Saturday, October 20, 2007

Cold Medicine For Children Under 2 Banned by FDA

A few years ago an infant inexplicably died in an Indiana day care setting .A woman was actually prosecuted for child abuse. She reached a plea. An innocedental finding was mentioned by the Doctor performing the autopsy that the baby had been given cold medication that morning. Behind the scenes, there was speculation that cold medicine could cause death in an infant but it never became an issue in the case because of the controversial plea agreement which involved no jail time. Now an FDA advisory panel has voted to ban over-the-counter cold products intended for children under the age of 6.

Dr. John Jenkins, director of F.D.A.’s office of new drugs, urges parents to read labels. The panel concluded that there was no proof that the medicines eased cold symptoms in children. More imortantly, they also noted there are rare reports that they have caused serious harm.
This ban could change the way parents cope with their young children's syptoms. A week earlier, major manufacturers agreed to withdraw more than a dozen cold products labeled for use in infants. However, manufacturers plan to fight the new recommendations which suggests a ban up to age 6.
“We believe these products will remain on the market,” said Linda Suydam, president of the Consumer Healthcare Products Association.


“We need to go back and review all these recommendations that we heard today and decide what the path forward might be,” Dr. John Jenkins. The panel voted, 21 to 1, to ban pediatric cold products for use in children under 2; however, the vote to extend the ban for 2- to 5-year-olds was 13 to 9. Dr. Joshua Sharfstein, Baltimore’s commissioner of health said drug makers and the agency should agree to end the marketing of cold medicines for children under 6.


PediaCare, Robitussin and Triaminic, which are made by Johnson & Johnson, Wyeth and Novartis are some of the products in issue. The panel concluded that there is no evidence that over-the-counter pediatric cold medicines have any effect on symptoms.


“I’m not going to name names among my acquaintances. But people do use these medications to make their children get some sleep,” Ms. Celento-Stamateris said. Approximately 800 pediatric cold products are sold in the United States that use one or more of 39 different drugs. Consumers spend around $500 million every year buying nearly 95 million boxes containing 3.8 billion doses of medicine. This is big business. The business just got smaller and needs to be further reduced.

Update 10-24:Speaking of child safety:

A recent Washington University School of Medicine study reported in the Washington post has found that the risk of accidental death or injury to babies from crib bumper pads exceeds their benefits. Findings were based on Consumer Product Safety Commission data from 1985-2005 that showed 27 deaths attributed to suffocation (or strangulation) from bumper pads or their ties. Health Day News, The Washington Post 10/22/2007
Read Article: The Washington Post

14 comments:

Yolanda said...

Good thing I read this. My kid was coughing and I was reaching for the cold medicine!

Yolanda

Anonymous said...

bummer. there goes my stocks?

Ms. Calabaza said...

Be very wary of over the counter medication folks!

colleency said...

Amen, Ms. C.!

There are safe alternatives to over-the-counter pharmaceuticals -

My family has been using homeopathic rememdies for 20 years. Effective, cheap, tested over hundreds of years, nontoxic (can't overdose) ... Works for us!

Anonymous said...

There goes my main way to get my kid to sleep!

Gewen said...

Kid Rock + Loser!

Gewen

Legal Pub said...

The issue is children and cough medicine, Gewen. The only way your post is relevant is if Kid Rock has a cough.

blond bombshell said...

Maybe Kid Rock is abusing children's cough medicine and that is why he is a loser in Gewen's eyes. Why did you not get that from this post, Legal Pub. LOL.

Shell

dollar bill said...

Cold medicine is big business. I am surprised they pulled the medicine. They must be worried about adverse affects of the medicine on young kids.

Dollar Bill

colleency said...

Dollar Bill,

I guess they're worried that Class Action suits will cut more deeply into their profits than pulling the products. Makes me wonder if the manufacturers knew more about possible ill-effcts than they revealed....

Dollar Bill said...

Colleency, pretty clear to us brainacs that this is a premptive strike to fend off class action suits. Also see legal pub article on Oxycontin Executives who were prosecuted for not warning that you could use the drug like heroine or coke!

Dollar Bill

trial advocate said...

I smell lots of money!


Trial Advocate

Anonymous said...

We need to protect our children. Money is a secondary issue!


Child's Rights parent

Legal Pub said...

Update 5-5-10: Another recall of children’s over-the-counter medicine. This time by McNeil Consumer Healthcare recalling some Children’s Liquid Motrin, Children’s Tylenol suspension, Children’s Zyrtec and Children’s Allergy Liquid Benydrl medicine. So far no reports of illness related to the recall. Nevertheless, the Food and Drug Administration are asking consumers not to use these products. Some of the medicine could have the wrong amount of active ingredients or the wrong amount of inactive ingredients. The recall includes: TYLENOL® INFANTS’ DROPS CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR 50580-144-01; CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR* 50580-144-15; CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE 50580-167-01; CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR 50580-143-15; CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR 50580-143-30; CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE – HOSPITAL 50580-144-18; CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE – SAMPLE 50580-144-40
CHILDREN’S TYLENOL® SUSPENSIONS, CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR 50580-123-02; CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR 50580-123-04; CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR 50580-166-04;
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH 50580-296-04;
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-407-04; CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR 50580-493-04; CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE 50580-123-01; CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL 50580-123-03;
CHILDREN’S TYLENOL® PLUS SUSPENSIONS. Also recalled: CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR 50580-247-04; CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR 50580-249-04; CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR 50580-253-04; CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR 50580-254-04; CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-255-04; CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR 50580-386-04; CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR 50580-387-04; CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR 50580-390-04; CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-391-04; MOTRIN® INFANTS’ DROPS CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE 50580-198-01; CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE 50580-198-15; CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR* 50580-100-15. Also recalled: CHILDREN’S MOTRIN® SUSPENSIONS
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE 50580-184-04, 2 OZ. BERRY FLAVOR 50580-601-02, 4 OZ. BERRY FLAVOR 50580-601-04,
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR 50580-215-04 and Grape Flavor 50580-603-04.

Also listed:
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-604-04
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE 50580-603-01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE 50580-604-01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE 50580-601-01
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL 50580-601-50
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR 50580-902-04
CHILDREN’S ZYRTEC® LIQUIDS IN BOTTLES
CHILDREN’S ZYRTEC® 4 OZ. BUBBLEGUM SYRUP 50580-721-04
CHILDREN’S ZYRTEC® DYE FREE 4 OZ. GRAPE SYRUP 50580-730-04
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ GRAPE 50580-730-15
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ BUBBLEGUM 50580-721-15
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID 50580-721-08
CHILDREN’S BENADRYL® ALLERGY LIQUIDS IN BOTTLES
CHILDREN’S BENADRYL® ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID 50580-535-04. So warned...