European Medicines Agency (EMEA) recommends revocation of marketing authorisation for bufexamac containing medicines.

April 27, 2010

April 27, 2010 – From an announcement by the EMEA we learn that bufexamac-containing medicines were to be taken off EU markets because of high risk of contact allergies.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that marketing authorisations for bufexamac- containing medicines be revoked. The CHMP recommendations follow a scientific review, which identified a high risk of sometimes serious contact allergic reactions with bufexamac. The risk was even higher in patients with pre-disposing conditions, such as certain forms of eczema, for which bufexamac is frequently prescribed.

Furthermore, the allergic reactions caused by bufexamac are very similar to the disease being treated, which may lead to a potential delay in the correct diagnosis and treatment of patients. It is also likely that the difficulty to differentiate between a treatment failure and an allergic reaction has led to the cases of contact allergic reaction being underreported. In addition to this, the data to support the effectiveness of bufexamac are very limited, so the Committee concluded that, based on the available information, the benefits of the bufexamac-containing medicines did not outweigh its risks and recommended that they be taken off the market across the European Union.

Bufexamac is a non-steroidal anti-inflammatory drug (NSAID), used as topical formulations to treat dermatological diseases (eczema and dermatitis) and proctological conditions (haemorrhoids and anal fissure). Bufexamac-containing medicines have been available in EU Member States since the 1970s. It had been known for some time that bufexamac may trigger contact allergic reactions. This has led to restrictions on the use of the medicines in a number of EU countries over the years. The latest review of the benefits and risks of bufexamac was completed in December 2009 by the German medicines regulatory authority, which decided to withdraw all marketing authorisations for bufexamac in Germany. As required by EU legislation, the German authority informed the CHMP of its regulatory action, so that the Committee could prepare an opinion on whether the marketing authorisations for these medicines should be revoked all over the EU or whether they should be maintained, changed or suspended.

Based on the available data the CHMP concluded that the marketing authorisations for Bufexamac should be revoked. The CHMP’s opinion has now been sent to the European Commission for the adoption of a decision.

Previously, medicines containing bufexamac have been authorised as Parfenac, Bufal, Calmaderm, Fansamac, Mastu, Parfenoide, Proctosan or other trade names in Austria, Bulgaria, the Czech Republic, France, Hungary, Italy, Latvia, Lithuania, Luxembourg, Portugal, Romania and Slovakia. They may be available as creams, rectal ointments and suppositories. Because of the restrictions placed on these medicines over the years, their use in the EU is limited.

Please read his press release, together with other information on the work of the European Medicines Agency, on the Agency’s website at www.ema.europa.eu.


Cardiovascular Risk with Sibutramine [Meridia] in Patients with a History of Cardiovascular Disease

April 11, 2010

April 11, 2010 – FDA is alerting healthcare professionals that Sibutramine [Meridia] is contraindicated in patients with a history of cardiovascular disease because the drug increases their risk of heart attack and stroke. Sibutramine [Meridia] is used to manage obesity.

In November 2009, an early communication from FDA reported preliminary study results suggesting that patients on Sibutramine [Meridia] had a greater frequency of cardiovascular events than those not taking the drug. Additional data from the study has shown that the excess risk occurred in patients with a history of cardiovascular disease.

Based on this information, Sibutramine [Meridia] is now contraindicated in patients with a history of cardiovascular disease, including coronary artery disease, stroke or transient ischemic attack (TIA), cardiac arrhythmias, congestive heart failure, peripheral arterial disease, or uncontrolled hypertension. Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using Sibutramine [Meridia] and discontinue the drug if there are sustained increases in these measurements.

They should also discontinue Sibutramine [Meridia] in patients who do not lose at least 5 percent of their baseline body weight within the first three to six months of treatment, because further treatment is not likely to be effective and exposes the patient to unnecessary risk. Patients using Sibutramine [Meridia] should talk with their healthcare professional about whether to continue using the drug.

It is noteworthy that the European Agency for Medicinal Products (EMEA) earlier this year already concluded that the risks of Sibutramine containing medicines, previously on the market in Europe as Reductil, Reduxade, and Zelium, are greater than their benefits and recommended the suspension of marketing authorisations for these medicines across the European Union.   The Agency said that doctors should no longer prescribe, and pharmacists should no longer dispense the medicine.

This action in the European Union was taken based on the data from the Sibutramine Cardiovascular Outcome Trial (SCOUT) showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, with sibutramine compared with placebo. The SCOUT trial, in which nearly 10,000 patients were enrolled for up to six years, was designed to determine the impact of weight loss with sibutramine on cardiovascular problems in a large group of overweight and obese subjects with known or high risk for cardiovascular disease.

The American Food and Drug Agency (FDA), on the other hand, notified health care professionals that its review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. The decision come after the agency’s November 2009 Early Communication about an ongoing safety review of sibutramine, marketed as Meridia by Abbott, which has agreed to add the stronger warnings. Based on the serious nature of the review findings, the agency requested and the manufacturer – Abbott – agreed to add a new contraindication to the drug’s label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including a history of: coronary artery disease (eg, heart attack, angina), stroke or transient ischemic attack (TIA) heart arrhythmias, congestive heart failure, peripheral arterial disease; and uncontrolled hypertension.

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Thalidomide may fight blood vessel disorder: Nosebleeds eased with once-maligned drug

April 5, 2010

April 05, 2010 – A very recent article by msnbc.com indicates that thalidomide, a drug that caused birth defects when it was launched as a morning sickness pill half a century ago, may be useful for treating a hereditary condition that affects blood vessels.

In a study in the journal Nature Medicine, French researchers found giving thalidomide to patients with a disorder called hereditary hemorrhagic telangiectasia (HHT) reduced the severity and frequency of nosebleeds, one of the main symptoms.

Franck Lebrin, who led the study with colleagues from the National Institute for Health and Medical Research in Paris, said experiments on mice with HHT showed thalidomide treatment was able to repair blood vessel wall defects through a mechanism involving proteins involved in cell growth. “Biopsies of the nasal surface tissue from patients with HHT showed that similar mechanisms may explain the effects of thalidomide treatment in humans,” he wrote in the study.

HHT affects about one in 5,000 people. Many patients develop recurrent, difficult-to-treat nosebleeds which can significantly harm their quality of life.

Thalidomide was used to treat nausea during pregnancy in the 1960s. The drug was taken off the market after severe teratogenic congenital defects appeared in the newborns of mothers who had taken it (referred to as “contergan scandal” in germany).

More recently, thalidomide – which has powerful anti-cancer properties – experienced a revival and is now being used to treat certain forms of cancer such as multiple myeloma, and the drug is on the market in the US as Thalidomide [Thalomed]. U.S. drugmaker Celgene has developed a successor drug to thalidomide, called Lenalidomide [Revlimid], which is also approved to treat multiple myeloma.


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