Botox and Dysport has serious health risks, warns USFDA

Botox and Dysport can spread to other parts of body, says FDA and asks for black box warning labels.

Botox and Dysport used y cosmetic surgeons to cure winkles can spread to distant parts of the body and become dangerous.

Botulinum toxin carrying drugs like Botox and Dysport used to remove wrinkes can cause serious challenges by spreading to other parts of the body, warned US FDA.

The US FDA asked the drug makers to carry the strongest warning on the labels of Botox and Dysport.

Dysport, manufactured by Paris-based Ipsen, is the latest antiwrinkle drug containing the paralytic agent botulinum toxin approved by USFDA. The injectable drug Dysport is considered the first low-cost competitor for Allergan’s largest selling antiwrinkle drug Botox.

Botox generated worldwide sales of about $1.3 billion last year according to Allergan.

Botox and Dysport: Health risks, dangers

Soon after approving Dysport, the US FDA said such drugs derived from botulinum toxin must carry “black-box” warning labels explaining that the material has the potential to spread from the injection site to distant parts of the body. This could involve serious risks including difficulties, like problems with swallowing or breathing. (See one of our archived stories on Botox dangers from 2008)

Black-box warning requires a drug to carry a box with bold-face risk information on the label is the strongest safety actions the US FDA can take. Black boxes are usually given for medications known to have serious or life-threatening risks. Antidepressants, for example, carry black boxes warning of the increased danger of suicidal thoughts and actions.

Injectable botulinum toxins are purified forms of the bacterial poison that causes botulism, a paralyzing disease that can be fatal. Botulinum toxin-based drugs temporarily reduce or halt muscle activity.

The maker of Botox and Dysport must also send warning letters to doctors about their risks and to produce a medication guide to be given to patients at the time of injection.

Even though botulinum toxins are safe when administered for approved uses at approved doses, the serious problems had occurred mainly in patients who received overdoses of the drug for unapproved treatments, like limb spasticity in children with cerebral palsy.

The FDA had received reports of 180 serious health problems and 16 deaths connected to the injections, revealed Public Citizen, a public advocacy group, which had asked USFDA more substantial warnings, over a year back.

US FDA, in a response letter to Public Citizen, said the agency had identified even more reports of complications, including 225 reports of problems caused by the drug spreading from the injection site to distant parts of the body.

USFDA has approved Botox to treat crossed eyes, eyelid spasms, severe underarm sweating, and cervical dystonia, a neck problem that can cause severe pain and abnormal head position. Botox is also approved to treat frown lines, under the name Botox Cosmetic.

In 2000, USFDA approved a different type of botulinum toxin, Myobloc, to treat cervical dystonia. And most recently, USFDA approved Dysport for frown lines and cervical dystonia.

Medicis Pharmaceutical, a company in Scottsdale, Ariz., is planning to bring Dysport to US market within 60 days.

Allergan has been able to raise the drug’s price annually, as there was no serious competition. But Dysport, which in Europe has been priced lower than Botox, is expected to capture up to 20 percent of the market in US.

Allergan’s shares fell following the FDA alert.

Dysport had sales of $189 million, according to an earnings statement from Ipsen.