A less-than-urgent new FDA “warning” about an asthma medication
If you saw someone strolling along a railroad track and you could see an approaching train coming around a bend that was not within the stroller’s field of vision, you’d probably shout out a warning, right? And it would probably go something like this: “Hey! HEY! There’s a train coming but I don’t yet have enough conclusive evidence to determine with certainty that the train will hit and kill you so at this time I would not recommend that you discontinue your stroll on the railroad track!”
And if that’s what you would shout, then you might have a future working at the FDA.
Again and again and again, when FDA officials announce new findings that reveal clear dangers of a certain drug, their advice is nearly always the same: Don’t discontinue use.
The current case: The FDA recently announced the results of a safety analysis of an asthma drug called Xolair. The analysis discovered that patients with mild to severe asthma who were taking Xolair might be at risk for the following:
- Ischemic heart disease
- Arrhythmias
- Cardiomyopathy
- Cardiac failure
- Pulmonary hypertension
- Cerebrovascular disorders
Embolic, thrombotic and thrombophlebitic events And here’s how Medscape Medical News described the agency’s reaction: “The FDA is not recommending changes to safety labeling for Xolair, and clinicians do not need to take their patients off the drug.”
Sure, all those risks aren’t so bad…compared to falling under the wheels of a train.
