Sokolove Success Blog – Our Perspective on Legal News that Matters

It’s supposed to help with your strep throat, but could a widely used antibiotic instead harm your liver?

Health authorities in Canada think so and have raised new concerns about popular antibiotic Avelox and possible increased risks of liver failure. In March, Health Canada (the Canadian equivalent of the US Food and Drug Administration) notified health care professionals and patients of changes to the labeling information for Avelox in Canada.  A safety review by the agency concluded that Avelox may be associated with the rare but potentially life-threatening risk of liver injury, including liver failure.

Avelox (moxifloxacin) is a prescription drug belonging to a class of antibiotics called fluoroquinolones. According to Bayer, the manufacturer, over 40 million patients worldwide have been treated with Avelox for a broad range of bacterial infections, including respiratory infections.

The Canadian report is not the first sign of trouble for Avelox.  In fact, there have long been concerns about whether fluoroquinolones contribute to tendon injuries, such as those experienced by our Levaquin clients. We have been engaged with these drugs since 2008 when the FDA issued a black box warning for the increased risk of tendinitis and tendon rupture associated with them.  Interestingly, reports of tendon-related issues had been reported for more than a decade, prompting a series of labeling revisions that finally culminated in the black box warning.

The same pattern seems to be emerging with respect to the risk of liver injury and Avelox.  In 2007, Bayer updated the labeling for Avelox in Europe to reflect this risk and sent a “Dear Doctor” letter to European physicians to draw attention to the change in early 2008.  Now Health Canada has stepped in and required the change in Canada.

Yet Avelox labeling remains unchanged in the U.S.  That doesn’t seem to make much sense, and it certainly could open the company up to liability claims should Americans be injured as a result of the product.

We’re continuing to monitor developments with this drug. If you are interested in working with us on cases related to Avelox or other fluoroquinolones, drop me a line.

What if the cost of lowering your cholesterol was excruciating muscle pain, or possibly kidney failure?  Is that a tradeoff you’d be willing to make?

I only ask because some patients are unwittingly making that choice.  The FDA recently issued a warning about the risk of muscle injury for patients who take the highest approved dose of Zocor, a popular cholesterol-lowering medication. Whether you are a gym rat or a couch potato, we’ve all pulled a muscle at some point.  That’s not what we’re talking about here. It’s far worse.

According to the FDA, muscle injury, myopathy, is a known side effect of all statin drugs.  But the warning says patients who are prescribed and use the 80 milligram dose of Zocor run an increased risk of developing muscle injury, including rhabdomyolysis. That’s right: “Rhabdo”.  Remember Baycol? Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and even death.

The risk of rhabdomyolysis is accelerated by potential drug interactions, and there is concern that patients are continuing to be prescribed higher doses of Zocor with other medications that are known to increase the risk despite dose limitations and drug-drug interaction precautions on the drug label. We first began following Zocor in 2008 when the FDA warned of an increased risk of rhabdomyolysis in patients taking this drug concurrently with the heart medication amiodarone.

An estimated 24 million Americans take cholesterol-lowering drugs. And the number is likely to go higher: Last month the FDA approved the preventative use of the cholesterol medication Crestor for millions of people who do not have a cholesterol problem.

We will continue to watch the unfolding announcements about Zocor and other drugs, and will be working with our co-counsel to identify cases where people have been injured.  As always, let me know your thoughts.

Call it food for thought.

The U.S. Food and Drug Administration (FDA) is reviewing the preliminary findings of a new study of the weight loss drug Meridia.  However, the agency recently released an early communication indicating that certain patients taking the drug may have a higher risk of heart attacks, strokes, and other cardiovascular problems. 

Consumer advocacy group Public Citizen last week asked the FDA to ban Meridia because of the study findings.  The group noted that a total of 84 deaths associated with the drug have been reported to the FDA as of June 2009.

The recent study tested sibutramine (sold under the brand name Meridia) in overweight or obese people with an increased risk for heart problems. The analysis of these data is ongoing and FDA was careful to say that it is making no conclusions about the preliminary findings at this time.

That said, the preliminary analysis suggests that patients using sibutramine experienced a higher number of cardiovascular events compared to those using a placebo. The preliminary data shows that cardiovascular events were reported in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population.

The FDA warned that doctors and their patients should continue to follow current guidelines, which recommend against using Meridia in patients with a history of heart-related health issues. As always, the FDA recommends that consumers should talk to their doctor about whether Meridia is right for them.

We at Sokolove Law will be continuing to monitor the FDA’s review of Meridia, and we’ll bring you any further news as it develops.

To plaintiffs’ lawyers, the claim is all too familiar.  Major drug manufacturer gets FDA approval for a new treatment, but the marketing campaign for the new drug allegedly overstates the benefits and downplays the risks.

Today, that claim is being levied at Bayer HealthCare Pharmaceuticals with respect to popular birth control pills Yaz and Yasmin.

The National Law Journal has the story here (free registration required).

In 2008, the pharma giant reached an agreement with FDA to run a $20 million corrective ad on the benefits and risks of Yaz.  The FDA had previously issued a warning letter to Bayer about its marketing activities.

This month, we’re seeing the first lawsuits being filed on this issue. According to the NLJ, the lawsuits allege: “that Bayer failed to warn women and their doctors of the pills’ increased risk of injury — most notably blood clots — while over promoting the benefits of the drugs.”

Janey Abaray, an attorney with Burg Simpson Eldredge Hersh & Jardine (A Sokolove Law affiliate) said there may be additional risks.  Here’s what she said in the NLJ story:

“ (our) firm has amassed evidence that shows that there are many more adverse events reported to the FDA for Yaz and Yasmin than for other birth control pills that have been around longer… We expect to be filing consistently over the next several weeks and months. We have many cases. It’s just a matter of getting all of the medical records”.

A spokesman for Bayer offered the typical “it’s perfectly safe if used as directed” response, which of course completely ignores the question of whether the advertising was fair and accurate, or whether the company adequately warned patients.

As always, stay tuned as we’re likely to see many more cases in this area.