When it comes to drug safety, how safe is safe? Take, for instance, three beta-agonist bronchodilators that have been used by asthma sufferers. One, Serevent (salmeterol xinafoate) was first suspected of causing the deaths of patients back in 1994, and so similar drugs fell under the same suspicion.
In 1996 Advair (salmeterol plus fluticasone propionate) was tested for its safety against a placebo, and researchers found a ‘small, but significant’ increase in the death rate among patients. The drug regulators recommended that the study continue its work, although finding recruits must have been a bit of a problem.
The American drug regulator, the Food and Drug Administration, acted in the way it knows best, and ordered a ‘label revision’. This is a harsh penalty, requiring a minute change to the small print.
The FDA’s drug advisory committee finally met up the other week to decide if the drugs should be allowed to stay on the market. To a man they decided that the drugs were safe enough to continue to be prescribed.
This might cause a flutter of uneasiness amongst doctors who had been prescribing the drugs as if they were sweets. After all, how safe is safe?
* Readers who are looking for better, and safer, ways to treat their asthma will find all the answers in our definitive guide, The Asthma Manual. It review and evaluates drug families, and the alternatives, including therapies as well as supplements. It’s in a ring binder so it updates easily. To order your copy, click here: http://www.wddty.co.uk/shop/details.asp?product=391