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

Wednesday, February 15, 2012

Prescription for Danger, Prescription and Over-the-Counter Drug Abuse

Prescription and Over-the-Counter Drug Abuse Among the Nation’s Teens is trending and it is a cause that we should attend. The drugs abused by teens include high strength painkillers, ( those drugs prescribed after a surgery); depressants,( sleeping pills or anti-anxiety drugs); and stimulants,(drugs prescribed for attention deficit hyperactivity disorder (ADHD)). Among 12- and 13-year-olds, prescription drugs are the drug of choice and more than 2.1 million teens ages 12 to 17 reported abusing prescription drugs.
They seem also abusing over-the-counter drugs, such as cough and cold remedies. All these are methods of getting high but an overdose of any of the above drugs could be dangerous and life threatening.
There are many resources to gain knowledge about this danger, we located a document prepared by "OFFICE OF NATIONAL DRUG CONTROL POLICY EXECUTIVE OFFICE OF THE PRESIDENT" Called " Prescription for Danger (PDF) "
We think it is fine starter for everyone including parents to learn about the danger and take steps to prevent and protect our precious youth, following is an excerpt from the document, including the executive summery;

National studies and published reports indicate that the abuse1 of prescription and over-the-counter (OTC) drugs to get high is a growing concern—particularly among teens—in the United States. In fact, more young people ages 12-17 abuse prescription drugs than any illicit drug except marijuana—more than cocaine, heroin, and methamphetamine combined. Prescription drugs provide benefits when used as directed under the care of a health provider. But when abused, they can be just as dangerous as illicit drugs.
Though overall teen drug use is down significantly nationwide in recent years, there are troubling signs that teens view abusing prescription and OTC drugs as safer than using street drugs. Of even more concern is that many parents may not be addressing the dangers with their teens, though they can have an immediate impact on curbing the supply by cutting off the access to prescription drugs in their own home and by talking to their teen about the risks of drug use.
EXECUTIVE SUMMARY
More teens abuse prescription drugs than any illicit drug except marijuana.
• • •
The majority of teens who abuse prescription drugs get them easily and for free, primarily from friends and relatives.
• • •
Teens are also abusing some over-the-counter (OTC) cough and cold remedies to get high, which is especially troubling given teens’ easy access to these products.
• • •
Many parents are not aware of teen prescription drug abuse. Teens say their parents are not discussing these dangers with them, even though research shows that parental disapproval is a powerful way to keep teens from using drugs.
• • •
Parents are in a unique position to immediately reduce teen access to prescription drugs because they are found in the home.
• • •
Teens are abusing prescription drugs because many believe the myth that these drugs provide a “safe” high and they are easily available.
• • •
There has been a dramatic increase in the number of poisonings and even deaths associated with the abuse of prescription and OTC drugs.
• • •
The prescription drugs most commonly abused by teens are painkillers, prescribed to treat pain; depressants, such as sleeping pills or anti-anxiety drugs; and stimulants, mainly prescribed to treat attention-deficit hyperactivity disorder (ADHD).
• • •
Some teens use prescription and OTC drugs with alcohol or other drugs, which could lead to dangerous drug interactions and other serious medical consequences.

Tuesday, February 14, 2012

You Will not find Pill millipedes on DomoPharma! But you are certain to find Millipred

Pill Millipede
Pill millipedes are so called because they roll in to a ball when disturbed and this roll looks like a pill as you can see from the above photo, which is the works of george francis. These millipedes are comparatively short and usually has about eleven to thirteen body segments. You might find Pill millipedes in wet woodlands, not in DomoPharma.

But when you search for the drug Millipred, on DomoPharma, you will be presented with more information with the support of DomoDrugs. Such as,
What is Millipred;
"Millipred Oral Solution (10 mg Prednisolone per 5 mL) is a dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of Millipred Oral Solution contains 13.4 mg prednisolone sodium phosphate (10 mg prednisolone base) in a palatable, aqueous vehicle.
Inactive Ingredients: Millipred Oral Solution (10 mg Prednisolone per 5 mL) contains the following inactive ingredients: anti-bitter mask, corn syrup, edetate disodium, glycerin, grape flavor, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic, potassium phosphate monobasic, purified water, and sodium saccharin."
What is used for; (Basically it decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions.)
"Millipred Oral Solution (10 mg Prednisolone per 5 mL) is indicated in the following conditions:

1. Allergic States

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.

2. Dermatologic Diseases

Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides.

3. Edematous States

To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia.

4. Endocrine Disorders

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.

5. Gastrointestinal Diseases

To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis.

6. Hematologic Disorders

Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia.

7. Neoplastic Diseases

For the treatment of acute leukemia and aggressive lymphomas in adults and children.

8. Nervous System

Acute exacerbations of multiple sclerosis.

9. Ophthalmic Diseases

Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia.

10. Respiratory Diseases

Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “Allergic States”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia.

11. Rheumatic Disorders

As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis.

12. Miscellaneous

Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents)."
Including how the label looks like;
 PRINCIPAL DISPLAY PANEL — 237 mL Bottle Label
NDC 16477-510-08
Millipred™
(Prednisolone Sodium Phosphate
Oral Solution)
Equivalent to prednisolone
10 mg/5 mL
ALCOHOL FREE / DYE FREE
Rx Only
8 fl oz (237 mL)
LASER
PRINCIPAL DISPLAY PANEL -- 237 mL Bottle Label
(click image for full-size original)
MILLIPRED
prednisolone sodium phosphate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16477-510
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE) PREDNISOLONE SODIUM PHOSPHATE 10 mg in 5 mL
Product Characteristics
Color YELLOW (Pale) Score
Shape
Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16477-510-08 237 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078465 07/01/2009
Labeler — Laser Pharmaceuticals, LLC (614417132)
Registrant — Pharmaceutical Associates, Inc. (044940096)
Establishment
Name Address ID/FEI Operations
Pharmaceutical Associates, Inc.
044940096 MANUFACTURE
Revised: 09/2009 Laser Pharmaceuticals, LLC

Thursday, February 9, 2012

DomoPharma, Searching The Drug Universe

Trovafloxacin
We would like to introduce the upcoming search engine for phama, DomoPharma. Even though it feels like to say "Google for drugs", "Bing for Pharma" or "Yahoo for Medicine", we will not. Because DomoPharma is different from traditional search engines.
We are very busy working on the innards of the site and hope to launch in the near future. We will keep you posted from this blog.

For an example, when you search for Trovafloxacin, you should and will find that it is an antibiotic manufactured by Pfizer and there is much more to this drug than it's chemical structure.