Prescrire international
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Prescrire international · Jun 2007
Packaging of pharmaceuticals: still too many dangers but several encouraging initiatives.
(1) In 2006 in France, several drugs sold in poorly designed packaging exposed patients to a risk of serious adverse effects. (2) In 2006, Prescrire used a standardised methodology to examine the packaging of all new pharmaceutical products (656 different boxes) assessed in the New Products section of our French edition, la revue Prescrire. About 75% of these boxes contained tablets or capsules, mostly in blister packs. (3) Poor labelling remains a major problem. The international nonproprietary names (INN) is hard to spot on most boxes of patented brand-name drugs and is often overshadowed by the brand name. ⋯ European Directive 2004/27/EC on medicines for human use provides for improvements in labelling (e.g. Braille) and patient information leaflets. Transposition of these measures into French law should lead to a number of improvements, provided the relevant regulations and guidelines place patients' interests first.
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Prescrire international · Jun 2007
Sodium oxybate: new drug. Fewer attacks of cataplexy in some patients.
(1) Narcolepsy is characterised by sudden, overwhelming daytime drowsiness, sometimes associated with cataplexy (more or less complete loss of muscle tone during an emotional reaction). (2) Modafinil moderately reduces daytime drowsiness but has no effect on cataplexy. Methylphenidate, an amphetamine psychostimulant, seems to act on both drowsiness and cataplexy, although its clinical evaluation is limited to observational series. (3) Oxybic acid, long used in general anaesthesia, but also misused for recreational and criminal purposes (chemical or drug-induced submission), has been approved to treat adults with both narcolepsy and cataplexy, in the form of an oral solution of sodium oxybate. (4) The rationale behind the use of sodium oxybate is to re-establish a near-normal pattern of the different phases of sleep. Because of its short-lasting action, sodium oxybate has to be taken once at bedtime and then again 2.5 to 4 hours later. (5) Clinical evaluation mainly consists of 4 double-blind placebo-controlled trials of sodium oxybate. ⋯ The results suggest that sodium oxybate is effective in the long term. (6) During clinical trials, 61% of patients had adverse effects attributed to sodium oxybate. These included gastrointestinal disorders (nausea (18%)), neurological disorders (dizziness (15%), headache (6%)), confusion (3%), and enuresis (7%). (7) Altered consciousness and respiratory depression occurred after a single intake of a dose two or three times higher than the recommended dose. (8) Misuse, especially to obtain chemical or drug-induced submission (i.e. as a 'date rape' drug), is facilitated by the odourless and colourless nature of the oral solution. (9) In practice, for some patients who are seriously affected by persistent episodes of cataplexy or drowsiness, despite treatment of narcolepsy, sodium oxybate is preferable to methylphenidate, which has been less thoroughly evaluated. However, the risks of misuse and overdose mean that this drug should only be proposed to patients in whom the benefits are likely to outweigh the risks.
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Too many adverse effects for a minor effect on weight loss, without reduced rates of complications.
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Prescrire international · Jun 2007
Pregabalin: new indication. Generalised anxiety: better to use benzodiazepine.
Seven placebo-controlled trials have shown that pregabalin has a modest effect on generalised anxiety in the short term. Pregabalin has not been shown to be as effective as a benzodiazepine or better tolerated.
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Prescrire international · Jun 2007
Human papillomavirus vaccine for genotypes 6, 11, 16 and 18: new drug. Cervical cancer prevention: high hopes....
(1) Most cases of high-grade anogenital dysplasia and malignancy are caused by human papillomavirus (HPV) genotypes 16 and 18. Anogenital papilloma and condyloma acuminata are mainly caused by HPV6 and HPV11. (2) A recombinant vaccine covering these four genotypes is now marketed in the European Union for the prevention of condyloma, precancerous lesions, and cancers of the female lower genital tract. (3) A three-dose vaccination schedule (0, 2 and 6 months) elicits an immune response in almost all women, but the minimum antibody titre required for clinical protection is not known. Immune protection lasts at least 5 years, but no one knows what happens after that time. (4) Three double-blind randomised placebo-controlled trials involving a total of about 18 000 women aged 16 to 23 had sufficiently similar designs to pool results for analysis. ⋯ There are no data on efficacy beyond 4.5 years. (6) These results are somewhat undermined by methodological problems, such as follow-up lasting only a maximum of 4.5 years whereas cervical cancer takes much longer to develop. In addition, there were very few cases of dysplasia in each trial, and results were largely based on post hoc subgroup analyses. (7) Apart from local reactions, which occurred in more than 80% of vaccinated women, the only adverse effect of papillomavirus vaccination was fever (12.9% of those on the vaccine versus 11% on placebo). (8) There is no evidence thus far that prenatal exposure due to HPV vaccination during the month preceding conception is harmful. (9) The clinical results are promising but further follow-up is needed to answer ongoing questions, such as the incidence of cervical cancer after vaccination and the duration of protection. Cervical cancer screening remains necessary, even for vaccinated women, and a continued need exists for measures designed to prevent all sexually transmitted diseases.