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FDA warnings about Codeine & Tramadol

FDA new warnings about the use of codeine and tramadol in children & nursing mothers

UPDATED April 20, 2017 // Children younger than 12 years should not take tramadol (multiple brands) or codeine, which pose the serious risk for slowed or difficult breathing and death, the US Food and Drug Administration (FDA) announced

Tramadol is indicated for pain, while codeine is indicated for both pain and cough. The latter opioid is found in some prescription pain and cough medicines and in some over-the-counter cough medicines.

The two opioids are problematic, the FDA said, because some people metabolize the drugs much more quickly than usual, causing life-threatening, high levels of the active ingredients that can lead to respiratory depression. This trait stems from a variation in an enzyme — cytochrome P450 isoenzyme 2D6 (CYP2D6) — that converts codeine into morphine and tramadol into a metabolite called O-desmethyltramadol (M1). The prevalence of CYP2D6 ultrametabolizers varies by race and ethnic group.

Labels for products containing codeine and tramadol will be revised as follows:

  • For children under 12 years of age, codeine is contraindicated for cough or pain, and tramadol for pain.
  • Tramadol is contraindicated for treating pain following tonsillectomy or adenoidectomy in children younger than 18 years of age.
  • Codeine and tramadol is not recommended in children 12 to 18 years of age who are obese, or have severe lung disease or obstructive sleep apnea. These conditions may increase the risk for breathing problems.
  • The FDA is cautioning nursing mothers that although the medical literature does not report adverse events associated with tramadol and breastfeeding, the drug poses the same risk for ultrametabolizers as codeine, which has a lengthy track record of respirator depression in breastfed infants. Tramadol and its metabolite MI show up in breast milk.

www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm553285.htm

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  3. Governor Rauf Aregbesola of Osun on Wednesday expressed regrets that
    the family of the late Senator Isiaka Adeleke has been using
    the unfortunate incident of his death to manipulate
    the minds of the people of the Ede ancient city.

    Aregbesola said it is sad that since the
    death of the former governor of Osun in April, many lies and fabrications have emanated from the family and few of his loyalists.

    Among the lies being peddled against him and his government include the fact
    that the younger brother of the politician, Dr. Deji
    Adeleke claimed that he borrowed the Aregbesola government
    money to pay workers salaries. He said it is also unthinkable that the Adeleke
    family would claim that Aregbesola begged Senator Adeleke to
    join APC.

    Aregbesola stated these when he led the campaign train of Senator Mudashir Husain to
    Ede in the series of mega-campaigns ahead of the July 8,
    2017 senatorial election.

    Ede is the home town of the late Adeleke.

    This was just as the Governor along with the Timi of Ede, Oba Muniru Adesola Lawal, sued for
    peace stating that the coming election should not be allowed to cause crisis.

    The Governor said anywhere where peace is absent there can be no
    development.

    He stated that God chooses whom he likes as a leader and so politicians should thread cautiously.

    He held that APC did the best it could have done for the first democratically elected Governor of the state when his then party, People’s Democratic
    Party PDP treated treated him by giving him the Senatorial ticket then.

    Aregbesola stated that it was the late senator
    who came to APC uninvited because of the treatment he received in the PDP.

    On the purported claim in some quarters that the Adeleke family helped his re election, the Governor said he never collected a Kobo from the younger brother of the late Senator,
    Dr. Deji Adeleke or any of the Adelekes.

    He added that his administration has never for any reason borrowed
    money from any individual or group to meet the state’s statutory obligations.

    Aregbesola held that with the volume of workers’ salaries arrears and pensions at
    that time, no individual could borrow the state the amount required at
    that time.

    According to him, “Deji Adeleke does not have the financial capacity to bail out Osun from its financial challenges even before now, not to talk about lending us money to pay workers’ salaries. If anything at all, it is their family that sought and got favours from the Osun State Government under my watch. It is to the glory of God that they got the Certificate of Occupancy of their university from our government. Why didn’t those who are their new friends give them C of O of that university?

    “If Deji Adeleke has so much money, why is
    he begging me to waive the payable tax of his university?
    Why cant he just pay?

    “I am bold enough to say this over and over again, because I have never sought for assistance from any of the Adeleke’s family even during the life time of Senator Isiaka Adeleke, nothing as such occurred.

    “Though my relationship with late Adeleke was cordial and beyond
    politics because we have known each other even before Osun politics because our residences are adjacent to each other in Lagos
    state.

    “He was a good brother and a friend to me while alive, but during this dire economic period, I never approach him for any financial assistance not to talk of obtaining cash from his brother.

    The governor commended the monarch for calling for peace to reign in the entire senatorial district before during and after the election.

    Aregbesola said it is the responsibility of the Oba to make sure peace reigns in his domains.

    According to him, “if the monarch fails to guarantee
    peace in his area, he will be the first person to be blamed for shirking in his responsibility.

    “I am very happy that you called for and preached peach to the people. As we all know there is no iota of gain in causing chaos.

  4. In his opening remarks at the meeting held at the old Banquet
    Hall, Presidential Villa, Abuja, Osinbajo said the meeting had become imperative in view of a spate of divisive statements in recent weeks, pitching the South-East against the North.

    “You are, by virtue of your vast knowledge, wisdom and experience, both a vital link with our past, and an important guarantee for the success of our future. This is why your role in national affairs is critical.

    “The reason for these series of meetings is well known to all of us; it became necessary in the wake of a spate of divisive statements,
    in recent months and weeks, pitching the South-East
    against the North.

    “We are all aware of the so-called ‘ultimatum’ issued by a group of Northern youths, asking that all Igbos living in the North vacate the region.

    “Before then, there was the clamour, and it’s still on-going, by some south-eastern youths,
    operating as IPOB and affiliated groups, demanding secession from Nigeria
    at all costs and by any means.

    “In all our previous engagements with Northern and South-Eastern leaders, we all came to the consensus that Nigeria is stronger and better together, and that these hate-filled and divisive rhetoric and agitations are unjustifiable, unacceptable and often times illegal. And I would like to reiterate that today.” he said.

    He stressed that Nigeria had already seen enough violence
    and bloodshed during its history.

    According to him, the price of Nigeria’s unity has already been paid with the blood and lives of hundreds of thousands
    of soldiers and civilians lost.

    What Acting Nigerian President Told Northern Traditional Rulers

    Recalling President Muhammadu Buhari’s commitment to one Nigeria from his
    experience in the military, Osinbajo said that Buhari fought side
    by side with Nigerians of every tribe and faith.

    The acting president said: “We must protect each other, put our lives on the line for each other; we were brothers even in the face of death. This is the type of nation we must maintain.

    “As royal fathers and leaders, I think you will agree with me that we all have a role to play in countering the voices of
    divisiveness, and the elements who seek to take us down a bloody path.

    “Let us continue to counsel the misguided elements among our youth, who think that ethnic confrontation is a game and that words can be thrown around carelessly without repercussion.”

    Osinbajo assured the traditional rulers that the “government is not deaf to the legitimate concerns and frustrations in parts of the country.

    “Every part of Nigeria has its own grievances. But these have to be expressed graciously
    and managed with mutuality rather than with scorn and disdain.

    “I would like to assure you all that we are here to listen and to answer, and, very importantly, to reassure everyone that we are committed to the unity of Nigeria, and that upon the foundation of that unity we can together build a prosperous and great country.”

    He urged all Nigerians never take the nation’s diversity for granted, saying the fullness of the nation’s strength
    “actually lies in that diversity.

    “And we must wield that diversity, not as divisive tool, but instead as
    a binding agent.

    “As we round up these consultations tomorrow with a meeting with governors, it is clear to me that we are all resolved to by words, conduct and action, promote the unity of our dear nation.” he said

    He, however, assured that the government would ensure that
    “the entire apparatus of government is deployed to ensure that no one threatens Nigeria’s territorial integrity and that no one threatens the lives or livelihoods of any Nigerian living anywhere in the country”.

    While thanking the traditional rulers for their
    unyielding cooperation and support, Osinbajo prayed that almighty God would continue to give them the wisdom and the strength to preside over their Kingdoms and the good health to
    reign long and reign well.

    Among those who attended the meeting included the Sultan of Sokoto, Sultan Muhammadu Sa’ad Abubakar III; Emir of
    Kano, Muhammadu Sanusi and the Etsu Nupe, AlhajiYahaya Abubakar.

    Others were, Alhaji Muhammed Isah Muhammed, theEmir of Jama’a
    in Kaduna State; Justice Lawal Hassan, the Emir of Gummi;
    the Coordinator of the Northern traditional rulers council, Sakaruyi of Karo Dr.
    Emmanuel Kyauta, and the representative of the Emir of Katsina,
    Prof. Sani Lugga ,the Waziri Katsina.

    The Emir of Ilorin, Alhaji Ibrahim Gambari; Alhaji
    Mustapha Agwai II, Emir of Lafia in Nasarawa State; Alhaji Kyari Umar El-Kanemi, Shehu of Bama representing
    Shehu of Borno and the Gbong Gwon Jos, Jacob Buba Jang, also attended the meeting.

    Also at the meeting were Alhaji Abubakar Shehu Abubakar, Emir of Gombe; Ndakwo Ameh Oboni II,Attah
    Igala,Kogi State; Alhaji Muhammadu Ibn Abali, the Emir of Fika in Yobe;, Alhaji Attahiru Ahmed Muhammed Emir
    of Anka in Zamfara and Prof. James Ayatse, the Tor Tiv.

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