FDA issues warnings to makers of misbranded STD drugs
ROCKVILLE, Md. The Food and Drug Administration on Thursday issued six warning letters to five U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet indicated for the prevention and treatment of sexually transmitted diseases.
“The products pose a serious health threat to unsuspecting consumers who don’t know that these products are not FDA approved and have not been proven safe or effective,” stated Janet Woodcock, deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research. “STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs.”
Some of these products, directed at U.S. consumers, falsely claim to have “FDA Approval” and some claim to be “more effective” than conventional medicine, the regulatory agency stated. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus.
Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products.
The products claim to prevent or treat a variety of STDs, including herpes, chlamydia, human papilloma virus, cervical dysplasia and HIV/AIDS.
Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products, the agency stated. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.
Possible new FDA diabetes drug guidelines could delay approvals
SAN DIEGO A draft of new guidelines proposed by the Food and Drug Administration for developing drugs to treat diabetes may lead to a delay of the approval for a new long-acting diabetes drug from Amylin Pharmaceuticals, according to the Associated Press.
The FDA suggested increased testing for macrovascular complications, or diseases affecting large veins, particularly for drugs that are linked to problems with those veins.
That could delay approval of Amylin’s diabetes drug candidate exenatide LAR, a weekly version of its Byetta treatment and a Type 2 injectable diabetes drug, which it co-manufactures with Eli Lilly, Lazard Capital Markets analyst Matthew Osborne wrote in a note to clients Monday. He said the guidelines could make clinical trials of diabetes drugs more expensive and difficult.
FDA approves Ranbaxy’s generic version of Risperdal
NEW DELHI, India Ranbaxy Laboratories has received approval from the Food and Drug Administration for a generic version of Janssen Pharmaceuticals’ schizophrenia drug, Risperdal, according to published reports.
Risperdal is also used to treat such behavior problems as aggression and self-injury, as well as sudden mood changes in teenagers and autism in children. The company has received approval to launch the generic risperidone in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths.
Risperdal had sales of $924 million in 2007.