JOYSMI capsules pose a serious risk to your health and should not be taken. Contains undeclared substances sibutramine, phenolphthalein and frusemide. - TGA

Therapeutic Goods Administration Australia - TGA

JOYSMI capsules pose a serious risk to your health and should not be taken.

3 April 2019

The Therapeutic Goods Administration (TGA) has tested a product labelled JOYSMI capsules and found that:

• The capsules contain the undeclared substances sibutramine, phenolphthalein and frusemide.

Consumers are advised that in Australia:

• Sibutramine is a prescription-only substance (which was the active ingredient in Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events.
• Phenolphthalein is a prescription-only substance previously marketed as an oral laxative, withdrawn from sale in the late 1990’s due to concerns over its carcinogenicity with long term use.
• Frusemide is a prescription-only substance used for the treatment of oedema and high blood pressure.

The supply of JOYSMI capsules containing undisclosed sibutramine, phenolphthalein and frusemide is illegal.

JOYSMI capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

Information for consumers

• Stop taking JOYSMI capsules and take any remaining capsules to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments of JOYSMI capsules from entering Australia.

If these capsules are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the internet:

• may contain undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Contact details

Phone	1800 020 653
Online:	Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email	info@tga.gov.au

• Category:Alert/Advisory
• Tags:buying online
• URL:https://www.tga.gov.au/node/874455

Abbott Laboratories agrees to withdraw its obesity drug Meridia (sibutramine)

Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events
[Posted 10/08/2010] Abbott Laboratories agrees to withdraw its obesity drug Meridia
FDA Earlier Alerted Public about the fact;
"Meridia (sibutramine) increases their risk of heart attack and stroke in patients with a history of cardiovascular disease"

“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “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.”

AUDIENCE: Primary Care, Consumers
ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.
BACKGROUND: 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 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 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 compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.
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.

[10/08/2010 - Drug Safety Communication - FDA]
[10/08/2010 - Questions and Answers - FDA][10/08/2010 - News Release - FDA]
Previous MedWatch Alert:
[01/21/2010 - Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review]

Meridia (sibutramine) increases their risk of heart attack and stroke in patients with a history of cardiovascular disease

FDA is alerting healthcare professionals that Meridia (sibutramine) is contraindicated in patients with a history of cardiovascular disease because the drug increases their risk of heart attack and stroke. Meridia is used to manage obesity.

In November 2009, an early communication from FDA reported preliminary study results suggesting that patients on 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, 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 Meridia and discontinue the drug if there are sustained increases in these measurements.

They should also discontinue 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 Meridia should talk with their healthcare professional about whether to continue using the drug.
Additional Information:

• FDA MedWatch Safety Alert. Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review. January 21, 2010.