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FDA Alert - Ketoconazole Can Harm Patients In Unapproved Usage

Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death

May 19, 2016

Audience: Dermatology, Family Practice, Pharmacy, Patient


ISSUE:

FDA is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not approved uses of the drug.
FDA approved label changes for oral ketoconazole tablets in 2013 to reflect these serious risks and to remove the indications for treatment of skin and nail fungal infections. However, an FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions. Since the 2013 labeling change, one patient death has been reported to the FDA due to liver failure associated with oral ketoconazole prescribed to treat a fungal infection of the nails.  See the full Drug Safety Communication for further information.


BACKGROUND:

 Ketoconazole in tablet form is indicated to treat serious infections caused by fungi and should be used only when other effective therapy is not available or tolerated. It works by killing the fungus or preventing it from growing. The topical forms of ketoconazole that are applied to the skin or nails have not been associated with liver damage, adrenal problems, or drug interactions.
In a July 2013 Drug Safety Communication, FDA warned that ketoconazole tablets should not be used as a first-line treatment for any fungal infection because it can cause severe liver injury and adrenal gland problems, and advised it can lead to harmful interactions with other medicines. FDA determined that the risks outweigh the benefits for treating skin and nail fungal infections and approved label changes removing this indication from the drug label and limited its labeled indication to treating only serious fungal infections.


RECOMMENDATION:

Health care professionals should use ketoconazole tablets only to treat serious fungal infections when no other antifungal therapies are available. Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Other treatment options are available over-the-counter and by prescription, but are also associated with risks that should be weighed against their benefits.
Patients should discuss with their health care professionals the risks and benefits of available therapies before using any medicine to treat skin and nail fungal infections. Patients taking ketoconazole tablets should seek medical attention right away if they experience any of these signs and symptoms of liver problems, which include loss of appetite, nausea, vomiting, or abdominal discomfort; yellowing of the skin or the whites of the eyes (jaundice); unusual darkening of the urine or lightening of the stools; or pain and discomfort in the right upper abdomen where the liver is located.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

•  Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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.

[05/19/2016 - Drug Safety Communication - FDA]

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections

May, 2016

 

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Audience: Internal Medicine, Family Practice, Pharmacy, Patient


ISSUE:

FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.
See the FDA Drug Safety Communication for a list of currently available FDA approved fluoroquinolones for systemic use.


BACKGROUND: The safety issues described in the Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.


RECOMMENDATION: Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. Patients should talk with your health care professional if you have any questions or concerns.


Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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

[05/12/2016 - Drug Safety Communication - FDA]

Faith And The Link

 The  Link - It Can Take You Anywhere You wish

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People speak of fate
and meetings of chance.
Finding of soul mates
and love at first glance.

Alignment of planets
Shooting stars up above.
Fullness of the moon
and pairs of white doves.

I've never taken stock
in these symbols and signs.
But having met you
proved I'd been blind.

Poets write of hearts
eternal devotion.
Flames of desire
and new found emotion.

Love ever lasting
a lifetime of bliss.
Heaven here on Earth
the passion of a kiss.

I've never found valid
these words foolishly penned.
Then you graced my presence
and proved me wrong again.

Singers sing of heartache
and the one that got away.
Internal emptiness
pain that still remains.

Missed opportunities
the hollowness of night.
Paths that never cross
timing that wasn't right.

I never dreamed those songs
could ever ring so true.
Until I thought of life
without ever knowing you.

- Ryan Mapes -

FDA Drug Safety Communication - Olanzapine

Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions

 

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May  2016

Audience: Psychiatry, Dermatology, Patient


ISSUE:

FDA is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. FDA is adding a new warning to the drug labels for all olanzapine-containing products that describes this severe condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
A search of the FDA Adverse Event Reporting System (FAERS) database identified 23 cases of DRESS reported with olanzapine worldwide since 1996, when the first olanzapine-containing product was approved. FAERS includes only reports submitted to FDA, so there are likely to be additional cases about which FDA is unaware. One patient taking olanzapine experienced DRESS and died; however, this patient was taking multiple medicines that could also have contributed to death (see the Data Summary section of the Drug Safety Communication for more information).
DRESS may start as a rash that can spread to all parts of the body. It can include fever and swollen lymph nodes and a swollen face. It causes a higher-than-normal number of infection-fighting white blood cells called eosinophils that can cause inflammation, or swelling. DRESS can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death. DRESS is a potentially fatal drug reaction with a mortality rate of up to 10%.


BACKGROUND: Olanzapine is an antipsychotic medicine used to treat mental health disorders schizophrenia and bipolar disorder. It can decrease hallucinations, in which people hear or see things that do not exist, and other psychotic symptoms such as disorganized thinking. Olanzapine is available under the brand names Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax, and also as generics.


RECOMMENDATIONS: Patients taking olanzapine-containing products who develop a fever with a rash and swollen lymph glands, or swelling in the face, should seek medical care right away. The combined symptoms together are commonly seen in DRESS. Talk with your health care professional about any questions or concerns. Do not stop taking olanzapine or change your dose without first talking with your health care professional. Sudden stopping of the medicine can be harmful without your health care professional’s direct supervision.


Health care professionals should immediately stop treatment with olanzapine if DRESS is suspected.  There is currently no specific treatment for DRESS. The important ways to manage DRESS are early recognition of the syndrome, discontinuation of the offending agent as soon as possible, and supportive care. Treatment with systemic corticosteroids should be considered in cases with extensive organ involvement. When prescribing the medicine, explain the signs and symptoms of severe skin reactions to your patients and tell them when to seek immediate medical care.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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

[05/10/2016 - Drug Safety Communication - FDA]