Mobic is used to relieve the symptoms of arthritis, primary dysmenorrhea, fever; and as an analgesic, especially where there is an inflammatory component.
Where to buy zicam cold sore gel swabs.
The FDA has said that some individuals and doctors have developed "profound medical effects" from the drug during pregnancy.
To prevent a possible future problem, the FDA has asked Johnson & Johnson, the maker of Zicam, to submit a new clinical trial to study the use of drug in pregnancy. The new trial must be approved by the FDA and conducted in a large number of women.
"We take these findings very seriously. As we plan for the safety and efficacy of Zicam in pregnant women, we are committed to taking actions ensure that we are providing the most accurate and current information to our patients and the health-care professionals treating them," said Thomas Schanker, a Johnson & spokesman.
According to the FDA's reports, women in second trimester of pregnancy are typically at risk, as long they already have an infection, like a cold sore, but still have vaginal intercourse. the reports also say that some women are allergic to the drug and that people use birth control pills and other products that inhibit the Zicam process, so drug cannot be used alone, either.
As a warning to other companies looking apply Zicam's active ingredient, which is zinc sulfate, to the contraceptive market, FDA has issued a new warning that says: "Use of Zicam may be associated with a risk of pregnancy. FDA intends to act expeditiously assess this risk of pregnancy."
Johnson & has previously said that its product is the first to contain active ingredient of a Zicam topical for contraception, because oral preparations were deemed less effective because they also inhibit the drug's action.
The new report comes as FDA reviews proposals under way to approve new drugs for use in the United States.
The agency is taking a closer look at the safety of an estrogen-based drug meant to prevent pregnancy. The FDA is taking public comments on drug approval requests from Eli Lilly & Co and Bayer AG on the drug, called Yaz, and is weighing whether the drug should be approved for sale in the United States.
The FDA has said that drug is approved in other countries, but the United Kingdom is reviewing its use in the United States. Another drug, called Mirena, is also being evaluated to see if it might be able to prevent pregnancy in some women.
Both companies are also considering whether to add the contraceptive ingredient other drugs, like its erectile dysfunction drug Viagra.
Zicam is made by Janssen Pharmaceuticals Inc. and approved by U.S. regulators in 2000 for arthritis and rheumatoid arthritis. Two years later, the drug was approved for prevention of pregnancy. The drug is taken intravenously and should be for a period of time after the menstrual period to break down the drug.
The FDA is reviewing studies to assess whether Zicam prevents the implantation of a fertilized egg, such as egg taken after unprotected intercourse.
Two years ago, the FDA said it had concluded that the drug is safe and effective for that purpose.
The FDA has set guidelines that specify products labeled only to prevent pregnancy need not contain the active ingredient of Zicam. But the FDA has been reviewing data and studies to determine if there are medical benefits for women who use Zicam as part of a multi-faceted medical regimen, rather than as a single drug used once during their monthly cycles.