Today’s news summary – December 28, 2011

Here is a summary of the important news from today.

• Cases of Tamiflu-Resistant Flu Concern Experts
• Avastin May Help Some With Ovarian Cancer: Studies
• Adding Lovenox Didn’t Reduce Blood Clot Death Risk in Study
• Doubt Cast on Use of Genetic Test Before Plavix
• Vitamins, Omega-3s May Keep Brain From Shrinking: Study
• Fungus Found in Sinks Can Cause Serious Infections
• Health Highlights: Dec. 28, 2011
• New Painkiller Worries Experts

Liquid Acetaminophen marketed for infants: Drug Safety Communication – Potential for Dosing Errors

December 22, 2011

Audience: Pediatrics, Consumers, Pharmacy.

ISSUE: The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available.  This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.

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FDA MedWatch Alert

Sent to subscribers of: gotu kola systemic

Recall: Eclectic Institute Dietary Supplements – Possible Salmonella Contamination

December 22, 2011

Audience: Consumer.

Include the products Gotu Kola (Centella Asiatica), Bladderwrack (Fucus Vesiculosus)

ISSUE: Eclectic Institute is voluntarily recalling specific lots of its freeze-dried capsules containing Gotu Kola (Centella asiatica) and Bladderwrack (Fucus vesiculosus) capsules because of potential Salmonella contamination.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, Salmonella infection can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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Here is a summary of the important news from today.

• Frankincense Production May Be Doomed
• Hepatitis B Vaccine Recommended for Adults With Diabetes
• Health Highlights: Dec. 22, 2011
• Eclectic Institute Dietary Supplements: Recall – Possible Salmonella Contamination
• Liquid Acetaminophen marketed for infants: Drug Safety Communication – Potential for Dosing Errors

No rest for the weary as the holiday approaches: vital FDA drug updates fill the headlines this week. New boxed warnings and label changes for Multaq are announced, and a revised simvastatin dose (when combined with amiodarone) is posted. Revised data on newborn pulmonary hypertension, and a new hypertension approval hails from the FDA. Finally, the multiple sclerosis drug Gilenya is associated with a death within 24 hours of the first dose, and the FDA continues to review the data.

Read the full roundup here…

Other News of Interest

• Isentress Approval Expanded to Include Children and Teens
• FDA Approves Edarbyclor (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
• Treating High Blood Pressure May Add Years to Life
• Drug Overdoses Kill More Americans Than Car Accidents: CDC
• Gilenya (fingolimod): Drug Safety Communication – Safety Review of a Reported Death After the First Dose
• Multaq (dronedarone): Drug Safety Communication – Increased Risk of Death or Serious Cardiovascular Events
• Blood Pressure Readings Differ When Guidelines Followed
• Poor Lifestyles Harming U.S. Heart Health: Report
• Zocor (simvastatin): Label Change – New Restrictions, Contraindications, and Dose Limitations

Here is a summary of the important news from today.

• Drug Users With HIV at Much Higher Overdose Risk
• New Device Approved for Children With Heart Failure
• Spouse’s Reaction May Affect Pain Management
• Dengue Fever Cases Subside in Florida, But Threat Remains
• Asthma Drugs in Pregnancy Might Pose Risk for Kids
• Life After Cigarettes Is Happier: Study
• Health Highlights: Dec. 16, 2011
• Blood Pressure Readings Differ When Guidelines Followed

Medicare will not pay prescription-drug bills if officials see evidence of fraud, which will let them avoid chasing down money after it has been paid out, Vice President Biden announced Tuesday…

The Federal Government’s Deeply Flawed System For Controlling Medicare Costs
By Sally Pipes; Forbes ~ Dec 12, 2011

Medicare’s hospital trust fund is set to be exhausted by 2024, according to the latest report from the program’s trustees. Federal officials are understandably looking for easy ways to cut spending in the entitlement program in hopes of shoring up its finances…

Report: Health care reform law causing Americans to lose insurance ahead of implementation
By Alexis Levinson; The Daily Caller ~ Dec 09, 2011

As a result of President Obama’s health care reform law, some Americans are already losing their health insurance coverage before the law’s regulations even go into effect, according to a new report…

Home Health Advocates Push Remote Monitoring In Medicare
By Jessica Marcy; Kaiser Health News ~ Dec 07, 2011

Home care technology can play a critical role in keeping patients out of hospitals and at home, but many providers believe new policies should be used to encourage its adoption.

10 Signs It May Be Time To Fire Your Doctor
From Deborah L. Jacobs; Forbes ~ Dec 08, 2011

There’s no such thing as a “best doctor,” despite the many books and lists compiling them. But there is such a thing as the wrong doctor for you…

Uncle Sam Can Help You Pay For Long-Term Care Insurance
By Ashley Ebeling; Forbes ~ Dec 06, 2011

Can a tax deduction help you afford long-term care insurance? If you’re buying it as an individual, maybe. If you’re self-employed and buying it through your business, absolutely…

Health Law’s Drug Discount Saves U.S. Elderly $1.5 Billion, Medicare Says
By Alex Wayne; Bloomberg ~ Dec 06, 2011

President Barack Obama’s administration says the health-care overhaul he championed has this year saved Medicare recipients an average of $569 a person in drug costs…

Feds to allow use of Medicare data to rate doctors
By Ricardo Alonso-Zaldivar, AP; The Bulletin ~ Dec 05, 2011

The government announced Monday that Medicare will finally allow its extensive claims database to be used by employers, insurance companies and consumer groups to produce report cards on local doctors – and improve current ratings of hospitals…

How to pay less for your medications
By Kristen Gerencher; MarketWatch ~ Dec 05, 2011

If you take prescription or over-the-counter medicine, you could be overpaying if you’re not part of a store discount program…

A new topical gel for the all-too-common overactive bladder, and more compact guidelines for latent tuberculosis top the news headlines for this week. A new study suggests side effects to antiestrogen therapy may be more than many women can tolerate, and infamous drospirenone may get stronger blood clot warnings in it’s package labeling. Finally, in a bold, and to some, confusing move, the HHS Secretary reverses a scientific decision by the FDA to place the morning-after pill on nonprescription status for all women.

Read the full roundup here…

Other News of Interest

• Could Statins Help Those Hospitalized With Flu?
• Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication – Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn
• Many Toddlers Wind Up in ER After Accidental Overdose
• Side Effects Cause Many Older Women to Drop Breast Cancer Drugs
• ADHD Drugs Don’t Raise Risk of Heart Problems: Study
• Endo Announces FDA Approval of a New Formulation of Opana ER Designed to be Crush-Resistant
• Americans Encouraged to Get Flu Vaccine
• CDC Issues New TB Treatment Guidelines
• Anturol Approved by FDA for the Treatment of Overactive Bladder
• Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step
• FDA Panels to Weigh Safety of Newer Forms of the ‘Pill’

Drug Safety Communication: Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants – Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn

December 14, 2011

Audience: Psychiatry, OB/GYN, Family Practice.

Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone)

ISSUE: FDA notified healthcare professionals and the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.  FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. FDA will update the SSRI drug labels to reflect the new data and the conflicting results.

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Here is a summary of the important news from today.

• Alcohol Use Down, Pot Use Up Among U.S. Teens
• Electronic Cigarette Makers Must Prove Safety of Products: Report
• Health Highlights: Dec. 14, 2011
• Could Statins Help Those Hospitalized With Flu?
• Drunk Driving-Related Deaths Surge During the Holidays
• Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication – Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn