March 3rd, 2011
By: Denise Mann
The FDA today announced steps to remove more than 500 prescription cold, cough, and allergy products from the market because of potential safety concerns.
The FDA asked companies to stop manufacturing the 500 products within 90 days and stop shipping them within 180 days. Some manufacturers must stop making and shipping their products immediately, the FDA warns.
There are no data on how often these now-banned medications are prescribed today, but many doctors may be unaware that they contain unapproved ingredients because these drugs are listed in the Physicians’ Desk Reference and may be advertised in medical journals.
Questions on Drug Safety
The FDA does not know if these prescription drugs are safe or not largely because they were grandfathered in before changes to the FDA’s drug approval process were enacted.
“We don’t know what they are, whether they work properly, or how they are made,” said Deborah M. Autor, director of the FDA’s Office of Compliance at the Center for Drug Evaluation and Research (CDER) in Silver Spring, Md., during a teleconference. “The problem is that we don’t know what the problem is.”
For example, some of these cough, cold, and allergy drugs are labeled as “time-release.” These are complicated to manufacture, and the FDA has not reviewed whether the active ingredient is released in a consistent matter over a period of time, she says. “They may be released too slowly, too quickly, or not at all.”
Kids Under Age 2
Others contain an “irrational” combination of the same types of products, such as two or more antihistamines, and some are inappropriately labeled for use by infants and young children, she says. Many contain the same ingredients as the over-the-counter cough and cold products that are no longer supposed to be used in kids under 2.
Yolandra Hancock, MD, a pediatrician at Children’s National Medical Center in Washington, D.C., praises the FDA’s move.
“The new FDA decision supports modern-day pediatric practice to avoid cough syrups in children under 2 because they do more harm than good,” she says. Some may slow down breathing, and others decrease cough and allow mucus to sit in the chest, where it can cause other problems such as lung infection, she says.
“I fully support the FDA’s move in controlling access to these medications in children; it is highly appropriate and long overdue,” she says.
As to the risks these drugs pose, “for the most part, [these adverse reactions] are not serious,” says Charles E. Lee, MD, medical officer of the division of new drugs and labeling compliance at the CDER.
After the FDA crackdown on the use of over-the-counter cough and cold medicine in children younger than 2, the number of emergency room visits for adverse events decreased by 50%, he says.
“We also know that 15% of these events came from prescription cough, cold, and allergy products and included sedation/drowsiness and irritability,” Lee says.
October 15, 2010
There is no evidence these syrups help children with a cough and the unpredictable side effects of codeine means they should not be used in under 18s, the UK drugs regulator has said.
Codeine can be addictive and different people react differently to it with side effects including restlessness or excitation, feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.
Packaging will be changed from April next year and pharmacists are being advised to warn parents of the changes.
The Medicines and Healthcare products Regulatory Agency said the products will remain available to children only on prescription.
A spokesman for the MHRA said all linctuses, syrups and cough mixtures containing codeine, such as Pulmo Bailly, Galcodeine Paediatric Linctus and Codeine Linctus BP will be affected.
It comes after the MHRA said in 2008 that children under the age of two should not be given cough and cold remedies and six products were removed from sale. Young children should be given paracetamol and honey and lemon to ease a cough as there was no evidence the cough syrups had any beneficial effect.
A spokesman said: “We are changing our approach to the treatment of coughs and colds in children.
“Many of the over-the-counter (OTC) medicines used to treat coughs have been used for several years.
“They came into use when clinical trials were not required to demonstrate that they worked in children. Therefore these medicines were not designed specially for children.
“Children should have access to medicines that are acceptably safe and designed for their use.
“Coughs can be distressing for both you and your child but they will get better by themselves within a few days.
“Using simple measures to ease symptoms are likely to be more effective. If your child is over the age of one, a warm drink of lemon and honey may ease the cough. If your child is not getting better after five days ask a healthcare professional for advice.”