TENS of thousands of packs of Valium are being recalled after blister strips of the sleeping pill and anti-anxiety drug were stolen from packs and other medicines substituted.
The Department of Health has failed to issue a media release to notify the public of the danger, even though NSW police are investigating and patients are at risk of double dosing on the substituted medicines.
When it became aware of the problem last week the Therapeutic Goods Administration put up a notice on its website.
Packs of paracetamol codeine pills used for pain, rosuvatstain pills used to control cholesterol and pantoprazole pills used for stomach ulcers have also been recalled in connection with the substitution.
Thirty thousand Valium prescriptions are dispensed each month to treat anxiety, relax muscles, to treat trembling, confusional states or anxiety associated with alcohol withdrawal, and/or to treat panic attacks.
Recall: Valium (diazepam) 5 mg tablets in 50 tablet blister packs. For details see https://t.co/gQomALUcKT— TGA Australia (@TGAgovau) May 26, 2017
A spokesman for Health Minister Greg Hunt said the TGA put out a public notification on its website on 26 May.
"In addition, the manufacturer is undertaking a public recall," he said.
THE FULL RECALL NOTICE
Recall - potential medicine tampering
Consumers and health professionals are advised that Roche Products, in consultation with the TGA, is recalling all batches of Valium 5 mg tablets supplied in blister packs of 50 tablets due to the discovery of evidence of medicine tampering.
Valium 5 mg tablets contain diazepam, which is used to treat anxiety disorders, alcohol withdrawal symptoms and muscle spasms.
It has been identified that blister pack sheets containing other medicines have been substituted into some packs of Valium 5 mg tablets. These medicines may include (but may not be limited to) BTC Paracetamol Codeine tablets, BTC Rosuvastatin 10 mg tablets and Apotex-Pantoprazole 40 mg tablets.
If a patient has an affected pack, there is a risk that they will not have adequate supply of their medicine and could take the incorrect medicine, which could have serious health consequences.
The issue is currently being investigated in conjunction with the relevant authorities. However, it is believed that the tampering is not widespread.
Information for consumers
If you or someone you provide care for takes Valium 5 mg tablets supplied in 50 tablet blister packs, do not take them and please promptly return any unused medicine to a pharmacy for a refund and to arrange alternative medicine (you may need to bring a valid prescription/repeat).
If possible, you're advised to return your Valium to the same pharmacy from which it was dispensed.
There are a number of generic diazepam products that are bioequivalent to Valium. They contain the same active ingredient and work in the same way, and in most situations can be safely substituted for any returned Valium.
Please note that all tablets or capsules supplied in a pack should be identical and any product names on the blister packs should match those on the external packaging. If you notice any discrepancies with your medicine, talk to your pharmacist.
If you have any other questions or concerns about this issue, talk to your health professional.
Information for health professionals
If you treat patients who take Valium, please be aware of this issue.
Roche Products has written to pharmacists providing further information about this issue, including details of the recall process. Please inspect your stock and quarantine all batches of Valium 5 mg tablets supplied in blister packs of 50 tablets before returning them to your wholesaler.
Patients returning unused or partially used packs of Valium 5 mg tablets in 50 tablet blister packs should be provided a full refund and, if possible, offered an equivalent generic product to ensure continuation of therapy and avoid any risks of discontinuation symptoms. If Valium was dispensed under instructions by the prescriber to not substitute, you may need to contact the prescriber to discuss this issue.
If you have any further questions or concerns about this issue, please contact Roche Products on 1800 233 950 (for general inquires).
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