LÄÄKKEIDEN TURVALLISUUS?

[Bb]

Lähettäjä: DrBorr Lähetetty: 20.11.2004 18:51

Kaikilla lääkkeillä on useita sivuvaikutuksia, mutta joillakin niitä on arveluttavan paljon. Seuraavassa artikkelissa esitellään 5 lääkettä joiden katsotaan joidenkin arvioiden mukaan aiheuttavan vakavia terveysriskejä. Huomionarvoista on että lääkkeet on tutkittu useilla testeillä ja syystä tai toisesta niiden on testien perusteella katsottu olevan käyttäjilleen turvallisia. Mitä tämä kertoo testeistä ja niiden luotettavuudesta? On myös muistettava että suuri osa lääketieteellisistä tutkimuksista on lääketeollisuuden rahoittamia.

Luettelossa mainitaan mm. kolesterolilääke (Astra Zenecan Crestor), joka voi aiheuttaa akuutteja munuaisvaurioita; syntymävikoja aiheuttava (raskaana oleville naisille) Rochen Accutane jota käytetään aknen hoitoon; niveltulehduksen hoitoon käytetty Bextra (Pfizer), joka lisää sydänkohtausriskiä yli kaksinkertaiseksi ja Glaxo Smith Klinen Serevent, jota käytetään astman hoidossa. Lääke lisäsi (90 %:n varmuudella) kuolinriskiä vakavissa astmakohtauksissa. On esitetty myös raportteja joissa potilailla on ollut lääkeinhalaattori kädessään kuolinhetkellään.

USA:ssa listattujen ao. lääketehtaiden osakkeiden arvo laski uutisen tultua julkisuuteen.


November 19, 2004

Page 3A

FDA scientist details problems of five drugs
By Liz Szabo and Rita Rubin
USA TODAY

During a Senate hearing Thursday regarding Vioxx, the arthritis blockbuster pulled off the market in September over concerns about increased risk of heart attacks and strokes, FDA scientist David Graham dropped a bombshell about five other drugs on the U.S. market. Graham, associate director for science in the FDA's Office of Drug Safety, said the five drugs pose serious safety concerns:

1. Abbott Laboratories' weight-loss drug Meridia can cause high blood pressure, Graham said. When he raised a question about the drug's usefulness in a report, though, Graham said he was forced to delete it. Abbott spokeswoman Laureen Cassidy defended Meridiaby saying it has been studied in more than 100 studies and has been used by 15 million patients worldwide.

2. Astra Zeneca's Crestor is the only cholesterol-lowering drug that causes acute kidney failure, Graham said. Emily Denney, a spokeswoman for AstraZeneca, says the drug has been prescribed to more than 3.5 million people worldwide and has been extensively tested.

3. Roche's drug Accutane, approved to treat severe acne, is a 20-year regulatory failure,Graham said. Accutane can cause serious birth defects if taken by pregnant women, he said, and the agency's efforts to prevent this problem are ineffective. He said the FDA should institute a system that would restrict the distribution of the drug. Carolyn Glynn, a Roche spokeswoman, said the company will now require all patients as well as their doctors and pharmacists to register with an independent agency that will track patient use.

4. Pfizer's arthritis medicine Bextra is in the same drug class as Vioxx. A recent study showed that the incidence of heart attacks and strokes among Bextra patients was more than double that of patients taking sugar pills. Pfizer spokeswoman Susan Bro says an analysis of previous studies found no increase in serious cardiovascular events in nearly 8,000 arthritis patients.

5. Glaxo Smith Kline's drug Serevent treats asthma and chronic obstructive pulmonary disease. Before the FDA approved this asthma drug, a British study found with 90% certainty that it increased the risk of death from serious asthma complications, Graham said. There have been reports of patients found dead clutching their Serevent inhaler, he said. GlaxoSmithKline issued a statement defending the medication, saying the FDA fully considered safety concerns last year when it issued a black box warning in the medicine's label.

Graham's testimony hurt the manufacturers' stock prices. AstraZeneca dropped $3.80 or 8.6%. GlaxoSmithKline dropped $1.45 or 3.2%. Pfizer was down 22 cents, or 0.8%, while Abbott Laboratories was down 28 cents, or 0.6%. Roche, a Swiss company, doesn't trade on U.S. exchanges.