Cold Drug Ingredient Findings a Concern
WASHINGTON — They are the boxes we reach for when the sniffles strike and a cough comes on, the heavily advertised artillery that aims to ease the common cold.
But now some consumers are taking a wary look at the cold remedies in their medicine chests to see if they contain a chemical suspected of causing strokes in young women. Some doctors are advising people to avoid the dozens of cold medicines and appetite suppressants that contain phenylpropanolamine, or PPA.
“There are safer alternatives out there, so why take the risk?” asked Dr. Ray Woosley, chairman of the pharmacology department at Georgetown University Medical School. “If it causes even one stroke, that’s one stroke too many.”
The warning comes because of a recommendation issued Thursday by an advisory panel of the Food and Drug Administration, which said that the chemical no longer should be considered safe for use in over-the-counter medicines.
PPA is used in many but not all cold medicines and diet pills, including some Contac, Alka-Seltzer, Robitussin and Dimetapp products. The industry says that 7.5 million or more people use PPA products each year.
An FDA spokeswoman said Friday that the agency would move “expeditiously” to evaluate the panel’s recommendation, which could result in an order to remove PPA from all over-the-counter products. That option is vigorously opposed by the pharmaceutical industry, which says PPA is safe. But, while the FDA deliberates, some doctors say that people should not use cold remedies or diet pills that include the chemical.
“Nobody should use any of these products at all,” cautioned an industry critic, Dr. Sidney Wolfe, director of Public Citizens Health Research Group. He said that concerns about the chemical were strong enough to warrant its removal from the market a decade ago. “If your nose isn’t stuffed up, you shouldn’t use a decongestant. And if your nose is stuffed up, use nose drops or a nose spray. They have a much lower dosage and go directly to your nose.”
One official with an industry trade group said that the FDA advisory panel did not give manufacturers a fair hearing. “PPA is safe and effective when used according to label directions. . . . The companies are standing behind the product,” said Dr. R. William Soller, director of science and technology for the Consumer Healthcare Products Assn., whose members make nonprescription drugs.
PPA has drawn attention at the FDA for more than a decade.
Since 1991, the agency has collected 22 reports of strokes in women, including four deaths, that might be linked to PPA products, an agency spokeswoman said. A 1991 FDA document mentions 44 reports of strokes associated with PPA diet pills dating to 1966.
In the early 1990s, manufacturers worked with the FDA to start a five-year, industry-funded, $5-million study of the relationship between PPA and strokes. That study, conducted by researchers at Yale University and completed late last year, was a key factor in the FDA panel’s recommendation that the drug no longer be “generally recognized as safe.”
Now, the industry is criticizing the study and its results.
The Yale study did not try to prove that PPA products cause strokes. Rather, it looked at 702 people, aged 18 to 49, who suffered a certain type of stroke and whether they had taken PPA in cold medicines or appetite suppressants within the previous three days.
Data from the study, first presented to the FDA in May, suggested that women who take PPA in an appetite suppressant face an elevated risk of stroke in the following three days, perhaps as much as 16 times higher than women who do not take the chemical.
In addition, women taking PPA for the first time in any type of product may face three times the normal risk of a stroke, the study found.
The study did not establish any link between PPA and stroke in men. Researchers said that partly is because of the particular men studied. For example, the study included no men who used PPA as an appetite suppressant.
Because strokes are uncommon in young people, researchers said, the total number of strokes that might be linked to PPA is small and chances of any one individual being stricken are remote.
“The increased risk is small but small is in the eye of the beholder,” Dr. Walter Kernan, one of the Yale researchers who conducted the study, said in a phone interview Friday.
While it falls to the FDA to interpret his findings for their public health consequences, Kernan said, “I do think it is appropriate for women considering the use of PPA in appetite suppressants, or in a first-time use, to be aware of the results of our study and to consider our study in making a decision about the use of these medications.”
The FDA’s own scientists have estimated that PPA may be the cause of 200 to 500 strokes a year in people under age 50.
Researchers say that people who took PPA weeks or months ago are unlikely to face any problems.
Industry officials challenged the Yale findings Friday. Among other things, they said, the study’s control group was too small, which made it impossible for researchers to adequately consider the role that lifestyle habits, preexisting medical conditions and other factors may have played in causing people to have strokes.
But Wolfe, the industry critic, said that the study was sound and that the FDA had ample evidence years ago of the dangers associated with PPA. “Instead of taking it off the market, the industry conned them into ‘Let’s do an epidemiological study,’ ” Wolfe said.
“It was a delaying tactic. It took three years to design the study and five years to do it and the study merely confirmed what was already known,” he added.
Many consumers are not so sure. In fact, if the FDA moves against PPA in her favorite medicines, Melanie Vracas is going to stock up.
“There are always so many pros and cons to medicines you take. You can make yourself crazy worrying about every little thing,” said Vracas, a marketing assistant for an international consulting firm, who was shopping in a downtown Washington, D.C., pharmacy Friday.
“It doesn’t bother me,” said Kathy Rogers, 49, at another Washington pharmacy. “I believe in medication. I’ve been taking an experimental medicine for a brain tumor for 20 years. I have worse things to worry about than cold medicine.”
The FDA already was considering banning PPA in nonprescription drugs. The panel’s vote, while not directly calling for a ban, strengthened the possibility that the FDA would enact one.
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Times staff writer Melissa Lambert contributed to this story.
