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Pfizer case: "Two of the nine defendants are already under arrest"...

July 26 2007 at 1:40 AM
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Response to JULY 2007: News on SSRIs, other Psych Drugs and Related Issues

"...There are several processes which the government needs to go through especially when you have foreign defendants," said government lawyer Babatunde Irukera.

Under Nigerian law, defendants must be present at their criminal trials. A source at the Justice Ministry said two of the nine defendants were already under arrest, without specifying the names..."

http://africa.reuters.com/wire/news/usnBAN547217.html

"Nigeria files criminal charges against Pfizer

Wed 25 Jul 2007, 12:16 GMT

 ABUJA (Reuters) - The Nigerian federal government has filed criminal charges against U.S. drugmaker Pfizer over a 1996 drug trial in the northern state of Kano in which 11 children died, a government lawyer said on Wednesday.

The federal government was already seeking $6.5 billion in a separate civil case. The government of Kano state is also seeking $2 billion in damages from Pfizer and has filed separate criminal charges too.

The charges were filed in May but this was not made public at the time. The case was due to come up in court on Wednesday, but in the absence of any representatives of the defendants, the case was adjourned until October 29.

"There are several processes which the government needs to go through especially when you have foreign defendants," said government lawyer Babatunde Irukera.

Under Nigerian law, defendants must be present at their criminal trials. A source at the Justice Ministry said two of the nine defendants were already under arrest, without specifying the names.

The case centers on 200 children who were given drugs during a meningitis outbreak in 1996, including Pfizer's antibiotic Trovan. In the civil case, the Nigerian government says Pfizer deceived authorities about the details of the tests and caused the deaths of 11 children.

Pfizer has steadfastly denied the allegations."

 

The Drug and its side effects:

http://www.medicinenet.com/alatrofloxacin-injection/article.htm

"GENERIC NAME: ALATROFLOXACIN - INJECTION (uh-lay-troh-FLOX-uh-sin)

BRAND NAME(S): Trovan

Warning | Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage

WARNING: This medication may cause serious, even life- threatening, liver problems. Therefore, first doses must be given in a hospital setting. Use should be reserved for serious infections and only when other safer drugs cannot be used. This drug has been restricted in its use in the U.S. market due to safety problems. Notify your doctor immediately if you develop yellowing eyes or skin, dark urine, or unusual fatigue.

USES: This medication is used to treat serious and life-or-limb- threatening infection.

HOW TO USE: After proper dilution, this drug is given slowly by vein (IV) exactly as directed by your doctor, usually once daily. Antibiotics work best when the amount of medicine in your body is kept at a constant level. Do this by using the medication at the same time each day. Continue to use this medication until the full prescribed amount is finished even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow resulting in a relapse of the infection. Use of this drug for more than 14 days is not recommended. Consult your doctor. This medication should not be given together with any solution containing multivalent cations (e.g., magnesium or calcium) in the same IV. Check visually for any particles or change in color of the solution (it should be colorless or pale yellow).

SIDE EFFECTS: Dizziness, nausea, change in taste sensation, headache or pain at the injection site may occur. If these effects persist or worsen, notify your doctor promptly. Unlikely but report promptly: vomiting, diarrhea, stomach pain, dark urine, yellowing eyes or skin. Very unlikely but report promptly: chest pain, unusually fast or slow heart beats, seizure, persistent sore throat or fever, muscle weakness or cramps, pain or swelling of tendons (e.g., tendons of the shoulder, hand and ankle), bleeding or bruising, increased sensitivity to the sun (sunburns), mental/mood changes, vision problems, increased thirst or hunger, change in the amount of urine. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include: rash, itching, swelling, fainting, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before using this drug, tell your doctor your entire medical history, including: any allergies (especially drug allergies), liver disease, brain/spinal disorders (e.g., seizures or severe blood vessel disease), heart disease (including irregular heart beats), lung disease. Use of this medication for prolonged or repeated periods may result in a secondary infection (e.g., oral, bladder or vaginal yeast infection). This medication increases sensitivity to the sun. Avoid prolonged sun exposure. Wear protective clothing and use a sunscreen when outdoors. Limit alcohol intake, as it may worsen certain side effects of this medication. Since this drug may cause dizziness, use caution if operating machinery or performing hazardous tasks (e.g., driving). To avoid dizziness or lightheadedness when rising from a seated or lying position, get up slowly. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast- feeding. Elderly patients may be more sensitive to the effects of this drug therefore caution is advised.

DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription medication you may use, especially: blood pressure medications (e.g., prazosin), other antibiotics (especially quinolone-type). Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate. This drug may increase and/or prolong the effects of caffeine. Also, certain cough/cold products (with "adrenaline-like" medicine such as decongestants), isoniazid and cholinesterase blockers such as tacrine and donepezil might increase the chance of seizures. Other medicines or IV additives should not be combined with this drug, or given through the same IV. Certain IV fluids (e.g., normal saline or lactated ringers) should not be used with this drug. Consult your pharmacist. Do not start or stop any medicine without doctor or pharmacist approval.

 

http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601201.html

"...Alatrofloxacin may cause side effects. Tell your health care provider if any of these symptoms are severe or do not go away:

  • dizziness
  • lightheadedness
  • headache
  • drowsiness
  • upset stomach
  • vomiting
  • diarrhea

If you experience any of the following symptoms, or those listed in the IMPORTANT WARNINGS section, call your doctor immediately:

  • skin rashes
  • hives
  • itching
  • sunburn
  • swelling of the face or throat
  • difficulty breathing or swallowing
  • depression
  • hallucinations
  • seizures or convulsions
  • change in vision
  • vaginal infection
  • pain, inflammation, or rupture of a tendon

 

IMPORTANT WARNING:  

Alatrofloxacin injection is no longer available in the U.S. If you are currently taking alatrofloxacin injection you should call your doctor to discuss switching to another treatment.

Alatrofloxacin has been associated with serious liver injury leading to liver transplantation or death. Alatrofloxacin-associated liver injury has been reported with both short- and long-term drug exposure. Alatrofloxacin use exceeding 2 weeks in duration is associated with a significantly increased risk of serious liver injury. Liver injury has also been reported following alatrofloxacin re-exposure. Alatrofloxacin should be reserved for use in patients with serious, life- or limb-threatening infections who receive their initial therapy in an in-patient health care facility (i.e., hospital or long-term nursing care facility). Alatrofloxacin should not be used when safer, alternative antimicrobial therapy will be effective.

If you experience any of the following symptoms, call your doctor immediately: increased fatigue, loss of appetite, yellowing of the skin and eyes, severe stomach pain with nausea and vomiting, or dark urine. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to alatrofloxacin.





 
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