Ba­bies risk suf­fo­ca­tion on sleep po­si­tion­ers

The FDA warn­ing is not a ban, but the agency is urg­ing an end to pro­duc­tion.

Los Angeles Times - - The Nation - Pa­tri­cia Cal­la­han and Ellen Gabler re­port­ing from chicago pcalla­han@tribune.com egabler@tribune.com

Fed­eral reg­u­la­tors and the nation’s lead­ing pe­di­a­tri­cian group on Wed­nes­day warned par­ents that pop­u­lar baby sleep po­si­tion­ers — mar­keted as safety prod­ucts — can be deadly and urged fam­i­lies to stop us­ing them, re­tail­ers to stop sell­ing them and man­u­fac­tur­ers to stop mak­ing them.

The prod­ucts have been linked to at least a dozen suf­fo­ca­tion deaths in the last 13 years, reg­u­la­tors said. The prod­ucts of­ten have foam bol­sters on the sides that help keep a baby in one po­si­tion, but in­fants can wig­gle or roll into un­safe spots. Ba­bies have suf­fo­cated on the foam or have be­come trapped be­tween the prod­uct and the side of the crib or bassinet.

For years, the Amer­i­can Academy of Pe­di­atrics and oth­ers have pro­moted sci­en­tif­i­cally backed ad­vice call­ing for ba­bies to sleep on their backs to re­duce the risk of sud­den in­fant death syn­drome, or SIDS. The sleep po­si­tion­ers ap­peal to the safety-minded par­ent who wor­ries a child will stray from that po­si­tion. Sales of the prod­ucts, which of­ten cost less than $20, took off in the last five years.

Al­though the warn­ing does not con­sti­tute a ban, Dr. Joshua Sharf­stein, a pe­di­a­tri­cian who is the No. 2 of­fi­cial at the Food and Drug Ad­min­is­tra­tion, said many of these prod­ucts are “il­le­gal de­vices” be­cause they tout their abil­ity to re­duce the risk of SIDS. The po­si­tion­ers, he said, have not been cleared for that use.

There is no ev­i­dence that they pre­vent SIDS, said Dr. Rachel Moon, chair of the Amer­i­can Academy of Pe­di­atrics

‘I would think good sense would stop a com­pany from mar­ket­ing a prod­uct like this know­ing that the Academy of Pe­di­atrics [and] the FDA … think that they could be dan­ger­ous and po­ten­tially lead to the death of chil­dren.’ — Dr. Joshua Sharf­stein,

No. 2 of­fi­cial at the FDA

SIDS Task Force.

Even if com­pa­nies with­draw their med­i­cal claims, they still could run into reg­u­la­tory trou­ble sell­ing sleep po­si­tion­ers, Sharf­stein said.

“I would think good sense would stop a com­pany from mar­ket­ing a prod­uct like this know­ing that the Academy of Pe­di­atrics, the FDA and the [Con­sumer Prod­uct Safety Com­mis­sion] think that they could be dan­ger­ous and po­ten­tially lead to the death of chil­dren,” he said.

The joint warn­ing from the FDA and the prod­uct safety com­mis­sion marks a more ag­gres­sive style in tack­ling haz­ards in the nurs­ery af­ter an avalanche of re­calls of cribs, toys and other baby prod­ucts. Typ­i­cally, the CPSC re­calls prod­ucts piece­meal, and par­ents are left to won­der whether other sim­i­lar prod­ucts share the haz­ard. Al­though none of these prod­ucts are sub­ject to a re­call, the mes­sage was clear that the FDA and the CPSC may pur­sue re­calls or other en­force­ment ac­tions if man­u­fac­tur­ers and re­tail­ers fail to re­move them from the mar­ket.

Ba­bies R Us, Toys R Us and Tar­get said they planned to stop sell­ing the prod­ucts on­line and in stores, ac­cord­ing to spokeswomen for the re­tail­ers. At least five man­u­fac­tur­ers told the FDA they planned to with­draw their prod­ucts.

Judy Sage, a New York mother, lost her 8-week-old son Andy when he suf­fo­cated on a sleep po­si­tioner in 2002. Andy’s pe­di­a­tri­cian rec­om­mended she po­si­tion the child, a twin, on his side to help with gas­troe­sophageal re­flux, a com­mon prob­lem in in­fants. She said she thought the Graco sleep po­si­tioner would keep Andy safe.

Now she can’t shake the im­age of find­ing him that Jan­uary night. “Andy would be here to­day had I not used a sleep po­si­tioner,” she said.

Sage has spent the last eight years try­ing to spread word of the dangers of these prod­ucts and was elated by the an­nounce­ment.

Many sleep po­si­tion­ers in­clude a warn­ing that par­ents should stop us­ing them when a baby be­gins to move around.

Such a warn­ing is dif­fi­cult to fol­low, Moon said, be­cause “you have to as­sume that your baby may be able to move around dur­ing sleep at any time.”

The FDA first ap­proved some sleep po­si­tion­ers in the 1980s for ba­bies with re­flux or for ba­bies whose heads flat­tened. In all, 18 prod­ucts were cleared by the FDA for sale for those pur­poses.

Man­u­fac­tur­ers that want to con­tinue sell­ing those prod­ucts will have to show ev­i­dence that the ben­e­fits of the prod­ucts out­weigh the risks of suf­fo­ca­tion, said Sharf­stein, the FDA of­fi­cial. For health sto­ries, tools, re­sources, ex­pert ad­vice and more, go to healthkey.com

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