Faster Word on Drug Alerts

- Washington Post

12/24/2007 - Smokers taking the Pfizer drug Chantix to help them quit might have missed a Food and Drug Administration report in late November that the drug has been linked to drowsiness and suicidal thoughts. That's because while a drugmaker may issue a press release and the FDA an advisory when a drug is recalled or has a warning added, neither is obliged to directly notify consumers taking the drug, says Areta Kupchyk, a food and drug lawyer with the D.C. law firm Reed Smith.

Given 10 or more drug recalls and warnings in 2007 -- including an alert about heightened risk of heart-related death and heart attack for the diabetes drug Avandia and the recall last week of more than a million doses of meningitis and hepatitis B vaccines -- the FDA and some companies are trying harder to rush advisories to patients who need them.

Here's how:

FDA e-mail alerts (http://www.fda.gov/emaillist.html):Early this month, the FDA moved to a speedier alert system, one that can generate e-mails minutes after an agency statement is released instead of hours or days later, as had sometimes been the case before, says FDA public health advisor Kristine Mejia.

At the FDA e-mail site, consumers can sign up for free "Medwatch Safety Alerts" to stay on top of drug warnings. An alert last week advised consumers that, despite earlier reports to the contrary, the FDA has found no increased heart attack risk from the heartburn drugs Nexium and Prilosec.

Consumers who list the drugs they take with iGuard, a firm launched this month, get free recall and warning alerts sent by e-mail. Each drug listed gets a color code (from green, "suitable for widespread use"; to red, "requires careful consideration of risk vs. benefit"). Avandia -- now under FDA review and appropriate for many patients, according to diabetes experts -- is coded orange for "talk to your doctor about reducing your risk from possible side effects of the drug."

Electronic Medical Records: About 10 percent of U.S. patients -- including those using the faculty practices at George Washington University -- now see doctors who use electronic medical records (EMRs), according to Mark Bard, president of Manhattan Research in New York. When the FDA issued a serious warning on Avandia earlier this year, Allscripts, the EMR firm that GWU uses, alerted the practices and gave them the name, address and phone number of all patients taking the drug, says Allscripts spokesman Todd Stein. GWU then gave its physicians the option of contacting their patients directly. To maximize your protection, update your EMR regularly and be sure it includes drugs prescribed by other doctors, says William Shrank, a pharmacoepidemiologist at Harvard Medical School.

Physican alerts: Some companies send out alerts to physicians' mobile communication devices. At least one of them, Epocrates, allows consumers to receive these warnings for free on their BlackBerrys and PDAs.

Alerts from health insurers: Pharmacy benefit managers, health insurers and some pharmacy chains sometimes send out e-mails or snail-mail alerts to patients about a drug warning or recall. These notices may include information on how to get a refund on a drug that has been yanked or help getting a new prescription from your doctor. Using your pharmacy card to get a prescription may also trigger a message that the drug you're taking has gotten a warning or been recalled, says Ann Smith, a spokesman for Medco Health Solutions, one of the largest pharmacy benefit managers in the country.

Whatever your source, if a drug you use is subject to a recall or warning, don't stop taking it without first seeking expert advice, says pharmacist and family physician Edward L. Langston, chairman of the American Medical Association's board of trustees. If you can't reach your doctor or pharmacist, Langston says, check the FDA's home page ( http://www.fda.gov), whose news section will often have instructions on what to do when a warning or recall is issued.