If you’ve taken prescription medications for colds and allergies, you could have inadvertently put your health on the line. The FDA has announced plans to pull 500 ineffective prescription drugs off the market. These drugs are cold and allergy medications that have untested combinations of cough suppressing ingredients and decongestants – a possibly dangerous mix.Why is the FDA just now cracking down on these medications?
Good question. As most know, before prescription drugs can be launched to the public they have to be submitted to the FDA for scientific review. But the drugs being recalled have slid under the radar for years. These medications are those that pre-date the FDA regulations. Up until now, they have escaped scrutiny . . . but that’s about to change.
What’s most concerning is the fact that all this time doctors have been prescribing unapproved drugs to their patients. They simply didn’t realize they were unapproved. It’s easy to make a mistake because the drugs in question are labeled just like FDA approved medications. Obviously, that is an acceptable practice to all concerned. And several different companies manufacture a lot of the older drugs. They often use different ingredients and dosages.Dangerous combinations.
According to Patti Gasdek Manolakis, a pharmacist and consultant, “That’s what makes them so dangerous: they have these shared names but different ingredients in different doses, so it’s very easy for medication errors to occur.”
Among the drugs listed for recall our products like Pediahist, a cold medicine labeled for children as young as one month old. The FDA does not recommend giving any type of cold medicine to children under two.
Some of the other drugs could be potentially dangerous because they combine variations of the same compound. These kinds of combinations can have negative side effects, yet they’ve been widely available to patients.
This latest crackdown isn’t the first. The recall began in 2006 and so far the FDA has gone after 17 types of medications and dozens of companies. In situations like this the FDA often orders drug companies to stop making and shipping the drugs and sometimes the FDA will seize millions of dollars worth of medications. However there is no law that prohibits the sale of unapproved drugs, and rarely are these kinds of cases prosecuted.
Deborah Autor, director of the FDA’s Office of Compliance states, “We don’t expect today’s action to have a negative impact on consumers. There are multiple other products available to treat cold, cough, and allergy symptoms.”
Okay, that’s all well and good. The problem is – and the latest actions by the FDA prove it –you never know what you’re going to get when it comes to prescription drug safety.