FDA suicide memo revealed in wrongful death case

Relatives of a Hard Rock Hotel executive who killed himself two years ago have uncovered a 2006 memo from the Food and Drug Administration that examines possible links between sleep aids and suicide.

Lawyers representing the family of Randy Kwasniewski, who fatally shot himself in March 2010, recently filed the document as an exhibit in their wrongful death case against sanofi-aventis U.S. — the company that makes the sleeping pill Ambien.

Also named as a defendant in the lawsuit is Nadine Leone, a marriage and family therapist who met with Kwasniewski five days before his death. The plaintiffs allege Leone knew Kwasniewski had been prescribed Ambien but failed to warn him about the possible mental and emotional effects of taking the drug.

In a recent motion, the plaintiffs’ attorneys further addressed Leone’s role. they mentioned the 2006 memo in a footnote to the motion and attached the memo as an exhibit.

"of course, it is possible that Ms. Leone was unaware of the magnitude of the problem with Ambien and suicide," according to the footnote. "In a study obtained by plaintiffs per the Freedom of Information Act (and not available on the Internet), suicide with the use of Ambien was of such concern that the FDA ordered additional studies and warnings."

According to the memo, a systematic review of the FDA’s adverse events reporting system, known as AERS, revealed multiple cases in which drugs used to treat insomnia had been linked to suicides or "suicidal ideation."

"a total of 71 cases were reviewed which reported suicidal thoughts, attempts, and completed suicides," according to the memo.

Of those, 49 involved zolpidem, the drug in Ambien.

"it is notable that a significant number of cases reported a suicide attempt/ideation within 8 days of initiation of therapy …" according to the memo. "furthermore, the majority of cases reported that the event occurred in the first 30 days of therapy."

The memo noted that insomnia, suicidal thoughts and depression may overlap in some patients and recommended further analysis to help determine whether the sleep drugs contributed to suicide-related events. The memo also recommended stronger product labeling.

In response to a request for comment on the memo and its recommendations, FDA spokeswoman Sandy Walsh released the following statement Thursday via email:

"over the past several years, the FDA has taken a close look at safety data on sleep drugs, including data on deaths, suicides, suicidal ideation, etc. That information is reflected in the current drug labeling and patient medication guides.

"In 2006, the FDA asked for a stronger, more prominent warning be added to Ambien (zolpidem) — and all drugs in the class — about abnormal thoughts and behavior, including suicidal thoughts and actions, based on the 2006 FDA safety review. Since then, we’ve continuously reviewed safety information for not only zolpidem products, but all drugs in this class, to make sure that health care professionals and patients have the best information possible."

Sanofi-aventis, a limited liability company based in Delaware, removed the Kwasniewski case from Clark County District Court in March and transferred it to federal court in Las Vegas.

The company also has filed a motion to dismiss the complaint, arguing that the family has "failed to plead sufficient facts to plausibly suggest that Mr. Kwasniewski’s death was caused by Ambien."

In their recent motion, the plaintiffs argue that the case should remain in state court.

Another exhibit attached to the motion provides details of Kwasniewski’s March 4, 2010, visit with Leone.

"Ms. Leone saw decedent one time," according to the motion. "she asked decedent what medications he was taking. Decedent advised that he was taking Ambien, and, indeed, Ms. Leone has it noted twice in her records."

The only symptom listed in a medical history section of the records is "loss of sleep."

According to the records, Kwasniewski was referred to Leone by his employer after he was accused of verbally abusing two employees, and the referral had caused him to experience anxiety.

In a section pertaining to Kwasniewski’s thinking, the box next to "no impairment" was checked, while the box next to "suicidal ideation" was not.

The records also described Kwasniewski’s "recovery environment" as good, noting he had been married for more than 20 years and loved his wife and children. His next appointment was scheduled for March 12, 2010.

Kwasniewski, 56, was found dead in his Summerlin home March 9, 2010. he died of a self-inflicted gunshot wound to the head, the Clark County coroner’s office reported.

His widow, Jennifer, and two children filed the wrongful death lawsuit. they are represented by Las Vegas attorneys Eckley Keach and Robert Murdock.

Kwasniewski had been in his position as president and chief operating officer at the Hard Rock Hotel since new York-based boutique hotel operator Morgans Hotel Group bought the resort in February 2007.

He had been overseeing a $750 million expansion that added two hotel towers, casino space and a larger concert hall to the property.

FDA suicide memo revealed in wrongful death case


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