June 9, 1998
Patient Information Leaflets Offer False Information
on Prescription Drugs
Many Leaflets Contain Incomplete Safety Information
WASHINGTON, D.C. — Inaccurate, completely unregulated, commercially produced drug information leaflets, distributed by pharmacists with prescription drugs, cause many deaths and serious injuries every year, said consumer group Public Citizen and others in a petition filed with the Food and Drug Administration (FDA) today.
“A large proportion of the patient information leaflets (PILs) produced by commercial information vendors and distributed by pharmacists to hundreds of millions of consumers when prescriptions are dispensed may contribute to thousands of drug injuries and deaths by giving the public a dangerously false sense of security about the safety of prescription drugs,” said the petition, which was co-signed by Public Citizen?s Health Research Group and Patricia and Ben Christen of Houston, Texas, whose 7-year-old son Cory died as a result of misleading patient drug information leaflets.
Cory Christen died in September 1996 from an adverse reaction to imipramine, which had been prescribed to treat his Attention Deficiency Hyperactivity Disorder. The commercially produced patient information leaflet given to Cory?s parents failed to provide information about drug-induced hallucinations and tremors, which Cory experienced, and about the potentially deadly adverse effects of the drug, such as cardiac arrhythmias, from which he died. Instead, it warned only of minor, nuisance reactions caused by imipramine, giving the Christens a false sense of security about the safety of the drug.
“If the leaflet had told us about the seriousness of the potentially harmful affects of imipramine, we would never had given it to Cory, and he would be alive today,” Patricia Christen said.
Studies conducted by Public Citizen?s Health Research Group show that a large proportion of PILs now being distributed contain incomplete safety information. “False, incomplete or out-of-date safety information is leading to needless drug-induced deaths,” said Dr. Sidney Wolfe, Director of Public Citizen?s Health Research Group. “Commercial information vendors, pharmacists and drug companies are all responsible for the information in these leaflets, and the FDA has the legal authority to ensure that PILs do not mislead the public but has failed to meet its responsibility.”
As PILs are part of the drug?s labeling, the FDA has jurisdiction to regulate their content. The petitioners urged the FDA to recall immediately those PILs whose inaccurate information is likely to cause substantial harm if not corrected.
Public Citizen?s Health Research Group examined the PILs being distributed by pharmacists for 15 non-steroidal anti-inflammatory drugs (NSAIDs) for sufficient information for patients to reduce the likelihood of severe NSAID-associated gastrointestinal toxicity. Only 15 out of 59 leaflets warned about stopping the drug if symptoms of GI toxicity such as abdominal pain occurred. A survey of PILs conducted by the FDA itself showed substantial differences in the quality of information provided by the commercial vendors, and discovered that life-saving warnings were omitted from some leaflets.
Under the Food, Drug and Cosmetic Act, a drug is misbranded if it is dispensed with misleading information. The companies producing PILs, and the pharmacists distributing them, are accountable if the drugs are misbranded. If a manufacturer knows that a PIL is misleading about its products, it is also responsible, the petitioners say.
“Cory Christen?s death was an avoidable tragedy,” Wolfe said. “There will be thousands more Corys until the public is guaranteed access to objective, complete information, written in non-technical language, that places the risks of prescription drugs in an easily understandable format.”