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January 1995
FDA Consumer special report

[U.S. Food and Drug Administration]

The most recent version of this article is available on this Website in PDF format.


On Lookout for Medical Product Problems

by Kevin L. Ropp


No, it's not some new doctor show on television.

MedWatch is the Food and Drug Administration's voluntary Medical Products Reporting Program for quickly identifying unsafe medical products on the market.

Between June 1993 and July 1994, FDA received 14,357 MedWatch reports. Of those, 9,879 were for adverse drug events; 2,648 for medical device events or problems; 1,406 for drug quality problems; 337 for biologic adverse events; 88 for medical food problems; and eight for veterinary medicine problems.

"Post-market surveillance is critical to our job of ensuring the safety of drugs, devices, and other FDA-regulated products," FDA Commissioner David A. Kessler, M.D., said in a May 4, 1993, address to health professional organizations, a month before the program got under way.

"There is simply no way that we can anticipate all possible effects of a drug or device during the clinical trials that precede approval," he said. "A new drug application, for example, typically includes safety data on several hundred to several thousand patients. If an adverse event occurs in 1 in 5,000 or even 1 in 1,000 users, it could be missed in clinical trials. But it could pose a serious safety problem when the drug is used by many times that number of patients."

MedWatch reports led FDA on Aug. 1, 1994, to recommend withdrawal of patients from the anti-epilepsy drug Felbatol (felbamate) because it was linked to 10 cases of aplastic anemia. Felbatol was approved in August 1993 for adults experiencing partial seizures and for children suffering Lennox-Gastaut syndrome, a serious form of childhood epilepsy.

No cases of aplastic anemia, a severe and rare blood disorder, were observed during pre-market testing of the drug in approximately 1,000 patients. However, since Felbatol's approval, the rate of aplastic anemia cases appears to be about 50 times higher than expected.

Another example is Omniflox (temafloxacin), an antibiotic drug first marketed in the United States in February 1992. Less than four months after its introduction into the marketplace, Omniflox was withdrawn after FDA received about 50 reports of serious adverse events, including three deaths. These occurred during the first three months of the drug's use in this country. Side effects included dangerously low blood-sugar levels in older patients; excessive destruction of red blood cells that was frequently associated with renal failure; abnormal liver function tests; and impaired blood clotting.

Before FDA approval, slightly more than 4,000 patients had received the drug in clinical trials, but in its first three months of marketing many more thousands of patients used it and the serious side effects became apparent.

"That is why it is so crucial to keep an eye on a product once it is in general use," Kessler said in his address. "And the health professionals who use the products are indispensable to that process."

Avoidable Tragedies?

The first post-marketing surveillance program was established in 1954 by the American Medical Association following reports of aplastic anemia (a blood disorder) associated with the use of chloramphenicol, an antibiotic, according to Charles Anello, Sc.D., deputy director of the Office of Epidemiology and Biostatistics in FDA's Center for Drug Evaluation and Research.

AMA's program, run by its Committee on Blood Dyscrasias, was expanded in 1961 to monitor all adverse drug events. The program was discontinued because of parallel efforts by FDA.

FDA had set up its own surveillance program to monitor adverse drug reactions in 1961 following another drug-related tragedy, birth defects caused by thalidomide, a sedative and hypnotic drug marketed in Europe for nausea during pregnancy.

"It turns out, that drug caused a condition called phocomelia--a congenital malformation where arms and legs are shortened or not developed," Anello explains. "By the time the problem was recognized, there were 10,000 cases of phocomelia worldwide. In the United States, the drug was under investigation but had not been marketed."

In an effort to avoid future tragedies, the World Health Organization and most industrialized countries, including the United States, implemented adverse reaction reporting systems.

The U.S. Congress passed the 1962 Drug Amendments to the Food, Drug, and Cosmetic Act, which required drug manufacturers to report to FDA all adverse drug events they became aware of that were associated with their products.

Reporting requirements, including biologics reporting, were further strengthened by regulations passed by FDA in 1985. These activities were focused in FDA's Bureau of Drugs (now the Center for Drug Evaluation and Research). The center also started in the late 1960s a voluntary marketplace surveillance program to monitor the quality of prescription and nonprescription products.

In 1973, the agency's Bureau of Medical Devices (now the Center for Devices and Radiological Health) established its surveillance system to monitor medical product quality problems and adverse events.

In all, by 1991, there were five different forms for manufacturers and health professionals to report medical product problems to the agency--a somewhat confusing system.

Enter MedWatch

MedWatch is designed to make it easier for health professionals to report serious adverse events.

A significant change to help simplify the procedure is use of a single form to report problems with any FDA-regulated medical product.

"Over a year-and-a-half, we worked closely with four FDA centers to consolidate five different reporting forms," says Dianne Kennedy, MedWatch director. "We also had input from several health professional organizations, including the American Medical Association and American Nurses Association.

"Now, all the health professional needs to do is pick up one form and send it in to us. Once it comes in here to our central triage unit we review it and deliver it to the program it belongs to."

Post-marketing surveillance and reporting can often signal potentially serious safety problems with marketed products--especially newly marketed products--and serve to prevent widespread tragedies such as occurred with thalidomide, according to Anello.

Through MedWatch, FDA officials hope to improve the safety of drugs, biologics, medical devices, dietary supplements, medical foods, infant formulas, and other regulated products by encouraging health professionals to report serious adverse events and product defects.

FDA does not want reported to MedWatch problems with other types of food items, veterinary products, or vaccines. Adverse events with veterinary products are reported to the agency's Center for Veterinary Medicine on a separate form. Vaccine adverse event reports are already required by law and are to be sent to the Vaccine Adverse Event Reporting System (VAERS) program. (See "Vaccine Reporting.")

An adverse event is any undesirable experience a patient has using a medical product. Serious adverse events--the ones FDA is primarily interested in--include death, life-threatening situations, initial or prolonged hospitalization, and situations requiring medical intervention to prevent permanent damage, disability, and congenital anomaly. Congenital anomalies include birth defects, miscarriage and stillbirth, or birth with cancer or some other serious disease.

The identity of patients involved in MedWatch reports is confidential and legally protected. The identity of the reporter may be shared with the manufacturer unless the reporter requests otherwise.

"Physicians should report when there is a suspicion that the drug or device may be related to a serious adverse effect; they are not expected to establish the connection or even wait until evidence seems compelling," Kessler wrote in a recent Journal of the American Medical Association article.

"On the other hand, the FDA does not want providers to report every adverse reaction observed; this would not be practical for the practitioner or useful to FDA," Kessler continued.

Problems should also be reported when there is concern about the quality, performance or safety of any medication or device. Product quality problems may occur during manufacturing, shipping or storage. These problems include contamination, defective components, poor packaging or product mix-up, questionable stability, and labeling concerns.

The agency's MedWatch central unit receives all the reports initially. From there, it is determined what type of product is involved. Within one working day of receipt of a report, it is in the hands of the appropriate program in the center responsible for the particular product.

"We were receiving about 100,000 reports each year of adverse events with drugs," Anello says. "Several thousand of those are serious and unlabeled [not listed in the product labeling] reactions. Not every one of those reports establishes cause-and-effect relationships. We have a staff of epidemiologists who assess the causes [of the reaction] and also the public health importance of these reported adverse events."

Once an adverse event or product problem is identified, FDA can take any of the following actions:

Sharing Information

Communicating FDA actions that resulted from MedWatch reports to health professionals is another primary goal of the new program.

"Already we have about 70 health-care organizations that have signed up to be our partners," Kennedy says. "They're doing news and journal articles, distributing forms, publishing print ads, public service announcements."

These organizations have also agreed to help disseminate information about the safety actions the agency has taken.

FDA also reports back to health-care professionals through "Dear Doctor" and "Dear Health Professional" letters, FDA Medical Bulletin, and press releases and journal articles.

"The plans are for us to provide whatever information comes out back to the health professional," Kennedy says. "We're certainly not able to individualize responses, although if a significant problem is discovered, we might look back at the reports used in discovering the problem and write to those who reported it."

What Does MedWatch Mean to You?

The MedWatch program will provide different benefits to different people.

For health professionals, the MedWatch program will help educate and inform practitioners of the need for adverse event reporting. It will also quickly correct product problems and remove defective or dangerous products from distribution.

But the greatest beneficiary will be the general public. "MedWatch will help identify problems earlier so that we [FDA] can prevent the continued occurrence of that problem," Kennedy says.

Simply put, MedWatch is expected to make medical products safer for consumers by ensuring the safety of products on the market and enabling faster removal from the market of those that cause problems.

As Kessler told the health professionals, "What MedWatch is all about is preventing illness and death. It is about someone in my family, in your family, someone anywhere in this country who will escape illness or even death because a health professional filed a report. And it is about every patient who will suffer because a report was not filed."

Kevin L. Ropp is a member of FDA's public affairs staff.

Vaccine Reporting

MedWatch doesn't include vaccines.

In 1986, Congress passed the National Childhood Vaccine Injury Act, requiring health-care practitioners and vaccine manufacturers to report serious adverse events with certain vaccines.

The Vaccine Adverse Event Reporting System (VAERS) began Nov. 1, 1990, collecting all vaccine reports for FDA and the national Centers for Disease Control and Prevention.

Congress passed the act after realizing litigation against manufacturers was driving up vaccine costs and motivating some companies to stop vaccine production.

Anyone--consumers, parents, manufacturers, and health-care providers--can submit a VAERS form, but patients or their representatives are encouraged to also consult their doctors.

For a VAERS form or more information on reporting vaccine adverse events, call the 24-hour VAERS hot line at (1-800) 822-7967.


Patients who suspect they've had a serious adverse event after using a medical product should ask their physicians to call the MedWatch hot line at (1-800) FDA-1088.

"MedWatch: On Lookout for Medical Product Problems" originally appeared in the November 1993 FDA Consumer and was substantially revised for the FDA Consumer Special Report on New Drug Development in the United States (January 1995).

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