The wrong prescription
Pharmaceutical companies deserve a taste of their own medicine
Jessica Stewin, volunteer staff
Many manufacturers recently decided to voluntarily pull their cold medications that were designed for children under two years of age from store shelves. Included in the disappearing drug act were medications like Dimetapp Oral Infant Cold Drops and Benylin for Infants Cough and Cold Drops. The Nonprescription Drug Manufacturers Association of Canada (NDMAC) said the withdrawal was “a highly cautionary response to rare patterns of misuse identified during the course of a review of safety data related to children’s cough and cold medicines.”
The pull correlated with the meeting of an advisory panel on Oct. 19. The meeting was designed “to provide advice and recommendations to the agency on FDA’s regulatory issues.” They recommended to the U.S. Food and Drug Administration (FDA) that over-the-counter cold medicines should not be given to children under six years of age. The panel consisted of two committees — the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee — the formations of which were prompted by a citizen petition submitted to the FDA. Included in the petition were signatures from the heads of pediatrics at the Johns Hopkins Hospital, Mercy Medical Center, Sinai Hospital, and others. The petition was concerned for the safety of children and with the efficacy of children’s cold and cough medications.
The concern stems from a general lack of data, clinical trials, and vague dosing guidelines. In 1997, the American Academy of Pediatrics reviewed the available data and concluded that indications for the use of cough suppressants in children had not been established. The academy decided that cough suppressants should be used cautiously because of a “lack of proven antitussive effects and the potential risks.” It is concerning that issues did not come forward earlier.
Also concerning is how excessively parents medicate their children. In 1994, the American Medical Association released a report that in a 30-day span 35.8 per cent of American 3-year-olds were given an over-the-counter cough and cold product. Considering the lack of evidence for the therapeutic effects, parents seem to have been deceived into thinking these medications will benefit their young ones without any risk. The display of children under six and the use of terms like “baby” and “infant” imply they’re safe to use for children under six. However, the evidence is limited for the implications, and petitioners were opposed to the use of these marketing techniques. The drug companies are playing on young parent’s naivete. There may be warnings for parents to always seek instruction from their doctor; however, in everyday situations a doctor is rarely contacted. Often parents are hoping to relieve their child’s symptoms without the need of seeking out a professional. The petition proposed that the use of pictures of small children and terms like “baby” and “infant” implied to parents that the medication had proper testing for those ages.
The meeting held on Oct. 19, however, found that there was little evidence for the dosages recommend. The FDA could only find 11 studies relating to children published over the last half-century. Many of the drugs have never been tested on children and the panel asked that drug manufacturers conduct studies on children to demonstrate that the medications are effective in children under 12. The dosages recommended on bottles were merely extrapolations from studies done on adults. The metabolism of adults and children is not equivalent, and such extrapolations are therefore unfounded.
The Academy of Chest Physicians stated that “in children with cough, cough suppressants, and other over-the-counter cough medicines should not be used as patients, especially young children, may experience significant morbidity and mortality.” With evidence that the rate of incidence of a disease and death could be increased by the use of these medications, it is disgusting that these companies could be allowed to sell the products. The petitioner requested the agency notify the manufacturers that they will be subject to enforcement action at any time, for the lack of scientific evidence to support the marketing of their products. The strong words are reasonable when one considers how many children are being drugged with useless, and perhaps harmful, medications. Dosages based on irresponsible extrapolation are taken seriously by parents who desperately try to help their ailed child.
Many U.S. pediatricians have been lobbying for restrictions on the sale of non-prescription cold medicines for years, noting that there have been too many incidents of overdose that have lead to hospitalizations and even deaths. However, little action has been taken until very recently, when these products were recalled. Pulling these products off the shelves should have been done much earlier.
Heath Canada is also reviewing children’s medications and following the FDA’s action on this panel. A recent statement from Heath Canada said that they “will consider the results of this meeting as we move forward with our review and recommendations regarding these products.”
With the lack of scientific evidence and many incidents of overdose, it seems ridiculous that these products have remained on store shelves for so long. There is such a strong call from U.S. pediatricians for restrictions; and the support of the medical community is clearly represented with signatures from the heads of pediatrics at a number of American hospitals for the call of this review. How is it that these pharmaceutical companies can be allowed to capitalize on parents who simply want to help heal their sick child?
Jessica Stewin is a University 1 student at the U of M.
