FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans

April 30, 2009

April 27, 2009 – The Food and Drug Administration, in response to requests from the U.S. Centers for Disease Control and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test.

The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization revoked by the agency.

Current drug label information for Zanamivir [Relenza] and Oseltamivir [Tamiflu] can be found at Drugs@FDA (relenza, tamiflu) and DailyMed (relenza, tamiflu). Relenza is approved to treat acute uncomplicated illnesses due to influenza in adults and children 7 years and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years and older.

Tamiflu is approved for the treatment and prevention of influenza in patients 1 year and older. The EUAs allow for Tamiflu also to be used to treat and prevent influenza in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year. In addition, under the EUAs, both medications may be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs, and accompanied by written information pertaining to the emergency use. They may also be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses.

In authorizing an EUA for the rRT-PCR Swine Flu Panel diagnostic test, the FDA has determined that it may be effective in testing samples from individuals diagnosed with influenza A infections, whose virus subtypes cannot be identified by currently available tests. This EUA allows the CDC to distribute the swine flu test to public health and other qualified laboratories that have the needed equipment and the personnel who are trained to perform and interpret the results.

Please, view the full announcement here.


Recall of the Dietary Supplement Libimax

April 30, 2009
April 29, 2009 – The Food and Drug Administration (FDA) and Nature & Health Co. notified healthcare professionals of a recall of the supplement product Libimax. FDA analysis found the product contains tadalafil. Tadalafil is the pharmacologically active ingredient of Cialis, an FDA-approved drug for the treatment of erectile dysfunction.

Libimax poses a threat to health because its active ingredient tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Libimax in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.

Drug Label Information on the FDA-approved Tadalafil [Cialis] can be found at Drugs@FDA and DailyMed. The company’s press release on the recall of Libimax can be found here.

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FDA Requires Additional Labeling for Over-the-Counter (OTC) Pain Relievers and Fever Reducers

April 29, 2009
The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

The final rule applies to drugs and OTC-products that contain the pharmacologically active ingredients acetaminophen, ibuprofen, ketoprofen, naproxen, and aspirin. Drug labeling information on drugs containing these active ingredients can be found at Drugs@FDA and at DailyMed.

To read the final rule on the relabeling of OTC pain relievers and fever reducers, go to http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm

To read the FR Notice announcing the FDA Advisory Committee meeting, see this link: http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-9380.pdf

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Association of Etanercept [Enbrel] with Histoplasmosis and Other Invasive Fungal Infections

April 24, 2009

April 21, 2009 – Endorsed by Health Canada, Amgen Canada informed the Canadian public of important updated safety information regarding Etanercept [Enbrel].

Thus, Amgen Canada alerted the public to the risk of invasive fungal infections, including histoplasmosis, in patients taking so-called Tumor Necrosis Factor (TNF) blockers, including Etanercept [Enbrel]. This way, patients and their health care professionals should be able to better recognize and treat these infections. The updated safety information reads as follows (adapted):

– There have been reports of patients developing serious fungal infections, such as histoplasmosis, coccidioidomycosis, and blastomycosis, in the lung and sometimes, spreading throughout the body (invasive fungal infection) while taking TNF blockers, such as Etanercept [Enbrel]. In some patients, these types of fungal infections were not recognized at first, delaying treatment. Some of these patients died from invasive fungal infection.

– If you are taking a TNF blocker, you should tell your doctor if you develop symptoms, such as fever, tiredness, weight loss, sweats, cough, or difficulty in breathing. You should also tell your doctor if you live or work in, or have traveled to, areas where these infections are more common.

Etanercept [Enbrel] is a medicine called a Tumor Necrosis Factor (TNF) blocker. It is currently authorized in Canada for the treatment of rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and plaque psoriasis.

Serious fungal infections such as histoplasmosis are non-contagious diseases caused by molds (fungus) usually found in the soil, or hay. Certain invasive fungal infections including histoplasmosis are seen most frequently in the central and eastern portions of the United States of America (U.S.A.) and in the Saint Lawrence River valley in Canada. Coccidioidomycosis is commonly found in the Southwestern portion of the U.S.A. The vast majority of people infected with this fungus have either no symptoms or mild flu-like symptoms that do not require medical attention, however, sometimes in people with weakened immune systems, the fungus can spread through the body and be fatal if untreated.

Patients with questions regarding their current treatment are asked to contact their doctor or pharmacist. The safety information in the Canadian Product Monograph (CPM) for Etanercept [Enbrel] has also been revised to highlight the risk of invasive fungal infection, and a letter has been sent to Canadian healthcare professionals to inform them of this update.

The original advisory by the Marketed Health Products Directorate (MHPD) Canada can be found here. The Canadian Product Monograph (CPM) can be found on the Amgen Website.

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Nationwide Voluntary Recall of Dietary Supplement Products Found to Contain Sibutramine, an Undeclared Drug Ingredient

April 23, 2009

April 20, 2009 — Universal ABC Beauty Supply International has been informed by the Food and Drug Administration (FDA) that FDA lab analyses of the dietary supplements distributed by the company were found to contain undeclared Sibutramine, the pharmacologically active ingredient of the FDA-approved Reductil, used as an appetite suppressant for weight loss. As a consequence, Universal ABC Beauty Supply International voluntarily recalls the affected products (as listed below) nationwide because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers.

These dietary supplements are not supposed to contain Sibutramine. The FDA has not approved these products, therefore the safety and effectiveness of these products is unknown. FDA advises that these products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

All lots of the following dietary supplement products are being recalled:

1.   ProSlim Plus, 60 capsules, bottle in box
2.   3 DAYS fit, 60 capsules, bottle in box
3.   EIGHT FACTOR DIET, 60 capsules, 3 pouches/box
4.   24hours Diet, 60 capsules
5.   Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box
6.   3X SLIMMING POWER, 60 capsules, bottle in box
7.   Extrim Plus 24 Hours RE-BURN Formula, 60 capsules
8.   Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box
9.   Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box
10. SLIM EXPRESS 360º C
11. SLIM EXPRESS 4in1, 60 capsules, bottle in box
12. ROYAL SLIMMING FORMULA, 60 capsules, bottle/box
13. BODY CREATOR, 90 capsules, 3 pouches/box
14. Slim Waistline (labeling written in Chinese)
15. BODY SHAPING, 90 capsules, 3 pouches/box
16. PERFECT SLIM, 90 capsules, 3 pouches/box
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula, 32 capsules, 2 pouches/box
20. Super Slimming, 60 capsules, bottle in box
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER, 60 capsules, bottle in box
25. SLIMMING FORMULA
26. SLIM FAST 2, 32 capsules, 2 pouches/box
27. SLIM FAST, 60 capsules, 3 pouches/box
28. Slim up, 120 capsules, bottle in box
29. 7 DAYS DIET, 60 capsules, 3 pouches/box
30. Perfect Slim Up, 60 capsules, bottle in box
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2

The company has discontinued distribution of these products. It sincerely regrets any inconvenience to customers. Consumers should not consume the above products and should return the dietary supplements on hand to the place of purchase for a full refund or partial refund of the unused portion.

Please find the original announcement by the FDA and the press release by the company here and here, respectively.


Natalizumab [Tysabri]: Yet another case of Progressive Multifocal Leukoencephalopathy (PML)

April 22, 2009

April 22, 2009 – The makers of Natalizumab [Tysabri], Biogen Idec, on April 20, 2009, have revealed yet another new case of progressive multifocal leukoencephalopathy (PML) in a multiple sclerosis patient being treated with Natalizumab [Tysabri].

That means that six patients have developed the potentially deadly brain infection since Natalizumab [Tysabri] was reintroduced to the market in July 2006. In the latest case, the patient had been on the drug for 31 months, the longest duration so far. The previous high had been 26 months and the average now is 19 months. Biogen added that 6,800 patients have been on Natalizumab [Tysabri] over 24 months, 14,400 over 18 months and 24,900 at least one year.

Progressive multifocal leukoencephalopathy (PML) is caused by the reactivation of a common virus in the central nervous system of immune-compromised individuals.  Polyomavirus JC (often called JC virus) is carried by a majority of people and is harmless except among those with lowered immune defenses.  The disease occurs, rarely, in organ transplant patients, people undergoing chronic corticosteroid or immunosuppressive therapy; and individuals with cancer, such as Hodgkin’s disease, lymphoma, and sarcoidosis.  PML is most common among individuals with acquired immune deficiency syndrome (AIDS). Studies estimate that prior to effective antiretroviral therapy, as many as 5 percent of people with AIDS eventually developed PML. For them, the disease was most often rapidly fatal.

Besides Natalizumab [Tysabri], there are other pharmacological agents associated with case reports of PML, including Tacrolimus [Prograf], Rituximab [Rituxan], Mycophenolate Mofetil [CellCept], and Mycophenolic Acid [Myfortic]. Most prominently, Efalizumab [Raptiva] is just being withdrawn from the market based on its association with progressive multifocal leukoencephalopathy (PML).

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Children whose mothers took valproate while pregnant have lower IQ’s

April 17, 2009
April 17, 2009 – Children born to women who took the epilepsy drug valproate while pregnant had lower IQs at least up to age 3 than the children of women who took rival epilepsy drugs, according to research reported in the New England Journal of Medicine on April 16, 2009.

Between 1999 and 2004 pregnant women with epilepsy who were taking a single antiepileptic agent (carbamazepine, lamotrigine, phenytoin, or valproate) were enrolled in a prospective, observational, multicenter study in the United States and the United Kingdom with the goal to compare the neurodevelopmental outcomes of their children at the age of 6 years after exposure to the antiepileptic drugs in utero.

The interim analysis of cognitive outcomes in 309 of these children at 3 years of age indicates that children who had been exposed to valproate in utero had significantly lower IQ scores than those who had been exposed to other antiepileptic drugs. Thus, the mean IQ was 101 for children exposed to lamotrigine, 99 for those exposed to phenytoin, 98 for those exposed to carbamazepine, and 92 for those exposed to valproate. On average, children exposed to valproate had an IQ score 9 points lower than the score of those exposed to lamotrigine, 7 points lower than the score of those exposed to phenytoin, and 6 points lower than the score of those exposed to carbamazepine. The association between valproate use and IQ was dose dependent. Children’s IQs were significantly related to maternal IQs among children exposed to carbamazepine, lamotrigine, or phenytoin but not among those exposed to valproate.

In conclusion, these data indicate that maternal exposure of the unborn child to valproate, as compared with other commonly used antiepileptic drugs, is associated with an increased risk of impaired cognitive function at 3 years of age. They lend support to the recommendation that valproate not be used as a first-choice drug in women of childbearing potential.

In the US, valproate ist in the is on the market as depacon and valproate sodium. Lamotrigine ist on the market as lamictal, lamictal CD, and generic lamotrigine. Carbamazepine is on the market as tegretol, tegretol XR, carbatrol, equetro, epitol, teril, and generic carbamazepine. Phenytoin is on the market as dilantin, dilantin-125, extended phenytoin sodium, phenytek, and generic phenytoin.

More information releated to this topic can be found at the: New England Journal of Medicine (2009) 360: 1597-1605, and at Drugs@FDA or DailyMed for antiepileptic drugs, their drug labels, and boxed warnings, where applicable.

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Voluntary Withdrawal of Efalizumab [Raptiva] From the U.S. Market. Statement by the FDA

April 9, 2009
April 8, 2009 – Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.

This action follows measures by the European Medicinal Agency (EMEA) earlier this year which led to a suspension of the marketing authorization for Raptiva in countries of the European Union and which led the Swiss Medicinal Agency (Swissmedic) to suspend the marketing authorization for Raptiva per May 1, 2009.

Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva’s labeling regarding PML. Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.

Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

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Crop herbicide may cause cancer

April 2, 2009
April 1, 2009 – Exposure to the crop herbicide imazethapyr might promote the development of some cancers, researchers report in the International Journal of Cancer.

Exposure to the crop herbicide imazethapyr might promote the development of some cancers, researchers report in the International Journal of Cancer.

Imazethapyr belongs to a group of chemicals called heterocyclic amines and “there is a wealth of evidence implicating several heterocyclic amines as (cancer causing), although not all of these compounds are equally harmful,” lead researcher Dr. Stella Koutros told Reuters Health. “Several heterocyclic amine compounds are used in occupational settings, such as use of the crop herbicide imazethapyr among farmers.”

Koutros of the National Cancer Institute, Rockville, Maryland, and colleagues analyzed data from 1993 to 1997 on more than 20,000 pesticide workers who had used imazethapyr. Through 2004, almost 3000 incident cancers developed in this group.

Workers exposed to the highest levels of imazehapyr were over twice as likely to develop bladder cancer than workers who were not exposed to the agent at all. Similarly, high exposure to imazethapyr increased the odds of colon cancer by 78 percent.

By contrast, exposure to the pesticide did not seem to cause cancers of the prostate, lung, or kidney, or the skin cancer melanoma.

The results suggest that imazethapyr exposure may be overlooked as a cause of bladder and colon cancer, Koutros said.

She and her colleagues therefore conclude, “The use of imazethapyr and other (related) compounds should continue to be evaluated for potential risk to humans.”

SOURCE: New York (Reuters Health), April 1, 2009, and International Journal of Cancer, March 1, 2009.


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FDA orders unapproved narcotic pain medication off market

April 1, 2009

March 31, 2009 – The Food and Drug Administration (FDA) today ordered 14 unapproved narcotic painkillers off the market. These painkillers contain the potent active ingredients morphine, hydromorphone or oxycodone. FDA told nine manufacturers to quit distributing the drugs within 90 days. For patients relying on opoid-type medications for pain relief there are plenty of legal versions of these painkillers being sold, and there will be no shortage for consumers, according to Dr. Deborah Autor, director of FDA’s drug compliance office.

With the current action the FDA targets the unapproved versions of high-concentrate liquid morphine sulfate and unapproved immediate-release tablets containing morphine sulfate, hydromorphone and oxycodone, most of which are generic. The move is part of the FDA’s years-long attempt to weed out thousands of prescription drugs that sell despite never being formally approved by the health regulatory agency. The FDA estimates that unapproved drugs account for 2 percent of all prescriptions filled.

Please note that even FDA-approved versions of these painkillers pose a risk of serious side effects. The active pharmaceutical ingredients morphine sulfate , hydromorphone, and oxycodone are potent drugs of the opioid class. Opioids are a family of related drugs that relieve pain. All of the opioids (sometimes called narcotics) are chemically related to opium, which is a substance collected from the poppy plant. Prescription opioids have benefit when used properly and are an essential component of pain management and treatment of pains such as cancer pain.

However, opioid drugs also have serious risks when used improperly. Tolerance to, and physical and psychological dependence on these drugs may rapidly develop with their use. They can also produce feelings of euphoria. As such, these narcotics have the potential to be highly addictive, and are extremely popular drugs of abuse. Use of morphine sulfate, hydromorphone, or oxycodone may impair motor skills or judgments, making it unsafe to operate machinery, drive, or engage in other potentially dangerous activities.  Improper use of morphine sulfate, hydromorphone, or oxycodone can lead to serious illness, injury, or death.  People who overdose on narcotics may stop breathing or have a heart attack. The unapproved products add an extra problem: Regulators haven’t checked that those versions work as well and are as pure as their approved competitors.

Consumers can find the complete information regarding both, FDA approved and unapproved drug products here.


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