose to accept or reject the non-binding decision but this hardly ever happens. Therefore, Qnexa’s future, at least this time around, depends on what happens this week. When the FDA previously turned Qnexa down, it asked Vivus for more clinical data on the medication’s potential impact on major adverse cardiovascular events and birth defects. One question the advisory committee will be asked to consider is whether Vivus should be required to conduct a large new clinical trial before the final approval is given to assess whether the drug increases the risk of heart attack. Facing more delays, possibly by several years, Vivus has proposed doing the study after approval. Studies also show that the use of topiramate during pregnancy increases the risk of oral clefts, such as cleft lip, by a factor of two to five, according to the FDA staff review released last week. That is a concern, the reviewers said, because “the major consumers of weight-loss drugs are women of childbearing potential,” leading to “the potential for large numbers of pregnancy exposures.”

Qnexa was picked as the most suitable weight loss drug because of the high level of weight loss reported in company studies, with an average of more than 10 percent total body mass reduced among participants of the study, USA Today is reporting. Reviewers for the FDA were still guarded in their approval. “Overall, the long-term clinical impact of the observed modest improvements in comorbidity outcomes is uncertain, particularly in a population with higher risk of CV adverse events,” the FDA wrote, referring to cardiovascular events such as heart attacks. The main cardiovascular concern is that Qnexa increases heart rate. Still, the reviewers did say that the effect of the drug in lowering blood pressure was “somewhat reassuring.” --- On the Net:

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  Food and Drug Administration (FDA
  
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  Vivus
  

Study shows increased heart attack risk with Pradaxa® use

20.02.2012 20:33:06

According to a study conducted by the researchers at Cleveland Clinic,
Pradaxa use may increase the risk for suffering a heart attack, or symptoms of heart disease by 33%. Researchers Ken Vchino, ivID and Adrian V. Hernandez, MD, PhD reviewed 30,514 patients though out seven clinical trials. The study compared Pradaxa with other similar medications such as warfarin.

Pradaxa (dabigatran is a blood thinning medication, or anticoagulant, and is included in a class of drugs known as “direct thrombin inhibitors”. Health care professionals typically prescribe the drug to patients with non-valvular atrial fibrillation, a condition in which the heart does not beat properly. Due to this condition, the blood does not flow the way it should causing blood cells to form into clots, or coagulate. These blood clots travel to the brain and cause stroke, or to the lungs and cause pulmonary embolisms. Pradaxa is designed to treat atrial fibrillation by preventing the enzyme which causes blood cells to clot.

The Food and Drug Administration approved Pradaxa in October of 2010. Shortly after the medication was approved, the health regulating agency received numerous reports from consumers who claim to have suffered from
side effects of Pradaxa.

Some reported side effects include heart attack, acute coronary syndrome, brain hemorrhaging, gastrointestinal bleeding, internal bleeding, and even death. The FDA has not issued a recall on Pradaxa, however, the agency released a
safety communication stating that they are investigating reports of internal bleeding.

Common symptoms of internal bleeding may include bruises with unknown causes, red or black stools, coughing up blood, unexpected bleeding, blood in vomit, and unexpected pain or swelling.

”The risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted dose warfarin, [Lovenox®], or placebo," Vchino and Hernandez concludes from the study.

Pradaxa attorneys are currently reviewing cases filed by individuals who suffered severe side effects.

Tags: 

Pradaxa

http://consumer-drug-report.com/content/study-shows-increased-heart-attack-risk-pradaxa-use#comments

Judge mandates separate MDLs for vaginal mesh lawsuits

20.02.2012 19:19:51

On Tuesday February 7, 2012 the U.S. Judicial Panel on Multidistrict Litigation issued an order mandating that all
vaginal mesh lawsuits, filed against manufacturers American Medical Systems, Inc., Boston Scientific Corp., and Ethicon, Inc., be separated during multidistrict litigation (MDL .

A number of lawsuits have been filed in recent months claiming vaginal mesh complications.
Vaginal mesh is a surgical mesh implanted in women that have pelvic organ prolapse or stress urinary incontinence.

Women who have had vaginal mesh surgically implanted reported that the side effects caused by the mesh are painful and debilitating. The complaints filed against the manufacturers of vaginal mesh claim that injuries such as mesh erosion, damage to the pelvic floor, infection, inflammation, and much more were caused by the mesh.

The Food and Drug Administration issued a warning regarding the dangers of surgical mesh in 2011. In this warning, the health agency advises that health professionals seek all other treatments for pelvic organ prolapse and stress urinary incontinence first before considering surgical mesh.

In 2011, the FDA also revealed that there was not sufficient evidence to suggest that there are any major benefits to
surgical mesh for the treatment of pelvic organ prolapse over other treatments.

American Medical Systems, Inc. currently faces about 84 pending lawsuits in 19 federal district courts in the U.S. The Boston Scientific Corp. is up against 23 pending lawsuits in 14 district courts, and Ethicon, also known as Gynecare, faces 37 pending lawsuits in 22 district courts.

All
vaginal mesh lawsuits will be transferred to the Southern District of West Virginia before Judge Goodwin for pretrial proceedings. This will prevent scheduling conflicts and will benefit those involved in the lawsuits. Since each lawsuit involves different manufacturers, each lawsuit will be kept separate.

Tags: 

transvaginal mesh

transvaginal mesh attorneys

transvaginal mesh lawsuits

mesh

surgical mesh

http://consumer-drug-report.com/content/judge-mandates-separate-mdls-vaginal-mesh-lawsuits#comments

Should We All Be Doing Inhalable Caffeine, or What? [Health]

20.02.2012 17:47:41

The FDA is
going to investigate whether the "Aeroshot" canisters of inhalable caffeine are actually safe. When you hear about widely available and totally unregulated drugs like this that are available with absolutely no medical supervision whatsoever to any kid who wanders into a convenience store, it makes you ask: is that stuff any good?
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US: FDA Ignores Scientists, Dentists Warning of Amalgam Mercury Pandemic

19.02.2012 23:42:00

Mercury found in dental amalgam fillings has been an issue within the dental community and beyond for many years. These fillings, used since the American Civil War, contain an estimated 50 percent mercury. Whenever friction meets these fillings, toxic mercury gases are emitted. This means that with each chew and dental drill comes an emission of mercury gases, leading to numerous health problems. While nearly half of dentists have stopped using amalgam fillings due to health dangers, the Food and Drug Administration has yet to act on these issues. In December 2010, the Food and Drug Administration convened its second scientific advisory panel on dental amalgams. Scientists yet again told the FDA that amalgam use in children, pregnant women, and hypersensitive adults must come to a halt. The toxic vapors emitted are harmful to everyone, but these groups of individuals especially suffer. According to Campaign for Mercury Free Dentistry:

Dr. Kotagal said there is "no place for mercury in children," Dr. Ismail said "children less than 6 years of age, I would restrict it significantly," Dr. Thompson said "definitely not in pregnant women and definitely not in those below 6 years of age," Dr. Fleming said we need contraindications for pregnant women, and Dr. Burbacher said, "why put amalgams in children if we know they're going to live with that for the rest of their lives? And we don't know what that's going to do."

Health Highlights: Feb. 20, 2012

20.02.2012 16:38:07

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Inhalable Caffeine Product to be Reviewed by FDA The safety of an inhalable caffeine product called AeroShot will be reviewed by the U.S. Food...

FDA to review inhalable caffeine

19.02.2012 20:40:40

U.S. Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-sized canisters is safe for consumers and if its manufacturer was right to brand it as a dietary supplement.

APNewsBreak: FDA to review inhalable caffeine (AP

20.02.2012 18:25:00

AP - U.S. Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-sized canisters is safe for consumers and if its manufacturer was right to brand it as a dietary supplement.

FDA to probe safety of inhalable caffeine

19.02.2012 18:54:01

U.S. Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-sized canisters is safe for consumers and if its manufacturer was right to brand it as a dietary supplement.