FDA seeks plan to curb opioid pain killer abuse
December 5, 2009 by admin · Leave a Comment
U.S. drug regulators asked on Friday for manufacturers of prescription pain medications to provide more specifics on an industry plan to curb growing abuse of morphine, methadone, oxycodone and other opioid drugs.
The Food and Drug Administration in February had asked manufacturers including Johnson & Johnson and King Pharmaceuticals to come up with a joint plan to deal with the public health problem, particularly involving slow release and long acting versions of the drugs. This is the first time the agency has sought to develop risk evaluation and mitigation strategy for an entire class of drugs.
At a Friday meeting, industry representatives told FDA they intended to develop a phased-in approach to deal with the problem. This could include a voluntary training program for doctors to better educate them about proper use of pain killers and government certification for prescribing of controlled substances.
Currently, a physician must be certified by the U.S. Drug Enforcement Agency to prescribe this class of drugs. Congress would have to approve any requirement for physician training to receive DEA certification.
The director of the FDA’s Office of New Drugs, John Jenkins, said the goal was to find a balance between reducing abuse of the drugs and maintaining access for patients who need the pain killers.
There was concern that doctors might opt out of prescribing the pain killers if the requirements are too burdensome.
FDA will hold more meetings with the industry group, doctors and the public next year.
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FDA Mandates Tougher Warnings for Pain Pills
July 8, 2009 by admin · Leave a Comment
TUESDAY, July 7 (HealthDay News) — Concerns about the possibility of fatal overdoses led U.S. health officials Tuesday to take several steps to limit the risk of using pain medications containing propoxyphene, including Darvon and Darvocet.
Manufacturers must strengthen the labels of propoxyphene-containing products by adding boxed warnings that emphasize the potential for overdose and developing medication guides to be given to each person filling or refilling a prescription.
The manufacturers must also conduct a new safety study to assess unanswered questions, such as how propoxyphene affects the heart when taken at higher-than-recommended doses, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, said during a news conference.
The FDA is also working with several health-care organizations to collect additional safety data on these products, Woodcock said, adding that “the data we accumulate could result in additional regulatory action.”
Woodcock also announced that the FDA has denied a petition from the consumer advocacy group Public Citizen asking for a phased withdrawal of products containing propoxyphene.
“The reason for the denial is that FDA has determined that propoxyphene is an acceptable option for relief of mild-to-moderate pain when taken as directed,” she said. “Moreover, FDA recognizes that other options clinicians might have for pain management come with their own safety concerns.”
Propoxyphene-containing products have been linked to fatal overdoses, FDA officials said. Between 1959 and 2005, 91 deaths attributed to an overdose of these products have been recorded in the adverse-events database, said Dr. Gerald Dal Pan, head of the FDA’s office of surveillance and epidemiology.
But that database would not necessarily register information on deliberate overdosing, Woodcock said.
Last month, European regulators called for the withdrawal of dextropropoxyphene from the market because people taking the 50-year-old drug have been dying from overdoses.
Dextropropoxyphene, which is called propoxyphene in the United States, is an opioid widely used to treat mild to moderate pain. It was first introduced in the United States in 1957 under the brand name Darvon and is marketed today by a wide number of generic drug makers.
Last week, an FDA advisory panel recommended that the popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, be banned.
Darvocet contains acetaminophen.
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Questions and answers about pain medicine dangers
July 7, 2009 by admin · Leave a Comment
CHICAGO – A Food and Drug Administration panel has recommended limits on Tylenol and other drugs containing acetaminophen because of risks for liver failure. Maximum recommended doses for over-the-counter Tylenol would be reduced. Percocet and Vicodin, two narcotic prescription drugs containing acetaminophen, would be banned.
Q: What’s the reason?
A: It’s easy to get too much acetaminophen because the drug is in many medicines and a few extra doses a day can cause liver problems.
Q: I’ve taken Tylenol at recommended doses for years. Could I be damaging my liver and should I get tested?
A: Doctors say recommended doses are safe and they aren’t recommending routine tests; possible liver damage can be detected with blood tests.
Q: Would I know if I have liver damage?
A: Liver damage from excess acetaminophen tends to cause sudden symptoms, within a few days of taking too much. These may include nausea, vomiting and jaundice — yellowing of the skin or whites of the eyes.
Q: What should I do if I’ve taken extra doses and develop these symptoms?
A: Seek immediate medical care. Quick treatment with antidote medicine can prevent permanent liver damage; waiting too long can be fatal.
Q: How can I avoid getting too much acetaminophen?
A: Carefully read drug labels; don’t exceed recommended doses and don’t take more than one medicine containing acetaminophen. Also, avoid drinking alcohol while using acetaminophen-containing drugs.
Q: Are the proposed limits likely to be adopted?
A: The full FDA has not taken any action but will likely consider the recommendations separately. Its decisions are months away.
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Celebrex Medication Ingredients and Side Effects
May 23, 2009 by admin · Leave a Comment
Celebrex is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain. Celebrex is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain. It is also used in the treatment of hereditary polyps in the colon.
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Things to consider before taking drug Celebrex
Taking an NSAID such as Celebrex can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.
You should not use this medication if you are allergic to celecoxib, or if you have a history of allergic reaction to aspirin, sulfa drugs, or other NSAIDs.
Before taking Celebrex tell your doctor if you are allergic to any drugs, or if you have:
- a history of heart attack, stroke, or blood clot;
- heart disease, congestive heart failure, high blood pressure;
- a history of stomach ulcers or bleeding;
- liver or kidney disease,
- a seizure disorder such as epilepsy;
- asthma;
- polyps in your nose; or
- a bleeding or blood clotting disorder.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take Celebrex.
Celebrex belongs to FDA pregnancy category C. Celebrex medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Celebrex during the last 3 months of pregnancy may harm the unborn baby. Do not take Celebrex during pregnancy unless your doctor has told you to. Celecoxib passes into breast milk and may affect a nursing baby. Do not take Celebrex without first talking to your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 2 years old without the advice of a doctor.
Celebrex side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Celebrex and seek medical attention or call your doctor at once if you have any of these serious side effects:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- swelling or rapid weight gain;
- urinating less than usual or not at all;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
- bruising, severe tingling, numbness, pain, muscle weakness.
Less serious Celebrex side effects may include:
- upset stomach, mild heartburn, diarrhea, constipation;
- bloating, gas;
- dizziness, nervousness, headache;
- skin rash, itching;
- blurred vision; or
- ringing in your ears.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
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Fioricet medication ingredients and side effects
May 20, 2009 by admin · Leave a Comment
Fioricet, a strong, non-narcotic pain reliever and relaxant, is prescribed for the relief of tension headache symptoms caused by muscle contractions in the head, neck, and shoulder area. It combines a sedative barbiturate (butalbital), a non-aspirin pain reliever (acetaminophen), and caffeine.
Acetaminophen is a pain reliever and fever reducer. Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow. Fioricet is a combination of acetaminophen, butalbital, and caffeine.
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Things to consider before taking Fioricet drug:
Butalbital may be habit-forming and should be used only by the person it was prescribed for. Fioricet should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.
You should not take Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.
Before using Fioricet, tell your doctor if you are allergic to any drugs, or if you have:
- kidney disease,
- liver disease; or
- a history of mental illness or suicidal thoughts.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take Fioricet.
Foricet belongs to FDA pregnancy category C. Fioricet medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Fioricet can pass into breast milk and may harm a nursing baby. Do not use Fioricet without telling your doctor if you are breast-feeding a baby.
Fioricet side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Fioricet and call your doctor at once if you have any of these serious side effects:
- fast, pounding, or uneven heartbeat;
- feeling light-headed or short of breath;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.
Less serious side effects may include:
- drowsiness;
- dizziness,, confusion or lightheadedness;
- dry mouth;
- nausea, vomiting, stomach pain, loss of appetite;
- feeling anxious or jittery;
- drunk feeling; or
- headache.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
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Codeine medication and side effects
December 28, 2008 by admin · Leave a Comment
Codeine is in a group of drugs called narcotic pain medicines. Codeine is used to treat mild to moderate pain.
Codeine may be habit-forming and should be used only by the person it was prescribed for. Codeine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking codeine. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol. Never take more than your prescribed dose of codeine. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Things to consider before taking drug Codeine
Do not use codeine if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, methadone, morphine, Oxycontin, Darvocet, Percocet, Vicodin, Lortab, and many others). You should also not take codeine if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus. Codeine may be habit-forming and should be used only by the person it was prescribed for. Codeine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
Before using codeine, tell your doctor if you are allergic to any drugs, or if you have:
- asthma, COPD, sleep apnea, or other breathing disorders;
- liver or kidney disease;
- underactive thyroid;
- curvature of the spine;
- a history of head injury or brain tumor;
- epilepsy or other seizure disorder;
- low blood pressure;
- gallbladder disease;
- Addison’s disease or other adrenal gland disorders;
- enlarged prostate, urination problems;
- mental illness; or
- a history of drug or alcohol addiction.
FDA pregnancy category C. Codeine may be harmful to an unborn baby, and could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Older adults may be more sensitive to the effects of this medicine.
Codeine side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- feeling light-headed, fainting;
- confusion, agitation, hallucinations, unusual thoughts or behavior;
- seizure (convulsions); or
- problems with urination.
Less serious side effects include:
- feeling dizzy or drowsy;
- nausea, vomiting, constipation;
- sweating;
- headache;
- trouble sleeping (insomnia);
- loss of interest in sex;
- dry mouth;
- blurred vision; or
- mild skin rash.
This list is not complete and other side effects may occur. Tell your doctor about any unusual or bothersome side effect.
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Ultracet Medication Ingredients and Side Effects
November 25, 2008 by admin · Leave a Comment
Ultracet is combination medicine, it consists of acetaminophen and tramadol. An opioid analgesic Tramadol and acetaminophen used together may provide better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.
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Things to consider before taking drug Ultracet:
You should not take this medication if you are allergic to acetaminophen or tramadol, if you are intoxicated (drunk), or if you have recently used any of the following drugs:
-
alcohol;
-
narcotic pain medicine;
-
sedatives or tranquilizers (such as Valium);
-
medicine for depression or anxiety;
-
medicine for mental illness (such as bipolar disorder, schizophrenia); or
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street drugs.
Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.
Seizures have occurred in some people taking Ultracet. Your risk of a seizure may be higher if you have any of these conditions:
-
a history of drug or alcohol addiction;
-
a history of epilepsy or other seizure disorder;
-
a history of head injury;
-
a metabolic disorder;
-
an infection of your brain or spinal cord, such as meningitis or encephalitis;
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if you are also taking an antidepressant, mood stabilizer, or another narcotic pain medicine; or
-
if you have taken an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.
Talk with your doctor about your individual risk of having a seizure.
Ultracet side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Ultracet and call your doctor at once if you have any of these serious side effects:
-
seizure (convulsions);
-
a red, blistering, peeling skin rash; or
-
shallow breathing, weak pulse.
Less serious Ultracet side effects may include:
-
dizziness, drowsiness, weakness;
-
nausea, vomiting, constipation, loss of appetite;
-
blurred vision;
-
flushing (redness, warmth, or tingly feeling); or
-
sleep problems (insomnia).
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
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