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FDA Says Ranbaxy Filed Corrective Action Plan

In an effort to resume imports of its generic drugs, Indian drug maker Ranbaxy Laboratories LTD has filed a corrective action plan with the U.S. Food & Drug Administration (FDA). The FDA barred some of Ranbaxy’s drugs from import to the U.S because of concerns about the safety of medications made at some of its overseas plants.

Based in India, Ranbaxy is one of the 10 largest generic-drug producers in the world and has been operating in the States since 1995. It has been involved in several scandals over the past year.  As we reported last September, the FDA had imposed an import ban on 30 different Ranbaxy drugs  because of the agency’s concerns about the “seriousness and extent” of violations of manufacturing standards at its  Paonta Sahib plant and a second  Ranbaxy facility in India.  At the time, officials said they were concerned about whether the practices employed at the facilities could ensure purity of drugs they made. (more…)

Texas, Illinois Latest States to See Avandia Lawsuits

Avandia lawsuits  have recently been filed by people in Texas and Illinois who claim the drug caused them or a loved one to suffer heart problems.

The Texas lawsuit, filed on May 13 in the U.S. District Court of the Eastern District of Texas, Texarkana Division, involves a man who had to have heart bypass surgery after having taken Avandia for five years.  The lawsuit alleges that GlaxoSmithKline employed “spectacular” marketing and distribution strategy despite knowing that “its drug was unreasonably dangerous and that the diabetic patient population was uniformed of the dangers.” (more…)

MDL Urged for Chinese Drywall Lawsuits

Parties involved in Chinese drywall lawsuits from around the country have petitioned to have them consolidated and transferred to a single jurisdiction.

Earlier this month, the Judicial Panel on Multidistrict Litigation  in Louisville, KY heard oral arguments requesting that all pending Chinese drywall cases filed around the country be consolidated and transferred to one jurisdiction.  A multidistrict litigation (MDL) allows all cases to be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court. When lawsuits are consolidated as an MDL each retains its own identity. If the MDL process does not resolve the cases, they are transferred back to the court where they originated for trial. (more…)

Doctors Warned of Fungal Infections With Simponi

A new TNF-alpha blocker called  Simponi may  cause severe and potentially fatal fungal infections, according to a  new “Dear Healthcare Professional” letter recently issued by Centocor Ortho Biotech, Inc.  Simponi was only approved in April as a treatment for adult patients with: moderate to severe rheumatoid arthritis in combination with methotrexate, psoriatic arthritis (either alone or in combination with methotrexate), and ankylosing spondylitis.

In the letter, Centocor Ortho  warns that invasive fungal infections are not consistently recognized in patients taking  TNF-alpha blockers.  This has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death.  For patients who reside or travel in regions where mycoses are endemic (eg, Ohio and Mississippi River valleys and southwestern United States), invasive fungal infection should be suspected if they develop a serious systemic illness,  the letter  warns. (more…)

Product Recalls: “Jitterbug” Cell Phones, Trampolines

“Jitterbug” cell phones and backyard trampolines are the latest product recalls announced by  the Consumer Products Safety Commission (CPSC).

“Jitterbug” Cell Phone Recall
Samsung Telecommunications of America is recalling 160,000 “Jitterbug” cell phones because of a defect that could result in  failure to connect to emergency 911 when the phones are in a no-service area and display an “out of range, try again later” message.   (more…)

Banco Santander to Pay $235 Million in Settlement with Madoff Trustee

Spain’s Banco Santander has reached a deal with the Bernard Madoff trustee, and will pay $235 million to Irving Picard to avoid being named in a claw back lawsuit, Bloomberg.com is reporting.  The settlement involves two hedge funds were operated by Santander’s Optimal Investment Services unit that invested heavily with Madoff.   Santander said that its agreement with Picard did not imply any wrongdoing on its part.

On March 12, Madoff pleaded guilty to 11 fraud counts. The former chairman of the NASDAQ stock exchange ran an investment advisory business for decades that was, in reality, a Ponzi scheme. Madoff faces up to 150 years in prison, and is scheduled for sentencing next month. (more…)

Decision on Expanded Botox Approval Delayed

The Food & Drug Administration (FDA) has delayed a decision on the approval of  Botox as a treatment for upper limb spasticity in stroke victims.  The agency is seeking more information from Botox maker, Allergan.

According to Reuters, the FDA wants to review  Allergan’s proposed Risk Evaluation and Mitigation Strategy [REMS]  plan for Botox  before making a decision on its application for expanding its use.  The agency is also seeking additional documentation and analysis of a clinical study included in the approval application. Finally, the FDA has also proposed certain label revisions, including one that could broaden Botox use to upper limb spasticity regardless of underlying cause, Reuters said. (more…)

Another VA City Bans Chinese Drywall

Virginia Beach, Virginia has become the second community in that state to ban the use of  Chinese drywall with the past week. According to WAVY.com, the Virginia Beach Chinese drywall ban becomes effective today.

The uncertainty surrounding the Chinese drywall had already prompted the city of Norfolk, Virginia to ban the material last week.  The Virginia Beach ban passed unanimously in City Council last night.  According to WVEC.com, councilman Jim Wood said the new ban would be enforced on the honor system.  “Right now you’re not allowed to use a lot of substances in construction.  You can’t use lead based paint, you can’t use asbestos,” Wood said.  “So the city doesn’t go out and specifically inspect for that, but you know you’re not supposed to use it.” (more…)

Avastin Tied to Holes in Gastrointestinal Tract

Researchers at Stony Brook University Medical Center in New York have confirmed that cancer patients treated with  Avastin are more likely to suffer gastrointestinal perforations – than those being treated with other drugs.  What’s more, such perforations are more likely to prove fatal when they occur  in people treated with Avastin.

The Stony Brook study involved 12,300 cancer patients in 17 clinical trial.  Of those patients, 6,490  took various doses of Avastin.  According to a report on WebMD, about 1% of Avastin patients developed holes in the gastrointestinal tract – twice the rate seen in patients not taking Avastin.  (more…)

Feds to Look at Virginia’s Chinese Drywall Problems

The search for answers to the growing Chinese drywall problem will soon be moving to Virginia.    According to WVEC.com, the Consumer Products Safety Commission (CPSC) is expected to be in the state in “a week or so” to test homes with Chinese drywall.  The CPSC has already been testing Chinese drywall homes in Florida.

At a Senate hearing last week, Senator Mark Warner (D-VA) voiced concerns that the Chinese drywall problem could turn out to be much worse than first thought.  “I fear that we’re just at the tip of an iceberg of what could be a… national disaster, that is both a health care disaster and for many families is going to be a financial disaster,”  Warner said. (more…)

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