Kaiser Foundation Hospitals, Livermore, CA, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

FDA determined that the firm was marketing Belladonna Alka/Ergotamine and PB (Bellamine S) tablets, a drug product containing ergotamine tartrate.

According to FDA, the drugs are utilized to treat vascular headaches and previously was marketed under an NDA approved for safety only prior to 1962. The drug product now requires an NDA to continue be sold legally.

Further, the drugs are available for prescription only and must have labels with adequate directions for safe use, the letter noted.

In addition, the agency stated that the label must bear a warning regarding possible risks of life-threatening ischemia, including fatalities and cases of gangrene, which have resulted from concomitant use.

Also, though some ergotamine products were found to be effective for certain indications, this does not necessarily mean that Bellamine S Tablets as currently formulated, manufactured, and labeled, is effective or safe. Lab; NDA; Doc. 14092W

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