In the 50’s – Botulinum toxin properties in reducing muscular spasms were discovered
In the 60’s and 70’s – Studies on the use of Botulinum for strabismus treatment were carried out.
1989 – After approval by the Food and Drug Administration (FDA), Allergan Inc. introduced Botox for blepharospasm and strabismus treatment.
2000 – FDA approved Botox use in the treatment of cervical dystonia.
April 15, 2002 – After a study conducted on 405 patients (while further 132 patients were treated with placebo, for a total number of 537 patients involved), FDA approved the cosmetic use of Botox for glabellar wrinkles.
February 2003 – Irena Medavoy filed an action against Allergan and dr. Arnold Klein for the adverse reactions she underwent (muscular problems) after Botox injections. The verdict acquitted Allergan
From 2003 to 2010 Botox consumers (both cosmetic and non cosmetic botox) exchanged on forums of various kind information about their experiences in relation to adverse effects (See annex A, forum).
2004 – FDA approved Botox use in the treatment of excessive perspiration (hyperhydrosis).
January 23, 2008 – Public Citizen, an association that assembles more than 100,000 American consumers, issued a notice listing the adverse effects cases submitted to the FDA between November 1, 1997 and December 31, 2006: 180 serious side effects including 16 deaths (See annex B).
April 2, 2008 – The Journal of Neuroscience publishes the article of dr. Matteo Caleo from the Neuroscience Institute of CNR (the Italian National Research Center) in Pisa, on the spread of the Botulinum toxin and possible alteration of neural circuits.
2008 – FDA rebuked Allergan Inc. asking the Company to include clear warnings on adverse effects in Botox information leaflets. The decision of the FDA arrived months after the Public Citizen’s notice, but for the Administration the cases involved would be even more: as at March 20, 2008 the reports would amount to 225.
2008 – Health Canada issued a warning on the potential risks of Botox and Allergan was compelled to communicate to the Authority further information on Botox and Botox Cosmetic.
February 8, 2009 – FDA required that all Botulinum toxin makers add specific “boxed warnings”, highlighting the risk of adverse effects connected to the spread of the toxin from the site of injection. In the FDA vocabulary, such “boxed warnings” are restricted to drugs involving serious, potentially life-threatening side effects. FDA also announced it would send a letter to all injectable Botulinum toxin producers, asking them to warn in writing the doctors using the toxin and to prepare Medication Guides to be dispensed to patients by the physician when the drug is injected.
September 2009 – Dr. Ivan Goldsmith promoted a class action suit against Allergan Inc. for the Company’s suggestions to physicians in the use of Botox: “off-label” use was promoted (using drugs off-label means that they are prescribed for conditions which have never been approved by the Authority ), at higher dosage than allowed, together with the possibility of reusing the same vial for different patients, with potential risk of HIV infection and the onset of other problems.
March 2010 – Allergan won the case against the parents of a little girl suffering from cerebral palsy and whose death was suspected to be caused by Botox therapeutic use (injections to relax limbs) in 2007.
May 14, 2010 – A maxi verdict for damages was obtained in the U.S. against Allergan Inc. For the first time the risks and damages connected to Botulinum use in leveling wrinkles were recognized by a jury announcing a record-setting $15 million verdict for damages to refund a 47-year-old woman, Sharla Helton, gynecologist, who declared that after receiving Botox injections in 2006 she had been suffering for years from double vision, continuous pain in her arms, hands and feet and breathing difficulties, thus becoming seriously ill and losing her job later on. A jury in Oklahoma sentenced Allergan Inc. to pay $15 million to dr. Helton for damages deriving from negligence, as the complete list of Botox potential side effects was not reported on medicine box..
July 2010 – The United Kingdom authorized the use of Botox Cosmetics in the treatment of migraine.
September 3, 2010 – Allergan Inc, the Botox producing company, will pay a maxi penalty of $600 million to the American Government for having promoted the improper use of the toxin between 2000 and 2005. (See annex G ).
September 20, 2010 – Allergan closed with an out-of-Court settlement the pending lawsuit concerning the death of Sondra Bryant, a woman who died after receiving Botox injections (100 units) to treat shoulder pains.
October 6, 2010 – The district Court of Atlanta, Georgia, ratified the agreement between Allergan Inc. and the American Justice Department after investigations into Botox. The terms of the agreement include Allargan admission of guilt, a criminal sanction of $375 million and a civil agreement with the federal government of $225 million, admission that beside promoting an off-label use of the drug the Company gave instructions to doctors on how to falsify claims in order to deceive the Government and obtain funding for non authorized applications of the drug.
The famous Botox producer will pay a maxi penalty to the American Government, $600 million, for promotion of improper use of the drug between 2000 and 2005. Allergan – the company producing and commercializing the famous drug that can “paralyze” wrinkles once injected – admits it has led promotional campaigns for the sale and the use of botox for a series of treatments that have never been approved by the Food and Drug Administration (FDA). Among the most common improper uses sponsored for the drug, which, according to public health experts, is even the most dangerous – there is the utilization of botox to treat the spasms caused by cerebral palsy in children. As to this specific point, the FDA received a series of reports concerning serious side effects in children treated with the drug, from breathing difficulties to suspicious death cases.
The lawsuit against Allergan is the last example of a campaign organized by the American Justice Department to crackdown on illegal and fraudulent drug promotion by pharmaceutical companies. In the lawsuit filed by the Government against Allergan Inc., the government’s civil complaint said that Allergan had “illegally, vigorously and, without any thought to the possible negative health effects to which it subjected patients, promoted” – Botox for uses that had not been deemed safe and effective by the FDA.. According to the complaint, the company also developed and put in place a wide-ranging marketing program, that included paying kickbacks to doctors to induce them to prescribe Botox for conditions not included in the drug’s label, and bribing foreign officers to have them run similar misbranding across the Atlantic. In the settlement, Allergan agreed to plead guilty to only few misdemeanors, but accepted to pay a reimbursement of $600 million and to publish the names of the doctors who had received money.
October 2010 – FDA approved Botox use in the treatment of muscle problems, upper limbs spasticity and chronic migraine.