The New Straits Times, August 3, 1998
In the sixth Biennial Asia-Pacific Meeting on Impotence held in Kuala Lumpur, October last year, "impotence" was dubbed as one of the most misunderstood medical disorders in the world today.
Medically, impotence is defined as the consistent inability to keep an erection suitable for sexual intercourse. The cause to this problem is varied, and drugs are not excluded. Over 200 prescription drugs are known to cause impotence apart from illicit drugs and cigarettes.
Some examples of impotence-causing drugs are anticholinergics, antihypertensives, antiparkinson agents and barbiturates.
Drugs of abuse include alcohol, cannabis, cocaine, heroin, methadone, morphine and tobacco.
The stigma of impotency seems to be vanishing today with the introduction of the drug, Viagra. This new anti-impotent drug received FDA approval earlier this year and is making headlines all over the world. Within a short span of time, Viagra has become almost a household name. Hailed as a "magic bullet", Viagra is predicted to be an instant best-seller.
It is poised to replace the various devices, implants, equipment and other drugs including hormone replacement therapy. Practically every day one reads about the much-hyped drug in the local daily and how it is transforming the male sexuality - now that the men too can be on the "pill".
It looks like the economic downturn is not the only thing that is pre-occupying the minds of many Malaysians.
However, Public Citizen Health Research Group, an NGO based in the US, has petitioned for a review on Viagra based on the evidence of its effectiveness. The petition is based on Sildenafil (generic name Viagra) clinical data submitted to the FDA by Pfizer prior to the drug's approval and on adverse drug reaction reports received by the FDA until June 30. The organisation noted that the following information should be made known to the public about Viagra.
In all of the large multi-centre clinical trials of Viagra, men with various medical conditions were excluded from the studies.
Among those excluded were people with blood pressure of less than 90/50 or more than 170/100; active peptic ulcer disease or bleeding disorder; any clinically significant baseline laboratory abnormality, need for anti-coagulants, androgens, or trazodone (an antidepressant); need for aspirin or NSAIDS (non-steroidal anti-inflammatory drugs) and a history of peptic ulcer disease; history of retinitis pigmentosa; uncontrolled diabetes or diabetic retinopathy; stroke or myocardial infarction within six months, cardiac failure, unstable angina, ECG ischemia (a common finding in people with coronary artery disease); or life-threatening arrhythmia within six months.
For this, the label as requested by the organisation should exclude the above patients from consuming Viagra.
In addition, the organisation also highlighted a missing fact from the label of Viagra, which is: many commonly used drugs can interfere with sexual function in both men and women, causing loss of libido, or can interfere with erection or ejaculation in men, or can delay or prevent orgasm in women. Drug-related effects on sexual function may be difficult to distinguish from the effects of depression or disease, but most are reversible when drug use is stopped and sometimes when dosage is decreased.
For the adverse reactions caused by Viagra, 174 reports have been received by FDA. Seventy-five listed one or more drugs being taken by the patient in addition to Viagra. Of these, the other drugs were fully listed in 69 of the reports. Of the 69, 32 (46.4 per cent) included one or more drugs known to cause sexual dysfunction.
Of the 75 reports in which patients were using one or more drugs in addition to Viagra, in 27 or 36 per cent, one or more drugs for the treatment of cardiovascular diseases were used, many of which were probably the diseases for which people were excluded in the pre-approval clinical trials.
Some of the cardiovascular disease (including diabetes) for which people are taking these drugs, in addition to Viagra, are themselves associated with an increased amount of sexual dysfunction. But to worsen pre-existing sexual dysfunction and then treat this with Viagra, instead of attempting to substitute another drug less likely to cause sexual dysfunction or to lower the dose of the offending drug seems to be an unwise medical decision, if indeed it is being made with full knowledge.
Thus, the best guideline to follow in the use of Viagra is to determine whether Viagra has been adjudged the best solution in overcoming erectile dysfunction. For this it is better to seek the advice of a medical professional before assuming that Viagra is the cure-all for erectile dysfunction. - National Poison Centre
