Terra Sigillata

Lack of health insurance, or selective lack of drug coverage by some insurance companies, has created a large, Internet-based market for cheaper prescription drugs. There have been many warnings about the risks of buying one’s drugs on-line from such sources from the FDA and the pharmaceutical industry but those warnings, especially from drug makers, are often viewed as self-serving.

This week, however, saw two examples of Internet drug-buying gone wrong that highlight the risks of purchasing medicines on-line.

On Friday, the US FDA released a warning to consumers that some who purchased specific depression and anxiety drugs (Ambien, Xanax, Lexapro, and Ativan) from Internet-based marketers were instead given the much stronger and inappropriate anti-psychotic drug, haloperidol (Haldol). Haldol is normally used to treat schizophrenia and can cause muscle spasms and stiffness as well as either agitation or sedation.

FDA laboratory analysis of the misrepresented tablets is ongoing, but preliminary analysis indicates they contain haloperidol, the active ingredient in a prescription drug used primarily to treat schizophrenia. FDA learned about these mislabeled and potentially dangerous products after their recipients complained to a U.S. pharmaceutical manufacturer.

The origin of these tablets is unknown but the packages were postmarked in Greece. Photographs of the tablets in question and the shipping packages can be seen at http://www.fda.gov/bbs/topics/news/photos/haloperidol.html. If the tablets received from an Internet seller resemble those in the photos and haloperidol was not specifically ordered, do not take these tablets. Instead, consumers should notify their health care provider and report the suspected products to FDA by submitting a product quality problem report at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

As of today, FDA has not named the specific Internet operations that supplied the misrepresented drugs, they state, “identifying the vendors is difficult because of the deceptive practices of many commercial outlets on the Internet. FDA is investigating this illicit trade and plans to release appropriate information when it is available.”

The other episode reported this week is a domestic case that follows from indictments made last September that involves a drug distributor in Georgia:

Prosecutors said Hi-Tech Pharmaceuticals of Norcross marketed the drugs as Canadian through unsolicited e-mails, but the pills actually were made in Belize. Investigators said many of the drugs had little or no medicinal value, and that those behind the scam netted more than $19 million. The drugs included anabolic steroids and generic versions of drugs such as Ambien, Valium, Viagra, Lipitor and Vioxx.

So, what’s a consumer to do to protect themselves? The FDA maintains a general consumer site on precautions for buying medicines and medical products online. FDA has also published a list of warning letters sent to on-line sellers who appear to be in violation of laws regulating the sale of prescription drug products (although many are regarding dietary supplements.).

If you’re willing to spend a few bucks, an independent consumer rating subscription service called PharmacyChecker.com is a reputable resource for buying drugs from Canada or other online pharmacies. Established by the founder of the dietary supplement rating service, ConsumerLab.com, PharmacyChecker provides detailed information on licensure and 40 other characteristics they have verified regarding specific site (ficitious sample evaluation of TrustWorthyPharmacy.com and DubiousPharmacy.com are illustrated here). A 90-day trial subscription is $15 but it seems that the 12-month membership for $19.95 is the better deal. (Disclosure: I have no financial relationship with either ConsumerLab or PharmacyChecker, but have recommended and subscribed to ConsumerLab for several years.)

So, be careful out there with buying your medicines on-line. Sometimes you actually do get what you pay for.

Comments

  1. #1 David
    February 19, 2007

    “So, what’s a consumer to do to protect themselves?”

    Golly, I don’t know, maybe buy pills at a local pharmacy down the street? Like my Dad used to say, you get what you pay for.

  2. #2 Joseph j7uy5
    February 19, 2007

    Living in southeast Michigan, I will sometimes tell patients that the shouldn’t buy from a Canadian Internet pharmacy, unless they first drive across the border to verify for themselves that the Internet site truly is operated by a bricks-and-mortar Canadian pharmacy. But it is not easy to do if you don’t live near the border.

    Most often I recommend that people use local pharmacies, preferably always using the same pharmacy for all prescriptions.

  3. #3 Ijeoma Eleazu
    February 20, 2007

    When I worked in a clinic setting I too would recommend consumerlab.com to my patients.

    A few times some elderly patients told me about these charter buses that they would take up to Canada specifically for elderly folks to buy their medications. They would make a mini vacation out of the trip and make the trip about 3 times a year. Not that I’m advocating this, just pointing out that there are some organized groups of senior citizens out there doing their due diligence.

  4. #4 Dan
    March 4, 2007

    I know this is a few days after the fact, but from my reading of the FDA notice – and the photos – it appears that people didn’t get counterfeit drugs at all: instead they got the wrong drugs, which clearly are – again, referring to the FDA pictures – Haldol.

    Not that this is better, but the fraud is not counterfeiting – it is sending something that isn’t the same as what the consumer asked for. Or is there something I’m missing?

  5. #5 Abel Pharmboy
    March 4, 2007

    Dan, indeed, this case was not counterfeiting (I used the word “misrepresentation” instead.) But if you were a first-time patient, you wouldn’t have known the difference and have taken a much more powerful drug that what was prescribed – that is the more concerning issue.