F.D.A. Issues Black Box Warning for Botox and Similar Products
On April 30th 2009, the F.D.A. issued its strongest
warning for Botox and other similar drugs. This latest development comes as a
direct response to a petition placed 15 months ago by a public advocacy group
called Public Citizen. At the time, the advocacy group claimed that the FDA had
received several hundred reports of serious health related problems and up to 16
deaths directly connected with Botox. The increased concern with these types of
drugs comes from reports that the effects of the botulinum toxin may spread from
the area of injection to other areas of the body, causing symptoms similar to
botulism such as, unexpected loss of strength, muscle weakness, hoarseness,
trouble breathing, swallowing and drooping of the eyelids.
Having a Black Box Warning attached, means that a specific
drug is known to have serious or life threatening risks. This is the most
significant of safety action labels issued by the F.D.A. When this type of
warning is associated with a drug, in this case Botox, Botox Cosmetic,
Myobloc and the newly approved Dysport, it requires a warning on all
boxes containing the product and a Risk Evaluation and Mitigation Strategy (REMS).
Also important to note is that makers of the medications will be required to
explicitly notify physicians of the risks by written documentation. Patients
receiving the treatments will be given a medication guide listing possible
negative effects that can be visible after a few hours or after a few weeks of
receiving the treatment.
Over the past two decades, the use of injectable purified
botulinum toxins has been approved by the F.D.A. to treat strabismus (crossed
eyes), eyelid spasms, severe underarm sweating and cervical dystonia, a
condition that can cause severe pain and abnormal head positioning. The frequent
use of botulism toxin products to treat muscle spasticity is not F.D.A.
approved. A considerable amount of the severe side effects of botulinum toxins
has been linked to treatment for muscle spasticity of the limbs. Botox and other
similar drugs are often used to alleviate this condition in children with
cerebral palsy. Symptoms consistent with the spread of the toxin from the
original site of injection have been reported in doses similar or lower than
doses used to treat cervical dystonia. New guidelines for approved usage and
dosage are expected from manufacturers within the next 30 days.
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