pregnant women

  1. Drug company launches new attack on compounding pharmacists

    It was the equivalent of David taking down Goliath: Earlier this year, compounding pharmacists stood up to a drug company -- and won big.

    But in this version of the tale, Goliath doesn't lie down and die. He gets back up -- and now, he's really ticked off.

    Before I get into that, let me recap the story so far: For years, compounding pharmacists made a generic version of 17-hydroxyprogesterone, a hormonal treatment given to pregnant women to lower the risk of a preterm birth.

    Despite its wide availability, it was considered an "orphan drug" by the FDA -- allowing KV Pharmaceuticals to swoop in, slap a patent on it, and re-name it Makena earlier this year.

    Then, the company raised the price to $1,500 a shot and threatened legal action against any compounding pharmacist who continued to make the cheap generic version.

    Naturally, women were outraged -- and they remained outraged even when the company cut the price to "only" $690 a shot. And that's when the FDA stepped in and told compounding pharmacists not to worry -- they could keep making their own version of the drug.

    Believe me, I'm still rubbing my eyes over that one.

    But maybe it really was a dream after all, because the company is still trying to get the generic hormone pulled from the market.

    And this time, they might succeed.

    KV quietly ordered samples of 17-hydroxyprogesterone from a handful of compounding pharmacists, then hired a lab to perform tests on behalf of the company.

    No conflict there, right?

    Naturally, the tests "found" that the compounded product was indeed different from Makena, which isn't the point.

    Of course they're different -- they're custom-made, but that doesn't mean the product is bad. There's no evidence that these variations make the treatment any less effective, and no evidence they pose any more of a risk than Makena.

    In fact, the same people who produced these "bad" samples are the same compounding pharmacists who've been reliably making the treatment for years -- giving them a much better real-world track record then Makena.

    But the company sent its test results to the FDA, and the agency is now "investigating." The feds even sent out a reminder saying that approved drugs like Makena come with a "greater assurance of safety and effectiveness" than those from compounding pharmacists.

    Stay tuned... but I think that last bit is a sign that the writing's on the wall: Goliath is back on his feet.

  2. Painkillers up miscarriage risk

    You wouldn't dream of pumping a newborn full of powerful painkillers like ibuprofen -- yet nearly a fifth of all pregnant women take these meds during pregnancy... and it's killing their unborn children.

    Some of the most common painkillers of all -- non-steroidal anti-inflammatory drugs like ibuprofen -- can dramatically boost the risk of miscarriage.

    Canadian researchers compared data on 4,705 women who suffered a miscarriage during the first five months of pregnancy to 45,050 women who did not, and found that those who took the painkillers had 2.4 times the risk.

    Putting that into stark real terms, a woman has a 15 percent risk of miscarriage right off the bat -- but if she's been popping these painkillers, that risk shoots up to 35 percent.

    And believe it or not, those numbers might be on the low side: The researchers used prescription drug records, not self-reported use, to figure out who had taken the painkillers.

    That leaves out the scores of women who take over-the-counter drugs -- because in Canada, as in the United States, both ibuprofen and naproxen are widely available.

    Other NSAIDs include rofecoxib, diclofenac and celecoxib -- but don't put too much effort into memorizing those names. Most of the drugs that have become a common part of the household medicine chest aren't nearly as safe as you've been led to believe, and that's especially true during pregnancy.

    On the other hand, you never needed those drugs in the first place -- and pregnancy is a great opportunity to wean yourself off them for good as you explore the safe and effective nondrug alternatives that have helped millions beat pain, even during pregnancy.

    One study a couple years back found that 81 percent of pregnant women who suffered from back pain got at least some relief from acupuncture -- versus 59 percent of women who got a sham treatment.

    The needles don't hurt -- in fact, you'll barely feel them.

    But if acupuncture's not for you, try a good rub: Not only is massage therapy proven to bring pain relief to pregnant women, but it also can have a powerful stimulating effect on the immune system.

    And that's something that can benefit mom and baby alike.

  3. Don't fear seafood during pregnancy

    In recent years, pregnant women have been scared to death of seafood because of the possibility that some of it may have high mercury levels.

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