Word: hexamethonium
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...another, there was evidence in the literature that hexamethonium might be unsafe. Togias did a search and didn't turn that up, but after-the-fact searches using different search engines and databases did turn up references to the potential risks to humans. The FDA also raised questions about the informed-consent forms that Roche and two other subjects had signed. On them, hexamethonium is referred to as a "medication" and as "[having] been used as an anesthetic"--giving subjects a false sense that it was an FDA-approved medicine and therefore safe. An outside review board commissioned...
...criticism: Togias failed to report that his first subject (Roche was the third) had developed a cough. It went away, and Togias assumed it had to do with a viral infection making the rounds at Bayview at the time. To be safe, he added a buffer solution to the hexamethonium--but without informing the IRB, which he should have done. That omission may be a reflection of the prevailing sentiment at many hospitals: that the IRB and its review process are a bureaucratic pain in the neck, not a clinical necessity...
Roche volunteered for a trial in which she took hexamethonium, a compound not currently approved by the FDA for use in humans. In these cases, the FDA requires that researchers obtain the agency's approval before administering such compounds. But because of the huge number of academic trials and the accompanying paperwork, the FDA had got into the habit of quietly discouraging universities from applying for approval, assuming that safety issues could be dealt with by the universities. Then, in 1999, the feds abruptly cracked down, stopping human research at Duke University Medical Center. One infraction they cited: the improper...
Hopkins officials note that hexamethonium was approved in the 1950s for treating high blood pressure, and was pulled only when other drugs proved more effective. "The decision to go ahead was based on the fact that this was not a new investigational drug," says Dr. Edward Miller, dean and CEO of Johns Hopkins Medicine. "On similar compounds, the FDA had ruled that their approval was not needed." Doctors, heal thyselves...
Since then, a host of other antihypertensive drugs have been introduced. Some, such as hexamethonium and chlorisondamine, are blocking agents. They work by interfering with the nerve signals and chemical reactions that cause blood vessels to constrict and raise blood pressure. Others, like hydralazine, are relaxers that seem to act directly on the muscle walls of the blood vessels, causing them to dilate and thus decrease pressure. Still others, such as guaneth-idine and reserpine-a drug extracted and purified from the Indian plant Rauwolfia serpentina-achieve the same effect by reducing the action of norepinephrine, the body chemical that...