FDA Unveils List of 20 Drugs In Side-Effect Probes

Goal Is to Provide Signs of Possibility Of Adverse Effects

By JARED A. FAVOLE

WSJ.com, September 5, 2008 8:07 p.m.

WASHINGTON — The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.

The list includes a wide array of drugs, from Eli Lilly & Co.’s antidepressant Cymbalta to Purdue Pharma LP’s painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated. (See the FDA’s list of drugs that are under investigation.)

The FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers — such as Johnson & Johnson’s Remicade — as being potentially associated with cancer in children. In June, the FDA said it was investigating the possible link. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn’s.

But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp.’s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but the FDA hasn’t previously said it was investigating the drug for this side effect.

The list, which the FDA will start issuing quarterly, is aimed at giving consumers and health-care professionals early indications of what the FDA is investigating, but it might end up creating more confusion. Indeed, the agency is concerned “that people will stop taking a drug inappropriately” because it is on the list, said Paul Seligman, associate director of safety policy at the agency.

The FDA said it alerted companies whose drugs appeared on the list prior to it being made public — several companies said they received word late Thursday — and intends to give drug makers a heads-up in the future as well.

Drug makers said they support the FDA’s additional efforts to be transparent about drug safety, but some expressed concern that the information was being communicated to patients without context and wondered about what patients might do with the information.

“It is very, very important that patients and their physicians understand the benefits and the risks of the drug. To speak about one without the other could have an impact on patient perception of their medications,” said Tony Jewell, a spokesman for AstraZeneca PLC, whose psychiatric medication Seroquel made the list for the possible safety concern of overdose due to confusing sample-pack labeling.

Companies also cautioned that just because a drug is posted on the site doesn’t mean a causal relationship has been identified, and it is also risky if patients go off their medications without consulting a physician.

The FDA’s intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage them to report any problems. The list doesn’t represent a comprehensive list of drugs the FDA is investigating, the FDA’s Mr. Seligman said.

The report is generated from the agency’s adverse-event-reporting database. That compilation consists of voluntary reports from patients and health-care professionals, and is widely considered to capture only a fraction of the actual adverse events associated with any given drug.

Mr. Seligman said the FDA is hopeful the quarterly reports will encourage people to report adverse events.

Write to Jared A. Favole at jared.favole@dowjones.com

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.