Levaquin (also known as levofloxacin) is a popular antibiotic that has been used for years for the treatment of upper respiratory infections, urinary tract infections, prostatitis, and bacterial infections.  It is part of a class of drugs known as fluoroquinolones, which were first marketed in the United States in 1997.  The fluoroquinolone class of drugs also includes the widely-prescribed antibiotics Cipro, Floxin, and Noroxin.  There have also been some notable fluoroquinolones that have been withdrawn from the market due to safety concerns, including Trovan (liver failure); Omniflox (low blood sugar; kidney failure, and anemia); Raxar and Zagam (prolonged QT syndrome); and Tequin (severe blood sugar reactions).

For several years, there have been rising concerns about adverse events associated with use of fluoroquniolones, especially Levaquin.  According to documents filed in the Levaquin litigation, being coordinated in the United States District Court in Minnesota, the Japanese company (Daiichi Pharmaceutical Co. Ltd.) that developed both Levaquin and Floxin knew prior to approval of Levaquin for sales in the United Sates that the drug was likely to cause Achilles tendon ruptures . This risk was well documented in the early years after introduction as it was marketed throughout Europe and began to cause harm to patients.

The warning label for Levaquin has included mention of the possibility of tendon ruptures in the past, but such labels were obscure and never adequately warned patients or prescribing physicians of the magnitude of the risk or the fact that Levaquin was more toxic than other, similarly effective drugs.  Other than placing a warning in December of 2001, based on postmarketing surveillance reports in the PDR, indicating that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly, the manufacturer did not provide any special label precautions. The manufacturer fell far short in their warnings, regarding the higher risks faced by older patients or those concomitantly taking steroids.

This is most unfortunate because deleterious effects of fluoroquinolones on tendons have been well documented since the 1980s .

Finally, in 2008, after more than 1,000 reports of serious tendon injuries and ruptures to the FDA, a Black Box warning (the highest level of warning) appeared on the label confirming that patients taking Levaquin are at greater risk for suffering a ruptured Achilles tendon.   Unfortunately, the label still fails to alert physicians and patients that Levaquin is more toxic than other similar drugs .

Levaquin is particularly risky for patients who are over the age of 60 and taking corticosteroids at the same time as Levaquin.  Studies conducted by the manufacturer  indicated that Levaquin was more toxic than Cipro; for example the study that Ortho McNeil completed in 2001, one that Johnson & Johnson completed in 2006 and another By Johnson & Johnson completed in 1993. Unfortunately, none of the studies conducted by these manufacturers were published in any noted journals . Undoubtedly, if this information were known to physicians in the Untied States, prescribers would have evaluated the risk differently and chosen one of a number of other antibiotics for treatment of their patients. As a result, doctors might have avoided subjecting their patients to the unnecessary pain and suffering associated with an Achilles tendon rupture and a host of other adverse events.

(more…)

Merck’s nightmare over Vioxx continues.  This is one that has cost the company dearly – on Wall Street, among physicians, in scientific circles, in the judicial system, and in the court of public opinion.  The latest blow came from the New England Journal of Medicine which published additional information regarding the APPROVe study, one of two studies that led to the recall of Vioxx in September of 2004.  This study included 2,586 patients who ingested Vioxx or a placebo.  After three years of use of these drugs, the study concluded that Vioxx users had a 3.6% incidence of thrombotic events (heart attacks and strokes) versus a 2% incidence in the placebo group.  The study further concluded that the increased risk of heart attacks and strokes associated with Vioxx emerged after just 18 months of use. 

As has been highly publicized, more than 50,000 patients who suffered heart attacks, strokes or died after ingesting Vioxx are now participating in a nearly $5 billion settlement program being administered through the federal court in New Orleans.  This settlement was announced after more than a year of secret negotiations and more than a dozen trials.  Just prior to announcement of the settlement, Merck faced the prospect of spending far more than $5 billion in order to continue its win-at-all-costs litigation tactics.  The Vioxx claims were submitted to a Claims Administrator over the Summer and partial payments began in August of 2008.  It is expected that all of the qualifying Vioxx claimants should have their claims reviewed and paid in full within the next 18 months.

A September of 2008 study published in the journal Radiology, sought to further identify those patients most at risk for the development of nephrogenic systemic fibrosis (NSF) as a result of exposure to gadolinium-based contrast agents.  Nephrogenic systemic fibrosis is an incurable, devastating disease that manifests itself as significant skin thickening, widespread fibrosis, and joint contractures.  This particular disease has only one cause – contrast agents commonly used in magnetic resonance imaging (MRIs) and angiograms.

In this study, the researchers reviewed medical records for nearly 75,000 patients treated at two hospitals over a ten-year period. The study noted that standard lab measurements of renal function were helpful in identifying patients most at risk for development of NSF.  Patients with a glomerular filtration rate (eGFR) of less than 15 were at highest risk, although NSF cases were also noted in patients with eGFR scores as high as 30.  This study is consistent with others that have confirmed that a wide range of patients are at risk for development of NSF, not just those patients with advanced renal failure.  The study noted that a shocking 8.8% of patients with an eGFR of less than 15 (and not undergoing dialysis) developed NSF. The study also concluded that patients receiving the highest doses of gadolinium faced the highest risks of developing NSF .

Caffeine, hands down, is the most popular, legal and widely abused drug on the planet.  It’s in everything including: caffeinated snacks; soft drinks; alcoholic beverages; over the counter supplements; not to mention popular face cream and products that boast a remedy for cellulite. Caffeine is legal, but even too much of a good thing can cause harm.  Perhaps the fastest growing new line of caffeine containing products is energy drinks. Blogger and author of “Nutrition for Dummies”, Carol Ann Rinzler, examined the labels of the top three energy drinks. (more…)

In the last couple of years, it seems as if there has been an increase in the recalls issued by the FDA; contact lens solutions, tainted meat, poisonous vegetables, toxic toys and poisonous pet food to name just a few. In response to concerns over the recent headlines“Infant Formula from China Tainted by Chemical”, the FDA has issued a warning that toxic baby formula “even though it is not legally approved for importation” may have made its way into local markets here in the USA.

The concerning chemical in the formula is melamine. As some of you may recall Melamine is the same chemical associated with the massive pet food recall in 2007 after thousands of U.S dogs and cats were poisoned and killed after ingesting toxic pet food. It was later determined, according to veterinary pathologists, “that the combination of melamine and cyanuric acid caused crystals to form in the urinary tracts of animals” leading to their untimely death.

As we have seen in the world of dietary supplements, manufactures and suppliers in China use the” nitrogen rich” Melamine to make the product appear to be containing more protein than it actually does to pass  the standard tests for protein ingredient  in bulk foods. The additive Melamine makes the product “appear to be gluten” and they are then sold “as gluten” to pet food manufacturers U.S. and Canadian.

Melamine causes chronic toxicity and “Ingestion of melamine may lead to reproductive damage, or bladder or kidney stones, which can lead to bladder cancer”.
Although the press release by the FDA cited that there is no “known threat” it is also not “known” as to whether or not some of the contaminated product has found it’s way into specialty stores in the USA. Although not very reassuring, they do urge  “Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.”

There have been many reports in the past decade over contaminated baby food and formula ranging from salmonella to this most  recent contamination threat of formula found to contain melamine, which has been cited as the culprit in China for babies developing serious kidney problems. CBC News reported that spokesman Mao Qunan stated, the agency investigators concluded the chemical (Melamine) was added when the milk was purchased from farmers but gave no other details. Quanan said, 78 “suspicious people” were summoned for questioning. Sanlu Group, the major Chinese dairy that produced the formula, has recalled 700 tons of the products, the Xinhua News Agency reported. “China Health Ministry issued a statement “Those responsible will face serious punishment.” 

In an effort to improve our nation’s beleaguered drug safety system, the Food and Drug Administration plans to post quarterly lists of drugs that are being investigated by the Agency due to safety concerns.  The FDA cautioned that the fact that a drug is included on the list only means that an investigation is ongoing and not that the drug has been determined to be “unsafe.”  This list is part of an overhaul of the FDA mandated by Congress in the aftermath of well-publicized drug safety failures, including Vioxx. 

The following drugs are included on the FDA’s list:

Drug and Use
 Concern
Suprane – anesthetic Cardiac arrest
Cymbalta – depression Urinary retention
Intelence – HIV Bleeding into joints (hemoarthrosis)
Carac and Kuric – skin creams Potential confusion due to similar names
Heparin – blood thinner Serious allergic or anaphylactic reactions
Humulin-R – insulin

Seroquel – bipolar disorder

R-Gene 10 – growth hormone

Nitrostat - angina Potential confusion over dosing instructions
Stromectol and Warfarin - anti-parasite drug and blood thinner Potential for drug interaction
Tykerb – breast cancer Liver damage
Revlimid – multiple myeloma Severe skin reaction (Stevens Johnson Syndrome)
Tysabri – MS Skin melanomas
Sandostatin LAR – abnormal bone growth Bowel obstruction (ileus)
OxyContin – pain medication Drug misuse, abuse, and overdose potential
Definity – cardiac imaging Cardiopulmonary reactions
Tyzeka – hepatitis Nerve damage (peripheral neuropathy)
Tumor Necrosis Factor (TNF) Blockers Cancers in children and young adults
Dilantin - epilepsy Serious skin reactions (“Purple Glove Syndrome”)

The FDA continues to rely upon a troubled adverse event reporting system in addition to reports from manufacturers in an effort to identify potentially-unsafe drugs.  The problem with this system is that it is believed that as few as 1% of safety issues with drugs are ever reported to the FDA by consumers and their physicians.  Also, the FDA’s antiquated guidelines do not require manufacturers to report every adverse event of which it may become aware, and such reporting is done on the honor system.  The new quarterly list will not include drug safety investigations that have been prompted by red flags received from clinical trials and studies. 

While the FDA’s efforts are to be applauded, they are only one piece of the drug safety puzzle.  The other very critical piece is the civil tort system.  Unfortunately, the ability of our court system to hold manufacturers accountable for dangerous drugs that harm consumers is currently under assault through back-door federalization and preemption efforts.  It is critical for the civil tort system to continue to play a role as an advocate for injured victims; an important part of the checks and balances.  The FDA has admitted the significant limitations to its ability to truly safeguard consumers from dangerous drugs, so it would be a travesty to remove the safety net provided to injured patients by the civil justice system. 

Judge Joseph R. Goodwin, a federal judge in Charleston, West Virginia, has been selected to oversee pre-trial coordination of the Digitek litigation.  Judge Goodwin will hold the first hearing to begin the ambitious process of organizing the discovery and pre-trial procedures for all of the Digitek claims on October 10, 2008, in Charleston. 

Digitek, also known as digitalis or digoxin, is a prescription drug that was recalled from the market in April of 2008 by manufacturers Actavis Totowa, LLC; Actavis, Inc.; Actavis US; Mylan, Inc.; Mylan Pharmaceuticals, Inc.; Mylan Laboratories, Inc.; Mylan Bertek Pharmaceuticals; and UDL Laboratories, Inc. 

Currently, more than 50 lawsuits have been filed against these manufacturers alleging personal injuries and wrongful deaths associated with a manufacturing defect in the recalled Digitek pills which led to excessive doses of the cardiac medication.  Digitek is prescribed to patients who have heart rhythm abnormalities such as atrial fibrillation, atrial flutter, and heart failure.  Patients who ingest excessive doses of the medication may experience visual changes, palpitations, irregular pulse, cold sweats, and other signs of digitalis toxicity, a potentially fatal adverse reaction.  

On August 28, 2008, I posted a story about Medtronic’s defective Sprint Fidelis defibrillator leads on InjuryBoard.com.

The story mentioned the difficulty surgeons would encounter in removing the defective Medtronic leads. In the meanwhile, the FDA and Medtronic have been cooperating to arrive at a workable interim solution to enable doctors to track down potential lead fracture. Today, the FDA approved Medtronic software update that gives doctors the capability of monitoring and identifying potential defibrillator lead fractures on a 24 hour basis. The ability to determine when and where lead fractures are occurring will benefit patients who may require crucial medical intervention.

The FDA final rule “establishing current good manufacturing practice requirements (CGMPs) ” in June 2008 was just the beginning of the lid being blown off the dietary supplements industry. It has become more than apparent that the impact of Dietary Health and Supplement Education Act (DSHEA) has surfaced and it is just the beginning of startling headlines of illness and death associated with OTC supplements. (more…)

This is Part V of a series on herbal supplements. For those who are suffering from and/or diagnosed with an illness herbal supplements may present an even greater risk.

According to the Hepatitis Foundation International” Doctors are very concerned that many herbal-related liver injuries go unrecognized because patients are often not asked about the use of herbs and diet supplements. Herbal remedies contain multiple ingredients, and the labeled and actual contents of a product may differ. This makes it impossible to identify liver injury rates for specific herbs.” (more…)