Don't Shy Away from Sharing Risks

Discussions about the use of drugs to treat attention deficit/hyperactivity disorder (ADHD) can get very heated. Recently, as I sat with a group of mothers, our casual chat about our children turned into a polarizing debate on ADHD drugs. “Prescription drugs are used way too much these days,” said one mother. “There is too much overmedication.”

“How can you say that when your child doesn’t have ADHD?” demanded another. “Drug treatment can make all the difference—I know firsthand as a parent.”

After hearing about FDA’s internal debate earlier this year on labeling warnings for these drugs, I believe that patients should be fully informed. Some experts within FDA had recommended the use of strong, black-box warnings about increased risks for cardiovascular conditions and psychosis, among others. Some industry participants and observers fear such warnings, as do some healthcare practitioners, worrying that it will cause some to forgo drug therapy. Others argue that parents must be made aware of the risks.

FDA’s Pediatric Advisory Committee discussed the issue in March, ultimately deciding against the use of a black box. “We did feel that there was an important message about improving communication about certain adverse events that we’re seeing both in the control data as well as adverse event data, but did not feel that rose to the level of the black box,” explained committee chair Robert Nelson, MD, who is from The Children’s Hospital of Philadelphia, Department of Anesthesia and Critical Care Medicine.

“FDA is changing [its] overall labeling as of January of this year, where there is now a half-page highlight box that’s at the very beginning of the label,” Nelson continues. “In many ways, that serves the same informational purpose as the black box used to serve, because it’s now at the beginning.”

Robert Temple, MD, added that the committee “agree[d] with the previous suggestion that there should be a so-called MedGuide—that is, a document directed at caregivers and patients that helps them understand what the benefits for it are and what to watch out for.” Temple is director, Office of Medical Policy and Center for Office of Drug Evaluation I, of FDA’s Center for Drug Evaluation and Research (CDER).

The debate on whether to warn or not to warn patients about side effects certainly goes well beyond ADHD drugs. Such was the debate regarding the potential side effects of nonsteroidal antiinflammatory drugs. And Biogen Idec and Elan will need to consider warnings for Tysabri.

Patients appear to want these warnings. According to a survey directed by American Enterprise Institute resident scholar John E. Calfee and conducted by Roper Public Affairs, patients “want FDA to review drugs thoroughly and to warn them about side effects.” The study was funded by Biogen Idec, but did not ask about a specific drug.

Parents who seek ADHD drug treatment for their children would want to be made fully aware of any drug risks. They aren’t looking for a quick fix. The mothers I spoke with had gone through years of varying diagnoses and had researched several solutions, later turning to drug therapy. As educated as they have become on ADHD, they certainly wouldn’t want any warnings withheld from them.

Most patients want as much information as possible about their drug therapies. Your job should be to share all the information you can—clearly and powerfully through labeling.

Daphne Allen


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