An independent advisory panel has raised concerns to the Food and Drug Administration that skin fillers may be dangerous.
Last month, the panel urged the FDA to revise the labeling on skin fillers such as Irvine-based Allergan Inc.’s Juv & #233;derm and Scottsdale-based Medicis Pharmaceutical Corp.’s Restylane and Perlane to include the possibility of bumps under the skin, blotches and scars.
News of the reports sent Allergan’s shares down as much as 10%.
The panel’s recommendation came after regulators received reports of serious problems in people treated with the injections. The FDA said those problems included facial palsy, disfigurement and rare, but life-threatening, events such as severe allergic reactions and anaphylactic shock.
Revising labeling is “almost a no-brainer. The current label is not adequate,” Michael Bigby, a Harvard Medical School dermatologist and FDA adviser, said in published reports.
Skin fillers, which have a gel-like texture, are injected into patients’ lower faces to smooth out wrinkles. The fillers have become popular in recent years as less-expensive, less-invasive alternatives to facelifts.
FDA scientists have data on more than 800 patients who have suffered serious reactions to skin fillers since 2003, which it is giving to the advisory board for further review.
No deaths were reported, but the complications were troublesome enough that 638 of those patients had to get follow-up medical treatment, the FDA said.
Makers of skin fillers and doctors maintain that the products are safe. Allergan spokeswoman Caroline Van Hove told Reuters last month that no serious problems were seen in clinical trials of Juv & #233;derm, and that the most common problem found since its approval was swelling in less than 1% of patients.
“Juv & #233;derm has a highly favorable safety profile based on long-term use and volume,” Van Hove said.
Allergan got Juv & #233;derm through its 2006 buy of Santa Barbara’s Inamed Corp.
FDA officials have expressed concerns that skin fillers are being used for purposes that they were never tested and approved for, such as plumping the lips, which are extremely sensitive.
In addition, regulators also said that there was a lack of clinical evidence on how darker-skinned patients fare after getting skin fillers. More African-American, Hispanic and Asian patients are having cosmetic procedures, and officials are concerned they may be more susceptible to blotching and other complications.
Boards Approves BPO Deal
Directors of Anaheim Hills-based BPO Management Services Inc. and Healthaxis Inc. of Irving, Texas, recently signed off on BPO’s plans to buy Healthaxis, according to a Securities and Exchange Commission filing.
The deal’s worth about $15 million, according to the filing.
BPO is a business outsourcing company that trades on the Bulletin Board exchange. It announced plans to buy Healthaxis, a technology company that works with health benefits administrators and claims processors, in September.
A date for Healthaxis shareholders to vote on the deal hasn’t yet been announced.
BPO intends to turn Healthaxis into its healthcare division, which will cater to small and midsize businesses looking to outsource healthcare administration.
When the deal is complete, BPO shareholders will have a 75% interest in the new company, with Healthaxis shareholders retaining 25%.
The combined company will keep the BPO name and be based in Anaheim Hills.
Figures from the statement show that the combined company isn’t profitable,it lost $3.3 million on revenue of $23.3 million in the six months ended June 30.
Patrick Dolan, BPO’s chief executive, will lead the combined company. John Carradine, Healthaxis’ chief executive, will become the healthcare division’s managing director.
In the meantime, Healthaxis has rejected unsolicited buyout offers from Ebix Inc., an Atlanta-based software company it competes with.
After the latest offer, Healthaxis chided Ebix and Robin Raina, its chief executive, in a letter. Healthaxis rejected Ebix’s proposal and said it wanted to address “misrepresentations that you have made in connection with the various and constantly changing versions of your proposals.”
Healthaxis also said in the letter that Ebix didn’t understand the requirements of making a competing offer, and that Ebix and Raina “are spending considerable effort” on a public relations campaign that Healthaxis said “mischaracterized and misrepresented the terms, conditions and benefits” of the BPO deal.
Bits and Pieces:
Lathian Health, a drug marketing services company in San Juan Capistrano, said it introduced trackable marketing programs that offer doctors the flexibility to request and receive information about drugs at their convenience. Lathian said the service, among other features, enables doctors to interact with drug company promotional content outside office hours without immediate Internet access Patient Care Technology Systems, a Mission Viejo subsidiary of Florida’s Consulier Engineering Inc., said that its emergency room workflow software is being implemented with ultrasound location technology being produced by Sonitor Technologies Inc. of Largo, Fla.
