The National Pharmacovigilance Commission recommends that anti-rheumatic drugs containing vasoconstrictors should no longer be sold over the counter and be subject to a medical prescription.
Will we have to go through his doctor to buy anti-cold medicine? In any case, this is recommended by the National Pharmacovigilance Commission (1), a structure under the authority of the Medicines Agency. In an opinion issued a few days ago, the Cnpv recommends that decongestants containing a vasoconstrictor, in particular those administered orally, be the subject of a medical prescription and no longer be sold over the counter in pharmacies. Clearly, these are very common products used to unclog the nose and more generally the ENT sphere such as Actifed-Cold, Dolirhume or Nirofen cold. The Commission even wanted to ban them completely but this decision would have been rejected at European level, confides a member of the Cnpv.
These are the results of a survey conducted between 2007 and 2011 by the Pharmacovigilance Center of Midi-Pyrénées that weighed in the opinion of the Cnpv. We must avoid using these drugs containing pseudoephedrine “whose risk is unacceptable in view of the pathology”, recently recalled the author of the study Dr. Emmanuelle Bondon-Guitton. The benefit / risk ratio would be appalling. Already in last april, the Toulouse center had noted that the vasconstrictor effect of the molecule increased, for oral forms, the risk of myocardial infarction and stroke.
For its part, on December 15, 2011, the Medicines Safety Agency (Ansm) recalled the proper use of these vasoconstrictor products following events that occurred during the year.
“Since January 1, 2011, wrote the Ansm in this note, 15 serious cases of cardiovascular or neurological adverse effects have been recorded (…)”. In 25% of cases, the recommendations were not followed. The daily dosage must be respected, reminded the Agency, the duration of treatment must not exceed five days, it is potentially dangerous to make combinations with two of these drugs. In addition, these products are contraindicated for children under the age of fifteen and people with a cardiac or neurological history. But the Ansm had not raised its alert level.
Today, the Medicines Agency reiterates its recommendations for good use but “does not for the moment consider applying this measure in a general and indiscriminate manner to all vasconstrictors”. But it could be applied, specifies the Ansm, “to certain specialties which are the subject of misuse”. An attitude of common sense, plead several specialists, who point out the advantages of these products with regard to the minor risks. Others believe that Ansm’s decision is based on more financial considerations. Subjecting these anti-cold drugs to a medical prescription would cost social security at least 21 million euros!
(1) The role of the National Pharmacovigilance Commission is to assess information on adverse drug reactions and to advise the Director General of the National Agency for the Safety of Medicines and Health Products (Ansm) on the measures to be taken to put an end to incidents and accidents which have been found to be linked to the use of these drugs and products.
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