RECENT FDA ALERTS
Counterfeit Viagra and warnings concerning domperidone.
The Food and Drug Administration (FDA) has reported that a Viagra (silde-nafil) counterfeit, the chemical composition of which is not yet known, has been sold in two California pharmacies, bearing the lot number of 3023803 and the expiration date "1 Mar 06," both of which, unfortunately, appear also on the packaging of the genuine product. While the size, shape, color, and imprinting of the counterfeit package and the pills are quite similar, there are some differences in the counterfeit, including a thicker font on the packaging label, more pronounced edges on the tablets, a film coating that is a lighter blue than that found on genuine tablets, and blue particles that can be seen throughout the core of the tablet when it is cut.
Patients in possession of Viagra bearing the numbers stated above should inspect it for any evidence of counterfeiting as outlined on the company's Web site (http://www.pfizer.com/subsites/counterfeit_importation/mn_pharmacist_viagra.html), or they may return it to the pharmacist for comparison with other Viagra products. If the drug is found to be counterfeit, the local office of the FDA should be contacted.
Another FDA warning concerns the unapproved drug domperidone. Recently, a few pharmacies were found to be compounding products containing domperidone and selling the mixture to postpartum women as an agent for increasing breast milk production; the product has also been available from overseas sources. Domperidone is approved in several countries outside the United States for the treatment of gastric disorders, but it is not approved in the United States for any use.
One possible effect of domperidone is the increase in the secretion of prolactin, the hormone necessary for breast milk production, although it has not been approved in any country for that purpose. In fact, in countries in which oral domperidone is sold, the label bears a warning against its use by women who are breastfeeding, because the drug is known to enter breast milk. Its effect on infants is unknown. In some countries, IV domperidone had been available but was taken off the market because of reports of cardiac arrhythmias, cardiac arrest, and sudden death in patients receiving the drug. Nurses should apprise lactating women of the nonpharmacologic strategies that can promote the production of breast milk before they seek a pharmacologic one; if the latter is necessary, they should advise them to use only drugs that have been FDA approved for that purpose.
U.S. Food and Drug Administration. FDA is alerting the public to counterfeit Viagra found in two California pharmacies. 2004. http://www.fda.gov/bbs/topics/news/2004/new01083.html.U.S. Food and Drug Administration. FDA warns against women using unapproved drug, domperidone, to increase milk production. 2004. http://www.fda.gov/bbs/topics/answers/2004/ans01292.html.
SALE OF UNAPPROVED DRUG ENDS IN IMPRISONMENT
Laetrile is not effective in treating cancer.
Jason Vale, found guilty of criminal contempt last year for selling amygdalin (known also as Laetrile, vitamin B17, or ground apricot pits), recently was sentenced in the U.S. District Court of the Eastern District of New York to 63 months in prison and three years of supervised release. Vale had advertised heavily on the Internet that his product, "Laetrile," prevented and cured cancer.
Years earlier, in 1998 American Online (AOL) had sued Vale's company, Christian Brothers Contracting Corporation, for sending its subscribers more than 20 million unsolicited "spam" e-mail messages advertising Laetrile, resulting in a judgment against the defendant amounting to $631,585 in damages awarded to the plaintiff. And it was because of those unsolicited e-mails that the Food and Drug Administration (FDA) received complaints about Vale and his company, prompting the government's charges against him for selling a substance that had not been approved as a chemotherapy drug.
Testimony introduced at Vale's most recent trial revealed that the product has never been shown to be effective in the treatment of any cancer and is toxic because it releases cyanide gas within the human body. Vale, himself a survivor of cancer, continued to sell the product even after the court issued an injunction against the activity in April 2000, maintaining that the product was helpful in the treatment of the disease. The FDA views the verdict and prison sentence as the products of a successful legal mechanism by which the public may be protected from the charlatanism of contemporary snake oil salesmen.
U.S. Food and Drug Administration. Lengthy jail sentence for vendor of Laetrile-a quack medication to treat cancer patients. 2004. http://www.fda.gov/bbs/topics/news/2004/new01080.html.Lewis C. Online Laetrile vendor ordered to shut down. 2004. http://www.quackwatch.org/02consumerprotection/fdaactions/vale.html.