FDA Notifies Public of Adverse Reactions Linked to Botox Use

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

In an early communication based on the FDA's ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.

The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.

The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.

The FDA is not advising health care professionals to discontinue prescribing these products.

The agency is currently reviewing safety data from clinical studies submitted by the drugs' manufacturers, as well as post-marketing adverse event reports and medical literature. After completing a review of the data, the FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions.

The notification is in keeping with the FDA's commitment to inform the public about its ongoing safety reviews of drugs. The early communication, which includes background information and advice for health care professionals, can be viewed at http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm

Most Popular Now

New strategy to treat Parkinson's disease

Northwestern Medicine scientists have used patient-derived neurons to develop and test a new strategy to treat Parkinson's disease by mitigating the effects of harmful ge...

AI could offer warnings about serious side effects…

The more medications a patient takes, the greater the likelihood that interactions between those drugs could trigger negative side effects, including long-term organ dama...

OPKO and Pfizer announce positive Phase 3 top-line…

OPKO Health Inc. (NASDAQ: OPK) and Pfizer Inc. (NYSE: PFE) announced that the global Phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with g...

Trastuzumab deruxtecan granted FDA Priority Review…

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics Lice...

The Bristol-Myers Squibb-Pfizer Alliance and Fitbi…

The Bristol-Myers Squibb-Pfizer Alliance and Fitbit announced at the TIME 100 Health Summit in New York that they are working together to help drive timely diagnosis of a...

Nplate® (romiplostim) now approved for earlier use…

Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) approved Amgen's Supplemental Biologics License Application (sBLA) for Nplate® (romiplostim...

Novartis announces that Jakavi® (ruxolitinib) meet…

Novartis today announced positive topline results from the Phase III REACH2 study evaluating Jakavi® (ruxolitinib) in patients with steroid-refractory acute graft-versus-...

Bayer launches LifeHub UK focused on artificial in…

Bayer launched LifeHub UK to accelerate and optimize disease detection and data-driven drug discovery by developing artificial-intelligence-enabled imaging solutions. The...

Amgen recommends rejection of 'mini-tender' offer …

Amgen (NASDAQ:AMGN) today announced that it has been notified of an unsolicited "mini-tender" offer dated Oct. 11, 2019, made by TRC Capital Corporation, a private Canadi...

First entirely digital clinical trial encourages p…

As little as a daily ping on your phone can boost physical activity, researchers from the Stanford University School of Medicine and their collaborators report in a new s...

Rare diseases: Over 300 million patients affected …

Rare diseases represent a global problem. Until now, the lack of data made it difficult to estimate their prevalence. Created and coordinated by Inserm, the Orphanet data...

Bed time is the best time to take blood pressure m…

People with high blood pressure who take all their anti-hypertensive medication in one go at bedtime have better controlled blood pressure and a significantly lower risk ...