Excerpts from leading news sources on the reality of the effectiveness of cold medicines

CNN November 2005 Cold Comfort: Cure won’t be soon Tal Mekel  

 “‘There are so many viruses and they change their structure all the time,’ says University of Michigan professor Dr. Howard Markel.”

 

“Other numbers are stacked against the scientists – the vast amount of particles in the air give little hope of blocking a cold virus from invading the body.  With that in mind, researchers will probably focus on stopping the virus from replicating and spreading in the body, says another physician at the University of Michigan, Dr. A. Mark Fendrick.”

 

“Because the cold is relatively benign, the risk for drug developers of making the cure’s side effects potentially worse than the disease is high, researchers say.”

 

“In the meantime, prevention is the best way to make the cold less common.”

 

“Besides getting plenty of sleep, eating well and exercising, a few precautions can limit the spread of germs from one person to another – washing hands frequently, avoiding the touching of eyes and nose and staying away from people who are coughing and sneezing, says University of Virginia’s Dr. Jack M. Gwaltney Jr.”

 

“‘The different symptoms are your body responding, and it’s not a bad thing unless you’re having a cold all the time,’ says naturopathic physician Margot Longenecker. ‘We’re trying to help the body… heal itself, yet at the same time do certain things that support the immune system.’”

 

“No hard evidence proves that echinacea or vitamin C can prevent colds, according to the Mayo Clinic”  

 

Newsweek (Atlantic Edition) January 2004, Volume 143, Issue 2, page 49 – 50 Cold Comfort Indeed Mary Carmichael

 

“Of all potential remedies, vitamin C is probably the best known – and it comes in tasty drops.  But as for effectiveness, it gets an F.  The C myth was started by the otherwise brilliant chemist Linus Pauling, who became convinced that large doses could stop a cold’s symptoms and shorten its duration.  Early studies hinted that Pauling might be right, but scientists now say those results were evidence of little more than a placebo effect.  (Patients who knew they were taking C fared well, but those who took it unknowingly did no better than the control group.)  Everyone seems to agree that large doses of vitamin C cause only one thing: diarrhea.”

 

“Big Pharma has a big hole to fill.  Because colds are caused by many germs, they’re difficult to target with pharmaceuticals (heavy side effects are unacceptable when treating a relatively innocuous disease).”

The Houston Chronicle August 2005, There’s still no common cure for the common cold; Multiple strains of viruses make it difficult to treat. David Kohn

 

“For decades, scientists have been seeking cold cures without much luck.  One key obstacle is that any practical treatment would have to work, without side effects, against all or most of the 101 rhino strains – a tall order for any medicine.”

 

“So [people have] turned to a variety of alternative treatments, such as Echinacea, zinc and vitamin C.  Americans bought more than $150 million worth of echinacea last year, according to the Nutrition Business Journal.

 

The problem is that none of these treatments works – at least not if you believe in scientific studies.

 

The latest echinacea study, in last week’s New England Journal of Medicine, examined 399 adults who had been exposed to cold viruses.  The patients were broken into four groups.  Three got different echinacea preparations, and one group got placebo.  About 90 percent of the subjects came down with colds, and echinacea takers did no better than those on the placebo.”

Contemporary Pediatrics December 1999 Treating colds: Keep it simple Diane E. Pappas, MD, JD, Gregory F. Hayden, MD, and J Owen Hendley, MD

 

“Unfortunately, little scientific evidence supports the efficacy of OTC [(over-the-counter)] products for relieving the symptoms of the common cold in children.”

 

“Despite the desires of patients, parents, and physicians, there is no effective pharmacological treatment of the common cold or its symptoms in children at the present time.  Neither decongestants, antihistamines, cough preparations, expectorants, nor zinc lozenges have been shown to have any benefit in children, and they may carry substantial risk of side effects.  Even routine symptomatic therapies such as antipyretics and humidified air may be counterproductive.”

 

“Cough and cold medications will not make your child feel better, improve her symptoms, or make her cold go away faster.  These medications can cause serious side effects in infants and children, as shown in the following chart.”

 

Pediatric News February 2006 A New ‘No’ to cough Medicines for Children Christine Kilgore

Pediatricians should take to heart an explicit recommendation by the American College of Chest Physicians against the use of over-the-counter cough suppressants and medicines in children, according to pediatricians who have dealt with drug issues for the American Academy of Pediatrics.

 

The ACCP’s recommendation is just the latest word on cough medicines.  The American Academy of Pediatrics said in a 1997 policy statement that there is no evidence to support the use of codeine or dextromethorphan – two common ingredients in cough medicines – as antitussives in children.

 

Numerous studies and reviews published since then, including an evidence based review published several years ago by the international Cochran Collaboration, have similarly cited a lack of demonstrated efficacy of cough medicine ingredients and preparations as well as reports of toxicity and adverse effects in children.

 

Dr. Ian M. Paul, a member of the AAP’s Section on Clinical Pharmacology and Therapeutics, said, however, that the new ACCP guidelines take the message one step further.”  “This [ACCP document] is actually recommending against using them – that’s the difference,” said Dr. Paul of Pennsylvania State University, Hershey.

 

The recommendations is part of the ACCP’s new evidence-based guidelines on diagnosis and management of cough (Chest 2006;129:260S-83S).  The guidelines say that over-the-counter cough medications “have little, if any, benefit in the symptomatic control of acute cough in children” and that “use of [the medications] has been associated with significant morbidity and even with mortality.”

 

Dr. Suman Wason, a pediatrician who serves as the senior director of medical affairs for Wyeth Consumer Healthcare, the manufacturer of Robitussin brand of cough medications, said that he agrees that there are few data to support the efficacy of cough medicines in children, and that a “placebo effect is [as real with cough medicines] as it is in all conditions.”

 

However, the new ACCP guidelines are also striking in that they recommend against the use of over-the-counter cough medicines for adults as well as children.

Infectious Diseases in Children July 2006 Novartis pulls Triaminic Vapor Patch off shelves.

 

“The FDA warned consumers not to use the Triaminic Vapor Patch marketed by Novartis Consumer Health due to reports of serious adverse events associated with accidental ingestion by children.”

 

“Novartis stated on its Web site that the company has received complaints of adverse events including seizures, resulting from the patch use. The Triaminic Vapor Patch contains camphor, eucalyptus oil and menthol. Reported adverse effects resulting from swallowing or chewing on products comtaining camphor or eucalyptus oils vary from minor symptoms, such as a burning sensation in the mouth, headache, nausea and vomiting, to more severe and life-threatening reactions, such as seizures. 

New York Times  March 2007 U.S. Reviewing Safety of Children’s Cough Drugs Gardiner Harris

“The official, Dr. Charles J. Ganley, director of the office of nonprescription drug products at the Food and Drug Administration, said in an interview that the agency was ‘revisiting the risks and benefits of the use of these drugs in children’ and that ‘we’re particularly concerned about the use of these drugs in children less than 2 years of age.’

 

In higher than normal doses, cold medicines can affect the heart’s electrical system, leading to arrhythmias. Some medicines affect the blood vessels and, in high doses, have been associated with hypertension and stroke. In rare cases, children have been injured even when given recommended doses.

In a recent study of hospital emergency room records from 2004 and 2005, the Centers for Disease Control and Prevention found that at least 1,519 children under age 2 had suffered serious health problems after being treated with common cough and cold medicines. Three of the children died, the disease control agency found.

 

The F.D.A. said it was too early to predict whether the review would lead to new regulations. Its comments came in response to a petition filed on Thursday by a group of prominent pediatricians and public health officials demanding that the agency stop drug makers from marketing cold and cough medicines for children under age 6. The petition says that the medicines do not work and that in rare cases they can cause serious injury.

 

Popular medicines like Toddler’s Dimetapp, Infant Triaminic and Little Colds, which are marketed for use in children as young as 2, should not be given to children younger than 6 under any circumstances, the petition says.

 

Like hundreds of older drugs, many of the medicines in these products did not receive thorough safety reviews by the F.D.A.

 

‘So many people use these products even though they have no effect on colds, and there’s a real risk of a problem,’ said an author of the petition, Dr. Joshua Sharfstein, a pediatrician and the health commissioner of Baltimore.

 

Dr. Ganley of the F.D.A. said most over-the-counter cold and cough medicines had not been adequately tested in children. The doses recommended on many of the products’ labels were no better than educated guesses, he said.

 

‘We have no data on these agents of what’s a safe and effective dose in children,’ Dr. Ganley said.”

 

“The pediatricians who petitioned the drug agency acknowledged that children’s cough and cold medicines were generally safe when given in recommended doses. But they added that overdoses were common, for a variety of reasons. Parents sometimes give their children two different brands, unaware that they contain the same active ingredients. Overdoses can also result when frantic parents try to shove eyedroppers or cups of medicine into the mouths of crying, spitting babies.

 

The safety problems might be worth risking, the petitioners said, if the medicines worked to suppress coughs or clear stuffy noses. But according to a growing number of studies in children, the drugs are no better than placebos.

 

‘There is widespread consensus that there is no good evidence for the effectiveness of several of the compounds used in cold medicines,’ said Dr. Ian M. Paul, an assistant professor of pediatrics at Penn State College of Medicine who has studied the medicines. Last year, the American College of Chest Physicians recommended that parents avoid using cough and cold medicines in children, especially young ones.”

 

“Dr. Sharfstein said there was now enough evidence about the dangers of the drugs for the F.D.A. to act.”

 

“There is this incredible disparity between how the products are regulated and what the scientific evidence and consensus states,” Dr. Sharfstein said.

New York Times October 2007 Manufacturers Remove Drugs for Infant Cold Gardiner Harris

 

“Major makers of over-the-counter infant cough and cold medicines announced Thursday that they were withdrawing their products from the market for fear that they could be misused. The voluntary withdrawal, already under way, affects only products labeled for use in infants, not for use in children 2 and older. And some small companies could continue selling infant products. More changes, perhaps mandated by federal drug regulators, could be in the offing.

 

The withdrawal comes two weeks after safety reviewers within the Food and Drug Administration urged the agency to consider an outright ban of over-the-counter cough and cold products for children under 6. Even the industry’s main trade group, the Consumer Healthcare Products Association, recommended two weeks ago that the products not be used in infants.

 

Despite the recommendation, giant drug makers like Johnson & Johnson, Wyeth and Novartis continued to sell cough and cold products labeled for infants. Last week, Representative Henry A. Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform, sent a letter to the industry’s trade association asking why the products were still being sold.”

 “’I don’t recommend their use in any child,’ said Dr. Daniel Frattarelli, a pediatrician from Detroit who serves on the American Academy of Pediatrics’ committee on drugs. ‘These medicines don’t help, they may hurt, so don’t use them.’”

 

“The products being withdrawn include Dimetapp Decongestant Infant Drops and Robitussin Infant Cough DM Drops, both made by Wyeth; Little Colds Decongestant Plus Cough, by Prestige Brands; Pediacare Infant Drops Decongestant and Tylenol Concentrated Infant Drops Plus Cold and Cough, both by Johnson & Johnson; and Triaminic Infant & Toddler Thin Strips Decongestant, by Novartis.”

 

“There is little evidence that cough and cold medicines are effective in young children, and there are increasing fears that they may be dangerous. From 1969 to 2006, at least 45 children died in the United States after taking decongestants, and 69 died after taking antihistamines, according to the F.D.A.”

 

“Many children were sickened after they were mistakenly given too much — either because parents failed to realize that products from two makers contained identical medicines or because parents had given improper amounts. But there are reports that even children given recommended doses are at risk.

 

The Poison Control Center of the Children’s Hospital of Philadelphia recently reported four cases of prolonged hallucinations in children as old as 6 who were given recommended doses.”

 

“Infant cough-and-cold products were approved decades ago without adequate testing in children because experts assumed that children were simply small adults, and that drugs approved for adults must also work in children. More recent research showed that neither assumption was true. Indeed, recent studies suggest that pediatric cough and cold medicines work no better than placebos.”

 

“Joshua M. Sharfstein, the Baltimore commissioner of health, cheered the withdrawals but said the F.D.A. should ban all such products so that smaller companies do not continue to sell them.

 

‘We believe that companies should also stop marketing cough and cold products for toddlers,’ Dr. Sharfstein said.”

 

 

US News and World Report September 2007 FDA Advisers Urge Ban on Cold Medicines for Young Children Review finds 123 deaths linked to the products since 1969 Steven Reinberg

 

“U.S. health experts on [September 28^th] urged the federal Food and Drug Administration to consider banning the sale of over-the-counter cough and cold medicines for young children.

 

The recommendation, from FDA safety officials, would apply to decongestant use in children under 2, and antihistamines in those younger than 6, according to agency documents released Friday, the Associated Press reported.

 

The products include approximately 800 popular medicines that are sold in the United States under names like Toddler's Dimetapp, Triaminic Infant and Little Colds, The New York Times reported.

 

FDA advisers will consider the recommendation during a meeting on Oct. 18 and 19, and will then offer their opinion to the full agency.

 

In the safety review released [September 28^th], the FDA experts recommended that all infant cough and cold products be removed from the market. They also recommended that the sizes of the droppers, cups and syringes packaged with products be standardized to reduce the possibility of confusion and overdose, the [New York Times] said.

 

An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine, the [Associated Press] said. Most of the deaths were children younger than 2.”

 

 

Associated Press October 2008 Doctors Urge FDA to Recall Cold Medicines for Children

 

“With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids' coughs and sniffles. Doctors question the drugs' benefits and worry about their risks.

Pediatricians are urging the Food and Drug Administration, which scheduled a public hearing Thursday on the issue, to demand a recall of the medicines for children younger than 6.

 

‘Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children,’ said Dr. Joshua Sharfstein, Baltimore's health commissioner. ‘There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6.’”

 

“[Colds] usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.”

 

“Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

 

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.”

 

“Sharfstein said Maryland saw an immediate benefit after OTC cough and cold remedies for [children under 2 years old] were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.” 

CNN Child Deaths Lead to FDA Hearing on Cough, Cold Meds Jennifer Pifer

 

“Devon Mehlberg-Alvarez was Alvarez's firstborn — and her mother's first grandchild. When he was 4 months old, Devon got a cold. Alvarez took him to the doctor. The doctor told her to give Devon an over-the-counter infant cold and cough medicine. Alvarez followed the doctor's directions and gave Devon the suggested amount.

 

However, a few mornings later when the Bloomington, Illinois, mother checked on her son, something was wrong. ‘I screamed,’ says Alvarez, ‘He wasn't breathing. He was cold.’

 

Devon was dead.

 

Deborah Mehlberg found out her grandson was dead after returning from a weekend trip. When she pulled into her driveway, her family was standing in the front yard. Her son told her the terrible news. ‘My heart fell out of my chest. I couldn't believe it,’ says Mehlberg. ‘No one in my family ever died this way.’ She needed answers.

 

At first, investigators blamed SIDS for Devon's death. But Mehlberg and her family were not convinced, so they pushed for more tests. "I'm a technical person," says Mehlberg. ‘I know that there's a cause and effect for everything, and I knew that there was something that caused this baby to die.’

 

A few months later, the results came back. The cause of death: Dextromethorphan intoxication. Devon's family says they were told later that Devon's body could not metabolize one of the key ingredients found in many infant cold and cough medicines.

 

Over the past two years, 1,500 babies and toddlers have wound up in emergency rooms after having a bad reaction to cold medicines, according to the U.S. Centers for Disease Control and Prevention.

 

On Thursday, the Food and Drug Administration will meet to discuss whether over-the-counter cold medicines are safe and effective in children age 6 and under. Earlier this year, the FDA completed a review that found between 1969 and the fall of 2006 there were 54 reported child deaths from decongestants and 69 from antihistamines. Most of the deaths occurred in children under 2. Baltimore Health Commissioner Dr. Joshua Sharfstein headed the push that led to the FDA hearing. He became alarmed when four Baltimore children died after their parents gave them excessive doses of cold medicines. ‘I didn't quite realize that it could potentially be a life-and-death issue,’ says Sharfstein.”

 

“Sharfstein says the industry must go further. He wants the FDA to ban the use of cold and cough medicines in children under age 6. ‘There's no evidence that they actually work,’ he says. In a statement on its Web site, the American Academy of Pediatrics states ‘No well-controlled scientific studies were found that support the efficacy and safety of narcotics (including codeine) or dextromethorphan as antitussives in children. Indications for their use in children have not been established.’

 

Since Devon's death, his grandmother has been on what she calls a ‘one-woman crusade.’ ‘I'm the nut that walks up to people in the grocery stores and asked them if they have ever heard of this.’ says Mehlberg. From her home in a quiet Bloomington neighborhood, Mehlberg says she e-mailed comments to the FDA and will be watching what happens at the hearings closely.

 

During a recent trip to Devon's grave, Mehlberg received word of the voluntary recall. ‘Oh thank God,’ she said with tears in her eyes. ‘I never want another family to go through what we have.’”

 

 

Washington Post Cold Drugs Put 7,000 Children A Year in ERs Study Cites Access, Dosage in Ages 2-5 January 29, 2008 Rob Stein

 

 

“More than 7,000 children get rushed to emergency rooms each year after suffering adverse reactions to cough and cold medicines, according to the first national estimate of the risks posed by the widely used remedies.

 

Most of the problems occur in children ages 2 to 5 who get into the medications on their own, researchers said. They based their conclusions on an analysis of data from a nationally representative sample of 63 emergency rooms in 2004 and 2005.

 

‘Anytime a child ends up in the emergency department because they had access to a bottle of medication, that is a problem that could be prevented,’ said Daniel S. Budnitz of the federal Centers for Disease Control and Prevention, which conducted the research.

 

The report comes as the Food and Drug Administration considers whether to further restrict the use of the products because of concern about their risks and questions about their effectiveness. Critics and supporters of the products seized on the new report to support their positions.

 

‘This is a lot of trips to the emergency room for products that have no known benefit,’ said Joshua M. Sharfstein, Baltimore's public health commissioner and the leader of a coalition of pediatricians that petitioned the FDA to restrict promotion of the products for use by children. ‘It's time to pull the plug on the marketing of these products.’

 

But Linda A. Suydam of the Consumer Healthcare Products Association, an industry group, said the report shows that the problem stemmed primarily from parents giving the wrong dose or failing to make sure the products were out of the reach of children.

 

‘These really are situations where parents were perhaps confused and gave the wrong dosage or inadvertently left out their medication in a way that children could get into them,’ she said. She defended the effectiveness of the products and their safety when used properly, saying parents want continued access to them.

 

Last fall, the industry voluntarily withdrew all products marketed for children younger than 2 but said the products were safe and effective for older children.

 

An FDA advisory panel, however, voted that there was no evidence that the products were effective and recommended against their use in children younger than 6.

 

On Jan. 16, the FDA formally urged parents not to use the products in children younger than 2, citing recent surveys showing that many parents continue to use them. Agency officials said they had not determined what to do about older children.

 

Sharfstein filed his petition after four children in Baltimore who had ingested the remedies died. The CDC said last year that at least 1,500 children younger than 2 had complications in 2004 and 2005 from the products, and an FDA review noted dozens of cases of convulsions, heart problems, trouble breathing, neurological complications and other reactions, including at least 123 deaths.

 

The new report, published online yesterday by the journal Pediatrics, is the first attempt to get a nationwide estimate of the extent of the problems.

 

Researchers analyzed data collected by a nationwide drug safety surveillance system that gathers information from 63 emergency rooms to provide a representative sampling of adverse drug events. The researchers identified 301 cases between Jan. 1, 2004, and Dec. 31, 2005. Extrapolated nationwide, that works out to 7,091 cases a year. Cold and cough drugs account for 5.7 percent of all medicine-related visits to the emergency room by children younger than 12, the researchers found.

 

In most of the cases, the researchers were unable to determine what symptoms the children experienced. But in those cases where that information was available, 19 percent had allergic reactions, and 13 percent had neurological symptoms such as sleepiness or problems walking.

 

Although the cases included prescription and over-the-counter products, the researchers said most of them involved nonprescription products.

 

Children ages 2 to 5 accounted for 64 percent of the cases, and nearly 80 percent of the cases in this age group involved situations where children got into the products without their parents' knowledge. But in the remaining cases, either the parents gave the wrong dose or a correct dose produced an adverse reaction.”