"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
- Patient Information:
Details with Side Effects
Lack of Interchangeabilty between Botulinum Toxin Products
The potency Units of MYOBLOC (botulinum toxin type b) are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of MYOBLOC (botulinum toxin type b) cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method (see DESCRIPTION).
Spread of Toxin Effect
Postmarketing safety data from MYOBLOC (botulinum toxin type b) and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death related to spread of toxin effects. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, and particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia.
Dysphagia and Breathing Difficulties in Treatment of Cervical Dystonia
Treatment with MYOBLOC (botulinum toxin type b) and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved.
Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin (see ADVERSE REACTIONS, CLINICAL PHARMACOLOGY).
Pre-Existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC (see ADVERSE REACTIONS).
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
INFORMATION FOR PATIENTS
The physician should provide a copy of the FDA-Approved Patient Medication Guide and review the contents with the patient. Patients should be advised to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking or breathing), or if any existing symptom worsens.
Patients should be counseled that if loss of strength, muscle weakness, or impaired vision occur, they should avoid driving a car or engaging in other potentially hazardous activities.
Only 9 subjects without a prior history of tolerating injections of type A botulinum toxin have been studied. Treatment of botulinum toxin na´ve patients should be initiated at lower doses of MYOBLOC (see ADVERSE REACTIONS: Overview).
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term carcinogenicity studies in animals have been performed.
PREGNANCY CATEGORY C. Animal reproduction studies have not been conducted with MYOBLOC (botulinum toxin type b) . It is also not known whether MYOBLOC (botulinum toxin type b) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MYOBLOC (botulinum toxin type b) should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when MYOBLOC (botulinum toxin type b) is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
In the controlled studies summarized in Clinical Studies, for MYOBLOC (botulinum toxin type b) treated patients, 152 (74.5%) were under the age of 65, and 52 (25.5%) were aged 65 or greater. For these age groups, the most frequent reported adverse events occurred at similar rates in both age groups. Efficacy results did not suggest any large differences between these age groups.
Very few patients aged 75 or greater were enrolled, therefore no conclusions regarding the safety and efficacy of MYOBLOC (botulinum toxin type b) within this age group can be determined.
Last reviewed on RxList: 8/14/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Myobloc Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.