The controversial iPLEDGE program was designed by drug companies to prevent pregnant women from being exposed to medications like Accutane, a last ditch anti-acne drug that causes profound birth defects.
But a new report on the program shows that 122 women taking Accutane or its generics, which contain isotretinoin, became pregnant anyway.
Chances are, once they found out they were pregnant it was too late; birth defects or miscarriages can occur soon after conception.
Clearly, too many pregnant women are still being exposed to the drug, and it's likely these women bought it over the Internet, bypassing the mandatory monitoring program.
But as officials review proposed changes to make the program safer, they should also consider another vulnerable population: breast-feeding mothers.
Most medications transfer into human milk, though the dose is quite small, according to Thomas Hale, author of "Medications and Mothers’ Milk," a resource every breast-feeding mom should be given before she leaves the hospital.
And while lactating mothers can use many drugs, including certain types of anti depressants, isotretinoin is one they should avoid because it is "extremely lipid soluable, and concentration in milk may be significant," according to Hale.
The manufacturer strongly recommends against using it while breast-feeding, but is the information getting out? If pregnant women are still using Accutane despite the known link to birth defects, chances are good that nursing mothers are too.
Hale, who recently spoke at La Leche League International’s 50th anniversary conference, gave nursing mothers several tips, which are also found in his book.
Avoid medications when possible, including herbs, high dose vitamins and unusual supplements. That said, don’t stop taking antidepressants because the risk of not taking them is too high. If you can, take Zoloft, which has been shown to be the safest. Prozac is "probably OK," said Hale, while Paxil is "not a great choice as neonatal withdrawal symptom has been reported." Still, even Prozac or Paxil is better than nothing if depression is a serious issue. Choose drugs for which we have published data, rather than those recently introduced. The age of the infant is critical. Use medications cautiously if you have a premature infant. Medications used in the first three to four days generally produce subclinical levels in the infant due to the limited volume of milk. Have your doctor help you determine whether the drug is absorbed from the gastrointestinal tract. Many drugs such as the aminoglycosides, vancomycin, cephalosporin antibiotics (third generation), morphine, magnesium salts and large protein drugs (heparin), are so poorly absorbed that it is unlikely the infant will absorb significant quantities. Be careful of barbiturates, benzodiazephines, meperidine and fluoxetine, which have long pediatric half-lives and can continually build up in the infant’s plasma over time. Choose drugs with short half-lives, high protein binding, low oral bioavailability or high molecular weight. Avoid Demerol at all costs. Avoid estrogen-containing products that may alter the mother’s milk production. Be careful with beta blockers "Drugs that stimulate milk production by increasing the prolactin level (Galactagogues) only work when prolactin levels are too low," Hales said. "If it’s going to work, it’ll happen right away, so don’t stay on the drugs for very long. Don’t overdose to get more milk, either. There’s no good evidence that super high doses enhance prolactin levels." (Though Hales says not everyone agrees with this.) Fenugreek probably can increase milk supply but studies are limited. Ask your doctor whether the drug can get