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Liver Failure Deaths Linked to Avandia

Public Citizen said yesterday that federal regulators have received 14 reports of Avandia-induced liver failure, including 12 deaths.  The consumer group is now calling on the Food & Drug Adminsitration (FDA) to ban the diabetes drug once and for all.

“The scientific evidence against Avandia is overwhelming,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in  news release. “The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug.” (more…)

PML Reported in Another Tysabri Patient

Another patient – the third since August – has developed the brain infection progressive multifocal leukoencephalopathy (PML) while taking Tysabri.

In August, Biogen Idec announced that Tysabri had been associated with two other cases of PML, this time among patients taking it in Europe. One patient had been taking Tysabri for 14 months and the other for 17. (more…)

Deaths Prompt Thoratec Heart Pump Recall

The Thoratec Company is urging patients with its HeartMate II Left Ventricular Assist System (LVAS) blood pump to have their doctors check the device, after they were linked to the deaths of five patients. Thoratec said it has confirmed 27 reports where wear and tear to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants.

All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. However, in five cases, pump replacement was not feasible and the patients died  The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months. (more…)

More Radon Dangers at Fernald Plant, Study Says

A new study says that workers at the Department of Energy’s (DOE) Fernald Plant near Cincinnati faced more danger from radon emissions than previously thought. An older study had identified two silos on the west side of the Fernald plant as the only source of radon exposure.  But researchers from the University of Cincinnati  said that review, conducted by the federal government, overlooked six other  silos cited in their study as a source of radon emissions.

The Cincinnati researchers said that the six silols, which once stored uranium in the plant’s production area exposed 12 percent of the workers at the Fernald plant to dangerously high levels of radon.  More than half of the workers at the plant would have been exposed to low levels of radon, the study said. (more…)

FDA Reviewing Chantix for Traffic Accident Link

After receiving dozens of traffic accident reports involving Chantix users, the Food & Drug Administration (FDA) is reviewing the drug again to see if the safety information on its label is adequate.

The FDA has already reviewed Chantix for a possible link to suicide and suicidal behavior.  In February, the agency asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning – the agency’s highest safety alert. (more…)

Regions Morgan Keegan Deceived Investors, Report Says

A newly released report concludes that  Regions Morgan Keegan misled investors about the risks associated with its bond funds, costing them millions of dollars.  The Memphis, Tennessee-based firm has already been named ins several class action lawsuits that alleg investors were not informed of the true risks associated with some of its bond funds to until well after they sustained significant losses in 2007.

In 2007, investors who purchased shares of the Regions Morgan Keegan Select Intermediate Bond Fund and Regions Morgan Keegan Select High Income Fund from December 6, 2004 through October 3, 2007 lost a total of $2 billion.  It was then that they learned that mortgage-backed securities and collateralized debt obligation (CDO) made up over 50 percent  of each fund’s portfolio.  (more…)

Group Details More Chantix Side Effects, Deaths

A report by the Institute For Safe Medicine Practices found that Chantix was the subject of 1001 adverse event reports in the first quarter of 2008 – the most attributed to any medication during that time period.

In May, researchers at the same Institute reported that Chantix had been the subject of   224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. At that time, there were also reports of a dozen traffic accidents linked to Chantix.  That study prompted the Department of Transportation, the Federal Aviation Administration and the Department of Defense to restrict the use of Chantix. (more…)

Treatment for Stress Urinary Incontinence, Pelvic Organ Prolapse Tied to Complications

Federal regulators are warning that transvaginal placement of surgical mesh, a common procedure used to treat Stress Urinary Incontinence and Pelvic Organ Prolapse in woman, has been linked to serious complications.  In 2006, one type of surgical mesh used in this procedure, the Mentor ObTape Vaginal Sling, was removed from the market because of its high complication rate.  Now, the Food & Drug Administration (FDA) is warning that other surgical mesh products are causing similar problems when used in this procedure.

According to the FDA, during the last 3 years, 9 surgical mesh manufacturers have submitted more than 1000 reports of complications that have included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.  The FDA said that bowel, bladder, and blood vessel perforations have also been reported. In some cases, vaginal scarring and mesh erosion have led to significant discomfort and pain, significantly decreasing the patient’s quality of life. (more…)

Two Infant Deaths Prompt Another Crib Recall

For the second time this month, a manufacturer is recalling defective cribs that have killed children.  This time, Delta Enterprises of New York City is recalling 1.6 million drop side cribs for entrapment and strangulation hazards.

Last week, Playkids USA of Brooklyn, New York recalled 2000 portable cribs  following the death of a 5-month-old child.  The cribs involved in the Delta Enterprises have been implicated in the deaths of two 8-month-old infants. (more…)

To Shore Up Bottom Line, Merck Markets Gardasil To Older Women

To prop up flagging sales, Merck & Co. is focusing Gardasi marketing efforts on women aged 19-26, even though many experts believe the vaccine is of little benefit to people in this age group.  Faced with declining sales of  Vytorin and Zetia, as well as questions about the safety of Singulair, its top-selling drug, Merck desperately needs to prop up Gardasil sales.

According to Bloomberg.com, US sales of Gardasil dropped by 33 percent this past summer.  To reach the older age group, Bloomberg.com reports that Merck is advertising on the networking Web site Facebook.com and in college bookstores and coffee shops. The company has also been selling $32 cervical-cancer awareness charm bracelets on the Internet. And, Merck is seeking Food & Drug Administration (FDA) approval to market Gardasil to women through age 45. (more…)

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