Archive for April, 2007

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Zelnorm Pulled From Market

Tuesday, April 3rd, 2007
FDA is issuing this public health advisory to inform patients and health care professionals that the sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm.  Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm.

 

FDA announces the following, effective immediately:

  • At FDA’s request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
  • Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition to prevent a Zelnorm heart attack or stroke.
  • Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a Zelnorm heart attack or stroke.
  • Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.
Zelnorm is a prescription medication approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation.   In late February and early March 2007, Novartis Pharmaceuticals gave FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions; the data from all the studies were combined to assess the chance of side effects on the heart and blood vessels.  In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm.  These 29 studies included 11,614 patients treated with Zelnorm and 7,031 treated with a sugar pill.  The average age of patients in these studies was 43 years and most patients—88%–were women.  

The number of patients who suffered a Zelnorm heart attack, stroke or severe heart chest pain that can turn into a heart attack was small.  However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill.  Thirteen patients treated with Zelnorm (0.1%) had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died), six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke.  Among the patients taking the sugar pill, only one (or 0.01%) had symptoms suggesting the beginning of a stroke that went away without complication.

Posted in Personal Injury Law | No Comments »

Counting Previous Years of Employment Under FMLA

Monday, April 2nd, 2007

On an issue of first impression amoung the circuit courts, the First Circuit of Appeals has held that a complete separation of employment for years does not prevent the employee from counting the previous employment toward the FMLA requirement.  To be eligible under the FMLA, an employee must have worked 12 months with the employer.  In this case, the employee had worked for several years with his employer (a car dealership) when he left to take a new job.  Fiver years later, he went back to work for the car dealership.  About seven months after he returned to work, he injured his back and took medical leave.  The dealership then terminated him.  The employee alleged discrimination claiming that the termination violated the FMLA.  The dealership moved to dismiss citing the fact that he had only worked there for seven months.  The Court denied the Motion finding that the months of employment need not be consecutive to qualify under the FMLA and in fact the months worked years ago and can be applied to be eligible under the FMLA.  The case name is Rucker v. Lee Holding, 471 F.3d 6 (1st Cir.2006).  Please be advised that the case is not controlling authority in Connecticut since Connecticut falls outside the jurisdiction of the First Circuit.  The Second Circuit of Court of Appeals has not been presented with this issue to rule upon as of the date of this posting.

Posted in Employment Litigation | No Comments »

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