More than 40 over the counter children’s medications were recalled on May 1st, 2010. These include all lot number of infant’s and children’s liquid Tylenol, liquid Tylenol Plus, liquid Motrin, liquid Benedryl and liquid Zyrtec due to concerns that the medications might have higher concentrations of active ingredients than specified on the bottle, others may contain particles and other might contain a higher concentration of inactive ingredients. The FDA is investigating. See the list below for recalls.
This is an alert to EVERYONE who has allergies/asthma, but I especially want to inform parents with children who have allergies and/or asthma(because parents are often the last to know). The FDA has updated the SIDE EFFECTS of this “miracle” drug to include:
California was prescribed this to control his asthma at the age of 2 even though his allergist determined that he didn’t have allergies. He refused to take it and I didn’t trust this drug for some reason. I had no reason NOT to trust it but something inside me told me not to give it to him. I am so glad that I didn’t!
Click HERE to read the news story associated with this information.
When Tennessee was a baby/toddler, his pediatrician advised me to give him all kinds of over the counter cold/cough/flu medication even if he just had a runny nose. In my heart, I knew that he was just soooooooooooooo little and he shouldn’t be taking medication unless that it was absolutely necessary…like a life or death situation. So, there were many times that I chose not to and a few times that I chose to give it to him anyway. One particular incident that comes to my mind was when we moved to Los Angeles from Nashville. I was concerned that Tennessee would cry the entire time since he was only 14 months old then. His pediatrician said “Just give him some Benedryl. That will make it so that he sleeps most of the way on the plane.” I did that. Didn’t work. He has a natural immunity to Benedryl…as a matter of fact, he seemed MORE wide awake and exciteable than normal. I am glad that I was smart enough to know not to just give him more until it works…but unfortunately MANY parents aren’t that smart.
Furthermore, the FDA made a very LOUD public statement last Fall about the dangers of giving cold/flu medications to babies/toddlers/children. They stated that these medications were unsafe for little ones PERIOD. Apparently, parents didn’t listen and continued to give these medications to their chldren because the FDA felt as though they needed to make the same URGENT STATEMENT as before. If the FDA’s warning isn’t strong enough for parents and caregivers to pay attention to then they should watch and listen to stories of parents who have lost their children to cold
Like I said before, the FDA made this public statement LAST Fall. So why did I see THIS when I went to Rite Aid, Target and CVS LAST WEEK???
Does the FDA really have our children’s best interest at heart or kickbacks from pharmaceutical companies? Dr. Lurie from the Health Research Group of Public Citizen believes that cold/cough remedies should be banned for all children under the age of 12. Read why HERE. And get this! According to the Associated Press, the “FDA never formally allowed infant-targeted cold remedies in the first place; Ganley said they evolved through a legal loophole”. Nice.
Make sure that all of the parents, grandparents, babysitters, nannies and all other possible caregivers that you know, understand that they should NOT to give these products to children under the age of 6…and even better let them know not to give them to children under thea age of 12 as well.
In addition to the warning for flu drugs for kids, the FDA is considering the safety of two asthma drugs that are prescribed for kids as well. The names of the drugs are Severent and Adavair.
Here is a link that you can copy and paste into your browser to read the entire news story: http://online.wsj.com/article/SB119582909121102143.html?mod=fpa_whatsnews
FDA Wants Warnings on Flu Drugs for Kids
Friday November 23, 2:10 pm ET
By Matthew Perrone, AP Business Writer
FDA Wants Added Label Warnings About Bizarre Behavior in Kids That Get 2 Widely Used Flu Drugs
WASHINGTON (AP) — Government health regulators recommended adding label precautions about neurological problems seen in children who have taken flu drugs made by Roche and GlaxoSmithKline.
The Food and Drug Administration on Friday released its safety review of Roche’s Tamiflu and Glaxo’s Relenza. FDA’s panel of outside experts will consider the government’s proposed labeling at its meeting Tuesday. FDA is not required to follow the advice of its outside experts, though it usually does.
FDA began reviewing Tamiflu’s safety in 2005 after receiving reports of children experiencing neurological problems, including hallucinations and convulsions.
Twenty-five patients under age 21 have died while taking the drug, most of them in Japan. Five deaths resulted from children “falling from windows or balconies or running into traffic.”
Over 48 million patients, including 21 million children, have taken Tamiflu since it was approved in 1999. The drug, which comes in capsule and liquid form, had sales of $2.4 billion last year.
There have been no child deaths connected with Relenza, but regulators said children taking the drug have shown similar neurological problems.
The label for British drug maker Glaxo’s Relenza does not list any neurological problems. A company spokesman said Friday no signficant behavioral issues have been recorded in clinical studies or patient safety reports. Sales of the drug last year were roughly $187 million.
While FDA said the reports of dangerous side effects could result from an unusual strain of flu or a rare genetic reaction to the drugs, the agency wants language about the possible side effects added to labeling for physicians who prescribe Tamiflu and Relenza.
Tamiflu’s current label lists the potential for self-injury and delirium, but does not mention that these behaviors could result in death. The FDA’s proposed label would include that information.
In a statement Friday, Roche suggested it would consider changing the label.
“If the FDA concludes that it is valuable to place additional details on the label with regard to specific adverse event reports, then Roche is open to that consideration,” the statement from Roche, which is headquartered in Basel, Switzerland, said.
However, the company also stressed there is no concrete evidence connecting its drug to the reported problems. It also pointed out that many children with flu experience neurological problems, even when they aren’t taking medication.