Sitaxentan [Thelin] to be withdrawn from market worldwide due to cases of unpredictable serious liver injury

December 13, 2010 – We learn today that the European Medicines Agency (EMEA) has been informed of Pfizer’s decision to voluntarily withdraw Sitaxentan [Thelin] from the market worldwide further to new information on two cases of fatal liver injury. Pfizer has also decided to discontinue all ongoing clinical trials.

Sitaxentan [Thelin], has been authorised in the European Union (EU) since 2006 for the treatment of pulmonary arterial hypertension (PAH). Sitaxentan [Thelin] was marketed in 16 European Union (EU) Member States, in Australia and in Canada.

Sitaxentan [Thelin] has been known to be associated with liver toxicity and since its initial marketing authorisation has been contra-indicated in patients with mild to severe hepatic impairment (Child-Pugh Class A-C) and elevated aminotransferases prior to initiation of treatment.

At this stage, patients taking Sitaxentan [Thelin] or participating in Sitaxentan [Thelin] studies are advised not to stop treatment and to consult their treating physician to review their treatment at their next scheduled appointment.

The Agency’s scientific Committee for Medicinal Products for Human Use (CHMP) will look at this issue during their plenary meeting on 13–16 December 2010 and will provide detailed advice for patients and prescribers.

There exist alternatives for the therapy of pulmonary arterial hypertension (PAH), among them, and depending on their availability in the different markets worldwide, Bosentan (Tracleer), Sildenafil [Revatio], Ambrisentan [Letairis, EU trade name Volibris], and Tadalafil [Adcirca].

Sibutramine [Meridia]: Market Withdrawal Due to Risk of Serious Cardiovascular events

October 08, 2010 – Today, we learn that Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary market withdrawal of Sibutramine [Meridia], an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Sibutramine [Meridia] was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving Sibutramine [Meridia] lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of Sibutramine [Meridia]  after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given Sibutramine [Meridia] compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received Sibutramine [Meridia].

RECOMMENDATION

Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

More information can be found at FDA Drug Safety Communications for Sibutramine [Meridia] and at FDA Questions and Answers concerning Sibutramine [Meridia].

European Medicines Agency Recommends Suspension of the Rosaglitazone Containing Drugs Avandia, Avandamet and Avaglim

September 24, 2010 – Please find below a very significant announcement by the European Medicines Agency (EMEA) regarding the market suspensions of Avandia throughout the European Union.

09/23/2010 – The European Medicines Agency today recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months.

Patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments. Patients are advised not to stop their treatment without speaking to their doctor.

Doctors should stop prescribing rosiglitazone-containing medicines. Patients taking rosiglitazone-containing medicines should be reviewed in a timely manner to amend their treatment.

The current review of rosiglitazone by the Agency’s Committee for Medicinal Products for Human Use (CHMP) was initiated on 9 July 2010 following the availability of new studies questioning the cardiovascular safety of the medicine.

Since its first authorisation, rosiglitazone has been recognised to be associated with fluid retention and increased risk of heart failure and its cardiovascular safety has always been kept under close review. Consequently, the use of rosiglitazone was restricted to a second-line treatment and contra-indicated in patients with heart failure or a history of heart failure when it was first granted a marketing authorisation as Avandia in 2000.

Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone. Further restrictions on the use of these medicines in patients with ischaemic heart disease were introduced.

The availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk of rosiglitazone. In view of the restrictions already in place on the use of rosiglitazone, the Committee could not identify additional measures that would reduce the cardiovascular risk. The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines.

The suspension will remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.

The Committee’s recommendation has now been forwarded to the European Commission for the adoption of a legally binding decision.

Notes

* Rosiglitazone was initially authorised as Avandia in the European Union in July 2000 as second-line diabetes type-2 treatment to be used when other treatments have either failed or are unsuitable for a patient. It was subsequently approved in combination with metformin as Avandamet and with glimepiride as Avaglim.

* The review of the marketing authorisations of Avandia, Avandamet and Avaglim was initiated on the request of the European Commission under Article 20 of Regulation (EC) No 726/2004, following the publication of two studies on 28 June 2010. References for the two studies are as follows: Graham DJ et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA doi:10.1001/jama.2010.920. Nissen SE et al. Rosiglitazone revisited. An updated meta analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med doi:10.1001/archinternmed.2010.207.

Recall of Products Marketed as Dietary Supplements Containing Aromatase Inhibitors

September 20, 2010 – We learn today from a press release by the American Food and Drug Administration (FDA)  the following (text adapted):

Aromatase inhibitors in products marketed as dietary supplements are being  recalled, including the products Arom-X, Arom-X UTT, Arom-XL, 4-AD, Decavol, ArimaDex, Clomed, Off Cycle II Hardcore, and Reversitol.

All these products marketed as dietary supplements contain aromatase inhibitors, commonly known as “ATD.” Adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events.

The FDA concludes that products containing aromatase inhibitors have a reasonable probability of resulting in permanent impairment of a body structure or function in at risk consumers. FDA has notified manufacturers that these products do not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act. Many of these products are or had been sold nationwide, both in retail stores and via the internet directly to consumers. Some have been discontinued but some online retailers may still have remaining inventory that they are offering for sale.

Recommendation by FDA:

Consumers who have any of these products in their possession should stop using it immediately. If consumers experience any adverse side effects due to its consumption they should contact a physician. Photos of the recalled products are available through links on the company press releases, seen below.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Programm at www.fda.gov/MedWatch/report.htm.

For your information, please find below the press releases of the individual companies concerned with this recall.

[09/15/2010 – Press Release – Kilosports, Inc]
[09/13/2010 – Press Release – Genetic Edge Technologies, Inc]
[09/16/2010 – Press Release – Advanced Muscle Science, Inc]
[09/16/2010 – Press Release – Fizogen Precision Technologies, Inc]
[09/16/2010 – Press Release – iForce Nutrition LLC]

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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