An Abbott Laboratories (ABT) promotional DVD in which basketball star Earvin "Magic" Johnson touts HIV drug Kaletra was misleading because it overstated the drug's efficacy and minimized its risks, the U.S. drug regulator said Wednesday.

The Food and Drug Administration sent Abbott a warning letter July 14 saying the DVD violated federal regulations that prohibit misbranding a drug. The agency asked the Abbott Park, Ill., company to stop disseminating the DVD, and to outline its plans to distribute truthful promotional materials in the future.

"These violations are concerning from a public health perspective because they suggest that Kaletra is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstances other than those for which the drug has been shown to be safe and effective," the FDA said in its letter to Abbott Chief Executive Miles White.

Abbott spokeswoman Michelle Johnson said "the material that is referenced in the FDA letter is no longer in use and we're working with the agency to address their comments as well as the guidance they provided within the letter."

The DVD was given to health-care professionals and AIDS advocacy groups.

According to the FDA, the promotional DVD features an interview with Magic Johnson, a star of the National Basketball Association in the 1980s who was diagnosed HIV-positive in 1991.

In the interview, Johnson discusses the benefits he has experienced from Kaletra, and briefly acknowledges fatigue as a side effect. The FDA said the discussion and interview portion of the DVD omits any mention of serious risks, and instead relegates this information until the end of the DVD, "where it is unlikely to draw the viewer's attention." The drug's serious risks include pancreatitis, diabetes and other conditions, the FDA said.

Attempts to reach Johnson through his business, Magic Johnson Enterprises, weren't immediately successful.

The FDA also said the DVD contained an outdated version of the approved product labeling for Kaletra. The outdated version didn't include important safety information regarding the use of Kaletra in children.

Abbott submitted the video for FDA review in November 2008, and the DVD's content was available on the Kaletra product Web site as recently as July 10, the FDA said.

It's not the first time Abbott has gotten into trouble with its Kaletra marketing. FDA sent Abbott a letter in 2004 expressing concerns about a print ad and poster the FDA considered to be misleading. "We are concerned that you are continuing to promote your product in a similarly violative manner," the FDA wrote this month.

Abbott recorded Kaletra sales of $635 million for the first six months of 2009, down 10% from a year earlier.

Abbott shares fell 95 cents, or 2%, to $44.05 Wednesday.

-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com