drug safety

RECENT POSTS

Ritalin Nation: ADHD Drugs Not Studied Enough For Rare Or Late Risks

The ADHD drug Ritalin (Wikimedia Commons)

The ADHD drug Ritalin (Wikimedia Commons)

If we’re going to keep putting millions of American children on ADHD drugs, we really need to study the meds longer and better to pick up rare and late-onset side effects.

That’s my takeaway from a study just out from Boston Children’s Hospital. It found that in many cases, ADHD drugs had not been studied for long enough — really, can a clinical trial of a few weeks be long enough for a drug that’s typically taken for many years? — or in enough people. And drug company promises to keep studying the drugs’ effects even after the FDA approves them have often fallen by the wayside.

From the press release:

Over the last 60 years, the U.S. Food and Drug Administration (FDA) approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers at Boston Children’s Hospital report today in PLOS ONE. The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process.

“This study doesn’t address whether ADHD drugs are safe, though their safety has since been established through years of clinical experience,” says study senior author Kenneth Mandl, MD, MPH, Boston Children’s chair in biomedical informatics and population health and director of the Intelligent Health Laboratory in Boston Children’s Informatics Program. “Instead, we point to the need for an agenda emphasizing improved assessment of rare adverse events and long-term safety through post-marketing trials, comparative effectiveness trials and more active FDA enforcement.”

The numbers: Continue reading

Tylenol’s Key Ingredient Under (More) Scrutiny

(Todd Kravos/Flickr)

(Todd Kravos/Flickr)

By Judy Foreman
Guest Contributor

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

Blogger Examines FDA’s Drug-Safety Problems And Asks If Anyone Cares

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?