European Medicines Agency (EMA) starts review of aliskiren-containing medicines

January 17, 2012 - Recently, the European Medicines Agency (EMA) has announced that it  is reviewing aliskiren-containing medicines, to assess the impact of data coming from the ALTITUDE study on the balance of benefits and risks of these medicines in their approved indication. Aliskiren-containing medicines are approved for the treatment of essential hypertension. ‘Essential’ means that there is no obvious cause for high blood pressure.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) started the review after it was informed on 19 December 2011 by the marketing authorisation holder of the decision to terminate the ALTITUDE study early. This clinical trial included patients with type 2 diabetes and renal impairment and/or cardiovascular disease. In most patients arterial blood pressure was adequately controlled. The patients included in the trial received aliskiren in addition to either an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).

Termination of the placebo-controlled phase III trial was recommended by the independent Data Monitoring Committee overseeing the study, because the results showed that there was no benefit with aliskiren and that there were more cases of stroke, renal complications, hyperkalemia and hypotension in patients who received aliskiren compared with patients who received a placebo.

The information available at present is limited. The Committee has asked the company to provide additional analyses to allow the CHMP to assess the impact of the results of the ALTITUDE trial on the overall benefit-risk profile of aliskiren-containing medicines and to determine the need for regulatory action.

Interim advice for doctors and patients

While the review is ongoing the CHMP recommends, as a precautionary measure, that doctors should not prescribe aliskiren-containing medicines to diabetic patients in combination with ACE inhibitors or ARBs.

Doctors should therefore review the treatment of patients taking aliskiren at a routine (non-urgent) appointment, and if patients are diabetic and are also taking ACE inhibitors or ARBs, aliskiren should be stopped and alternative treatments considered.

Patients should not stop any of their treatment before speaking to their doctor, because stopping anti-hypertensive medication without medical supervision can put them at risk. They are advised to discuss their treatment with their doctor at their next scheduled (non-urgent) appointment.

Patients in clinical trials with aliskiren should contact their study site for guidance on their medication.

Further information on the review of aliskiren-containing medicines will be provided when available.

 Additional Notes

• Eight aliskiren-containing medicines are authorised in the European Union since 2007: Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Riprazo, Riprazo HCT, Sprimeo, Sprimeo HCT. Some of these medicines (Rasilamlo, Rasilez HCT, Rasitrio, Riprazo HCT and Sprimeo HCT) are combinations of aliskiren with other antihypertensive medicines.
• The review of aliskiren is conducted in the context of a formal review, initiated at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004.

Bevacizumab [Avastin]: Process for Removal of Breast Cancer Indication Begun Because of Lack of Efficacy

December 16, 2010  -  Today, the American Food and Drug Administration notified healthcare professionals and patients that it is recommending removing the breast cancer indication for Bevacizumab [Avastin] because the drug has not been shown to be safe and effective for that use. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

Background:

The Food and Drug Administration (FDA) is making this recommendation after reviewing the results of four clinical studies of Bevacizumab [Avastin] in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. None of the studies demonstrated that patients receiving Bevacizumab [Avastin] lived longer and patients receiving Bevacizumab [Avastin] experienced a significant increase in serious side effects. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

Recommendation:

Oncologists currently treating patients with Bevacizumab [Avastin] for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

Patients currently receiving Avastin for breast cancer should speak with their oncologists about whether to continue their treatment or explore other treatment options.

More Information:

[12/16/2010 - News Release - FDA]
[12/16/2010 - Questions and Answers about Avastin - FDA]
[12/15/2010 - Avastin Decision Memo (PDF - 125KB) - FDA]

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Gemtuzumab Ozogamicin [Mylotarg]: Market Withdrawal

June 21, 2010 -  FDA notified healthcare professionals that results from a recent clinical trial raised new concerns about the product’s safety, and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

Background:

Gemtuzumab Ozogamicin [Mylotarg], indicated for treatment of acute myeloid leukemia (AML), a bone marrow cancer, was approved in May 2000 under the FDA’s accelerated approval program. A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Gemtuzumab Ozogamicin [Mylotarg] to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Gemtuzumab Ozogamicin [Mylotarg] compared with those receiving chemotherapy alone.

Recommendation:

Gemtuzumab Ozogamicin [Mylotarg] will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Gemtuzumab Ozogamicin [Mylotarg] of the product’s potential safety risks. Any future use of Gemtuzumab Ozogamicin [Mylotarg] in the United States will require submission of an investigational new drug application to the FDA.

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FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products

May 03, 2009 – The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus are Oseltamivir [Tamiflu] and Zanamivir [Relenza].  Tamiflu and Relenza, in addition to their approved labeling, have Emergency Use Authorizations that describe specific authorized uses during this public health emergency.

However, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are urgently alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus.  The agencies are also advising operators of offending web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.

“Consumers who purchase products to treat the novel 2009 H1N1 virus that are not approved, cleared or authorized by the FDA for the treatment or prevention of influenza risk their health and the health of their families,” said Michael Chappell, acting FDA Associate Commissioner for Regulatory Affairs. “In conjunction with the Federal Trade Commission, the FDA has developed an aggressive strategy to identify, investigate, and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.”

Products that are offered for sale to the public with claims to diagnose, prevent, mitigate, treat, or cure infections caused by the H1N1 influenza virus that have not  been proven to be safe and effective for these uses must be carefully evaluated. Many of these deceptive products are being sold over the Internet via illegitimate web sites. The operators of these web sites take advantage of the public’s concerns about H1N1 influenza and their desire to protect themselves and their families.  These fraudulent products come in all varieties and could include dietary supplements or other food products, or products purporting to be drugs, devices or vaccines.  Such fraudulent products will not prevent the transmission of the virus or offer effective treatments against infections caused by the H1N1 influenza virus.

More information about FDA-approved antiviral drugs for influenza is available here. More information on CDC recommendations regarding use of antiviral drugs against the current novel 2009 H1N1 influenza is available here. Consumers should also visit FDA’s web site for tips about how to protect themselves when buying medicines online.

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

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.

Crop herbicide may cause cancer

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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Mycophenolate Mofetil [CellCept] Medication Guide

On February 12, 2009, FDA and together with Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.

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Mycophenolic Acid [Myfortic] Medication Guide

On March 24, 2009,  FDA and together with Novartis notified healthcare professionals of the introduction of a Myfortic Medication Guide to provide important safety information in language that patients can easily comprehend. By May 15, 2009, a copy of the Myfortic Medication Guide will be enclosed with every Myfortic bottle. Pharmacists are required to distribute a copy of the Medication Guide with every Myfortic prescription.

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Benzamidenafil and Zencore Plus: Voluntary Recall

On March 20, 2009, Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of all the company’s supplement product sold under the name Zencore Plus. FDA lab analysis of Zencore Plus samples found the product contains benzamidenafil, an undeclared drug product and a phosphodiesterase-5 (PDE-5) inhibitor.

Although different in chemical structure, benzamidenafil, not approved for any use, is likely to have the same pharmacological effects as the three FDA-approved PDE-5 inhibitors sildenafil [Viagra], tadalafil [Cialis], and vardenafil [Levitra], widely used in the therapy of male erectile dysfunction. Thus, the use of Zencore Plus by an unsuspecting user oforganic nitrates may pose a life-threatening risk of sudden andprofound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates. Zencore Plus is sold in health food stores and by mail order on internet nationwide. Consumers who have this product in their possession should stop using it immediately.

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FDA Uncovers Additional Tainted Weight Loss Products

The U.S. Food and Drug Administration is expanding, for the second time, its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients.

Such products pose a serious health problem to consumers worldwide in that they are easily available through a variety of online pharmacies, online health stores or from manufacturers directly. Sometimes, the information accompanying such products refers to some “miracle” type of ingredient whitout clearly itentifying it as to its chemical nature, its pharmacological effects, or its associated health risks. This leaves consumers with no clues, largely unprotected and at considerable risks for their own health. FDA and health authorities of many other countries thankfully have started to identify and alert the public about products at fault.

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