2 Popular Diet Pills Linked To Problems With Heart Valves
1/02/2018
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Correction Appended
Doctors with the Mayo Clinic in Rochester, Minn., possibly at a medical clinic in Fargo, N.D., said yesterday a very rare heart ailment had appeared in 24 females who took a favorite diet pill combination. Their report has prompted the Food and Drug Administration to send warnings to 1000s of doctors.
The women, all previously healthy, were taking fenfluramine and phentermine, or fen-phen, a well known combination of diet pills, after they developed a rare and serious heart valve problem. Eight of which also stood a potentially fatal overuse injury in which the arteries that supply blood to the lungs constrict.
The women sought medical help because they had such signs of heart problems as fatigue, breathlessness and fluid accumulation within the ankles or abdomen. Doctors then made the connection to the diet drugs, but they have not clearly shown cause and effect.
The observations, made inside the normal length of medical practice in lieu of in clinical studies, cannot be used to estimate potential risk of the weightloss pills. But F.D.A. officials said these were concerned, and quickly warned doctors being on the lookout for cardiovascular disease in patients taking the drugs.
The mix of fenfluramine and phentermine never was approved with the F.D.A. But all the two drugs was approved for usage by itself, abbreviated periods of time, for patients who have been severely obese.
In practice, people who were only mildly overweight have taken the drugs, and many people have got them for too long periods. The girls that developed the heart disease had been using drugs to have an average of a year.
Last year, doctors wrote 18 million prescriptions a month for the two drugs. The F.D.A. said the amount of patients while using the drug was proprietary information.
A leading cardiologist, Dr. Jeffrey Isner, said that the peculiar valve damage reported inside study of patients taking diet pills was so rare that ''in 20 years of clinical practice, I have seen one patient like this.''
The valve condition had only been affecting patients who ended up exposed to enormous doses of your nerve hormone, serotonin, a chemical common inside brain and nervous system, for too long periods. They include patients with tumors that secreted serotonin and people who had taken a migraine drug, ergotamine, for long periods. Ergotamine mimics serotonin.
Common antidepressants like Prozac increase serotonin levels, but not to levels anything like that seen with tumors or ergotamine, said Dr. Isner, a cardiology professor at Tufts Medical School.
A report describing the brand new findings was to have been published on Aug. 28 in The New England Journal of Medicine, nevertheless the journal lifted its normal restrictions on prepublication publicity because the findings might be of such importance on the public's health, its editors said.
Dr. Friedman said the F.D.A. was sending letters to a huge number of doctors, including heads of medical specialty organizations, telling them in the observations, and was posting its warning letter on its homepage.
The F.D.A. said in the letter who's knew of 33 ladies who developed heart disease after taking the weightloss pills - the 24 women reported through the Mayo Clinic and Fargo doctors in addition to 9 other women that doctors reported towards the F.D.A. The agency is asking doctors to consider and report any patients who are utilizing the drug combination and who develop the valve defects or primary pulmonary hypertension.
Doctors with the Mayo Clinic in Rochester, Minn., possibly at a medical clinic in Fargo, N.D., said yesterday a very rare heart ailment had appeared in 24 females who took a favorite diet pill combination. Their report has prompted the Food and Drug Administration to send warnings to 1000s of doctors.
The women, all previously healthy, were taking fenfluramine and phentermine, or fen-phen, a well known combination of diet pills, after they developed a rare and serious heart valve problem. Eight of which also stood a potentially fatal overuse injury in which the arteries that supply blood to the lungs constrict.
The women sought medical help because they had such signs of heart problems as fatigue, breathlessness and fluid accumulation within the ankles or abdomen. Doctors then made the connection to the diet drugs, but they have not clearly shown cause and effect.
The observations, made inside the normal length of medical practice in lieu of in clinical studies, cannot be used to estimate potential risk of the weightloss pills. But F.D.A. officials said these were concerned, and quickly warned doctors being on the lookout for cardiovascular disease in patients taking the drugs.
The mix of fenfluramine and phentermine never was approved with the F.D.A. But all the two drugs was approved for usage by itself, abbreviated periods of time, for patients who have been severely obese.
In practice, people who were only mildly overweight have taken the drugs, and many people have got them for too long periods. The girls that developed the heart disease had been using drugs to have an average of a year.
Last year, doctors wrote 18 million prescriptions a month for the two drugs. The F.D.A. said the amount of patients while using the drug was proprietary information.
A leading cardiologist, Dr. Jeffrey Isner, said that the peculiar valve damage reported inside study of patients taking diet pills was so rare that ''in 20 years of clinical practice, I have seen one patient like this.''
The valve condition had only been affecting patients who ended up exposed to enormous doses of your nerve hormone, serotonin, a chemical common inside brain and nervous system, for too long periods. They include patients with tumors that secreted serotonin and people who had taken a migraine drug, ergotamine, for long periods. Ergotamine mimics serotonin.
Common antidepressants like Prozac increase serotonin levels, but not to levels anything like that seen with tumors or ergotamine, said Dr. Isner, a cardiology professor at Tufts Medical School.
A report describing the brand new findings was to have been published on Aug. 28 in The New England Journal of Medicine, nevertheless the journal lifted its normal restrictions on prepublication publicity because the findings might be of such importance on the public's health, its editors said.
Dr. Friedman said the F.D.A. was sending letters to a huge number of doctors, including heads of medical specialty organizations, telling them in the observations, and was posting its warning letter on its homepage.
The F.D.A. said in the letter who's knew of 33 ladies who developed heart disease after taking the weightloss pills - the 24 women reported through the Mayo Clinic and Fargo doctors in addition to 9 other women that doctors reported towards the F.D.A. The agency is asking doctors to consider and report any patients who are utilizing the drug combination and who develop the valve defects or primary pulmonary hypertension.
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