The US Food and Drug Administration (FDA) has sent Mission Pharmacal Company, the Texas-based pharmaceutical manufacturer of the trichomoniasis drug Tindamax (tinidazole), an Untitled Letter accusing the company of making unfounded and improper claims.
Trichomoniasis-sometimes shortened to just "Trich"-is a sexually transmitted disease which disproportionately affects women, who most often experience the disease's symptoms of itching or burning.
Mission Pharmacal's oral tablet drug Tindamax is FDA-approved to treat trichomoniasis. Because it is an antibiotic, FDA's indication for Tindamax cautions that it should only be given to a patient after the infection is confirmed to be trichomoniasis, and not caused by another organism.
"To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tindamax and other antibacterial drugs, Tindamax should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria," the agency wrote. "When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy."
The drug also contains a Boxed Warning, sometimes referred to as a Black Box Warning, about the drug's potential carcinogenic effects and hypersensitive reactions in some patients. Several other warnings are also listed on the Package Insert (PI).
Untitled Letter: Safety Omissions
The problem, FDA wrote in its Untitled Letter, is that a sales sheet issued by Mission Pharmacal failed to convey "any of the contraindications for use of Tindamax and the warnings and precautions regarding neurological adverse reactions and blood dyscrasias associated with the drug." In addition, the company's promotional material failed to disclose some of the more "common" adverse reactions associated with use of the drug.
As with numerous other companies that have found themselves on the receiving end of Untitled Letters, the company had reportedly tried to use a statement to absolve itself from needing to include the full list of warnings: "Please see attached full prescribing information, including Boxed Warning."
But as with the other companies, FDA said that statement fell short of its interpretation of regulatory requirements. "This [statement] does not mitigate the omission of the aforementioned risk information," the agency wrote. "By omitting serious and common risks associated with the drug, the sales sheet misleadingly suggests that Tindamax is safer than has been demonstrated."
Other Problems: Claims and Patients
The company was also accused by FDA of broadening the patient population for Tindamax beyond that which had been approved by FDA. The company's material included one notable statement that the drug "is the one and only treatment for bacterial vaginosis that gives your patients [the following benefits]." However, the statement fails to include the caveat that it is only intended for use in non-pregnant women, FDA said.
"Therefore, the sales sheet misleadingly broadens the patient population or condition of Tindamax by suggesting that it is approved for the treatment of BV in all women, including those that may be pregnant, when this is not supported by substantial evidence or substantial clinical experience."
FDA said this was "especially concerning" given the inclusion pictures of women in the sales sheet who appeared to be of "child-bearing age."
The sales sheet also allegedly included several unsubstantiated claims of efficacy, none of which were backed by what FDA considered to be substantial evidence.
The Untitled Letter goes on to request that Mission Pharmacal withdraw the sales sheet, cease its dissemination and respond to FDA's Office of Prescription Drug Promotion by 6 February 2014 explaining whether it intends to comply.
FDA Untitled Letter to Mission Pharmacal