// October 27th, 2010 // 1 Comment » // Impotence

In November, 1998, just six months after Viagra was approved, 6 million prescriptions had been written for this medication and 50 million Viagra tablets had been dispensed. In this interval, 130 men died sometime after they took Viagra. We know this because of what is called post-marketing surveillance.

Once a medication has been approved for use and is available by prescription, doctors continue to look for an unexpectedly high number of their patients developing one problem or another.

The close relationship that most doctors have with their patients allows for a frank discussion of treatment results and adverse effects of any new medication. Most patients do not hesitate to tell their doctors when a medication has caused a particular problem. Doctors all over the country then gather this information and report back to the drug company — in this case Pfizer — or the FDA, which is obliged to survey and keep accurate records of problems that were not apparent before but surface only after a new drug is released. The official term for this data collection is “post-marketing surveillance.”

As a result of post-marketing surveillance, we know that abnormal liver function tests may occur with some common cholesterol-lowering medications. Thus, doctors prescribing these medications periodically do special blood tests to see if their patients have had any disruption in their liverfunction tests, and if so, they stop the medication so that that liver function returns to normal.

Hours Elapsed Between Sex and Fatal Symptom, Usually Chest Pain*
Chest Pain Number of men
During sex 27
4-5 hours 44
More than 5 hours 6
More than 24 hours 8
More than 48 hours 5
3-7 days later 4

* Most (70%) of the men who died had one or more risk factors for heart disease including high blood pressure, elevated cholesterol levels, cigarette smoking, diabetes mellitus, obesity or a known cardiac history. Some even had vials of nitroglycerin tablets in their pockets at the time of death. Only tweleve men had no cardiac history, but for them the interval between the use of Viagra and the onset of their symptoms was so prolonged that it seemed unlikely that Viagra actually contributed to their deaths. Nonetheless, they are included in the survey. For Viagra, post-marketing surveillance provided valuable information on the number of men who died after using this medication and also provided more information on those men for whom Viagra was risky. Details leading up to the deaths were varied. For example, one man was murdered and another drowned. Three expired after suffering strokes, and 77 had heart problems. Forty-one of those 77 had definite or suspected heart attacks, and 27 men died because their heart stopped beating (cardiac arrest).Excluding the 2 men who were murdered or drowned, we know that 44 (34 percent) of the 128 men who died had the onset of heart symptoms, usually chest pain, four to five hours after they took Viagra. Twenty-seven had their symptoms during or immediately after sexual intercourse. Six experienced heart pain much later on that same day. In others, the association between Viagra use and onset of symptoms was more tenuous, with 8 noticing chest pain more than twenty-four hours later, 5 fortyeight hours later, and 4 three to seven days after Viagra use.As a result of these findings as well as other post-marketing surveillance problems such as painful prolonged erection (priapism), a new set of warnings regarding safe use of Viagra was issued. Men should not take Viagra if they have:

  1. Very high (> 170/110 mmHg) or very low ( <90/50 mmHg) blood pressure.
  2. Severe heart disease and chest pain from angina pectoris.
  3. Had a heart attack, stroke, or irregular heartbeat (arrhythmia)   within the last six months.
  4. Retinitis pigmentosa.
  5. A prior history of painful prolonged erections.
  6. Liver failure.
  7. Severe kidney disease.


// October 27th, 2010 // 1 Comment » // Impotence

Along with its obvious pleasures, sexual intercourse poses a definite risk to a man’s health. We have known for some time that the heart works harder to keep pace with the excitement and passion of sexual intercourse. Under normal circumstances, when healthy men have sexual intercourse their heart rate and blood pressure increase. When men with heart disease have sexual intercourse, their damaged hearts cannot always keep pace. Often, men with heart problems can neither muster the pulse increase nor blood pressure elevation their bodies expect. The act of sexual intercourse demands a physiologic response that is sometimes beyond what the damaged heart can supply.

In the pre-Viagra era, for example, men questioned after they had heart attacks (myocardial infarctions) recalled that chest pain was the first clue to their impending heart attack. They can often relate the onset of their chest pain to some physical or emotional stress. Sometimes that stress is physical, like the exertion required to lift a heavy object or shovel snow. Sometimes the physical exertion is the act of sexual intercourse.

· Men who die immediately after having had sexual intercourse (also known as coitus) are said to have experienced a “coital death.” Heart attacks are what kill most men. Occasionally, doctors are curious enough to inquire into the events preceding a man’s fatal heart attack and want to know if he was:

1. Sleeping quietly in bed and never woke up the following morning.
2. Rushing to catch a train when he had chest pain and then collapsed on the rail station platform.
3. Embroiled in a fractious argument with a business colleague or competitor or with a rebellious child, wife, or lover.
4. Lifting weights or shoveling snow.
5. Having sex sometime during the twenty-four hours before he expired. If so, then he would be classified as having had a coital death.

In 1963, thirty-five years before Viagra, we knew that among men who die suddenly very few (0.6 percent) have coital deaths. Some men have their fatal heart attack during or immediately after sexual intercourse. Subsequently, other reports told us that:

Twelve percent of men admitted to the hospital with nonfatal heart attacks will admit that they have had sexual intercourse two to twenty-four hours prior to the onset of their chest pain.
The heart’s response to sexual intercourse has actually been studied in some detail. In the interest of science, some men with known heart disease have agreed to have their pulse, blood pressure, and heart strain measured during sexual intercourse. After being hooked up to wires that record their heart rate and change in cardiogram pattern, they have sex in the privacy of their own bedrooms. The next day, their records are analyzed. The men also keep a log of any cardiac symptoms (chest pain, palpitations, and so on) they might have experienced during sex.

These reports told us that almost one-third (31 percent) of men had cardiogram patterns suggesting heart strain (called coronary ischemia). Only 7 percent had chest pain during sex. The majority (24 percent) of those with heart strain during sex had no discomfort and were classified as having “silent coronary ischemia.”