FDA significantly restricts access to the diabetes drug Avandia

The FDAd announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.”

Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.

The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.

“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Also today, the FDA ordered GSK to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs. During the course of the FDA’s review of the RECORD study, important questions arose about potential bias in the identification of cardiovascular events. The FDA is requiring this independent review to provide additional clarity about the findings.

In addition, the agency halted the GSK’s clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial compares Avandia to Actos and to standard diabetes drugs.

The FDA may take additional actions after the independent re-analysis of RECORD is completed.

734 Rich Honey

ClinicalPharmacology MadeIncrediblyEasy 3rdEdition

Written in the award-winning Incredibly Easy! style, this book provides complete and clear explanations of how drugs act and interact in the treatment of disease. Focusing on mechanisms of drug action, the book details specific drugs by pharmacologic class for all body systems as well as drugs for pain, psychiatric disorders, infection, fluid and electrolyte imbalances, and cancer. Potentially dangerous drug and drug-herb interactions are highlighted. This thoroughly updated edition covers the newest drugs in each pharmacologic class and includes information on obesity drugs, a new chapter on genitourinary system drugs, a new medication safety feature, and a new appendix on common herbal preparations and their drug interactions.





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Clinical Laboratory Medical

The AABB publication Clinical Laboratory Medicine contrives a set of multiple choice questions for each topic in Blood Banking and Transfusion Medicine. Not only will the questions test your knowledge and problem solving skills, the key provides a comprehensive review of all of the choices given for a specific question. You will find your weak points and be reassured by your strengths when answering the questions.








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GOODMAN & GILMAN'S THE PHARMACOLOGICAL BASIS OF THERAPEUTICS - 11th Ed. (2006)

The Only Therapeutic Reference Organized For the Way The World Practices Medicine

For more than fifty years, Goodman and Gilman's remains the drug reference of choice for practicing physicians, students, and pharmacists around the world. No other reference insures your ability to identify the most important aspects of therapeutics for a particular disease and provide accurate patient treatment.

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Manual of Clinical Problems In Pediatrics 5th Edition (2000)

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Availability of draft guidance re: development of antivirals for Chronic Hepatitis C, including coinfection with HIV

At present, there are a large number of drugs for the treatment of chronic hepatitis C (CHC) in active development. The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral agents (DAAs), defined as agents that interfere with specific steps in the hepatitis C virus (HCV) replication cycle. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process, such as early phases of clinical development, phase 3 protocol designs, and endpoints for the treatment of CHC to support approval of treatments for CHC, including patients with compensated and decompensated cirrhosis and those co-infected with HIV. The guidance also addresses pre-approval access in the form of treatment investigational new drug applications (INDs) and intermediate-sized safety protocols (collectively known as expanded access).

Important issues addressed in this guidance include: drug development methods to reduce the emergence of drug resistance, types of trial designs to assess optimal dose and treatment duration, combination therapy with multiple investigational drugs, recommendations on development of drugs to meet unmet medical needs, and use of treatment INDs or other smaller safety protocols to provide early access of multiple DAAs for patients at risk of imminent progression of liver disease.

The draft guidance, when finalized, will represent the agency’s current thinking on developing DAAs for treatment of CHC virus infection. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf

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FDA approves new drug for gout

The U.S. Food and Drug Administration today approved Krystexxa (pegloticase) to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy.

Gout occurs due to an excess of the bodily waste uric acid, which is eventually deposited as needle-like crystals in the joints or in soft tissue.  These crystals can cause intermittent swelling, redness, heat, pain and stiffness in the joints.

Gout is strongly associated with obesity, high blood pressure, high cholesterol and diabetes, and occurs more often in men, in women after menopause, and in people with kidney disease.

“About 3 percent of the three million adults who suffer from gout are not helped by conventional therapy. This new drug offers an important new option for them,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

For patients with gout, the conventional therapy is to receive drugs that lower the amount of uric acid in the blood, as, for example, the xanthine oxidase inhibitors Zyloprim (allopurinol) and Uloric (febuxostat). Krystexxa is an enzyme that lowers uric acid levels by metabolizing it into a harmless chemical that is excreted in the urine. The drug is administered to patients every two weeks as an intravenous infusion.

Two six-month clinical trials of 212 total patients demonstrated that the drug lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue.

Since one out of every four patients in the clinical trials experienced a severe allergic reaction when receiving an infusion of Krystexxa, health care providers should dispense a corticosteroid and an antihistamine to their patients beforehand to minimize the risk of such a reaction. Other reactions during the clinical trials included gout flare, nausea, injection site bruising, irritation of the nasal passages, constipation, chest pain and vomiting.

Physicians are also being warned to be cautious about administering Krystexxa to patients with congestive heart failure because the drug was not studied in this patient population.

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Male Breast Reduction

A popular cosmetic surgery for men may also be a surprising one-male breast reduction. This procedure is typically performed to treat a condition known as gynecomastia (enlarged breast tissue in men) or breasts enlarged as a result of fatty deposits from obesity. 

Gynecomastia can affect men of any age. According to a report published by The Mayo Clinic, it occurs as a result of a hormonal imbalance in which testosterone levels are decreased relative estrogen levels. Several common causes of this imbalance include: natural hormone changes, certain health conditions, exposure to anabolic steroids or estrogen, side effects of some medications or street drugs, and certaincancer treatments.

Depending on the cause, gynecomastia often resolves on its own or will resolve after treating any underlying medical conditions or stopping the usage of drugs associated with gynecomastia. In other times, surgical treatment may be necessary. 

Gynecomastia surgery can help men with this condition gain a new sense of body confidence by reducing the appearance of overdeveloped breast tissue or removing fat deposits that enlarge the breasts. "Male breast reduction is actually more common than one might think," said Felmont Eaves III, MD, President of ASAPS. "Surgery can be very effective in men who have breast enlargement due to either an unusual amount of actual breast tissue or fatty deposits." 

Although generally not considered a serious medical problem, gynecomastia or other male breast enlargement causes many sufferers to experience significant embarrassment. Men with gynecomastia will sometimes change the way they dress, such as by wearing thick shirts, or avoid activities that require going shirtless, such as swimming, to keep their condition hidden and avoid teasing or social stigma. 

Will, a young man who had gynecomastia corrected by a plastic surgeon after diet and exercise did not work, says, "No matter what I did, no matter how much I bench pressed, no matter how hard I worked out, there was still an unnatural amount of breast fat...it's terrible for a guy to have that." 

In most adolescents who are not obese, the condition will resolve itself spontaneously as the boy progresses through adolescence. Dr. Eaves says that most young men should wait until puberty is complete before undergoing surgery for gynecomastia. 

Breast reduction is the fourth most popular cosmetic surgical procedure among males, according to the American Society for Aesthetic Plastic Surgery (ASAPS). Nearly 17,000 male breast reduction procedures were performed in 2009, a 50 percent increase since 1997. The majority of these procedures (58 percent) were performed on men ages 19-34. 

Source: 
American Society for Aesthetic Plastic Surgery (ASAPS) 

Cough Medications Should Stay As Over-The-Counter Drugs

Dextromethorphan-containing cough medications have been used increasingly by teenagers as a cheap way to get high, but they carry a risk of hypertension (high blood pressure), accelerated heart rate and fever. An FDA (Food and Drug Administration) panel of experts has voted 15-9 against the proposal that would require all dextromethorphan-containing cough medications to have a doctor's prescription.

Dextromethorphan is an active ingredient that is added to over 140 OTC (over-the-counter, no prescription required) drugs. Dextromethorphan abuse, sometimes termed robotripping, has become increasingly more common among teenagers.

The Advisory Committee's (the panel of experts) recommendations are not binding; the FDA can ignore them if it so wishes, but it rarely does. The Committee was asked if dextromethorphan should be scheduled - a move aimed at reducing access to medications with potential for abuse.

Apart from the risks mentioned above, abusers of dextromethorphan can also suffer from the side effects of other ingredients present in some cough medications, such as acetaminophen (paracetamol), which can damage the liver.

According to the National Institutes of Health, in 2008 there were approximately 8,000 emergency hospital visits related to dextromethorphan abuse, 70% more than in 2004.

Another public body, the DEA (Drug Enforcement Agency) had asked the FDA to review dextromethorphan-containing medications, suggesting they become prescription-only drugs.

EMG/NCS – FREQUENTLY ASKED QUESTIONS

What does the EMG/NCS test?
The EMG/NCS study examines the integrity of the peripheral nerves and muscles of the
body. The study does NOT examine the brain or spinal cord. It is important to realize
that you can have a nerve or muscle problem, even though you may not “think” you have
any nerve or muscle problems. This test does NOT measure pain. You may have a
normal EMG-NCS study, even though you have severe pain.
What are the different parts of the study?
The study is usually done in two parts: (1) NCS, and (2) EMG (i.e. “needle” exam).
How long is the study?
Each EMG/NCS study varies from patient to patient, depending on what results are
obtained. As such, the study may take as little as 20 minutes, or as much as 2 hours.
What is the Nerve Conduction Study or NCS?

The NCS involves examining the nerves in your arms or legs. This consists of attaching
wires to the surface of your skin, and administering a small “shock” to see how well the
nerves react and function. These results are monitored on a computer.
What is the Electromyography or EMG?
The EMG examines the muscle activity in your body. This study consists of inserting a
sterile, individually wrapped, needle into your various muscles and monitoring their
activity. These results are monitored on a computer. You will probably be stuck 5-7
times per arm or leg. There is NO shocking during the EMG.
Is the EMG or NCS painful?
The “shocks” during the NCS are not painful, although they may feel slightly
uncomfortable. The needle “sticks” during the EMG feels like a small ant bite, and can
sometimes be uncomfortable, but not painful.
Do I have to tell the Doctor about any specific medical conditions?
Yes, Please notify the physician prior to the study if:
1) you think you may have AIDS or hepatitis, or
2) if you are taking any blood thinners, such as Coumadin or Aspirin
What type of clothing should I wear?
Men: If possible, wear shorts and T-shirt.
Women: If possible, wear a loose dress and T-shirt.
****Please remove any watches or rings you might be wearing on BOTH your
hands/fingers****
Can I wear lotion on my arms or legs on the day of the study?
Please DO NOT use any Lotion or Cream on the day of the test. Such Lotions or Creams
will make it difficult to perform the study.
What do I need to do before I enter the exam room?
If you have accidentally used any type of lotion or cream on your hands or feet, PLEASE
wash BOTH your hands and feet with soap and water in the office restroom, BEFORE
entering the exam room.
When will I have the results?
The physician who ordered the test should have the results within the next seven working
days.

Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections

[09-01-2010] The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was determined using a pooled analysis of clinical trials. The cause of the excess death in these trials is often uncertain, but it is likely that most deaths in patients with these severe infections were related to progression of the infection.
The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. Tygacil is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infection. Tygacil is approved by FDA for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia.
FDA has updated the Warnings and Precautions and Adverse Reactions sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil. Healthcare professionals have also been informed of this increased risk via a Dear Health Care Professional letter.
dditional Information for Healthcare Professionals
The greatest increase in risk of death with Tygacil was seen in patients with ventilator-associated pneumonia, an unapproved use.
Alternatives to Tygacil should be considered in patients with severe infections.
Report adverse events involving Tygacil to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.

Data Summary
The pooled analysis grouped 13 trials with patients given Tygacil for both approved and unapproved indications by type of infection (see Table below), comparing the overall mortality for Tygacil vs. pooled control agents. Overall, in the trials, death occurred in 4.0% (150/3788) of patients receiving Tygacil and 3.0% (110/3646) of patients receiving comparator antibiotics. An adjusted risk difference for all-cause mortality based on a random effects model stratified by trial weight was 0.6% (95% CI 0.1, 1.2) between
see more in http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm