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Healthy Skepticism Library item: 14761

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: news

Wang SS.
Drug-Safety Data: Too Much Information?
The Wall Street Journal 2008 Dec 9

Full text:

After a series of prescription-medication scares in recent years, consumers are receiving a flood of safety information about the drugs they take — so much that it risks scaring some people.

Too much information about drug safety — disseminated through media, online alerts from consumer watchdog groups and even by the Food and Drug Administration itself — might overwhelm patients and raise undue alarm, some medical professionals caution. Consumers may forget about the benefits of a medication if they focus only on risk. And the health consequences associated with stopping a medication, particularly for a chronic condition, may be far worse than the possibility of a side effect.

Stephen Webster
A Pfizer Inc. survey of 300 medical professionals in March found that 89% of respondents were at least somewhat concerned that patients might stop their medications if potentially negative safety information was released to the public too early.

Deborah DeRousse of Houston says the smoking-cessation drug Chantix was making her feel depressed, so she quit the drug last year, but resumed taking it a few months ago after her smoking habit returned. The 55-year-old read a so-called early-communication letter issued by the FDA late last year that warned the drug could be linked to increases in suicidal thoughts. Worried how low her mood might go, Ms. DeRousse quit taking Chantix for a second time last month and is now smoking again.

The FDA recommended in its letter that doctors monitor Chantix-taking patients for mood and behavior changes, and that patients bring up their concerns with their doctors. But Ms. DeRousse says she stopped taking the drug without talking to her physician. “The doctors just don’t have the time to sit and talk to you to really get into” your feelings of depression, she says. The FDA has since ordered that the Chantix label carry a warning of serious neuropsychiatric symptoms.

Pharmaceutical companies, including Pfizer and Wyeth, are ramping up efforts to be more open about drug safety, including launching Web sites that go beyond traditional lists of side effects. Johnson & Johnson’s new site, for example, is designed to help doctors and patients balance the risks and benefits associated with the company’s arthritis drug Remicade. The site, called Medversation, contains clinical data written in plain English about the efficacy of the medicine and in-depth explanations of its side effects.

“It’s a higher priority to take even small [safety] signals even more seriously than we did before,” says Geno Germano, head of Wyeth’s pharmaceutical unit.

FDA Alerts
The FDA also is taking steps to continue alerting consumers about drug-safety issues while trying not to cause unnecessary worry. The agency plans to revamp its early-communication letters, launched in 2007 to notify the public as soon as the FDA has a specific concern about a medicine, to include more information, such as the number of adverse events that have occurred compared to the number of people who take the drug, says Paul Seligman, an FDA drug-safety official. The alerts will soon be posted on WebMD under an agreement between the FDA and the popular consumer health site.

Drug safety communications from the FDA at a glance

Public health advisory — contains important drug safety information and recommendations of actions that can be taken to avoid or minimize harm from a drug. Written at a level for consumers.

Healthcare professional information sheet — known as “Dear Doc” letters, these are sent to medical professionals with information regarding updated label changes or enhanced safety warnings about specific products when the FDA wants professionals to initiate action. Written at a level for medical professionals (e.g., data points, information on how to treat patients).

Early communication — contains information about adverse events that have been reported about a drug that the FDA has decided warrants communication to the public, but for which the drug hasn’t yet been shown to be the cause of the safety issue. These are intended to raise awareness of emerging issues but don’t instruct professionals to change prescribing practices yet.

Potential signal of serious risk — known as the “quarterly report,” these list medicines for which adverse events have been reported during the quarter and that the FDA is currently investigating. There may be no link between the safety concern and the medication.

Label updates — issued when the link between a drug and a safety risk is strong enough that the FDA feels it should be listed on the medication label. New, serious reactions can be added to the already existing list, added in bold, or listed with a box around it. Such “black box” warnings are the strongest of the FDA label warnings.

The moves come after a series of medication scares in recent years that resulted in lawsuits against some drug makers and pressure on the FDA to more closely monitor drugs, even after they are approved. Merck & Co. in 2004 voluntarily pulled its pain pill Vioxx off the market, after it was shown to raise the risk of heart attack in some patients. Later, GlaxoSmithKline PLC’s diabetes drug Avandia turned out to present a similar risk in some patients.

Many consumers have doubts about the safety of their medications, although drug industry officials say the heightened skepticism might be temporary. Only 27% of the public feels “very confident” that prescription drugs sold in the U.S. are safe; just over half feel that pharmaceutical companies do enough to test and monitor the safety of their drugs, according to a study this year conducted by the Kaiser Family Foundation and Harvard School of Public Health.

Elona Boykin, 54, of Blacklick, Ohio, has for years been taking six medications for diabetes, high blood pressure and gout. She says the growing amount of drug-safety information available on the Internet and television has made her much more attentive to possible side effects. When she hears something new, she says, she quizzes her doctor with questions like: “What’s your spin on this and should I continue to take it?”

Ms. Boykin says her doctor has been “hounding” her to start a cholesterol-lowering pill, AstraZeneca PLC’s Crestor. She is reluctant: Her brother and sister have experienced side effects from a similar medicine, she says, and she’s heard that Crestor can lead to serious conditions like pancreatitis. Still, she says, if her doctor reassures her at the next visit, she has decided she will start taking the drug.

Some medical experts say that one source of confusion for consumers is what it means for a drug to be “safe” — which some patients take to mean it should present virtually no risk. “There are no guarantees, and there are always risks,” says Timothy Lesar, director of Clinical Pharmacy Services at Albany Medical Center and a member of the FDA’s drug-safety advisory committee. But, he says, “If we’re going to take risk, we need to make sure there are benefits here.”

Being Informed on Drug Safety

Consumer education about medication safety from the FDA ( Information about how to buy and use medications properly.

Latest drug product and safety information from the FDA ( Links to the FDA’s various drug alerts, including early communication letters.

FDA quarterly list of potential safety signals ( Medicines for which adverse events have been reported and that the FDA is investigating.

WebMD ( A consumer health site that includes FDA information about drug-safety concerns. Also will soon include FDA early communication letters.

MedWatch ( Doctors and patients can report and learn about adverse events associated with prescription medications.

Pfizer medicine safety education Web site ( Information about how drug safety is monitored during clinical trials and after the medication reaches the market.

Medversation ( Johnson & Johnson’s site to help doctors inform patients about the risks and benefits of its anti-inflammatory biologic Remicade.

Pristiq ( Wyeth updated its site for the antidepressant Pristiq to include more safety information. Wyeth plans to update additional drug-specific sites.

Pfizer’s recently launched Web site is intended to educate the public about the way medicines are monitored for safety during clinical trials and after they reach the market. The site doesn’t mention any Pfizer products. New safety concerns can crop up once drugs become publicly available because they are being used by many more people and in a more diverse population than during clinical trials.

Wyeth is retooling existing Web sites that focus on specific drugs to add safety information for consumers and to include tools to help patients keep track of whether they took their medication and experienced any change of symptoms.

Among the FDA’s recent safety alerts about drugs already on the market, the agency warned consumers and doctors about increased cardiovascular risks and potential tumor growth in some patients with the class of anti-anemia drugs known as erythropoiesis-stimulating agents, including Amgen Inc.‘s Epogen. FDA safety advisories include both brand and generic names of medications so patients taking either will be alerted.

Black-box Warning
The FDA also plans to study how consumers react to and use safety information, says Dr. Seligman, adding that the consequences of providing more safety data may not always be clear.

For instance, the FDA in 2004 required a so-called black-box warning label — the agency’s toughest — on antidepressants to caution about the increased risk of suicidal thoughts and behaviors among teenage patients. Following that, the number of prescriptions for the drugs decreased. But over the same period, the rate of teenage suicides went up, recent studies have shown.

Whether the higher suicide rate is linked to the lower number of prescriptions written isn’t clear. The FDA is currently trying to understand the data but “it’s really hard to sort through and make sense of it,” Dr. Seligman says.

“We’re always aware and want to strive to make sure that this [safety] information is provided in a way that outweighs any unintended consequences,” he says.


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