List of high-profile incidents related to the development, marketing or use of pharmaceuticals

The list contains incidents that have caused a stir in connection with the development, marketing or use of medicines .

Market withdrawals due to adverse risk-benefit ratio

year	Incident or drug	Brief description
1937	Sulfanilamide disaster	Over 100 people died after taking cold juice containing the antibiotic agent sulfanilamide . The cause of the poisoning was the sweet-tasting compound diethylene glycol used as a solvent .
1961/1962	Contergan scandal	The use of thalidomide-containing sleeping pill Contergan during pregnancy led to severe fetal malformations. The criminal case against the manufacturer was dropped in 1970 because of minor guilt of the accused and lack of public interest in prosecution.
1982	Coxigon	Eli Lilly and Company discontinues sales of Coxigon ( benoxaprofen ). There were disorders of the liver and kidneys , pathological changes in the optic nerves and skin tumors . The real scandal was that the Federal Health Office (today BfArM ) had already stated an unfavorable risk-benefit ratio when it was approved .
1985	Enoxacin	Withdrawal due to interactions
1992	Temafloxacin	Withdrawal from the market due to liver and kidney toxicity, HUS, anaphylaxis, anemia
1993	Lomefloxacin	Withdrawal from the market due to phototoxicity, liver toxicity, CNS ADRs
1998	Mibefradil	Withdrawal from the market of Posicor ( Hoffmann-La Roche ) and Cerate (Asta Medica) with the active ingredient mibefradil due to multiple, life-threatening drug interactions.
1999	Trovafloxacin	Withdrawal from the market due to liver failure, liver toxicity
1999	Grepafloxacin	Withdrawal due to cardiotoxicity
2000	Pefloxacin	Market withdrawal u. a. because of phototoxicity, tendinitis
2001	Clinafloxacin	Phototoxicity, influence on sugar metabolism
2001	Sparfloxacin	Withdrawal from the market due to phototoxicity, CNS ADRs
2001	Lipobay incident	Withdrawal of Lipobay ( Cerivastatin , Bayer AG ) worldwide due to fatal interactions with gemfibrozil .
2003	Nefazodone	January 2003: Withdrawal of the antidepressant Nefadar (Nefazodon, Bristol-Myers Squibb ) in Sweden due to the occurrence of threatening liver damage.
2004	Vioxx scandal	Worldwide market withdrawal of all dosage forms of Vioxx ( MSD Sharp & Dohme ) due to cardiovascular toxicity . In addition, MSD is discontinuing all clinical studies with the COX-2 inhibitor .
2004	Fleroxacin	Withdrawal from the market due to phototoxicity, CNS ADRs
2004	Gatifloxacin	Market withdrawal due to influence on sugar metabolism
2005	Valdecoxib	Withdrawal of Bextra (Valdecoxib, Pfizer ) in the USA, EU and Switzerland. An increased risk of cardiovascular complications in patients after bypass surgery has been established and the occurrence of life-threatening skin reactions has been described.
2006	Ximelagatran	AstraZeneca takes its oral thrombin inhibitor Exanta and Melagatrin (ximelagatran) due to hepatic safety in long-term use of the market and stop two ongoing clinical trials.
2006	Buflomedil	Buflomedil tablets were withdrawn from the market in France due to serious neurological complications. 2011/2012 Extension of the recall to other EU member states and to parenteral dosage forms.
2007	Zelmac	Withdrawal of Tegaserod ( Zelmac , Novartis ) in Switzerland due to the increased occurrence of cardiovascular events
2007	Clobutinol	Withdrawal of all drugs containing clobutinol (e.g. Silomat , Boehringer Ingelheim and a number of generics ) from the German market. During treatment with the non-prescription drug, which was introduced as a cough suppressant in 1961 , in rare cases severe cardiac arrhythmias occurred.
2007	Trasylol	Bayer is stopping sales of the drug Trasylol ( aprotinin ) worldwide , following an order from the Federal Institute for Drugs and Medical Devices (BfArM) and recommendations from the US FDA . The interim analysis of a Canadian study showed that there was an increased 30-day mortality rate in patients treated with aprotinin. Aprotinin was used to reduce the tendency to bleed during heart and liver operations.
2007	Lumiracoxib	Withdrawal of the osteoarthritis drug Prexige ( Lumiracoxib , Novartis ) in Germany and other EU countries due to liver damage.
2008	Acomplia	The weight loss product Acomplia ( Rimonabant , Sanofi-Aventis ) is being withdrawn from the market due to neurological side effects. The slimming pill has been shown to increase the risk of suicide .
2009	Gemifloxacin	Withdrawal due to genotoxicity and liver toxicity
2010	Avandia	September 2010: Market withdrawal of the diabetes drug Avandia ( Rosiglitazon , GlaxoSmithKline ) in Europe due to an increased risk of heart attack.

Incidents in development

year	incident	Brief description
2006	" TeGenero incident"	In the course of the development of the monoclonal antibody TGN1412 devastating side effects occurred, whereby its development for the treatment of autoimmune diseases came to an abrupt end.
2016	" BIA 10-2474 incident"	As part of the clinical development of a new active ingredient for the treatment of pain, several test subjects experienced severe neurological side effects, and one subject died as a result.
2019	Death after fecal micriobioma transfer	In the United States, a patient died of an infection with a multidrug-resistant bacterium following a stool transplant in a clinical study , and a second became seriously ill. The donor's stool sample had not previously been tested for these bacteria.

Incidents in the making

year	incident	Brief description
1930	Lübeck vaccination failure	The introduction of BCG - vaccination against tuberculosis occurred in 1930 in Lübeck to Lübeck Impfunglück , the largest Impfunglück the 20th century. The cause was very likely a mix-up of the vaccine cultures. Because of the incident, the introduction of BCG vaccination in Germany was delayed until after the Second World War.
2018	Valsartan scandal	In July and August 2018, it became known that the blood pressure lowering drug valsartan from certain active ingredient manufacturers was contaminated by dimethylnitrosamine , which is thought to be carcinogenic, presumably as a result of a change in the synthetic route that had taken place years ago . Affected drug lots have been recalled in Europe, Canada and the USA.

Counterfeiting and placing on the market of knowingly improperly manufactured drugs

year	incident	Brief description
1970s	Infections from HCV-contaminated anti-D prophylaxis sera	In 1978/79 several thousand women in the GDR were infected by HCV-contaminated anti-D sera, although the manufacturer in Halle must have known that the blood donors were infected.
1980s	Infections from blood products contaminated with HIV	Employees at a company in Koblenz did not examine donor blood samples individually, but instead mixed them together or did not test them at all. The administration of the contaminated blood products resulted in many deaths.
2008	Heparin scandal	The anticoagulant agent heparin has been diluted with an inferior, cheaper fabric.
2014/2015	GVK Biosciences scandal	Alleged falsification of data: A large number of generics had been approved on the basis of bioequivalence studies , the data collection of which subsequently turned out to be non-compliant with the law. Patients were not harmed.
2016	Medical scandal Alte Apotheke Bottrop	A pharmacist from Bottrop had violated the Drugs Act in numerous cases and deliberately manufactured and sold underdosed cancer drugs in his pharmacy. He was sentenced to 12 years in prison in 2018.
2018	China vaccine scandal	The Chinese pharmaceutical company Changchun Changsheng is said to have falsified data since April 2014 and in some cases put ineffective and expired rabies vaccines into circulation. Ineffective DTP combination vaccines are also said to have been placed on the market in 2017. Hundreds of thousands of children are affected. Company employees were arrested in July 2018.
2018	Selling stolen cancer drugs	In 2018 it was revealed that a network of various companies, including a drug importer from Brandenburg , is said to have placed cancer drugs illegally obtained from abroad in Germany. Some of the drugs were stolen in Greece and transported to Germany without the necessary cold chain.

Unfair Marketing

year	incident	Brief description
2009	Illegal promotion by Zyprexa	Between 2000 and 2003, Eli Lilly is said to have encouraged doctors to prescribe the schizophrenia drug Zyprexa, among other things, for age-related dementia , although it was not approved for this indication . In 2009, Eli Lilly accepted a $ 1.4 billion fine.

See also

• List of disasters

literature

• Hans-Jochen Luhmann: The blindness of society. Filter of risk perception. Gerling Academy, Munich 2001
• Eckart Roloff , Karin Henke-Wendt: Damaged instead of cured. Major German medical and pharmaceutical scandals. Hirzel, Stuttgart 2018
• Caroline Walter: patient in sight. The new strategy of the pharmaceutical companies. Hoffmann & Campe, Hamburg 2010
• Frank Wittig: The white mafia. How doctors and the pharmaceutical industry are putting our health at risk. Riva, Munich 2013

Individual evidence

1. ↑ Died of Coxigon . In: Die Zeit , No. 33/1982.
2. ↑ Ulrich Moebius: Who will protect us from drug failure? In: Der Spiegel . No. 40 , 1983 ( online ).
3. ↑ ^{a b c d e f g h i j k} North Rhine Medical Association: Gyrase inhibitors - restrictions on use . In: Medical Association of North Rhine (ed.): Rheinisches Ärzteblatt . tape 197 , no. 9 , 2008, p. 9 ( aekno.de [PDF]).
4. ↑ BDI Circular 8/9 1998 ( Memento of the original of September 27, 2007 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. . 
5. ↑ arznei-telegram 34, vol. 1, 2003 .
6. ↑ Withdrawal of valdecoxib (Bextra®) from the market, April 7, 2005 (from the archive of the Drugs Commission of the German Medical Association, AkdÄ).
7. ↑ AstraZeneca: Rote-Hand-Brief, February 14, 2006 (PDF; 292 kB) from the archive of the Drugs Commission of the German Medical Association, AkdÄ
8. ↑ Pharmacovigilance et la sécurité d'emploi du buflomédil. Agence nationale de sécurité du médicament et des produits de santé (ANSM), 30 November 2006.
9. ↑ Archived copy ( Memento of the original from September 27, 2007 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. 
10. ↑ Rote-Hand-Brief, August 30, 2007 (PDF; 35 kB) Boehringer Ingelheim.
11. ↑ Press release of the Federal Institute for Drugs and Medical Devices, November 5, 2007 ( Memento of the original of November 13, 2013 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. . 
12. ↑ Press release, November 19, 2007. ( Memento of the original from November 13, 2013 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Federal Institute for Pharmaceuticals and Medical Products. 
13. ^ Off for slimming products from Sanofi-Aventis . In: Handelsblatt .
14. ↑ The weight loss pill increases the risk of suicide . Welt Online , June 11, 2007.
15. ^ European Medical Agency (EMA): Factive: Withdrawal of the marketing authorization application. In: European Medical Agency. European Medical Agency, June 2009, accessed January 2020 . 
16. ↑ EU supervisors demand a stop on sales of diabetes drugs . Spiegel Online - Wissenschaft, September 23, 2010.
17. ↑ Drug scandal - dormant drug approvals: patients receive a replacement product . Health city Berlin, December 14, 2014.
18. ↑ Drugs scandal - EU authorities advise against 52 drugs . Deutschlandfunk , January 23, 2015.
19. ↑ Vaccine scandal in China - Chinese pharmaceutical manager arrested . Deutsche Apothekerzeitung, July 25, 2018.
20. ^ A. Ettel, M. Neller: The cancer drug scandal is widening . welt.de, August 25, 2018.