Personal Health

We  should all know this.

States of the Heart
An average heart pumps 2.4 ounces (70 milliliters) per heartbeat. And, as we already mentioned, an average heartbeat is 72 beats per minute. Therefore an average heart pumps 1.3 gallons (5 Liters) per minute. In other words it pumps 1,900 gallons (7,200 Liters) per day, almost 700,000 gallons (2,628,000 Liters) per year, or 48 million gallons (184,086,000 liters) by the time someone is 70 years old. That’s not bad for a 10-ounce pump.
Coronary artery disease is caused by a blockage in one of the coronary arteries. When a coronary artery is partially blocked, that artery cannot supply enough blood to the heart muscle to meet its needs during exertion. When someone with coronary artery disease exerts himself or herself, it causes chest pain. This is due to lack of blood and oxygen to that part of the heart muscle and is called angina. If the obstruction worsens (more frequent angina episodes, with less exertion) a condition called unstable angina can occur. A heart attack happens when a coronary artery is completely blocked and no blood or oxygen is getting to the heart muscle served by that artery. This also causes chest pain and causes death to the heart muscle served by that artery.

What is angina, and what are the symptoms of angina?

Angina (angina pectoris – Latin for squeezing of the chest) is chest discomfort that occurs when there is a decreased blood oxygen supply to an area of the heart muscle. In most cases, the lack of blood supply is due to a narrowing of the coronary arteries as a result of arteriosclerosis.

Angina is usually felt as:

  • pressure,
  • heaviness,
  • tightening,
  • squeezing, or
  • aching across the chest, particularly behind the breastbone.

This pain often radiates to the neck, jaw, arms, back, or even the teeth.

Patients may also suffer:

Angina usually occurs during exertion, severe emotional stress, or after a heavy meal. During these periods, the heart muscle demands more blood oxygen than the narrowed coronary arteries can deliver. Angina typically lasts from 1 to 15 minutes and is relieved by rest or by placing a nitroglycerin tablet under the tongue. Nitroglycerin relaxes the blood vessels and lowers blood pressure. Both rest and nitroglycerin decrease the heart muscles demand for oxygen, thus relieving angina.

Angina is classified in one of two types: 1) stable angina or 2) unstable angina.

Stable angina

Stable angina is the most common type of angina, and what most people mean when they refer to angina. People with stable angina have angina symptoms on a regular basis and the symptoms are somewhat predictable (for example, walking up a flight of steps causes chest pain). For most patients, symptoms occur during exertion and commonly last less than five minutes. They are relieved by rest or medication, such as nitroglycerin under the tongue.

Unstable angina

Unstable angina is less common and more serious. The symptoms are more severe and less predictable than the pattern of stable angina. Moreover, the pains are more frequent, last longer, occur at rest, and are not relieved by nitroglycerin under the tongue (or the patient needs to use more nitroglycerin than usual). Unstable angina is not the same as a heart attack, but it warrants an immediate visit to your healthcare provider or hospital emergency department as further cardiac testing is urgently needed. Unstable angina is often a precursor to a heart attack.

Actually this is all important, i believe every single person has felt that pain in their chest, click this for all the info on that.

God forbid someone should take an ineffective pill ? wtf people gotta do a thousand person trial to resell something they have been selling for 100 years, nitroglycerin tablets (notfor bombs) lower your blood pressure and makes your heart use less oxygen. They can be used occasionally or just at the instant you get chest pain to help prevent heart attack and death.

No shame, right in the artice they (the FDA) tell the 2 other guys they have to stop making and shipping pills with 90 days, and pfizer says they will be able to meet the entire market production within the year. Soulds like a bustout with monopoly take over.. you read it and tell me

F.D.A. Says Millions Got Unapproved Heart Pills

By NATASHA SINGER
Published: March 26, 2010

Doctors in the United States wrote more than four million prescriptions last year for nitroglycerin tablets, heart drugs placed under the tongue to reduce the chest pain angina or to stop a heart attack.

David Maxwell for The New York Times

“If it’s not approved and no one has tested it, we can’t be sure that it’s safe and effective,” said Dr. Harry Lever, a cardiologist.

But the majority of the drugs sold had not been approved for sale, nor had their safety and effectiveness been vetted, by the Food and Drug Administration.

And many doctors, who discovered only last week that pharmacies were giving their patients unproved heart tablets, now say they have no way of knowing whether patients have suffered unnecessarily as a result.

“If it’s not approved and no one has tested it, we can’t be sure that it’s safe and effective,” said Dr. Harry M. Lever, a cardiologist at the Cleveland Clinic. If patients with angina took substandard or ineffective nitroglycerin tablets, Dr. Lever said, their pain might not subside and the problem could potentially progress to a heart attack.

The F.D.A., which in recent years has been cracking down on a decades-old backlog of unapproved drugs, sent warning letters last week to two drug makers ordering them to stop marketing unapproved nitroglycerin tablets. But the drugs are still being sold at pharmacies while the order takes effect.

The drug makers said they would comply with the order, but said that their tablets were safe.

The F.D.A. said that it had not examined the quality of the products it was ordering off the market but that it had recorded problems with other unapproved nitroglycerin products in the past. The agency advised people who take unapproved nitroglycerin to continue taking their tablets but to consult their doctors about replacement prescriptions.

Cardiologists regularly prescribe nitroglycerin to relieve chest pain associated with coronary artery disease. Placed under the tongue, the drug quickly dissolves into the blood, where it dilates the coronary artery, slightly decreasing blood pressure and reducing heart exertion.

When taken during an initial episode of chest pain, nitroglycerin can prevent a heart attack in 3 to 4 percent of patients, said Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic.

The problem of the unapproved tablets stems from a longstanding ambiguity about the rules for drugs whose use predates the establishment of the F.D.A. in 1927. Only one brand of nitroglycerin pills is federally approved: Nitrostat, made by Pfizer, on the market since 2000.

Many makers of various drugs, not only nitroglycerin tablets, have long contended that their medications did not require F.D.A. review because they were grandfathered as pre-1938 drugs. (The F.D.A.’s powers to require new drugs to demonstrate safety before being marketed came in 1938 with passage of the Food, Drug and Cosmetic Act.) But the agency is now disputing that interpretation of its rules. It took action on nitroglycerin tablets after looking into the matter and being struck by the large volume of prescriptions being filled with unapproved versions.

“These drugs are historical remnants,” said Michael Levy, a division director in the F.D.A.’s Center for Drug Evaluation and Research. “Pharmacies likely mistake them for generic drugs or for drugs likely to be grandfathered, neither of which is the case.”

Of the nearly 4.4 million prescriptions for under-the-tongue nitroglycerin tablets last year in this country, about 80 percent were filled with unapproved drugs, according to data from the research firm IMS Health.

Leading cardiologists said they were shocked to learn that for years their patients might have been taking crucial heart drugs whose safety and potency had not been vetted by the F.D.A.

“I was taken aback,” said Dr. Ralph G. Brindis, the president of the American College of Cardiology, a professional association representing nearly 26,000 cardiologists in the United States.

Dr. Harlan M. Krumholz, a professor of medicine at the Yale School of Medicine, said it would not have occurred to him that licensed pharmacies might be filling prescriptions with unapproved drugs. “Nobody ever teaches you that in medical school,” he said.

On March 16, the agency sent warning letters to two leading suppliers of the unapproved tablets, Konec Inc. of Tucson and Glenmark Generics Inc. of Mahwah, N.J., giving them 90 days to stop making the drugs and 180 days to stop shipping them.

In response to a query from a reporter, a spokesman for Glenmark Pharmaceuticals in Mumbai, India, the parent company of Glenmark Generics, sent a statement saying that the company intended to comply with the agency’s directive to stop making the unapproved drugs.

It added that the F.D.A. warning letter had not asked for a recall — an immediate action in which a company removes products for sale from the market.

The president of Konec, Enrique Durazo, said his company regularly conducted its own lab tests to ensure that its nitroglycerin pills had the equivalent potency and stability to the approved brand-name drug.

But the company has not conducted the kind of human tests, called bioequivalence studies, required for F.D.A. approval of generic drugs, he said. Konec now plans to conduct such tests and seek approval as a generic.

Pfizer, which according to IMS Health sold about 900,000 prescriptions of Nitrostat last year, says it had stepped up production of the drug and expected to be able to meet the entire market demand in the United States.

At CVS, the cash price for a pack of 100 tablets of 0.4-milligram Nitrostat is $21.99; the same amount of the Glenmark product costs $19.99.

With the F.D.A. giving Konec and Glenmark six months to continue marketing their unapproved nitroglycerin tablets, some major pharmacy companies said they planned to continue selling them.

“We still have the product available,” said Robert Elfinger, a spokesman for Walgreens, which sells the Glenmark nitroglycerin. “This is not a recall.”

A spokesman for CVS, which has been selling the Glenmark drug since early 2009, said that the company would make any changes in dispensing that the F.D.A. might require.

Nitroglycerin drugs are not to be confused with the explosive ingredient in dynamite. But even in drug form, nitroglycerin is an unstable chemical, which is why doctors say they cannot be sure how potent the unapproved versions might be.

Moreover, because patients have varied responses, some cardiologists say they now have no way of knowing whether they have been treating their patients with an inferior product.

Dr. Lever, of the Cleveland Clinic, for example, recalls a heart surgery patient telling him that something was wrong with her new tablets. They did not relieve chest pain, he recalled, and they did not cause side effects she had previously experienced.

She then gave the pills, a bottle of Glenmark tablets, to Dr. Lever.

Glenmark did not respond to a query from a reporter seeking comment about the matter.

Dr. Lever, who has kept the bottle in his desk ever since, recalled the episode after learning of the F.D.A.’s action last week.

“Every day, when I’m writing a prescription,” he said, “I’m thinking, ‘Is the patient going to get the right stuff?’ ”

This article has been revised to reflect the following correction:

Correction: April 3, 2010

An article last Saturday about millions of heart patients’ receiving nitroglycerin tablets never approved by the Food and Drug Administration misstated the year the F.D.A. was established. It was in 1927, when it was spun off from the Bureau of Chemistry, not in 1938. (Its powers to require new drugs to demonstrate safety before being marketed came in 1938 with passage of the Food, Drug and Cosmetic Act.)

A version of this article appeared in print on March 27, 2010, on page B1 of the New York edition

There would be 4 plus million scripts out there if the shit was killing people, they just want their cut.

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