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June 2004 Newsletter
Accolate warning revision announced by FDA
-May 17, 2004
The FDA has approved an Accolate revision to the warnings and precautions sections due to the risk of hepatoxicity. 
read article ....
Accolate
Potential liver problems associated to Accolate cause shares to slip
-April 19, 2004
After a letter said an analysis of safety databases indicate some Accolate patients experienced liver problems, including hepatitis, shares in Accolates AstraZeneca Plc slipped. read article ....
Accutane
Despite time on the market Accutane continues to cause birth defects
-April 26, 2004
Accutane was approved in 1982 as a prescription medication for severe or cystic acne. While Accutane labels warned pregnant women should not use the medication, the FDA and manufacturer Roche was criticized for failing to adequately convey the dangers of the drug to women if becoming pregnant. read article ...
Baycol
Bayers Baycol problems continue
-May 3, 2004
Baycol hit the U.S. market in 1998 and was an immediate success. Millions of people worldwide switched from using other statin drugs to Baycol, some in part to the lower cost. read article ....
Celebrex
Celebrex not beneficial for everyone
-May 25, 2004
Popular drugs prescribed for the treatment of arthritis, including Celebrex, Bextra, and Vioxx have benefits but is not the right choice for everybody. Especially patients with cardiovascular disease risk factors, Celebrex is a medication called cox-2 inhibitor, which can reduce the risk of gastro-intestinal problems but it still does pose a risk. read article ....
Crestor
Public Citizen renews petition for immediate ban of Crestor
-May 18, 2004
Public Citizen consumer group has renewed its petition to the FDA for the immediate removal of Crestor from the market. Approved in August 2003, Crestor was linked to seven cases of a muscle destroying condition called rhabdomyolysis and nine cases of kidney failure by March 2004, leading the consumer group to issue its first petition to the FDA for the ban of Crestor. read article ....
Cyclosporine
Cyclosporine and citrus soda cause adverse reactions
-April 16, 2004
A double lung transplant patient suffering abnormal blood chemistries during post-transplant check ups discovered a link between citrus soda and its effect on cyclosporine. read article ....
Dexamethasone
Dexamethasone use among babies linked to lower IQ and poor motor skills
-April 16, 2004
Researchers presented a study at the British Psychological Society annual meeting after comparing 77 premature children treated with postnatal steroids with 66 premature children who did not receive the drugs, as well as 25 siblings who were not premature. read article ....
Ephedra
Company challenges FDA ephedra ban
-May 4, 2004
The FDA issued an ephedra recall in December 2003 after the supplements were linked to 155 deaths. Now, Nutraceutical Corporation and its subsidiary Solaray have filed federal lawsuits against the FDA claiming its products are safe because it only contains low doses of ephedra. read article ....
Ephedra
Book questions ephedra ban as based on politics and not on science
-April 27, 2004
In December 2003, the FDA banned all products containing ephedra after being linked to 155 deaths. A new book has just been released, questioning why there are still ephedra containing products on the market despite the government ban. read article ....
Ephedra
FDA looking into safety of ephedra substitutes
-April 20, 2004
The FDA commissioner is determined not to allow another ephedra episode to occur, after taking two years to get the supplement linked to 155 deaths banned. Now the FDA commissioner has said regulators are compiling data on three other supplements to help decide if they should also be banned. read article ....
Fen-Phen
$1 billion fen-phen award upheld
-May 17, 2004
In April, a $1 billion verdict against Wyeth was awarded after fen-phen was linked to the death of fen-phen user from primary pulmonary hypertension (PPH). Hundreds of PPH diagnoses have been made because of the use of fen-phen. read article ....
Fen-Phen
Fen phen payouts delayed
-May 12, 2004
A federal judge has ordered a two-month halt on 40,000 fen phen payouts from the fen phen recall. Both fen phens maker and lawyers representing claimants agree that the $3.75 billion settlement is underfunded and support a revision to add $1.275 billion to the fund. read article ....
Fen-Phen
Additional $1.275 billion set aside to settle fen-phen lawsuits
-May 6, 2004
Years after the fen-phen recall, Wyeth has never quite bounced back. Still heavily affected by fen-phen litigation, Wyeth has just agreed to set aside an additional $1.275 billion to settle fen-phen cases. read article ....
Lariam
Government studying Lariam effects
-April 27, 2004
Lariam, a drug given to thousands of soldiers to prevent instances of malaria, will be studied by the Defense Department and Veterans Affairs Department to better determine Lariam risks. read article ....
Lotronex
Second Lotronex recall requested
-May 5, 2004
Lotronex was approved in February 2000 to treat irritable bowel syndrome, but a Lotronex recall was issued by November 2000 after evidence of ischemic colitis. Ischemic colitis is a life-threatening condition where the bowel tissue dies because of a lack of blood flow to the colon. read article ....
Meridia
Meridias limited weight loss effects leaves much room for new drug option
-May 10, 2004
The drug industry has long been battling to tap into the sharply increasing market of overweight Americans. Any drug to come onto the market thus far that has shown significant weight loss effects has been pulled because of its dangerous health effects. read article ....
Neurontin
Pfizer pleading guilty to criminal charges of misbranding Neurontin
-May 13, 2004
U.S. criminal charges were brought against Pfizer Inc.s Warner-Lambert unit for misbranding the epilepsy drug Neurontin. read article ....
OxyContin
OxyContin maker criticized for failing to create a new formula
-May 21, 2004
Purdue Pharma, makers of the strong painkiller OxyContin, has been criticized for failing to live up to its commitment from three years ago to have a new OxyContin formula ready by 2004. read article ....
OxyContin
OxyContin addictions one of nations highest priority drug problem
-May 11, 2004
Opiate painkiller abuse, including OxyContin has dramatically risen in the last five years. Due to the fairly new increase in prescription painkiller abuse, there is an absence of epidemiological data. read article ....
Paxil
New York City sues GlaxoSmithKline over Paxil
-May 18, 2004
New York City has filed a lawsuit claiming GlaxoSmithKline has engaged in anticompetitive, fraudulent, and inequitable conduct when it acquired over a dozen Paxil patents over the past ten years. read article ....
Prozac
Government report shows toxicity of Prozac to the fetus
-April 28, 2004
According to an expert panel, using Prozac late in pregnancy may have toxic effects on the fetus. Mothers using Prozac during the third trimester may be risking premature delivery and putting their infants at risk for poor neonatal adaptation according to the government report. read article ....
Rezulin
Rezulin lawsuits continue despite Rezulin recall in 2000
-April 14, 2004
Pfizer bought Warner-Lambert in June 2000 just months after Warner-Lambert issued a Rezulin recall for the anti-diabetes treatment. There have been thousands of Rezulin lawsuits and another trial in Los Angeles Superior Court is alleging Rezulin liver damage warnings were withheld. read article ....
Risperdal
FDA tells Janssen to stop misleading Risperdal claims and promotions
-April 27, 2004
The FDA warned Risperdal maker Janssen Pharmaceuticals, a unit of Johnson & Johnson that its November 2003 letter issued to doctors was misleading. read article ....
RotaShield
RotaShield to be approved and marketed once again
-May 4, 2004
In 1998, RotaShield was FDA approved to prevent rotavirus infections, which kills an estimated 600,000 children and causes over 135 million cases of diarrhea worldwide a year. read article ....
Serzone
Serzone ban finally issued
-May 20, 2004
Serzone has been linked to dozens of liver failures, including at least 21 U.S. deaths. In 2002, the FDA required Bristol Myers Squibb add serious liver warnings to Serzone, but this measure was not considered adequate enough as reports continued to be made. read article ....
Vioxx
Vioxx treatment associated to greater risk of acute myocardial infarction
-May 7, 2004
Researchers that conducted a matched case control study involving 54,475 patients aged 65 years or older has data showing treatment with Vioxx is associated with a greater risk of acute myocardial infarction than Celebrex or no NSAID therapy. read article ....
Zicam
Zicam side effects being reported
-May 20, 2004
Zicam users have been reporting the nasal gel used to fight the common cold has resulted in the loss of the sense of smell. Zicam lawsuits have been surfacing representing Zicam users that have claimed the use of the nasal spray has, in some cases, permanently affected the sense of smell and taste. read article ....
Zoloft
Serotonin syndrome an unknown life-threatening condition
-May 24, 2004
Zoloft works by regulating serotonin in the brain, but too much serotonin can lead to a life-threatening side effect called serotonin syndrome. A rare and unknown side effect of medications including Zoloft, serotonin syndrome is so serious that antidepressant users should be warned. read article ....
Zyprexa
Nationwide Zyprexa class action lawsuit filed
-May 21, 2004
Zyprexa antipsychotic drug has been linked to serious side effects including diabetes, hyperglycemia, pancreatitis, ketoacidosis, and diabetic coma. The drug has been controversial, especially after the Japanese Health and Welfare Ministry and the Great Britain Medicines Control Agency issued emergency Zyprexa warnings because of diabetes reports in 2002. read article ....
General Lawsuit News
Lawsuit raises issue of off-label drug marketing
-May 12, 2004
A former saleswoman for a small biotechnology company has sued her previous employer, claiming she was fired for failing to join an illegal effort to sell its top drug for unapproved uses. The lawsuit and corporate documents provided by other former sales reps for the same company display how a $50,000 a year treatment for two extremely rare childhood diseases was somehow turned into hundreds of millions of dollars of profit. read article ....
