Fluoroquinolones are a group of potent broad-spectrum antibiotics approved for the treatment and prevention of certain bacterial infections. Bayer’s Cipro (ciprofloxacin) and Ortho-McNeil’s Levaquin (levofloxacin) are the two most prominent examples of fluoroquinolone antibacterials, though fluoroquinolones are marketed under various other brand and generic names including Factive (gemifloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin, and generic ofloxacin and ciprofloxacin.

The new ‘black box’ warning labels follow in the wake of a lawsuit filed by consumer group Public Citizen against the FDA to force the agency to warn consumers and doctors of potential tendonitis and tendon rupture risks accompanying use of the drugs. Manufacturers of fluoroquinolone drugs will also be required to provide medication guides for patients and doctors detailing the drugs’ possible side effects.

While current fluoroquinolone warning labels do mention the elevated risk of tendon rupture, continued reports of tendon injuries led FDA officials to believe those warnings were not being heeded by enough doctors or patients.

Although the connections between fluoroquinolone use and tendon problems are not clearly understood right now, the FDA’s Dr. Renata Albrecht stated that studies have shown that fluoroquinolones can increase the risk of tendonitis and tendon rupture by as much as 400 percent.

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According to California Highway Patrol spokesmen, Bill Mesa, 57, and Roberts-Mesa, 29, had been at a family gathering Saturday afternoon before leaving on a Harley-Davidson motorcycle and crashing into a utility pole on Lyons Valley Road approximately a quarter-mile east of Skyline Truck Trail.

Alcohol is suspected as a factor in the crash, though Cheryl Mesa, Mesa’s wife of 31 years, denied the two were intoxicated at the time of the fatal wreck. Toxicology reports regarding the incident are expected in four to six weeks from the San Diego County Medical Examiner’s Office.

Mesa, a retired police officer boasting a 20-year record of service, had been involved for years with efforts to build a casino on his tribe’s six-acre reservation. San Diego County Second District Supervisor Dianne Jacob stated that while her position often brought her into conflict with him, Mesa worked tirelessly to accomplish what he believed to be the best for his fellow tribe members.

Roberts-Mesa was a lifelong East County resident who married Mesa’s son, Robert Mesa, less than a year ago. Roberts-Mesa had recently completed her master’s degree in public health at San Diego State University.

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The proposed warnings would be ‘black box’ warnings, which indicate that medical studies have shown that the labeled drug carries a risk of serious adverse side effects. ‘Black box’ warnings are the most serious warnings issued by the FDA.

An FDA analysis of epilepsy drugs released earlier this year showed that patients taking anti-seizure medications were around twice as likely to have suicidal thoughts and behaviors. Although three of the 11 drugs studied did not indicate an increased risk of suicidal problems, the proposed warning label would apply to all epilepsy drugs.

Among the drugs which would be newly labeled under the proposal are Lyrica, Gabitril, Trileptal, Lamictal, Topamax, Depakote, Tegretol, Felbatol, Neurontin, Keppra, and Zonegran; the affected drugs sold a combined total of over $8 billion last year. While around 2.7 million Americans have epilepsy, anti-seizure drugs are widely used to treat a variety of conditions including chronic pain, migraine headaches, and bipolar disorder.

A panel of outside medical experts is expected to discuss and comment on the proposed warnings at an FDA-sponsored public meeting on Thursday. Drug manufacturers including GlaxoSmithKline Plc, manufacturer of Lamictal, are also expected to comment upon the proposal at that time.

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The study, to be conducted at the Mesothelioma Center of the Herbert Irving Comprehensive Cancer Center at New York-Presbyterian Hospital and Columbia University Medical Center, will explore whether a combination of chemotherapy and radiation may be successful in treating the fatal disease by targeting cells on the surface of affected lungs while sparing healthy tissue. It is hoped that the new treatment will help preserve the quality of life of mesothelioma victims and improve treatment outcomes while avoiding the need for major surgery. The current standard treatment for mesothelioma is to remove the affected lung.

Mesothelioma is a form of cancer which has been directly tied to asbestos exposure. Pleural mesothelioma is most common form of the disease, accounting for around three-quarters of mesothelioma victims.

It is estimated that over 25 million Americans were exposed to asbestos between 1940 and 1979, and current trends indicate that the number of American citizens diagnosed with the disease may continue to rise in the near future. While incidence of mesothelioma is relatively rare, affecting approximately 15 people per million in the United States in 2004, the disease can occur between 20 to 50 years after asbestos exposure.

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By a vote of 14-2 on Wednesday, the panel of advisers advised the FDA to require drug makers to demonstrate that experimental diabetes drugs submitted for FDA approval do not increase cardiovascular risks. While the panel’s recommendations are not binding, the FDA generally tends to follows such recommendations as a matter of course.

Cardiovascular problems are the leading cause of death in diabetics. Last year, a firestorm of controversy erupted when GlaxoSmithKline’s Avandia, then the top-selling diabetes drug, was said to raise the risk of heart attacks in an analysis published in the New England Journal of Medicine. GlaxoSmithKline has consistently denied the allegations and asserts that Avandia is completely safe; the drug remains on the market despite an FDA safety alert regarding the potential heart safety issue.

If new, stricter standards are imposed, research and development costs for drug makers could rise in order to comply with new testing requirements. AstraZeneca and Bristol-Myers Squibb are expected to submit their new diabetes drug saxagliptin (proposed brand name Onglyza) for FDA approval soon; Merck has already received FDA approval for its diabetes drug Januvia, which would not be subject to any new requirements.

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Along with Continental Airlines, Continental mechanic John Taylor, Continental chief of maintenance Stanley Ford, Aerospatiale director Henri Perrier, former Concorde chief engineer Jacques Herubel, and Claude Frantzen of the French civil aviation authority were identified as defendants in the case.

In 2004, French investigators concluded that the July 25, 2000 crash of Air France Flight 4590 was caused by a titanium metal strip which fell off of a Continental Airlines DC-10 onto a runway at Charles de Gaulle airport and punctured the Concorde jet’s tires as it attempted to take off. The Concorde’s fuel tanks were also determined to be insufficiently shielded from shock, a defect Concorde’s makers were reportedly aware of since 1979.

Continental, which has consistently denied responsibility for the crash, vehemently denounced the indictments in an official statement and characterized the charges as “outrageous” and “completely unjustified.” If found guilty in the case, said to be likely to begin in 2009, Continental could face a multi-million dollar fine.

Flight 4590 was the only fatal Concorde flight in the aircraft’s 27-year history of regular service. The 2000 crash led to all Concorde airliners being withdrawn and refitted with additional safety modifications before being officially retired in 2003.

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Under the terms of the agreement, all airlines arriving at or leaving from airports located within the EU would be subject to emissions caps and emissions credits trading rules intended to reduce airline emissions to 95 percent of 2004-2006 emissions levels by 2012.

Because the terms of the agreement mean that the restrictions would also apply to non-EU carriers, international trade groups such as the US Air Transport Association, the International Air Carrier Association, and the Association of European Airlines were quick to express displeasure with the decision. Following the announcement, the director general of the International Air Transport Association called the decision “crazy” and asserted that jurisdiction over international emissions standards should fall to the International Civil Aviation Organization, a United Nations body.

Airline industry lobbyists also indicated that any costs incurred by US airlines required to purchase emissions credits to operate within the EU would likely pass those costs on to consumers and that air carriers are already financially stressed due to the rising cost of aviation fuel.

Before taking effect, the emissions agreement must be approved in a European Parliament vote (currently scheduled for July 9) and ratified by the governments of the individual EU countries.

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The new amount of the punitive damage award was set at $507.5 million, equivalent to the amount of compensatory damages in the case. The amount of the punitive award had originally been set at $5 billion in 1994, but was reduced upon appeal. Including interest since 1989, the current value of the punitive amount is estimated to be around $1 billion.

Justice David Souter, who authored the majority opinion in the decision, indicated that the ruling was intended to curb the unpredictability of punitive damages in maritime liability cases and establish a standard limiting the amount of punitive damages in maritime law cases to the amount of compensatory, or actual, damages in a particular case. While this new 1-to-1 ratio currently applies only in maritime shipping cases, advocates of limitations on punitive awards hailed the decision and stated that while the new standard is not binding outside of maritime law, the justices’ decision is likely to become influential in a broad range of tort law cases.

Justices John Paul Stevens, Ruth Bader Ginsburg, and Stephen Breyer dissented from the majority opinion in the case. Justice Samuel Alito recused himself from the case due to his ownership of Exxon Mobil stock.

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The northern face of the fourth through seventh floors of the 30-story Hilton San Diego Bayfront hotel were knocked out by the explosion, which occurred about 2 p.m. Pacific Daylight Time on Monday. Nine construction workers injured in the blast and one firefighter were transported to UCSD Medical Center, where five workers were admitted in critical condition. Three of those critically injured workers have been placed in medically induced comas to receive treatment for second and third degree burns covering up to 35 percent of their bodies. Four other workers were treated at Scripps Mercy Hospital.

While onlookers and first responders expressed initial concerns that the blast could have been the work of terrorists and arson and bomb squad investigators were summoned to the scene, a spokesman for the San Diego Fire-Rescue Department said that the explosion was caused by an accumulation of natural gas which was ignited by an as-yet undetermined source, most likely an electrical spark or boiler flame.

The 1,190-room hotel was previously scheduled to open in December. It is undetermined whether the opening will be delayed due to the damage.

The accident scene is currently under investigation.

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Daniel C. Price, of La Mesa, California, was diagnosed as having contracted the West Nile Virus from a mosquito bite while employed by marine construction contractor Connolly-Pacific. Although Price worked on board the derrick barge “D.B. Long Beach” five days per week, he was not required to live aboard the vessel. Instead, Price was given special permission to park a camper truck in a Connolly-Pacific parking lot near the job site.

After contracting the virus, Price was unable to return to work and his employment was subsequently terminated. Citing maritime law provisions requiring vessel owners to provide “maintenance and cure” to injured or ill seamen in their employ, Price filed suit against Connolly-Pacific for compensation for his food, lodging, and medical care.

Although Connolly-Pacific conceded that it was likely that Price contracted the virus during the period he was employed by the company, the California Court Of Appeal, Second Appellate District affirmed that because Price was not obligated to remain on company property after his working hours, he was not covered under the “maintenance and cure” provision, which was intended to cover “blue water” seamen who are required to live aboard a vessel during the entire period of their employment.

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