The Business Of Law

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.