Generic Drugs Misconceptions

The site where sleeping pills and diuretics have been switched will be inspected on Monday. Justice is investigating the death of a patient.

According to our information, three pharmacists (two inspectors and an expert in quality defects) from the National Medicines Safety Agency ( ANSM ) are leaving Monday morning, direction Sens (Yonne). Their mission letter was sent to the public prosecutor of Sens. The latter will also receive the results of the investigations of the health authority to determine whether or not to give a criminal follow-up to the case.

The goal of the mission, which will last several days: to understand why and especially how drugs could have ended up in boxes that were not theirs. In this case, zopiclone ( sleeping pill ) replaced furosemide ( diuretic ) following a packaging error. "This kind of incident is scarce," we tell ANSM. And what is even rarer is that this problem has fallen through the cracks of the site's quality control. Typically, the boxes do not leave the factory; the manufacturer realizes it beforehand. "

Risk of pulmonary enema

Among the avenues that the inspectors will have to follow: malicious acts, problem of staff training, foul "line empty" (drugs would have remained in the packaging line). For the moment, all the hypotheses are studied. "Because without any certainty about what happened, it is not possible to say how many companies are concerned. However, in the field of drugs, when we do not know, we start from the worst hypothesis," we add to the Agency.

The Sens site, which does not manufacture Teva's drugs, but is content to package them, had been inspected a year and a half ago by the ANSM. Nothing, in particular, had been observed. And this control was a matter of routine.

Diuretics are generally prescribed to patients (most often elderly) suffering from heart problems to treat the water retention responsible for enema and resolve high blood pressure problems. As for zopiclone, this sleeping pill is placed in boxes instead of the diuretic, it acts in a few minutes, and its effect lasts from a few hours to a day or two in the elderly. This means that for patients already taking a sleeping pill, the drowsiness will be heightened - there is even a risk of coma.

In addition, people with heart failure who will not have their diuretic dose because they will take a sleeping pill instead have an increased risk of pulmonary enema.

Saturday evening, a 91-year-old man died in the 7th arrondissement of Marseille from "what appears to be pulmonary enema," said Jacques Dullest, the public prosecutor of Marseille. He was taking furosemide from the Teva laboratory, and several boxes were found at his home. However, "among those open, one belonged to the famous poorly conditioned lot," said the prosecutor. An autopsy was to be performed on Sunday, supplemented by toxicological analyses.

Similar tablets

The case began early Friday afternoon. An older woman goes to her pharmacist in Ille-et-Vilaine. She takes a diuretic every morning to treat her high blood pressure but complains of drowsiness after swallowing her tablets. Inspired, the pharmacist asks him to bring back all his boxes of medicines. Decidedly particularly vigilant, he takes out the pills from each box and each "blister," the aluminium blisters containing the tablets. He realizes that in the box stamped furosemide of Teva, there is a tablet of zopiclone, whereas the blisters correspond well to furosemide.

"These two tablets are white, round, scored, and about the same size. You have to be very careful to succeed in differentiating it," explains Isabelle Ardent, president of the Council of the Order of Pharmacists. However, few people look at their pills with a magnifying glass before swallowing them; the pharmacist of Ille-et-Vilaine contacts the laboratory, which warns the Agency of the drug. The alert was issued on Friday evening, and the boxes were withdrawn from sale. The lots concerned are lots Y 175 (put on the market on May 3) and Y 176 (placed on the market on March 27), i.e., two lots of approximately 95,000 boxes each. Patients are encouraged to return these boxes to their pharmacist.

The affair falls badly in a real crisis of French confidence towards drugs and generics in particular. Contacted Sunday, Teva, through the voice of Erick Roche, the president of Teva Laboratories in France, immediately attacked: "We learned this morning of the death of a patient in Marseille. We want to express our condolences to his family." In terms of communication, the moment is crucial for the company, which does not want to see the spectre of the controversial management of the Mediator file by Servicer. Hence the necessary "common sense" and "compassion" desired by Erick Roche. The latter indicates that the first elements at his disposal "suggest that the problem could be limited to very few boxes."

Several generic Viagra will be available in pharmacies on June 22. On that date, the American laboratory Pfizer will lose the patent protecting its flagship drug against erectile dysfunction, and around ten laboratories have applied for authorizations to market generics.

I am starting with Pfizer itself. The American group will market its auto generic under the name Sildenafil-Pfizer. A complete copy of the brand name drug, except for the colour. While Viagra is blue, the generic Pfizer pill will be white. A way for the million French people who have already used Viagra since its launch in 1998 to use it "with complete discretion," underlines Michel Ginette, president of Pfizer France.

As for the price, it will be lower. But Pfizer, which has opted for a 30% discount in Belgium, refuses to reveal it in France before June 22. This price may also vary from one pharmacy to another since, since Viagra is not reimbursed, pharmacists set their costs themselves. However, the treatment of erectile dysfunction, distributed only by prescription, like everywhere in the world, will not be sold on the Internet.