Not on my watch

The Food and Drug Administration (FDA) recently added eight more drugs to its “watch” list, due to potentially serious safety concerns. The new drugs to make the list include ones used to treat conditions like cancer, epilepsy, hypertension, and malaria.

At this rate, they’ll have almost every drug on the list by the decade’s end. (If only…) But making the FDA’s watch list doesn’t mean anything actually happens to these drugs.

Rather than banning these potentially dangerous drugs pending investigation, the FDA will leave them on the market while they study them further. And this of course means the pharmaceutical companies get to keep selling and making money off of drugs with potentially lethal side effects.

Then, if it establishes a causal link between the drug in question and the adverse effect, the FDA would consider (just consider, mind you) a “regulatory response.” Such as gathering more data to “better characterize the risk” (i.e. the old “twiddle our thumbs” approach again), revising the drug’s label, or requiring a “risk-evaluation and mitigation strategy.” All of which would occur while the drug was still available for sale.

The FDA doesn’t even go so far as to suggest that doctors stop prescribing watch-list drugs, or that patients stop taking them.

In what other industry would this be okay? When they find something wrong with a part of an airplane, that model may be grounded world-wide. But for drugs that millions of people take every day, it’s a “wait and see,” laissez-faire approach.

It makes no sense.

And neither does risking your life on one of these dangerous medications. So in case you haven’t seen the rundown yet, here are the most recent entries on the FDA’s drug watch list, along with the risks cited against them:

  • Cetirizine HCl (Zyrtec)–common allergy medication. Associated with oculogyric crisis (the technical term for your eyeballs rolling back into your head involuntarily)
  • Codeine sulfate–common cough medication. Associated with respiratory depression or arrest, resulting in death in children taking the drug
  • Docetaxel (Taxotere)–chemotherapy drug. Associated with serious interaction with the atrial fibrillation drug Multaq, resulting in death
  • Fluoroquinolone products (Cipro/Levaquin)–antibiotic. Associated with retinal detachment, which can result in permanent vision loss
  • Levetiracetam (Keppra)–epilepsy medication. Associated with strong potential for abuse, misuse, or dependence
  • Mefloquine HCl (Lariam)–antimalarial drug. Associated with vestibular disorder (i.e. problems with the inner ear, leading to balance issues, dizziness, and other issues)
  • Olmesartan (Benicar)–blood pressure medication. Associated with malabsorption resulting in severe diarrhea and weight loss
  • Proton pump inhibitors–common acid reflux medications. Associated with pneumonia

I would bet you or someone you know has taken at least one of these drugs. (After all, proton pump inhibitors alone are dispensed like candy in America.) We need to get a lot more serious about the use of prescription drugs, how they interact with each other, and let the alternatives have a chance to show what they can do.