Cold Medications Recalled by FDA

After continuous debate and warnings, pharmaceutical companies voluntarily removed children's cold and cough medicine from the shelves. On Thursday October 11, over the counter medications, marked for cold and cough, were pulled for children under the age of two. Why were theses drugs pulled? What steps do parents of children two and under now take to help their child?

Representatives for drugs companies assert that the OTC's are more likely safe and productive. Yet, they feel the misuse of these medications is the cause of the greatest concern. Organizations encouraging the OTC change are hopeful labels once directing precaution will change to not to be used at all in the age under two years age group.

In September of 2007, The FDA conducted a study into the use of OTC cough and cold medicines. These findings are what lead to the recent recall. The FDA found that 54 children died form 1969-2006 after being administered medicines containing diphenhydramine, brompheniramine, and chlorpheniramine at home. The majority of these deaths were of children under the age of two. Research by other organizations have implied that the medications were also responsible for illnesses and health issues in children under two (who were administered the medications).

As well, on October 1, 2007, the FDA said it would take enforcement actions against companies marketing cough and pain medications for children that contain hydrocodone. Hydrocodone is a narcotic also used in adult medications like Percocet and Vicodin. The drug is linked to health complications and addictions. The agency says the narcotic has not been approved for treatment of coughs and colds in children.

Parents interviewed in studies and those of children who suffered from use of the medications, were found to often dose to high. Some parents felt more would enlarge the OTC's effectiveness. Others felt that using the medications for there sedative effect, was not dangerous. Parents looking for a quick fix to energized children, who were not sick, often use drugs such as Benadryl (containing the antihistamine diphenhydramine) to help their children sleep. This, along with the questions about basic safety and effectiveness, has become the backbone of those who want the recall to spread into the under six-year age bracket.

Children absorb medicines at a different rate then adults. They also absorb them, as well as metabolize them, differently child to child. A dosage for a child under two who is in one weight class would be different for a child under two of a different weight. However, many parents were dosing by age, not the suggested height and weight. Doctors and Pharmacists have been found to suggest, "Giving a little more won't hurt" when prescribing fever medications like Advil or Tylenol. Parents then take the same concept and apply it to other medicines, which is not safe. Doctors also warn that parents who are using "cocktail" medications should be leery of there effects and necessity. An OTC containing a cough medication, antihistamine, and decongestant, for example, is not necessary for a child with a simple runny nose.

What are parents to do now? How do they take care of the needs of their children under two years of age when a cough or cold hits? Many professionals in the medical community contend, medicines can actually prolong a child's (or adults) cold. The secretions from the nose for example, are the bodies' way of fighting or ridding the body of bacteria and viruses. If antihistamines are used, the body depends on the medication and does not have the same opportunity to rid itself of the cold. In addition, a child can be made comfortable during this time, without medications. Doctors recommend the use of humidifiers and creams or bath supplies made specifically for congestion. They should also consume extra fluids, which can help thin out the mucus in the nose and throat. A child's main concern is a high-grade fever. Many pediatricians say that a fever is often a good sign, letting you know the body is fighting the illness. If the child is able to tear up, sweat, or urinate, parents can be more confident their child is well hydrated and safe. A pediatrician should check coughs that do not become productive (expelling mucus). As well, any cold that prolongs needs checking by a professional. Colds or coughs accompanied by severe pain, headaches, infections, or fevers with headaches and lethargy, need immediate attention. Any parent who has concerns about their child's well being, at any age, is encouraged to contact their pediatrician or local emergency room.

Parents can also try natural or alternative treatment for their child's symptoms. However, remember that with any treatments, a health professional should be consulted before administering. Precaution is also key to the fight against colds. Viruses and bacteria born illnesses can be avoided or the effect lessoned by pre-emptive treatments. Washing hands after bathroom uses and use of hand sanitizers when using buggies or store provided strollers and child friendly cars. Children should consume the recommended daily intake of vitamins such as C and B to support their immune system. Fruits and vegetables can easily supply these vitamins. For children who are not eating a balanced diet, ask your doctor or pharmacist for multivitamin recommendations. To keep their immune system at a healthy level, children should get the required sleep for their age, as well as a healthy level of exercise. Children should also be discouraged to share drinks or silverware with others, especially during the cold and flu season. Some children may be able to have flu-shots, ask your pediatrician for your child's qualifications.

At this point only major brands have agreed to the recall. However, officials are hopeful the generic or store name brands will soon follow. While the safety of the medications are not fully understood, neither are the risks, and the FDA is urging parent to be safe rather than sorry.

The major companies involved in the OTC recall are Tylenol, Dimetapp, Pediacare, Robitussin, Triaminic, and Little Colds. Little Colds is one of the major brands used for children under two years of age.

Parents who find their child is having sleeping difficulties should refer to their pediatrician for help. Self-diagnoses and treatment with medications without there intended use could be dangerous.

For further information, contact you child's pediatrician or your local pharmacy.