Prescrire international
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Prescrire international · Jun 2014
Delta-9-tetrahydrocannabinol + cannabidiol. A reasonable option for some patients with multiple sclerosis.
Conventional drugs have only a limited impact on spasticity associated with multiple sclerosis and are rarely satisfactory. A solution for oral transmucosal delivery (spray) containing a mixture of cannabis extracts (2.7 mg of delta-9-tetrahydrocannabinol + 2.5 mg of cannabidiol per spray) has been granted marketing authorisation in France for patients who are inadequately relieved by standard treatments. Three double-blind, placebo-controlled trials in a total of about 300 patients tested this combination, in addition to ongoing treatment, for periods of 6 to 14 weeks. ⋯ Pharmacokinetic interactions due to P-glycoprotein inhibition are likely. Treatment during pregnancy may lead to neonatal withdrawal symptoms. In practice, about 10% of patients in whom standard anti-spastic medications are unsatisfactory benefit from a specific effect of the cannabis extracts contained in this oral spray.
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Prescrire international · May 2014
Comparative StudyTapentadol. Acute or chronic pain: no therapeutic advance.
The standard opioids for relieving moderate to severe pain are: codeine as a step 2 analgesic and morphine for step 3. Tapentadol is an opioid similar to tramadol. An immediate-release form has been authorised in France for moderate to severe acute pain in adults and a sustained-release form for severe chronic pain in adults. ⋯ Gastrointestinal disorders appeared less common with tapentadol than with oxycodone, but the data could well be biased due to the use of a relative overdose of oxycodone in the trials. In practice, the evaluation of tapentadol was not designed to show whether this drug represents a therapeutic advance. Its analgesic efficacy remains unclear, and it provokes the adverse effects common to all opioids.
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Drug packaging is important both in protecting and informing patients. Some improvements were made in 2013, but many of the products examined by Prescrire still had poor-quality or even dangerous packaging. Problem packaging is a major concern for patients who are more vulnerable to adverse effects, particularly children and pregnant women. ⋯ Looking back at 20 years of Red Cards that Prescrire has issued to products with dangerous packaging reveals several improvements, but too many dangers persist. Urgent action needs to be taken by regulatory agencies and drug companies: patient leaflets must be more explicit with regard to adverse effects, especially those of nonsteroidal anti-inflammatory drugs during pregnancy; accidental ingestion by children must be prevented; and companies must design safer dosing devices. Healthcare professionals and patients must remain vigilant and report all packaging issues to the relevant authorities.
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Nicotine is widely used in smoking cessation aids. They are marketed in many forms, including: chewing gum, sublingual tablets, lozenges, transdermal patches, cartridges for oral inhalation, and mouth spray. French poison control and toxico-vigilance centres identified 318 cases of exposure to nicotine replacement products in children under the age of 10 years between 2000 and 2010. ⋯ Most cases of poisoning involving transdermal patches occur when a child finds an unused patch, or a used patch that an adult has discarded in a bin without taking proper precautions. Sometimes they involve patches that have become detached from an adult's skin. In practice, it is important to warn adults using smoking cessation aids containing nicotine that these products are dangerous