Tip:
Highlight text to annotate it
X
>> THIS IS
"FDA PATIENT SAFETY NEWS."
IN THIS EDITION --
A NEW GENOTYPING TEST THAT CAN
HELP SELECT A PATIENT'S
MEDICATIONS AND
INDIVIDUALIZE DOSES,
A PUBLIC HEALTH ADVISORY ABOUT
THE USE OF NSAIDs,
A WARNING ABOUT LIVER INJURY
IN PATIENTS TAKING STRATTERA,
AND MORE ON PREVENTING
FATALITIES FROM MEDICAL
GAS MIX-UPS.
THESE STORIES AND MORE
ON THIS EDITION OF
"FDA PATIENT SAFETY NEWS."
WELCOME TO■■ THE PROGRAM.
FOR THE U.S.
FO■■OD AND D■■RUG ADMINISTRATIO,
I'■■M MARK BARNETT.■■
>> AND I'M ANITA RAYNER.■■■■
LET'S START WITH A■■ MEDICAL
PRODUCT FDA RECENTLY CLEARED■■■■
FOR MARK■■ETING.
>> FDA HAS CLEARED THE FIRST
LABORATORY TEST SYSTEM THAT USES
DNA MICROARRAY TECHNOLOGY TO
PROVIDE GENETIC INFORMATION THAT
CAN HELP SELECT A PATIENT'S
MEDICATIONS AND
INDIVIDUALIZE DOSES.
IT'S CALLED THE AMPLICHIP
CYTOCHROME P450 GENOTYPING TEST,
AND IT'S MANUFACTURED BY
ROCHE MOLECULAR SYSTEMS.
FDA CLEARANCE OF THIS PRODUCT
PAVES THE WAY FOR SIMILAR TESTS
TO BE DEVELOPED IN THE FUTURE.
>> Rayner: USING A BLOOD SAMPLE,
THE NEW TEST ANALYZES AN ENZYME
FROM ONE OF THE GENES IN THE
CYTOCHROME P450 FAMILY OF GENES.
VARIATIONS IN THIS GENE CAN
AFFECT THE PATIENT'S ABILITY
TO METABOLIZE CERTAIN DRUGS,
INCLUDING SOME ANTIDEPRESSANTS,
ANTIPSYCHOTICS, BETA BLOCKERS,
AND CHEMOTHERAPEUTIC AGENTS.
>> Barnett: THIS TEST CAN'T BE
USED BY ITSELF TO DETERMINE
OPTIMUM DRUG DOSAGES.
IT'S INTENDED TO BE USED ALONG
WITH CLINICAL EVALUATION AND
OTHER TOOLS.
>> FDA RECENTLY ISSUED A PUBLIC
HEALTH ADVISORY ABOUT THE USE OF
NSAIDs, INCLUDING
***-2 SELECTIVE AGENTS SUCH AS
CELEBREX AND BEXTRA.
>> THIS SEEMS TO BE A RAPIDLY
CHANGING SITUATION.
NOW THERE'S EVIDENCE ABOUT■■■■
CARDIOVASCULAR EVENTS?■■■■
>> THAT'S RIGHT.
RECENTLY RELEASED DATA FROM
CONTROLLED CLINICAL TRIALS
SUGGESTS THAT THESE ***-2
SELECTIVE AGENTS MAY BE
ASSOCIATED WITH AN INCREASED
RISK OF SERIOUS CARDIOVASCULAR
EVENTS.
IN THESE STUDIES, THE INCREASED
RISK WAS ASSOCIATED WITH LONG-
TERM USE OF THE DRUGS, OR USE IN
VERY HIGH RISK SETTINGS --
IMMEDIATELY AFTER HEART SURGERY,
FOR EXAMPLE.
>> NOW, YOU'RE TALKING ABOUT■■
STUDIES WITH RECENTLY RELEASED■J
DATA -- HOW DO THOSE STUDIES■J■J
COMPARE WITH STUDIES THAT HAVE■J
ALREADY BEEN DONE ON■J
THESE DRUGS?■■
>> WELL, THE■J RESULTS OF THESE
STUDIES ARE PRELIMINARY, AND, IN
FACT, THEY CONFLICT WITH RESULTS
FROM OTHER STUDIES OF THESE
SAME DRUGS.
STILL, FDA IS MAKING SOME
INTERIM RECOMMENDATIONS
AT THIS TIME.
IN ESSENCE, WE'RE ADVISING
PRESCRIBERS OF CELEBREX OR
BEXTRA TO CONSIDER THIS EMERGING
INFORMATION WHEN THEY'RE
WEIGHING THE BENEFITS AGAINST
RISKS FOR INDIVIDUAL PATIENTS.
>> WELL, NOW, ON THE BENEFIT■■■■
SIDE OF THE EQUATION, THERE ARE■
SO■■ME PATIENTS WHO WOULD BE
APPR■■OPRIATE ■JCANDIDATES FOR■■
THESE DRUGS.■■
>> Rayner: THAT'S RIGHT.
IN SOME PATIENTS, THE BENEFITS
MAY OUTWEIGH THE RISKS.
THEY INCLUDE PATIENTS AT
HIGH-RISK OF GI BLEEDING,
WHO HAVE A HISTORY OF
INTOLERANCE TO NON-SELECTIVE
NSAIDs, OR WHO AREN'T DOING WELL
ON NON-SELECTIVE NSAIDs.
AND ON THE OTHER SIDE OF THE
EQUATION, YOU HAVE TO TAKE INTO
ACCOUNT THE PATIENT'S INDIVIDUAL
RISK FOR CARDIOVASCULAR EVENTS
AND OTHER ADVERSE REACTIONS
TO NSAIDs -- IT'S A DIFFERENT
SITUATION FOR EACH PATIENT.
>> WELL, THIS SOUNDS LIKE IT'S A
CONTINUING STORY.
>> I■■T IS.■■
FDA IS ANALYZING THE MOST RE■■C■
STUDIES OF BOTH ***-2 SELECTIVE
AND NONSELECTIVE NSAIDs TO
DETERMINE WHETHER ADDITIONAL
REGULATORY ACTION IS NEEDED.
WE'LL UPDATE OUR WEB SITE AS
MORE INFORMATION BECOMES
AVAILABLE.
>> IN EARLY DECEMBER,
UNOMEDICAL, INC. RECALLED
CERTAIN AIRWAY ADAPTERS BECAUSE
SEVERAL OF THEM WERE FOUND TO BE
OCCLUDED, AND THAT COULD■■
INTERFERE WITH A PATIENT'S
ABILITY TO BREATHE.
THE RECALLED ADAPTERS WERE USED
IN A NUMBER OF PRODUCTS,
INCLUDING NEBULIZER CIRCUITS,
VENTILATOR CIRCUITS,
ANESTHESIA CIRCUITS,
TRANSPORT CIRCUITS,
AND FACE MASKS.
THESE PRODUCTS WERE SOLD UNDER
UNOMEDICAL'S HOSPITAK BRAND
NAME, AND ALSO UNDER THE NAMES
VIASYS, UNOMEDICAL, DRAGER,
AND BIO-MED DEVICES INC.
>> ALTHOUGH THE RECALLED
PRODUCTS WERE PRIMARILY USED IN
HOSPITALS, SOME WERE ALSO SOLD
FOR HOME USE.
IF YOU OR YOUR PATIENTS HAVE
PRODUCTS MADE BY HOSPITAK,
VIASYS, UNOMEDICAL, DRAGER,
OR BIO-MED DEVICES, INC. THAT
USE THESE AIRWAY ADAPTERS,
YOU SHOULD CHECK WITH
UNOMEDICAL, INC. BEFORE
USING THEM.
IF YOU'RE UNSURE OF THE
MANUFACTURER OR MODEL NUMBER OF
YOUR AIRWAY ADAPTERS, YOU MAY
WANT TO GET THIS INFORMATION
FROM YOUR SUPPLIER.
>> YOU'LL FIND A COMPLETE LIST
OF THE RECALLED PRODUCTS AND THE
MODEL NUMBERS ON OUR WEB SITE,
ALONG WITH THE PHONE NUMBER OF
UNOMEDICAL, INC.
>> FDA IS ADVISING HEALTH
PROFESSIONALS ABOUT A NEW
WARNING FOR THE DRUG STRATTERA,
USED TO TREAT ATTENTION DEFICIT
HYPERACTIVITY DISORDER IN ADULTS
AND CHILDREN.
>> THE DRUG'S LABELING IS BEING
UPDATED WITH A BOLDED WARNING
ABOUT THE POTENTIAL FOR SEVERE
LIVER INJURY IN PATIENTS
TAKING STRATTERA.
THE LABEL WARNS THAT SEVERE
LIVER INJURY CAN PROGRESS TO
LIVER FAILURE IN A SMALL
PERCENTAGE OF PATIENTS.
IT CAUTIONS CLINICIANS TO
DISCONTINUE THE DRUG IN PATIENTS
WHO DEVELOP JAUNDICE OR
LABORATORY EVIDENCE OF
LIVER INJURY.
IT ALSO NOTES THAT THE ACTUAL
NUMBER OF CASES OF SEVERE
LIVER INJURY FROM THE DRUG IS
NOT KNOWN BECAUSE OF
UNDER-REPORTING.
>> STRATTERA'S MANUFACTURER,
ELI LILLY, HAS AGREED TO SEND A
LETTER TO PHYSICIANS, ALERTING
THEM TO THE NEW INFORMATION.
THE COMPANY WILL ALSO UPDATE THE
PATIENT PACKAGE INSERT TO
INCLUDE INFORMATION ABOUT THE
SIGNS AND SYMPTOMS OF LIVER
PROBLEMS.
>> IF YOU LEARN OF UNEXPECTED
ADVERSE EVENTS WITH STRATTERA,
INCLUDING LIVER DAMAGE,
PLEASE REPORT THEM, EITHER
DIRECTLY TO ELI LILLY,
OR TO FDA'S MedWatch PROGRAM.
AND YOU'LL FIND THE ADDRESSES ON
OUR WEB SITE.
>> TODAY, WE WANT TO REMIND YOU
ABOUT AN IMPORTANT FDA PROGRAM
CALLED MedWatch.
MedWatch ALLOWS HEALTH CARE
PROFESSIONALS AND CONSUMERS TO
REPORT SERIOUS PROBLEMS THAT
THEY SUSPECT ARE ASSOCIATED WITH
THE MEDICAL PRODUCTS THEY
PRESCRIBE, DISPENSE, OR USE.
THESE REPORTS, ALONG WITH
FOLLOW-UP INVESTIGATIONS,■■♪
CAN HELP TO IDENTIFY IMPORTANT■■
SAFETY CONCERNS.■
>> Barnett: TAKE THE EXAMPLE OF
THE ANTIBIOTIC ZYVOX.
WITHIN THE FIRST SIX MONTHS OF
ZYVOX'S MARKETING, FDA BEGAN
GETTING MedWatch REPORTS OF
MYELOSUPRESSION FROM CLINICIANS
WHO SUSPECTED THAT THE DRUG
MIGHT BE RESPONSIBLE.
>> AFTER INVESTIGATING THE
PROBLEM, WE WORKED WITH THE
MANUFACTURER TO CHANGE THE ZYVOX
LABELING TO WARN ABOUT THE
POTENTIAL FOR MYELOSUPRESSION.
>> Barnett: SOMETIMES MedWatch
REPORTS HIGHLIGHT ERRORS IN
PRESCRIBING OR ADMINISTERING
MEDICATIONS.
FOR EXAMPLE, FDA RECEIVED
REPORTS OF PATIENT INJURIES
DUE TO NAME CONFUSION BETWEEN
LANOXIN, WHICH IS A HEART
MEDICATION; AND WHAT USED TO BE
CALLED LEVOXINE, WHICH IS A
THYROID MEDICATION.
>> Rayner: AS A RESULT, FDA
ASKED THE MANUFACTURER TO CHANGE
THE NAME OF LEVOXINE, AND NOW
IT'S KNOWN AS LEVOXYL, WHICH IS
LESS LIKELY TO BE CONFUSED
WITH LANOXIN.
>> THE MedWatch SYSTEM CAN ALSO
HELP DETECT PROBLEMS WITH
MEDICAL PRODUCTS OTHER
THAN DRUGS.
FOR EXAMPLE, FDA RECEIVED TWO
REPORTS OF PNEUMOCOCCAL EYE
INFECTIONS IN PATIENTS WHO HAD
RECEIVED CORNEAL TRANSPLANTS.
>> AN FDA INSPECTION IDENTIFIED
NUMEROUS MANUFACTURING PROBLEMS,
WHICH LED THE COMPANY TO RECALL
THE IMPLANTS.
>> OF COURSE, MedWatch REPORTS
ALONE RARELY CONFIRM A CAUSAL
RELATIONSHIP BETWEEN AN ADVERSE
EVENT AND A MEDICAL PRODUCT --
IT MAY TAKE A FORMAL
EPIDEMIOLOGIC STUDY TO DO THAT.
STILL, MedWatch REPORTS ARE
VITAL IN MAKING SURE THAT
MEDICAL PRODUCTS ARE SAFE,
BECAUSE THEY PROVIDE A RAPID
SIGNAL TO THE FDA THAT PROBLEMS
MAY BE OCCURRING.
>> IT'S IMPORTANT TO KEEP THE
MedWatch SYSTEM WORKING, AND WE
CAN'T DO THAT WITHOUT YOUR HELP.
HERE ARE THE KINDS OF REPORTS
WE NEED FROM YOU.
>> FIRST OF ALL, WE'RE ASKING
THAT YOU
REPORT ANY SERIOUS ADVERSE EVENT
THAT MIGHT BE ASSOCIATED WITH A
DRUG, A BIOLIC, A MEDICAL
DEVICE, OR A DIETARY SUPPLEMENT.
AND BY "SERIOUS," WE MEAN
FATALITIES, HOSPITALIZATIONS,
AND MEDICALLY SIGNIFICANT
EVENTS.
WE'RE ESPECIALLY INTERESTED IN
SERIOUS ADVERSE EVENTS THAT
ARE NOT LISTED IN THE PRODUCT
LABELING.
>> Rayner: SECONDLY, REPORT
THERAPEUTIC FAILURES -- CASES
WHERE THE DRUG OR DEVICE FAILED
TO WORK AS IT SHOULD.
FOR EXAMPLE, LET US KNOW IF A
PATIENT HAS TO SWITCH FROM ONE
BRAND OF A DRUG TO ANOTHER
BECAUSE THE ORIGINAL ONE WAS
INEFFECTIVE.
>> THIRD, TELL US ABOUT CASES OF
USE ERRORS WITH MEDICATIONS OR
DEVICES, INCLUDING SITUATIONS
WHERE THE ERROR MAY HAVE BEEN
DUE TO POOR COMMUNICATION; OR TO
AMBIGUITIES IN PRODUCT NAMES,
DIRECTIONS FOR USE,
OR THE PACKAGING.
>> AND FINALLY, WE'D LIKE TO
KNOW ABOUT PRODUCT QUALITY
ISSUES, SUCH AS SUSPECTED
COUNTERFEIT PRODUCTS,
DEFECTIVE COMPONENTS,
POTENTIAL CONTAMINATION,
DEVICE MALFUNCTIONS,
AND POOR PACKAGING.
>> Barnett: WE ENCOURAGE YOU
TO REPORT THESE PROBLEMS TO
MedWatch EVEN IF YOU'RE NOT SURE
THAT THE PRODUCT WAS THE CAUSE.
IT'S EASY TO REPORT BY INTERNET,
PHONE, FAX, OR MAIL.
YOU'LL FIND MORE COM■PLETE
INFORMATION ON WHAT TO REPORT
AND HOW TO REPORT ON OUR
WEB SITE.
>> CENTOCOR HAS NOTIFIED
HEALTHCARE PROFESSIONALS ABOUT
NEW WARNINGS FOR REMICADE,
A DRUG USED TO TREAT RHEUMATOID
ARTHRITIS AND CROHN'S DISEASE.
THE NEW SAFETY INFORMATION
DESCRIBES RARE BUT SEVERE
HEPATIC REACTIONS, INCLUDING
ACUTE LIVER FAILURE, JAUNDICE,
HEPATITIS AND CHOLESTASIS IN
PATIENTS BEING TREATED
WITH REMICADE.
>> THESE REACTIONS OCCURRED
BETWEEN TWO WEEKS TO MORE THAN
A YEAR AFTER THE REMICADE
TREATMENT WAS STARTED.
SOME OF THESE CASES WERE FATAL
OR RESULTED IN LIVER
TRANSPLANTS.
>> SO CENTOCOR SAYS THAT
PATIENTS WITH SYMPTOMS OR SIGNS
OF LIVER DYSFUNCTION SHOULD BE
EVALUATED FOR EVIDENCE OF
LIVER INJURY.
REMICADE SHOULD BE DISCONTINUED
IF PATIENTS DEVELOP JAUNDICE, OR
IF THEIR LIVER ENZYMES BECOME
ELEVATED TO A LEVEL THAT'S 5 OR
MORE TIMES THE UPPER LIMIT
OF NORMAL.
>> Barnett: THE COMPANY ALSO
NOTES THAT REMICADE, LIKE OTHER
IMMUNOSUPPRESSIVE DRUGS,
HAS BEEN ASSOCIATED WITH
REACTIVATION OF HEPATITIS B IN
CHRONIC CARRIERS OF THIS VIRUS.
THE COMPANY SAYS THAT THESE
PATIENTS SHOULD BE EVALUATED AND
MONITORED BEFORE AND DURING
TREATMENT WITH REMICADE.
>> IN PREVIOUS PROGRAMS, WE
REPORTED ON PATIENT DEATHS FROM
MEDICAL GAS MIX-UPS, WHERE
PATIENTS WERE ACCIDENTALLY GIVEN
THE WRONG GAS, SUCH AS NITROGEN
OR CO2, INSTEAD OF OXYGEN.
WE STRESSED THAT THESE
FATALITIES COULD BE PREVENTED BY
NOT USING ADAPTERS, AND NOT
CHANGING THE CONNECTORS OR
FITTINGS ON GAS CONTAINERS TO
MAKE THEM FIT THE OXYGEN
CONNECTOR ON THE PATIENT'S
GAS DELIVERY SYSTEM.
>> Barnett: THESE FATALITIES
CONTINUE TO OCCUR.
THE INSTITUTE FOR SAFE
MEDICATION PRACTICES RECENTLY
RECEIVED A REPORT ABOUT AN
OXYGEN FLOW METER BEING FORCED
INTO A NITROUS OXIDE WALL OUTLET
THAT WAS IMMEDIATELY ADJACENT TO
THE OXYGEN OUTLET IN
A RADIOLOGY SUITE.
INSTEAD OF RECEIVING OXYGEN,
THE PATIENT RECEIVED NITROUS
OXIDE, AND DIED.
>> TWO FACTORS PLAYED A PART
IN THIS INCIDENT.
FIRST, BECAUSE THE ROOM WAS
DIMLY LIT IN PREPARATION FOR A
C.A.T. SCAN, THE TECHNICIAN
WASN'T ABLE TO DISTINGUISH THE
BLUE COLOR OF THE NITROUS OXIDE
CONNECTOR FROM THE GREEN COLOR
OF THE OXYGEN CONNECTOR.
AND SECOND, THE PIN INDEX SAFETY
SYSTEM ON THE OXYGEN FLOW METER
WAS BROKEN AT THE TIME.
SINCE THE PIN SYSTEM IS DESIGNED
TO PREVENT INCORRECT
CONNECTIONS, A FLOW METER WITH
A BROKEN OR MISSING PIN SHOULD
NEVER BE USED.
>> ISMP POINTS OUT THAT THE
OPPORTUNITY FOR ERRORS OF THIS
KIND MAY INCREASE AS GENERAL
ANESTHESIA IS USED MORE OFTEN
OUTSIDE THE O.R.
FOR EXAMPLE, MORE INVASIVE
PROCEDURES WITH GENERAL
ANESTHESIA ARE BEING CONDUCTED
IN RADIOLOGY, AND GENERAL
ANESTHESIA IS USED IN
BRONCHOSCOPY, CARDIAC CATH,
AND ENDOSCOPY.
>> HERE ARE SOME OF THE THINGS
ISMP RECOMMENDS TO HELP REDUCE
THE LIKELIHOOD OF THIS KIND OF
GAS MIX-UP ERROR.
>> Barnett: FIRST, STANDARDIZE
THE TYPE OF FLOW METERS,
REGULATORS, AND CONNECTORS
THAT ARE USED THROUGHOUT
YOUR FACILITY,
AND USE ONLY THOSE WITH INDEXING
SYSTEMS TO HELP PREVENT
MISCONNECTIONS.
>> Rayner: SECOND, MAKE SURE
THAT THE LABELING OF ALL GAS
CONNECTIONS AND SOURCE■ IS
VISIBLE DURING ACTUAL USE
CONDITIONS, SUCH AS IN DIM LIGHT
OR UNDER CROWDED CONDITIONS.
>> Barnett: THIRD, IF A PATIENT
DOESN'T RESPOND TO TREATMENT
WITH SUPPLEMENTAL OXYGEN,
CONSIDER THE POSSIBILITY THAT
THE WRONG GAS IS BEING
ADMINISTERED, AND IMMEDIATELY
CHECK THE CONNECTIONS.
USING AN OXYGEN SATURATION
MONITOR CAN PROVIDE AN EARLY
ALARM OF HYPOXIC GAS DELIVERY
TO THE PATIENT.
>> FINALLY, BE SURE THAT
BIOMEDICAL ENGINEERING STAFF
PERFORM REGULAR PREVENTIVE
MAINTENANCE ON GAS DELIVERY
SYSTEMS, AND THAT ONLY TRAINED
AND CERTIFIED PERSONNEL ARE
ALLOWED TO USE OR SERVICE
THIS EQUIPMENT.
>> IN A PREVIOUS PROGRAM, WE
CITED REPORTS FROM THE INSTITUTE
FOR SAFE MEDICATION PRACTICES
ABOUT DANGEROUS MIX-UPS BETWEEN
TWO DRUGS WHOSE PACKAGING
LOOKS SIMILAR.
BRETHINE, OR TERBUTALINE
SULFATE; AND METHERGINE
(METHYLERGONOVINE MALEATE) ARE
USED FREQUENTLY IN LABOR AND
DELIVERY SETTINGS, BUT THEY'RE
PHARMACOLOGIC OPPOSITES THAT ARE
USED FOR VERY DIFFERENT
CLINICAL REASONS.
>> Rayner: BRETHINE IS USED
OFF-LABEL TO TREAT PRETERM
LABOR, AND METHERGINE IS USED
PRIMARILY AFTER DELIVERY OF THE
PLACENTA TO TREAT HEMORRHAGE
AND FAILURE OF THE UTERUS
TO CONTRACT.
METHERGINE SHOULD NOT BE USED
IN PREGNANCY EXCEPT AFTER THE
DELIVERY OF A NEWBORN, AND IT'S
ESPECIALLY DANGEROUS TO
A PATIENT IN PRETERM LABOR.
DESPITE PREVIOUS WARNINGS, ISMP
RECENTLY REPORTED ON ANOTHER
ERROR THAT OCCURRED BECAUSE
THE AMPULS OF THESE TWO PRODUCTS
LOOK ALIKE.
>> Barnett: BOTH DRUGS CONTINUE
TO BE AVAILABLE AS 1-MILLILITER
AMPULS, PACKAGED IN AMBER
PLASTIC TUBS THAT ARE COVERED BY
A FOIL LABEL WITH THE PRODUCT
NAME IN TINY PRINT, WHICH MAKES
THEM DIFFICULT TO TELL APART.
BOTH AMPULS ALSO HAVE SIMILAR
COLORED "RINGS" AROUND THEIR
NECKS, AND THAT MAKES THEM LOOK
EVEN MORE ALIKE.
>> THE MANUFACTURER OF BRETHINE,
aaiPharma, NOW PACKAGES THE DRUG
IN VIALS INSTEAD OF AMPULS, TO
REDUCE THE CHANCE OF MIX-UPS.
BUT ISMP SAYS THAT EVEN THOUGH
BRETHINE AMPULS WERE LAST
SHIPPED IN JANUARY 2004, THE
AMPULS MAY STILL BE AVAILABLE
IN THE SUPPLY CHAIN.
SO ISMP RECOMMENDS THAT
HOSPITALS AND BIRTHING CENTERS
THAT STILL HAVE BRETHINE AMPULS
IMMEDIATELY REPLACE THEM
WITH VIALS.
>> WELL, THAT'S ALL FOR
THIS EDITION OF■■
"FDA PAT■■IENT SAFETY NEWS."
REMEMBER, YOU CAN GET MORE
INFORMATION ON ALL THE STORIES
YOU'VE SEEN HERE TODAY
BY VISITING OUR WEB SITE.
>> WE ALSO URGE YOU TO USE THE
WEB SITE TO REPORT PROBLEMS■■
YOU'VE ENCOUNTERED WITH MEDICAL
PRODUCTS.
THAT'S HOW WE LEARN ■■ABOUT
PROBLEMS SO WE CAN ALERT OTHERS.
>> WE'LL BE BACK NEXT MONTH WIT■
ANOTHER EDITION.
SO WATCH FOR US.
UNTIL THEN, FOR THE U.S.
FOOD AND DRUG ADMINISTRATION,■■
I'M MARK BARNETT.