Tuesday, January 22, 2013

What Is Botox, (Botulinum Toxin Type A)?


Botox (botulinum toxin type A) is a synthetic form of toxin or the biological toxin produced by the bacterium Clostridium botulinum. It's the same toxin that causes a life-threatening type of food poisoning called botulism. If one consumes the toxin, orally, in sufficiant ammounts, the toxin blocks nerve signals from a persons brin to the muscles, paralyzing the person. Immediate medical care must be sought if botulism poisoning is suspected.

Alan Scott, MD, a San Francisco ophthalmologist, and Edward Schantz were the first to work on a standardized botulinum toxin preparation for therapeutic purposes. The same toxin, in very small amounts are used by doctors to treat health and cosmetic problems, including;

Temporary removal of facial wrinkles
Severe underarm sweating
Cervical dystonia - a neurological disorder that causes severe neck and shoulder muscle contractions
Blepharospasm - uncontrollable blinking
Strabismus - misaligned eyes or lazy eyes
Overactive Bladder Treatment

There are more than 119 clinical research involved in treating various other conditions with Botox.
Botox injections work by weakening or paralyzing certain muscles or by blocking certain nerves. The effects last about three to four months. Side effects can include pain at the injection site, flu-like symptoms, headache and upset stomach. Injections in the face may also cause temporary drooping eyelids. You should not use Botox if you are pregnant or breast feeding.

According to FDA, there are three botulinum toxin product in this class,
OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic),
AbobotulinumtoxinA (marketed as Dysport)
and
RimabotulinumtoxinB (marketed as Myobloc)

Information for Healthcare Professionals by FDA

For more Journal Articles.


MYOBLOC® is a registered trademark of Solstice Neurosciences, Inc.
Botox® marks owned by Allergan, Inc.
Dysport™ is manufactured by Ipsen Biopharm Ltd.

Wednesday, June 6, 2012

Counterfeit Of Teva’s Adderall In Circulation, FDA Warns.

FDA is warning public of a counterfeit version of Teva's Adderall (an Approved drug), used to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy. The Adderall   is classified as a controlled substance, a class of drugs for which special controls are required for distribution.
FDA found wrong active ingredients, completely different from the authentic Adderall..Counterfeiters are using the current shortage of the Adderall to distribute counterfeit drugs over the internet.
If your Adderall matches the following description, please stop using them and consult your physician, as the counterfeit versions of Adderall should be considered as unsafe, ineffective and potentially harmful.
According to FDA;
The Adderall 30 mg product may be counterfeit if:
1. The product comes in a blister package.
2. There are misspellings on the package.
  • “NDS” instead of “NDC”
  • “Aspartrte” instead of “Aspartate”
  • “Singel” instead of “Single”
3. The tablets are white in color, round in shape, and are smooth.
4. The tablets have no markings on them


The authentic Teva's Adderall 30 mg tablets produced by Teva are round, orange/peach, and scored tablets with “dp” embossed on one side and “30” on the other side of the tablet. Teva’s Adderall 30 mg tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02 listed

Press Release by FDA;

For Immediate Release: May 29, 2012
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA warns consumers about counterfeit version of Teva’s AdderallTablets purchased on the Internet contain wrong active ingredients
The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – a class of drugs for which special controls are required for dispensing by pharmacists.
FDA’s preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.
Currently on the FDA’s drug shortage list, Adderall is in short supply due to active pharmaceutical ingredient supply issues. Teva continues to release product as it becomes available. Consumers should be extra cautious when buying their medicines from online sources. Rogue websites and distributors may especially target medicines in short supply for counterfeiting.
The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers. Any product that resembles the tablets or the packaging in the photos below and claims to be Teva’s Adderall 30 mg tablets should be considered counterfeit. The counterfeit versions of Adderall should be considered as unsafe, ineffective and potentially harmful.
Authentic Adderall 30 mg tablets produced by Teva are round, orange/peach, and scored tablets with “dp” embossed on one side and “30” on the other side of the tablet. Teva’s Adderall 30 mg tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02 listed

The Adderall 30 mg product may be counterfeit if:
1. The product comes in a blister package.
2. There are misspellings on the package.
  • “NDS” instead of “NDC”
  • “Aspartrte” instead of “Aspartate”
  • “Singel” instead of “Single”
3. The tablets are white in color, round in shape, and are smooth.
4. The tablets have no markings on them

Anyone who believes they have the counterfeit version of Teva’s Adderall 30 mg tablets should not take or should stop taking the product. Consumers should talk to their health care professional about their condition and options for treatment.
Consumers and health care professionals are encouraged to report adverse events or side effects from the suspect counterfeit Adderall to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online: www.fda.gov/MedWatch/report.htm1.
  • Download form2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Consumers who believe they have received counterfeit Adderall should contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989 or http://www.fda.gov/OCI3.
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Issues An Alert On Reumofan Plus

Food and Drug Administration is alerting people on Reumofan Plus marketed as a Natural dietary supplement for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions..
Consumers who are currently taking Reumofan Plus or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers should not buy or start using the product.
Follow the link for the pictures of Reumofan Plus and the full FDA press release, both in English and En EspaƱol.

Reumofan Plus Alert By FDA | Health Officials In Mexico Recall The Dietary Supplement

Monday, May 14, 2012

Hospira Recalls Hydromorphone HCI

Recallr has information on Hospira Hospira Recalls Hydromorphone HCI recall.
Anyone with an existing inventory of Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.
Recallr: Hospira Recalls Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject

Thursday, March 8, 2012

Surfaxin (Lucinactant) Approved By FDA For The Prevention Of Respiratory Distress Syndrome (RDS) In Premature Infants.

FDA has approved Surfaxin (Lucinactant) for preventing premature infants from the respiratory distress syndrome (RDS).
The lungs of premature infants are not able to make enough surfactant, a liquid that coats the inside of the lungs and helps to keep them open. Without enough surfactant, the lungs collapse and the infant has difficulty breathing. Most babies who develop RDS show signs of breathing problems and a lack of oxygen at birth or within the first few hours after birth.

Surfaxin is the fifth drug approved in the United States to treat RDS in premature infants. The other FDA-approved surfactants include Survanta (beractant), Curosurf (poractant alpha), Infasurf (calfactant), and Exosurf (colfosceril palmitate), which is no longer marketed.

A single randomized, active-controlled, multi-dose study involving 1,294 premature infants demonstrated the safety and efficacy of Surfaxin. Within 30 minutes of birth, infants in the study received either Surfaxin, Exosurf or Survanta. Surfaxin and Exosurf served as the primary comparison for this study; Survanta served as another comparison. Surfaxin demonstrated significant improvement in both RDS at 24 hours after birth and RDS-related mortality through two weeks, when compared with Exosurf.

The most common side effects of Surfaxin are related to its administration down a premature infant’s breathing tube (endotracheal tube) and include endotracheal tube reflux, skin paleness, endotracheal tube obstruction, and need for dose interruption.

Surfaxin is manufactured by Discovery Laboratories Inc. of Warrington, Pa.
Drug Name(s)SURFAXIN (Brand Name Drug)
FDA Application No.(NDA) 021746
Active Ingredient(s)LUCINACTANT
CompanyDISCOVERY LABORATORIES INC
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
SURFAXIN
®
(lucinactant) Intratracheal Suspension is indicated for the prevention of respiratory
distress syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN reduces the
incidence of RDS at 24 hours and mortality due to RDS.
2 DOSAGE AND ADMINISTRATION
For intratracheal administration only.
SURFAXIN should be administered by or under the supervision of clinicians experienced in
intubation, ventilator management, and general care of premature infants.
2.1 Dosing
The recommended dose of SURFAXIN is 5.8 mL per kg birth weight. Up to 4 doses of
SURFAXIN can be administered in the first 48 hours of life. Doses should be given no more
frequently than every 6 hours.
No information is available on doses greater than 5.8 mL per kg birth weight, the effects of more
than 4 doses, or dosing more frequently than every 6 hours.
Dosage may be determined from Table 1.
Table 1. Dosing Chart
Birth Weight (g) Total Dose (mL)
600-649 3.5
650-699 3.8
700-749 4.1
750-799 4.4
800-849 4.6
850-899 4.9
900-949 5.2
950-999 5.5
1000-1049 5.8
1050-1099 6.1
1100-1149 6.4
1150-1199 6.7
1200-1250 7.0

AeroShot “caffeine inhaler” Warned By FDA For False Or Misleading Labeling And More.


AeroShot “caffeine inhaler”
FDA, the U.S. Food and Drug Administration, warned Breathable Foods Inc., makers of AeroShot, for false or misleading statements in the labeling of their product. FDA told the company that the Agency has questions about the safety of the “caffeine inhaler.” The agency was also concerned about children and adolescents using the product in combination with alcohol.
FDA works to protect consumers and acts very seriously about any problems caused by products it regulates.Consumers who believe they have suffered illness or injury from using AeroShot should also report those events to their regional FDA Consumer Complaint Coordinators. The agency also encourages healthcare providers to report to FDA any adverse events in their patients that are associated with AeroShot.


Saturday, February 18, 2012

MicroCHIPS,, Implanted Remote-Controlled Drug Delivery Could reduce Doctor Visits

OncoWikia Blog is reporting of a device that is implanted within patients body to deliver drugs, periodically by a physician, remotely. The device is made by MicroCHIPS, a USA company and the device delivered Teriparatide [recombinant human PTH(1–34)], an expensive hormone treatment that improves bone formation and reduces the risk of fracture in osteoporosis patients.
"A microchip that continues to deliver teriparatide with this or similar consistency and efficiency over 12 to 24 months could improve bone mass, density, architecture, and strength," said study co-author Robert Neer, Founder & Director of the Massachusetts General Hospital Bone Density Center and Associate Professor of Medicine at Harvard Medical School
Follow the link below for more information and the press release by MicroCHIPS.
MicroCHIPS,, Implanted Remote-Controlled Drug Delivery ~ Oncowikia Blog