FDA Withdraws Approval for ADD Drug

Updated: Monday, Oct. 24, 2005
WTOP News

"WASHINGTON (AP) - The FDA has withdrawn approval for a drug used to treat attention deficit hyperactivity disorder because it has been associated with liver problems, including death, agency officials said Monday.

"The move means drug manufacturers will no longer produce generic versions of pemoline, which was developed by Abbott Laboratories and sold under the name Cylert. Abbott discontinued the drug earlier this year, but generic versions have remained available.

"FDA is not recalling the drug, instead allowing pharmacies to sell their remaining stock as doctors still using it switch patients to alternative treatments, the agency said in a statement.

"...In a statement, the FDA said it has 13 reports of liver failure resulting in transplant or death among people who took the drug, which has been available for 30 years. There are additional reports of less serious problems.

"Although that is a small number, it is well above what the normal rate of such problems among the general population, the FDA said.

"'FDA has concluded that the risk of liver failure with this drug outweighs the potential benefits,' the agency statement says, noting that alternative treatments for ADD have come on the market since pemoline was introduced." Click the title to read the article.

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Pregnancy poses extra risks from drugs

By January W. Payne
The Washington Post
Posted October 23 2005
Sun-Sentinel.com

"While no drug -- prescription or over-the-counter -- has been proven 'absolutely safe when you are pregnant,' many medications are thought to be safe for the mother and developing fetus, according to the National Institutes of Health's Center for the Evaluation of Risks to Human Reproduction.

"Particularly for women with chronic medical conditions like asthma, diabetes and high blood pressure, the risks of allowing health problems to go uncontrolled during pregnancy may outweigh the risks of the medications typically prescribed for them, say experts. This stance assumes that the drugs are taken under a doctor's supervision, and then only for the shortest time and at the lowest dose needed.

"The Food and Drug Administration uses five risk categories -- from A, the least problematic, to X, the most dangerous -- to rank the safety of prescription drugs during pregnancy. The FDA does not categorize OTC drugs but requires them to carry at least this standard warning, 'If pregnant or breast-feeding, ask a health care professional before use.' Tylenol (acetaminophen), for example, carries this warning and is generally considered safe to take during pregnancy. Some OTC drugs must carry a more specific warning. Labels on aspirin, naproxen sodium (Aleve) and ibuprofen (Advil, Motrin) advise against use during the last trimester because they may harm the fetus or cause complications during delivery.

"The FDA is currently revising its pregnancy risk categories; below is where some drugs currently reside:..." Click the title to read the article.

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Tips During Prescription Errors Education and Awareness Week

Thu 20-Oct-2005
Source: Veterans Affairs (VA) R&D
Newswise.com

"Newswise — October 24-31 is Prescription Errors Education and Awareness Week. Billions of prescriptions are filled in the United States every year. More than 100,000 Americans take their prescription medications incorrectly, which can lead to hospitalization or even death.

The Department of Veterans Affairs (VA) aims to eliminate medication errors with Bar Code Medication Administration, a system that greatly reduces inaccurate inpatient medication administration and improves patient safety. VA makes use of bar code technology (by placing bar codes on all medications and scanning patients’ wrists as well as the medicines) to ensure that the right medication is given in the right amount to the right patient at the right time...The Bar Code Medication Administration also provides online medication records for the computerized patient record system, which allowed VA to have access to patient history following Hurricane Katrina. VA’s innovative use of technology keeps medication errors low in daily operations as well as emergency situations.

"You can play a role in reducing prescription errors by following these tips:

"• Pharmaceutical companies have increased drug advertising and are targeting consumers. Do not pressure your doctor to prescribe drugs seen in commercials. Allow your doctors to make prescriptions based on their professional opinions instead of on what you see in advertisements.

"• Make sure your doctor knows what allergies or adverse reactions you have had to past medicines. Keep a journal of all the medicines you take as well as the side effects you experience to help you remember your reactions.

"• Tell your doctor about all medications you are taking. This includes prescription, over-the-counter medications, and dietary supplements such as vitamins and herbs. It may be dangerous to mix certain prescription drugs with certain herbals and over-the-counter medications.

"• Ask lots of questions. Make sure you completely understand what is being prescribed to you and what the medication is supposed to do for you. If you do not understand, ask your nurse, doctor, and pharmacist. There is no such thing as a dumb question when it comes to your health." Click the title to read the article.

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METH REMEDY BARS MORE COLD MEDS

staff reports - Free-Market News Network
Tuesday, October 18, 2005 - FreeMarketNews.com

"In an effort to crack down on methamphetamines, states are introducing laws that regulate and restrict the sales of over-the-counter cold medicines. States are justifying their crackdown because Pseudoephedrine, a common ingredient in OTC medications, is also used as an ingredient of methamphetamines, according to the Associated Press.

"Only 13 states, including New York and Nevada, have no Pseudoephedrine limitations but pressure is mounting for legislators to create new restrictions. Already, 37 states have some level of restrictions; the range in severity from limiting the number of cold medications sold to one customer to requiring a prescription. Massachusetts and Ohio are currently contemplating introduced legislation.

"While only a handful of states without Pseudoephedrine restrictions will soon exist, drug enforcers argue that federal level laws may be needed in order to prevent buyers from traveling to different states. The Senate has already approved a recently introduced bill to fight crystal methamphetamines. Under the new regulations consumer purchases of cold medicines would be tracked and consumers would only be allowed to buy about 7.5 grams of Pseudoephedrine per month." Click the title to read the article.

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Cymbalta to Carry Expanded Warning Concerning Potentially Serious Liver-Related Problems

Date Published: October 18, 2005
Source: Newsinferno News Staff

"The Food and Drug Administration (FDA) and Eli Lilly have notified healthcare professionals of a significant revision to the PRECAUTIONS/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride); Lilly’s antidepressant indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain.

"Cymbalta, which already carries a Black Box Warning regarding 'Suicidality in Children and Adolescents,' is now linked to post-marketing reports of hepatic injury (including hepatitis and cholestatic jaundice) that suggest 'patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage.'" Click the title to read the article.

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Majority of Older Adults With Chronic Pain Know Stomach Ulcers Are a Common Side Effect...

"ROCKLIN, Calif., Oct. 12 /PRNewswire/ -- Nearly two-thirds (65 percent) of U.S. adults age 55+ with chronic pain know that stomach ulcers are a common side effect of certain pain medications, yet less than one-third (31 percent) perceive themselves to be at moderate or high risk for developing one over the next 10 years. Despite this perception, many adults age 55+ have one or more factors that put them at increased risk for stomach ulcers that can result from chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin, ibuprofen and naproxen. The survey also found that among people who suffer with chronic pain age 55+ who opt not to take pain medication, more than half (53 percent) say that side effects are a concern.

"'People with pain need to know about the risks associated with their medication,' said Penney Cowan, Executive Director of the American Chronic Pain Association. 'The good news is that knowledge is power, and if side effects are understood they can be properly managed.'

"The online survey found that many adults age 55+ were at increased risk for an NSAID-related stomach ulcer.(i) For example, almost half (45 percent) of the survey respondents take over-the-counter or prescription NSAIDs four or more times a week, 73 percent are age 60 or older and nearly one in five (17 percent) has been diagnosed by a health care provider with an ulcer in the past.

"According to the American College of Gastroenterology, NSAID use is the second major cause of gastric ulcers. In the United States, gastrointestinal complications caused by NSAIDs result in more than 100,000 hospitalizations and an estimated 16,500 deaths annually.(ii) This figure rivals the number of deaths per year from either AIDS, liver or ovarian cancer and is more than twice that of deaths from cervical cancer.(iii)" Click the title to read the article.

SOURCE American Chronic Pain Association
Web Site: http://www.harrisinteractive.com
http://www.managingyourrisk.org http://www.hieurope.com
http://www.novatris.com

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Facts about potential drug interaction with grapefruit juice, Questions and Answers

Category: Nutrition/Agriculture News
Article Date: 11 Oct 2005
Medical News Today

"P: -- Is it true that drinking grapefruit juice while taking medication is dangerous?
HCP: -- Grapefruit juice is safe to drink while taking most drugs, though it is true that certain prescription medications may interact. We can assess this potential with your medication(s) and determine whether an alternative, non-interacting medication is a viable solution if you'd like to continue drinking grapefruit juice.

"P: -- Does fresh grapefruit also interact with certain medications?
HCP: -- The components in grapefruit juice responsible for suppressing the CYP3A enzyme are also found in fresh grapefruit, and may cause interactions with the same medications affected by grapefruit juice.

"P: -- Which drugs interact with grapefruit juice?
HCP: -- Prescribed drugs known to interact are mostly limited to certain immunosuppressant, statin, calcium-channel blocker, HIV, hormone, antihistamine and psychiatric medications. In most cases, we can consider non-interacting, alternative medications within each drug class that should offer appropriate, safe treatment. In addition, it is safe to consume grapefruit and grapefruit juice while taking any over-the-counter medication.

"P: -- Can drinking grapefruit juice with over-the-counter medications, like cold pills or aspirin, cause bodily harm?
HCP: -- No. It is safe to consume grapefruit and grapefruit juice while taking any over-the-counter medication." Click the title to read more questions and answers.

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