liquidocean
Bluelighter
- Joined
- Nov 8, 1999
- Messages
- 7,865
70 deaths in 7 years? For heartburn medication? The FDA knew it caused serious heart problems 1.5 years ago, but sat on its ass til now. Propulsid alone almost grossed US $1B in sales. Did you think their was a $1B market for heartburn medication in the US? Sounds pretty lucrative. Imagine everyone in the country spending $4 on average.
Sounds pretty fishy. Oh a couple dozen deaths a year? No worries, our lobbyists are doing their best to remedy the situation (i.e. hefty bags of cash).
FDA please help the american people, not lining your pockets!
--one concerned American
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From cnn.com http://www.cnn.com/2000/HEALTH/01/25/heartburn.warning.ap/index.html
Copyright 2000 The Associated Press.
FDA warns consumers about heartburn drug Propulsid
January 25, 2000
Web posted at: 12:57 PM EST (1757 GMT)
WASHINGTON (AP) -- The popular heartburn drug Propulsid can cause dangerous irregular heartbeats and even sudden death, the government said Monday. The medicine should be used only as a last resort -- and only by patients first given heart tests to ensure they are at low risk for the side effect, it warned.
Patients now taking Propulsid should ask their doctors about switching medication, and doctors should not prescribe the drug without first performing an EKG, or electrocardiogram, the Food and Drug Administration said.
Nor should anyone with heart disease or a list of other illnesses use the drug, the FDA said.
The FDA's unusually strong warning comes in the wake of 70 deaths and 200 other reports of irregular heartbeat and other heart rhythm disturbances since Propulsid hit the market in 1993.
Manufacturer Johnson & Johnson mailed the warning to thousands of physicians Monday.
The FDA first warned that Propulsid can cause serious heart problems in June 1998, but it continued to receive reports of deaths and hospitalizations.
So Monday, the agency took additional steps to make sure Propulsid is used only by patients with severe nighttime heartburn who get no relief from other drugs -- and only if they appear at low risk for the cardiac side effects.
Johnson & Johnson shares on Monday closed at $83.683/4, down 6.183/4, or 6.9 percent.
Propulsid had sales of about $970 million last year, according to analysts.
The FDA said it was not pulling Propulsid off the market because the drug can help some patients and because the new warnings should make using it safer.
The cardiac risk is relatively small considering an estimated 30 million Propulsid prescriptions have been written since 1993, and most people who suffered the heart problems had clear risk factors, said Dr. Florence Houn, FDA's chief of gastrointestinal drugs. That means careful doctors who heed the new warnings should be able to keep Propulsid away from the patients most likely to be hurt, she said.
"We want warnings to go out. We want education to the prescribers to be reinforced," she said. "This drug requires careful prescription."
But an expert on drug-induced irregular heartbeats said it will be difficult for the doctors who most prescribe Propulsid _ gastrointestinal specialists -- to comply.
"FDA warnings have not been as successful as we would like in being translated into care," said Dr. Raymond Woosley, a pharmacologist at Georgetown University Medical Center. "This one will be especially difficult because of the fact that many physicians don't have an EKG" machine in their offices.
Also, some computerized EKG equipment doesn't accurately read a critical type of heartbeat measurement called "QT prolongation," requiring doctors skilled in reading EKGs to determine that manually, he said.
Among FDA's warnings:
Do not prescribe Propulsid to anyone with heart disease, including valvular disease, or who has ever had an irregular heartbeat, abnormal EKG or QT prolongation.
Do not prescribe Propulsid to people with kidney disease; lung disease; low blood levels of the electrolytes potassium, calcium or magnesium; an eating disorder; dehydration or prolonged vomiting.
Never take Propulsid while using a list of other medications, including antibiotics like erythromycin; antifungals like ketoconazole; AIDS-fighting protease inhibitors; drugs for irregular heartbeat; certain antidepressants and antipsychotics such as Elavil or Serzone. Also do not take with grapefruit juice.
In addition to an EKG, patients being considered for Propulsid should undergo blood tests to check electrolyte levels.
Sounds pretty fishy. Oh a couple dozen deaths a year? No worries, our lobbyists are doing their best to remedy the situation (i.e. hefty bags of cash).
FDA please help the american people, not lining your pockets!
--one concerned American
-------------------------
From cnn.com http://www.cnn.com/2000/HEALTH/01/25/heartburn.warning.ap/index.html
Copyright 2000 The Associated Press.
FDA warns consumers about heartburn drug Propulsid
January 25, 2000
Web posted at: 12:57 PM EST (1757 GMT)
WASHINGTON (AP) -- The popular heartburn drug Propulsid can cause dangerous irregular heartbeats and even sudden death, the government said Monday. The medicine should be used only as a last resort -- and only by patients first given heart tests to ensure they are at low risk for the side effect, it warned.
Patients now taking Propulsid should ask their doctors about switching medication, and doctors should not prescribe the drug without first performing an EKG, or electrocardiogram, the Food and Drug Administration said.
Nor should anyone with heart disease or a list of other illnesses use the drug, the FDA said.
The FDA's unusually strong warning comes in the wake of 70 deaths and 200 other reports of irregular heartbeat and other heart rhythm disturbances since Propulsid hit the market in 1993.
Manufacturer Johnson & Johnson mailed the warning to thousands of physicians Monday.
The FDA first warned that Propulsid can cause serious heart problems in June 1998, but it continued to receive reports of deaths and hospitalizations.
So Monday, the agency took additional steps to make sure Propulsid is used only by patients with severe nighttime heartburn who get no relief from other drugs -- and only if they appear at low risk for the cardiac side effects.
Johnson & Johnson shares on Monday closed at $83.683/4, down 6.183/4, or 6.9 percent.
Propulsid had sales of about $970 million last year, according to analysts.
The FDA said it was not pulling Propulsid off the market because the drug can help some patients and because the new warnings should make using it safer.
The cardiac risk is relatively small considering an estimated 30 million Propulsid prescriptions have been written since 1993, and most people who suffered the heart problems had clear risk factors, said Dr. Florence Houn, FDA's chief of gastrointestinal drugs. That means careful doctors who heed the new warnings should be able to keep Propulsid away from the patients most likely to be hurt, she said.
"We want warnings to go out. We want education to the prescribers to be reinforced," she said. "This drug requires careful prescription."
But an expert on drug-induced irregular heartbeats said it will be difficult for the doctors who most prescribe Propulsid _ gastrointestinal specialists -- to comply.
"FDA warnings have not been as successful as we would like in being translated into care," said Dr. Raymond Woosley, a pharmacologist at Georgetown University Medical Center. "This one will be especially difficult because of the fact that many physicians don't have an EKG" machine in their offices.
Also, some computerized EKG equipment doesn't accurately read a critical type of heartbeat measurement called "QT prolongation," requiring doctors skilled in reading EKGs to determine that manually, he said.
Among FDA's warnings:
Do not prescribe Propulsid to anyone with heart disease, including valvular disease, or who has ever had an irregular heartbeat, abnormal EKG or QT prolongation.
Do not prescribe Propulsid to people with kidney disease; lung disease; low blood levels of the electrolytes potassium, calcium or magnesium; an eating disorder; dehydration or prolonged vomiting.
Never take Propulsid while using a list of other medications, including antibiotics like erythromycin; antifungals like ketoconazole; AIDS-fighting protease inhibitors; drugs for irregular heartbeat; certain antidepressants and antipsychotics such as Elavil or Serzone. Also do not take with grapefruit juice.
In addition to an EKG, patients being considered for Propulsid should undergo blood tests to check electrolyte levels.
