Product Liability Attorney Blog

The Food and Drug Administration has urged health care professionals to carefully consider whether the benefits of prescribing the antibiotic drug Levaquin are outweighed by the risks.

Those risks include pain, swelling, inflammation and tears of the tendons including the shoulder, hand and Achilles located at the back of the ankle. The odds that a patient will experience a debilitating and painful tendon tear or tendinitis are increased if the patient is over the age of 60, taking steroids, and a kidney, heart or lung transplant. Patients may experience tendinitis or tendon rupture while taking Levaquin or long after drug therapy has ended.

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According to a report released by the nonprofit Institute for Safe Medication Practices, the U.S. Food and Drug Administration received a record number of adverse drug-reaction reports in the first quarter of 2008.

The FDA received almost 21,000 serious adverse reactions in the first three months of 2008, including 4,800 deaths.

Chantix, Pfizer’s anti-smoking drug, and the blood thinner heparin were the two drugs that accounted for highest number of serious problems.

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The U.S. Food and Drug Administration will open an office in China before the end of the year, according to a statement released by the federal government last week.

The FDA’s first office will open in Beijing and subsequent outposts are planned for Shanghai and Guangzhou, the Associated Press reports. A total of eight staffers are expected to man the three offices.

In addition to China, food and drug regulators are expected to be placed in India, Latin America and the Middle East.

The announcement comes after the safety of imported food and drugs has come under fire. There have been at least 149 deaths in the U.S. of people who had allergic reactions after receiving contaminated doses of the Chinese-made blood thinner heparin.

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Bank of America Corp. has agreed to buy back as much as $4.7 billion in auction-rate securities as part of a settlement announced Wednesday.

According to the Securities and Exchange Commission, the settlement would cover about 5,500 investors, small business and charities left holding the frozen investments when the market collapsed in February.

Bank of America reached the settlement with the SEC, the New York attorney general’s office and a coalition of state regulators. The agreement resolves the government agencies’ claim that BOA lied to its customers when it told them that auction-rate securities were as safe as cash.

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The general counsel of UBS’s investment bank has agreed to pay $6.5 million in order to settle a claim of insider trading involving auction-rate securities.

The settlement was reached yesterday between former senior UBS executive David Aufhauser, 57, and the New York attorney general’s office. Last August, as the New York attorney general Andrew Cuomo investigated UBS’s sale of auction-rate securities, Aufhauser resigned.

Cuomo’s office sued UBS for insider trading, alleging that several senior executives traded $21 million worth of auction-rate securities knowing the market was about to collapse.

Aufhauser is notable not only because he was a top executive at UBS but he was also the highest ranking in-house lawyer at the Treasury Department and served on the Justice Department’s corporate fraud task force.

Aufhauser will give up a $6 million bonus he was to receive from UBS and will pay a $500,000 penalty. In addition, he is barred from working in the securities industry for two years and may not work as an attorney for two years.

In a news release from the New York attorney general’s office, Andrew Cuomo stated:

“While thousands of UBS customers were kept in the dark as the auction rate market began to collapse, David Aufhauser, one of the company’s top executives, acquired insider information and quietly dumped his personal holdings of auction rate securities.”

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Levaquin, a powerful antibiotic used to treat lung, sinus, skin and urinary tract infections, has been linked to serious side effects, including increased risk of tendinitis and tendon rupture.

Made by Ortho-McNeil-Janssen Pharmaceuticals, Levaquin (known generically as levofloxacin) was approved by the U.S. Food and Drug Administration to treat bacterial infections in many different parts of the body. The drug can be administered in the form of a pill, as an injection or in an intravenous drip.

On July 8, 2008, the FDA issued an alert requiring Ortho to add a black-box warning to Levaquin’s label. The warning advises patients that Levaquin increases their risk of tendinitis—inflammation or irritation of a tendon, one of the thick fibrous cords that connect muscle to bone. Some patients who have taken Levaquin have reported the rupture of tendons in the shoulder, hand and heel.

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