UPDATED at 6:00 p.m.
The Food and Drug Administration continued a push against unapproved drugs today, ordering 500 prescription cold products off the market because their safety record is unclear.
Most are timed-release products and many contain unnecessary combinations of drugs to relieve congestion, sneezing, and coughing, FDA said.
“Given that so many cough, cold, and allergy drug products exist that are FDA-approved prescription products or are appropriately marketed OTC [over the counter], taking an unapproved prescription product is an unnecessary risk,” the agency said in a statement.
“This action is necessary to protect consumers from the potential risk of unapproved drugs,” Deborah Autor, director of FDA’s Office of Compliance, told reporters in a telephone briefing.
“We don’t know what is in them, whether they are prepared properly,” she added.
Dr. Richard Irwin, chair of the American College of Chest Physicians' cough guidelines and a professor of medicine and nursing at the University of Massachusetts, said the older prescription cold drugs are being used more commonly because of several other federal enforcement actions.
"I think they are prescribed very commonly," Irwin said in a telephone interview. "A few years ago, most of the prescription antihistamine/decongestant medications that were available suddenly became unavailable."
It has been a hard time for anyone looking for medication for a cold, stuffy or runny nose, or cough.
The FDA began warning that the cough medication phenylpropanolamine could cause strokes in 2000, and finally banned the drug in 2005. Johnson & Johnson, the maker of children's Tylenol, has had several recalls of its products because of safety concerns, and in 2007, Johnson & Johnson, Wyeth, and other makers of infants' nonprescription cough and cold products recalled many of their products because of the risk of overdose.
Irwin said the two most effective ingredients are pseudoephedrine, a decongestant, and brompheniramine, an antihistamine, but doctors had trouble finding drugs containing these products after the recalls. Adding to the problem, Congress limited the sale of pseudoephedrine in 2005 because it can be used to make the illegal drug methamphetamine. Consumers can still buy products containing pseudoephedrine, but most pharmacies require a signature and limit purchase amounts.
Physicians were looking for alternatives," Irwin said.
So many turned to the older prescription products, not realizing they had come on the market long before FDA began regulating them as new drugs are now regulated.
No one has reported a serious side effect from any of the drugs, FDA said, although they can make patients sleepy or irritable. This especially applies to children. Plus, some of the makers have labeled the drugs for use in babies and toddlers under 2 years old, even though the FDA advises against giving cold drugs to such young children.
“FDA has several concerns about this class of unapproved drugs. Many are labeled as timed-release. We know from experience that these kinds of products are complicated to manufacture,” Autor said.
She said some of the drugs have been on the market for years, but that does not mean they are safe. Consumers and doctors alike may also be unaware that some of these drugs are not FDA-approved, she said.
Autor stressed that plenty of over-the-counter products -- which can be bought without a prescription -- are available for people to treat cold symptoms.
“We do not expect that this action will have any effect on consumers,” Autor said.
Some of the cold medicines FDA wants pulled include Cardec, a combination antihistamine and decongestant available as syrup or drops that's made by Qualitest, and Lodrane, an extended-release antihistamine made by ECR Pharmaceuticals. Other brand names include 24D and Organidin.
“This is the 17th action on a drug class as part of FDA's Unapproved Drugs Initiative, which began in June 2006,” FDA said. “The initiative is the agency's risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process.”
So what can you do now for a cough? Honey seems to work very well, Irwin says.