A box of tissues, a bottle of Robitussin, and a bag of throat lozenges; when you're suffering the common cold, you'll probably want these items close at hand. Decongestants or expectorants may also provide relief. Sooner or later, these drugs will nurse you back to your everyday health.
But a new study has determined that certain over-the-counter (OTC) drugs may be doing more harm than good, resulting in the removal of several common medications from drugstore shelves.
According to a recent study by researchers at Yale, an ingredient in many OTC cold medicines, phenylpropanolamine (PPA), may be linked to hemorrhagic stroke, a type of stroke characterized by bleeding in the brain. Women between the ages of 18 and 49 are especially vulnerable, the study says.
As a result of the Yale findings, the US Food and Drug Administration (FDA) Non-Prescription Drugs Advisory Committee asked suppliers and pharmacies that market pharmaceutical or drug products containing PPA to pull them off their shelves.
The Yale study matched 702 patients who had suffered hemorrhagic strokes with patients from similar demographic categories who had not suffered strokes. The research found evidence that the stroke sufferers were 50 percent more likely to have taken products containing PPA than those who had never experienced stroke symptoms.
Those women who use appetite suppressants that contain PPA, such as Acutrim and Dexatrim, experienced 16 times more risk of stroke after the first three days of use than those who did not. The median age of female stroke patients was 35. Increased risk was reported with suppressant dosages of more than 75 milligrams.
In general, the chance that a causal user of OCDs will suffer a hemorrhagic stroke is very low. But the risk increases when combined with factors such as age, high blood pressure, smoking, alcohol, and the use of blood-thinning medications. The study also found that while men did not show the same levels of risk, they might also be in danger if use they continue to use PPA drugs.
Because of the seriousness of the findings, the FDA has taken quick action. The Yale study was completed last May, and reports appeared in medical journals in October. A month later, the national media received press releases - an uncharacteristically rapid action by the FDA.
"When scientific information is spread it takes a little while and people need to think about it a little bit. I think that the FDA acted quite quickly, and they are not known for acting quickly," said Margaret Higham, Medical Director of Tufts' Health Services.
The medical establishment has been aware of the risks associated with PPA for more than 20 years. Some associates in the FDA criticized the recent findings, arguing that the results were published prematurely and that making such wide-based claims will negatively effect the general population - especially pharmaceutical providers, such as CVS and its 4,100 stores and Walgreens, which operates 3,200 stores nationwide. According to a WebMD article, about 100 companies are expected to voluntarily stop marketing products containing PPA while the FDA drafts new regulations that will effectively ban its use.
The FDA concluded that it could not predict what group is most at risk from using PPA drugs, and the type of problem PPA drugs alleviate - a sore throats or stuffed nose - is not significant enough to keep PPA medications in stores.
"I don't think that the removal of PPA is as much of a concern. I think the greater concern is, what about the other medications that are also decongestants that haven't been specifically studied. Those are still being widely used," Higham said.
"No one has asked me if Sudafed is okay. Well, we're still recommending Sudafed, but to be honest, we don't know that it's okay," she added.
Pharmacies are stocking up on alternative medications that contain safe cough-cold formulas such as pseudoephedrine, chloropheniramine, which is found in Chloro-Trimeton, and diphenhydramine, the ingredients in Benadryl. Those using OTC appetite suppressants will have to switch to prescription weight loss products, since all OTC drugs contain PPA.
"I've never approved of those medications and I still don't. Studies have shown that is not an effective way to lose weight," Higham cautioned.
With flu season in full effect, many students depend on OTC drugs to get them through the day. Though some students are reluctantly waving goodbye to Dimetapp and other OTC drugs, others are not that concerned about the study's results.
"People have been using these medications for years, so I am not going to freak out because now the FDA says they are bad," senior Veronica McMahon said.
Some students, however, are heeding the FDA advice. "I think they should keep PPA products off the shelves until further studies can be done," freshman Rob Curry said. "If a problem is found, then let them stay off."
For students who grew up taking drugs with PPA, the findings are a bit disconcerting. "I don't use the products with PPA in them anymore, but as a kid I practically lived off the stuff from October until March every year," sophomore Emily Cappetta said.
At her advisory capacity at Tufts, Higham cautions students about their choice of medication. "I tell people that they are welcome to try some of the other over-the-counter medications, but they need to decide whether they make a difference or not," Dr. Higham said.
"The best thing to do is be patient and wait it out. People just have to be aware that if they are using any medications, herbal or otherwise, they don't always know what is in them. You can't promise them that they are going to be okay because we just don't know," she said.
