By Judy Foreman
Pain relievers are in the news again — and the news isn’t great.
Acetaminophen, the active ingredient in Tylenol, is the focus of a series of scary investigative articles by ProPublica, the online new organization. The bottom line of the series: about 150 people per year die from accidentally taking too much acetaminophen, and even though the line between a therapeutic dose and a dangerous dose is slim, the FDA (and the drug companies that sell the products) have done little to warn consumers.
To be sure, treating pain with any medication is an intrinsically dicey, though often necessary, business. Opioids can reduce pain, though not entirely, and carry the risk of dependence, immune and hormonal changes and, in some cases, abuse and overdose.
In some ways, acetaminophen is the slipperiest of all the pain medications to understand because it’s not just in over-the-counter medications such as Tylenol, but in a whopping 600 prescription and OTC products, including cough syrup and in combination pain-relievers such as Vicodin, a mix of acetaminophen and hydrocodone. Continue reading
Alison Bass raises several excellent points in her post today about a recent Institute of Medicine report on deficiencies at the FDA when it comes to drug-safety oversight.
Basically, she writes, the IOM’s takeaway is that the FDA isn’t doing an adequate job of assessing the risks and benefits of drugs:
Two weeks ago, I headlined my blog with this question: Is the FDA violating its own mandate to approve safe drugs? Four days later, the national Institute of Medicine (IOM) released a 233-page report concluding that FDA’s current approach to drug oversight “is not sufficiently systematic and does not ensure consistent assessment of benefits and risks associated with a drug over its lifecycle.” In other words, the FDA may indeed be violating its own mandate.
It’s troubling enough that the FDA may not be safeguarding the drug supply, Bass notes, but it’s particularly frustrating that the media isn’t paying attention:
Last week, the British Parliament came out with a report concluding that Rupert Murdoch is unfit to run News Corp., and its findings made headlines on this side of the Atlantic. How come when the Institute of Medicine comes out with a 233-page report concluding that the FDA is not doing its job, the only mention I can find of it is near the bottom of a short news article in one scientific journal? Why doesn’t this report merit front-page news too?