When Mead Johnson Nutritionals recalled a batch of its Portagen nutritional powder earlier this year, it was a matter of some urgency. An infant being fed formula containing the powder had contracted a rare form of meningitis, and the bacteria that caused the illness had been traced to a 17,000-can supply of Portagen, a food supplement for people who cannot absorb or digest fats. The infant, who had been born prematurely and was hospitalized in a neonatal intensive care unit when the infection was discovered, died.
When an investigation of the death ended a year later, not only did the company act, so did the Food and Drug Administration (FDA). Instead of relegating a warning about the apparently contaminated sample to an obscure page on its Web site, as it would have done in past years, the agency placed the alert on its home page. Prompted by the alert and by a press release in which Mead Johnson Nutritionals announced a recall of the batch implicated in the infant's death, several newspapers reported warnings against using any of the cans they might have on hand.Every year drug companies initiate about 400 recalls, but whether people find out about these actions depends largely on manufacturers' and retailers' diligence, consumer vigilance and media cooperation.
Recalls generally involve only a few lots of a specific product. By contrast, withdrawals involve fundamental problems that lead the FDA or a manufacturer to take a drug off the market.
About 15 recalls each year are prompted by problems that can be life-threatening -- such as the manufacture of albuterol canisters without any medication inside, a situation that has prompted several recalls. The FDA ranks these as Class I recalls, the most serious of its three categories.
Less serious recalls have recently involved bottles of clonazepam that were mislabeled as having either more or less of the antiseizure medication than they actually contained -- errors that could exacerbate the drug's side effects or diminish its effectiveness. In another case, some Nasonex allergy medicine dispensers were recalled because the drug came out in a spray instead of a thin mist, delivering too much medication per dose. There are about 250 such Class II recalls annually.
Class III recalls are those in which exposure to the defective drug isn't likely to cause any health consequences. In early September, for example, Aventis Pharmaceuticals recalled two lots of the antihistamine Allegra because labels indicated that they contained capsules when they actually contained tablets. About 125 Class III recalls occur each year.
Except in Class I cases, there are no regulations for how consumers are to be alerted; the FDA requires only that drug companies have a plan for each type of recall, says David Bloch, a food and drug lawyer with the Washington firm Reed and Smith.
Several years ago, after the recall of some epinephrine injectors, which are used to counter potentially life-threatening allergic reactions, several members of Congress considered drafting legislation to improve consumer notification of defective drugs. But the effort languished and staff members say the issue is no longer being addressed aggressively.
Because the federal government outlines few specific steps for alerting health care professionals or consumers, many remain uninformed of routine actions.
"We rely on what [information] comes to us from manufacturers,'' says David Martin, owner of Sherwood Hall Pharmacy in Alexandria. "But often it comes late, and sometimes it doesn't come at all. In fact, sometimes it's the customer who has seen it on a Web site or reads about it in the news who alerts me to a recall."
But sometimes the word doesn't reach consumers, either.
Knowing Where to Look
Recalls generally come about in one of two ways, says Susan Allen, associate director for scientific and medical affairs in the Office of Compliance at the FDA's Center for Drug Evaluation and Research.
Either a drug maker finds a problem during testing or the FDA identifies one during routine inspections of drug plants. In Class I cases, drug companies then work with the FDA to determine the seriousness of any threat posed and the means of alerting health care professionals and, if necessary, consumers.
Then there are defects, such as in the Portagen case, that are discovered only after the drug has caused death or illness.
Recalls get officially announced in two ways: The FDA posts weekly enforcement reports on its Web site (www.fda.gov), but only Class I recalls generally appear on the home page. The rest are tucked away on a harder-to-access page. To get there from the home page, a viewer would select "Recalls and Alerts" and then click on "Enforcement Report." (To get there directly, the viewer could also go to www.fda.gov/opacom/Enforce.html.)
Manufacturers also notify health care professionals, usually by mail. But these letters, says Susan Winckler, vice president for policy at the American Pharmaceutical Association (APhA), a national society of pharmacists, are often indistinguishable from other manufacturer mailings, which means they may gather dust or never be opened at all.
Winckler says APhA raised the issue with the FDA's new Drug Safety and Risk Management Advisory Committee last year. She is hoping the agency will push drug manufacturers to find an effective way to highlight significant recalls so as to better get the attention of practitioners.
Pharmaceutical Research and Manufacturers of America (PhRMA), a drug industry trade association, says it has no information on why recall notices don't indicate their importance to health professionals.
When a recall announcement does reach them, physicians and pharmacies generally use their own discretion about notifying their patients. Pharmacies often post significant recall notices at the drug counter, but how and when to alert consumers is up to each pharmacy, says Crystal Wright, spokeswoman for the National Association of Chain Drug Stores.
Physicians also make individual decisions, according to J. Edward Hill, chairman of the American Medical Association board of trustees and a family practice physician in Tupelo, Miss.
David Pearle, director of the coronary care unit at Georgetown University Hospital, says he checks drug company letters as well as medical journals for recall information. For patients known to be using a drug involved in a Class I recall, Pearle says he will generally alert them at their next visit.
Spreading the Word
In addition to the FDA's posting of the most serious alerts on its home page, other efforts may help consumers keep track of drug recalls.
Electronic record-keeping systems offer the potential for speeding patient notification by doctors; when the cholesterol- lowering drug Baycol was withdrawn (not recalled) last year after it was linked to more than 30 deaths, one Delaware practice was able to switch almost all affected patients to a safer drug within a day by asking them via e-mail to phone in for a prescription change. Such swift action is likely to become more common as more practices computerize their records, according to the AMA's Hill.
PhRMA is working on a process that would immediately download recall notices to pharmacists, who could then forward the information to patients using the affected drugs, says Alan Goldhammer, PhRMA's vice president for regulatory affairs. The system, however, is still a few years off.
Patient privacy is not an issue here and shouldn't be, say lawyers and health care experts. Federal privacy rules that will take full effect in April will allow health care professionals to use and disclose health records for patients' protection and public health purposes -- such as in the case of a drug recall or withdrawal, says Reed Smith's Bloch.
Some manufacturing changes might may reduce the number of recalls.
A recently proposed FDA initiative might encourage new technologies to help identify manufacturing problems before defective products are shipped out. And proposed changes to FDA's manufacturing-practice guidelines could permit more companies to install equipment that Allen says could reduce production errors.
Could these measures pay off? Perhaps. In the meantime, the most reliable recourse for consumers is their own vigilance.
Francesca Lunzer Kritz is a regular contributor to the Health section.