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

Saturday, December 24th, 2011 at 1:14 am

FDA MedWatch Alert

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.

FDA Alert – Recall: Eclectic Institute Dietary Supplements – Possible Salmonella Contamination

Saturday, December 24th, 2011 at 1:12 am

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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.

Today’s news summary – December 22, 2011

Saturday, December 24th, 2011 at 1:10 am

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Today’s news summary – December 22, 2011

Here is a summary of the important news from today.

Weekly News Round Up – December 21, 2011

Thursday, December 22nd, 2011 at 1:25 am

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Weekly News Round Up – December 21, 2011

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

Daily News Summary 12/15/2011

Sunday, December 18th, 2011 at 2:18 pm

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Today’s news summary – December 16, 2011

Here is a summary of the important news from today.

Weekly Drug Use Round Up – 12/14/2011

Thursday, December 15th, 2011 at 3:17 pm

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Weekly News Round Up – December 14, 2011

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

Drug Alerts – Potential Risk to Newborns from SSRI’s

Thursday, December 15th, 2011 at 3:07 pm

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FDA MedWatch Alert

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.