FDA warns consumers about Chinese ED supplements
ROCKVILLE, Md. The Food and Drug Administration on Friday advised consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai and Shangai Regular, also marketed as Shangai Chaojimengnan, products.
These products, which originate in China, are being marketed for the treatment of erectile dysfunction and for sexual enhancement, the agency said. Although labeled as dietary supplements, the products do not quality as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction. The products are thus drugs that are illegal because they lack FDA approval.
The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.
“Products like these put consumers at considerable risk because they contain undeclared active ingredients in FDA approved drugs that require a prescription to obtain,” stated Janet Woodcock, FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. “An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions.’’
FDA performed chemical testing of the products that revealed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction. Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.
FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they feel are related to the use of these products. Consumers and health care professionals can report adverse events to FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. FDA recommends that consumers should talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.
The products are packaged and distributed by Shangai Distributor of Coamo, Puerto Rico.
Generic drug makers announce FDA approval for Zyrtec
ALLEGAN, Mich. Like Claritin before it, Zyrtec will be faced with private-label competition not too long after reaching store shelves. Mylan, Perrigo and Caraco Pharmaceutical on Friday separately announced that they have received final approval from the Food and Drug Administration for their abbreviated new drug application, for over-the-counter cetirizine, 5 mg and 10 mg.
The products will be comparable to McNeil Consumer Healthcare’s Zyrtec, indicated for allergy and hives relief, which is expected to reach store shelves Jan. 24.
According to Wolters Kluwer data provided by Perrigo, brand sales for the original prescription strength version of the product for the 12 months ending October 2007 were approximately $1.4 billion.
Brand sales for comparable Claritin and Claritin D were a combined $285.9 million for the 52 weeks ending Oct. 7 across food, drug and mass (excluding Wal-Mart) channels, according to Information Resources, Inc.
Bayer recalls glucose meter test strips
TARRYTOWN, N.Y. Bayer Diabetes Care last week initiated a voluntary market recall of test strips used exclusively with the Contour TS Blood Glucose Meter.
In the course of its routine quality control monitoring processes the Bayer identified a manufacturing issue with test strips from specific lots that could result in blood glucose readings with a positive bias that is outside of product specifications. Test results may demonstrate results between 5 percent and 17 percent higher, the company reported.
This issue is unrelated to the Contour TS meter itself and pertains only to certain test strips used with the meter, Bayer clarified. Additionally, this issue has no impact on the performance of strips used with other Bayer meters including Ascensia Contour and Ascensia Breeze2 systems, the company said.
Healthcare providers, retailers, patients and other customers who use Contour TS are advised to check the lot number on the bottles of Contour TS strips and to contact Bayer Diabetes Care for information regarding return and replacement of strips. The affected lots begin with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters (for example WK7ED3E52C). Only bottles of test strips with the characters 7D, 7E, 7F, or 7G in the third and fourth position in the sequence are affected.
In the U.S., the affected product code numbers include: 1802, 1802N, 1820, 1823, 1825 and 9578.