FDA demands new warnings on dermal fillers from Actavis, Galderma

Dermal fillers are meant to minimize the appearance of wrinkles and give the face a smoother, fuller appearance. But they may also have some nasty consequences if injected incorrectly, and so the FDA is calling for some updated labeling on the products.

The agency has asked the drugs' makers--such as Actavis ($ACT) and Nestlé unit Galderma--to include the possibility for serious injury if the products are unintentionally injected into blood vessels in the face, Reuters reports. The fillers could block the vessels and restrict blood supply to tissues, potentially causing problems such as vision impairment, blindness and stroke.

While the fillers' labels already include some information about the blood-vessel risk, regulators think the add-on will better inform healthcare providers and patients, the news service notes.

The new concerns will hit Galderma's Restylane, Suneva's Artefill and Actavis' Juvéderm, to name a few. The Dublin drugmaker inherited Juvéderm when it snapped up Allergan in the largest pharma deal of 2014, a move the one-time generics specialist has said would help it double its branded drug sales this year.

But Allergan also brought along a host of other skin products that will help soften any blow from the label update--including blockbuster Botox, which boasts several indications--and has more in the works. The product helped Actavis achieve its branded ambitions in Q1, with those sales hitting $1.7 billion for the period--a hefty increase from the $572 million it posted the year prior.

As for Galderma, it's under new ownership, too--partially. Nestlé last year shelled out to take sole possession of the venture, which it previously shared with L'Oreal, folding the company into a new division called Nestlé Skin Health. But unlike Allergan, Galderma's growth was slipping at the time it got picked up, with sales expansion slowing to 3.9% from more than 10% in prior years. To reignite that growth, the Swiss company has been looking to its global marketing muscle--a strategy it's using to help it diversify beyond the slumping packaged food business.

- read the FDA's letter (PDF)
- get more from Reuters

Special Reports: Pharma's top 10 M&A deals of 2014 - Actavis/Allergan | Pharma's top 10 M&A deals of H1 2014 - Nestlé/Galderma

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