According to Hale’s (bfing and drugs bible), domperidone taken orally is totally safe for mother and baby.
There are suggestions that the FDA is cracking down on the importation of drugs from Canada and this has nothing to do with lactating women as they (the FDA) did not even consult any Lactation experts. There is also speculation that the formula industry has a hand in this. Did you know that the FDA does not test infant formula, all they ask is that the formula industry test it themselves and submit the results…don’t you love self-regulating industries :dubious: .
I would love to get some Doper’s opinions on this.
Speculation doesn’t wash in GD. If you have a cite for the formula industry’s interference, please give it.
As far as testing drugs for safety, no drug is tested by the FDA itself. Drug companies conduct clinical trials, then submit their results to the FDA for approval. Even after the drug goes on the market, adverse reactions are monitored, and a drug manufacturer can either be required to add warnings (as Tylenol recently had to do when it was shown that it can cause liver damage in people who drink), or can be pulled off the market altogether. This can happen for any adverse reaction or side effect, if it’s deemed serious enough.
That said, nursing mothers represent a small fraction of the American drug-using population. They also should take responsibility for themselves and educate themselves on the drugs they take, and what affect they can have on lactation and their baby.
Sorry, but I don’t see the FDA banning drugs because of issues with a relatively small population.
The “suggestions” and “speculation” do not add up to hard information.
In case you missed this from the linked article: “FDA counts over 2,000 reports of side effects from 33 countries related to domperidone. An intravenous form was banned worldwide after it was linked to cardiac arrest, sudden death, and irregular heartbeat. Seizures and other neurologic side effects have been reported with high oral doses, FDA warned.”
The FDA has a mission to ensure that drugs intended to treat a specific condition have been adequately tested, are effective as intended and have an acceptable risk/benefit profile. If domperidone turns out to meet these criteria it will be legally marketed in the United States. I am not impressed by sellers sneaking it in via the back door and then benefiting from claims of government harassment.
The FDA has had a role for many years in blocking sale of dubious and dangerous drugs, both domestic and foreign. The most outstanding example is of a sedative used widely abroad, marketed as wonderfully safe for everyone, including expectant mothers. Despite various pressures, the FDA held up approval here, denying millions of people the opportunity to take the medication.
Eh? What’s this I hear about telling nursing mothers they shouldn’t use Dom Perignon? If anybody has a right to glass of expensive champaigne, it’s a woman who just had a baby!
Not to put too fine a point on things, but thalidomide does have some legitimate uses. It’s approved for a particular form of leprosy, but IIRC, it has off-label uses in other diseases. Cite.
It was re-approved by the FDA in the United States, but users must agree to use at least two reliable forms of birth control; for example, women must use birth control pills AND an IUD, even if she is infertile, unless she’s had a hysterectomy or is at least two years postmenopausal. There is a specific protocol that doctors must follow to be eligible to even prescribe it.
The fact that the drug eventually was found to have some value in a few unusual cases and may prove useful in others depending on the outcome of research, doesn’t change the fact that it 1) was originally mass-marketed decades ago as a popular sedative in Europe, and 2) its sale in the U.S. was blocked by that the Food and Drug Administration, saving thousands of babies from horrific birth defects.
Thalidomide was also sold as an anti-nausea agent. Perhaps its greatest appeal was as a “safe” sedative and alternative to barbiturates, since you supposedly couldn’t fatally overdose on it.
“Another good example is the FDA’s recent ban on ephedra.”
The ephedra ban can be seen as a good example of various things, depending on one’s point of view. For some, it’s an example of the government trampling on an individual’s right to freely buy and take a drug which is really safe, if one is an intelligent user who would never ever abuse it and after all, those strokes and other serious complications just happen to other people who are not as smart.*
For others, it’s an example of the FDA moving too slowly to prevent unnecessary deaths and injuries at the hands of mass marketers, who sold a drug that has never been shown to be effective for long-term weight loss.
*This can be summarized as the “Wildest Bill Philosophy”.