Breaking News: Vitabiv Antibiotic Associated With Birth Defects

I have just received a breaking news update from Astellas regarding risks of using their antibiotic Vitabiv in pregnant women.   This is one of the most strongly worded warnings on use of an antibiotic in pregnancy I have seen recently.  I received a generic warning update last week from the American College of Ob Gyn that “some warning regarding a drug in pregnancy” was coming today.

As the letter reads:

The purpose of this letter is to inform you of important safety information for VIBATIVâ„¢
(telavancin) for injection, a once-daily intravenous antibiotic indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following organisms.
An informational program for healthcare providers has been established to help minimize the risks associated with the use of VIBATIV; the most important relates to the use of the product during pregnancy. Animal data indicate that use of VIBATIV during pregnancy is associated with reduced fetal weights and increased rates of digit and limb malformations in offspring, although these malformations were infrequent.
Women of child bearing potential should have a serum pregnancy test prior to administration
of VIBATIV. Patients should be counseled on the risks and benefits of VIBATIV. Consideration
should be given to using an alternative course of therapy, if a positive test result is obtained.
The use of VIBATIV should be avoided during pregnancy unless the potential benefit to the
patient outweighs the risk to the fetus. Women of childbearing potential (those who have not
had: complete absence of menses for at least 24 months or medically confirmed menopause,
medically confirmed primary ovarian failure, a history of hysterectomy, bilateral oophorectomy, or tubal ligation) should use effective contraception during VIBATIV therapy. Patients should be
instructed to notify their prescribing physician/healthcare provider if they become pregnant while taking VIBATIV. A pregnancy registry has been established to collect information about the effects of VIBATIV use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the pregnancy registry by calling 1-888-658-4228.

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