DDMAC UNTITLED LETTERS: 7157W.

Berlex Labs, Montville, NJ, Dec. 9, 1998 (DDMAC). The agency said a fact sheet for Levlite (levonorgestrel and ethinyl estradiol) was misleading because it implied the superiority of this dosage in providing health benefits, made unsupported superiority claims and suggested that it was the only oral contraceptive with the lowest hormonal dose. A file card and visual aid were cited for a similar low dosage claim. Berlex was asked to stop using these and any similar materials and submit a statement agreeing to comply, along with a list of items to be discontinued. ID #7357

Missing thalidomide risk information yields untitled letter to Celgene

7158W

Leaving out risk information in press releases on Thalomid (thalidomide) elicited an untitled letter to Celgene, Warren, NJ, Nov. 9, 1998. The drug, which became infamous for causing severe birth defects, as well

as fetal and infant mortality, carries three boxed warnings and is approved for marketing only under a specially restricted program.

According to the letter, one press release omitted any reference to risk. Two others mentioned birth defects and other side effects, but not in enough detail to satisfy FDA=s concerns.

ADDMAC considers these limited disclosures inadequate in conveying the extent and severity of the many risks associated with the use of Thalomid,@ the letter stated.

In addition, the firm had not submitted the items for review. DDMAC told Celgene to cease disseminating these and all similar materials and submit a statement of its commitment to comply. ID #7269