The dangerous diet drug fenfluramine, an ingredient in Fen-Phen, may continue to damage the heart years after a patient stops taking it, according to a study published in BMC Medicine.  The study has shown  that people who stopped using Fen-Phen 11 years ago had damaged heart valves up to seven years later.

The study, conducted by researchers at the Central Utah Clinic, involved both fenfluramine and dexfenfluramine, another diet drug that is closely related to fenfluramine.  The Food & Drug Administration (FDA)  ordered fenfluramine and dexfenfluramine off the market in September 1997 after those drugs were linked to heart valve problems. Since its withdrawal, tens of thousands of lawsuits have been filed against the maker of fenfluramine by people injured by the drug.

This is the largest study to examine duration of exposure to the drug and the first to estimate the incidence of heart valve surgery among prior users. The researchers looked at 5,743 former users of fenfluramine and/or dexfenfluramine.

The patients were seen by doctors at the Central Utah Clinic between July 1997 and February 2004.  Each patient got an echocardiogram and 1,020 patients got two or more echocardiograms 30 months apart, on average.

When the study started, nearly 20% of the women and almost 12% of the men had at least mild regurgitation through the aortic valve or moderate regurgitation through the mitral valve.  Women, and people  who used the drugs the longest were most likely to have such problems.

Follow-up echocardiograms showed that aortic and mitral regurgitation usually stayed about the same or worsened, but improved in some cases. Thirty-eight patients — less than 1% — got heart valve surgery. Such surgery wasn’t common, but it was more common than in the general public, and in 25 cases, heart valve damage was linked to the drugs.

“We found clear evidence for a strong, graded association between duration of exposure to fenfluramines and prevalence of aortic regurgitation and for mild or greater mitral and tricuspid regurgitation,” lead researcher Charles Dahl, told Science Daily.

Chantix has been linked to 10 suicides in the United Kingdom, according to that country’s health regulators.

This is the first time officials at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) have revealed the link between Chantix and suicide in that country.  Earlier this year, the U.S. Food & Drug Administration (FDA) said it had linked 37 suicides to Chantix.

Chantix, approved in both the US and Britain in 2006, works by blocking nicotine receptors to the brain. Chantix was the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.

But the drug has been the subject of disturbing side effect reports.  In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

In the UK, where Pfizer sells Chantix under the name Champix, the MHRA website says a total of 24 people taking the medication have died, and of those, 10 were suicides. A further 213 claimed they had experienced suicidal thoughts and 407 said they were suffering depression.

The MHRA also says the number of users reporting adverse side effects while using Chantix  has doubled in the past seven months – up from 1,811 in February to 3,541 in September.  The British health watchdog is now  warning doctors and nurses to monitor the effects of the drug on smokers over the New Year, when many will try to kick the habit.

Last December, the European Medicines Agency ruled that the  inserts in boxes of Chantix be updated to include warnings about suicide and depression.

The Associated Press (AP) is reporting that Minnesota has joined many states seeking compensation from Lilly over the way it has marketed its popular anti-psychotic drug, Zyprexa.

Minnesota has joined several other states insurers, pension funds and unions accusing Lilly of concealing Zyprexa’s tendency to cause weight gain and diabetes and of marketing the drug for off-label uses.

The AP report notes Minnesota spent over $175 million through public health programs on Zyprexa prescriptions between 2000 and 2007.  The lawsuit helps the state learn more about the drug’s impact on Minnesota through the discovery process.  Lilly just recorded a third-quarter loss largely due to a $1.4 billion charge related to the investigation of Zyprexa marketing practices.

Zyprexa is a potent brain tranquilizer that calms hallucinations related to schizophrenia and bipolar mania; however, internal Lilly documents and e-mail messages indicate Lilly marketed Zyprexa off-label.  Zyprexa can cause severe weight gain and an increase in blood sugar in many patients.  According to the American Diabetes Association, Zyprexa is likelier to cause diabetes than most other medicines for schizophrenia and bipolar disorder.