Baycol: profile and news

Bayer gets subpoena regarding withdrawn cholesterol drug  06 Mar 2006
Dow Jones/AP) _ Bayer AG disclosed Monday that it received a subpoena from the US attorney for New Jersey relating to its withdrawn Baycol/Cerivastatin anti ... - Newsday,

Public Citizen Petitions FDA to Ban Darvon  Feb 28, 2006
For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Bextra, Rezulin, Baycol, Propulsid and many other drugs years before the ... - Consumer Affairs

Bayer: cardiovascular concerns could run deep  Feb 3, 2006
...costs of litigation could also mean bad news for the company's bottom line, which has been struggling to make up for the withdrawal of cholesterol drug Baycol. ... - Pharmaceutical Business Review

Tysabri, an MS Drug with Potentially Deadly Side-Effects, Gets FDA ...  Feb 18, 2006
Lotronex – 9 months; Duract – 11 months; Posicor – 12 months; Redux – 17 months ; Raplon – 19 months; Raxar – 23 months; Baycol – 27 months ... - Newsinferno.com,

Bayer: cardiovascular concerns could run deep  Feb 3, 2006
...costs of litigation could also mean bad news for the company's bottom line, which has been struggling to make up for the withdrawal of cholesterol drug Baycol. ... - Pharmaceutical Business Review

Bayer's Trasylol Clotting Drug Boosts Heart Risk, Study Says  Jan 25, 2006
Medicine. Bayer split off some chemical units last year as it tried to recover from the 2001 recall of the cholesterol treatment Baycol. ... - Bloomberg

Bayer falls on negative Trasylol study results  Jan 26, 2006
...increased the risk for investors from Bayer's pharmaceuticals business, which is recovering from a $1 billion recall of cholesterol drug Baycol over patient ... - Reuters

The FDA's Label Fix  Jan 18, 2006
Take, for instance, the 1999 label change for Baycol, a cholesterol drug from Bayer (nyse: BAY - news - people ) that has since been withdrawn from the market. ... - Forbes

Statin drugs must carry health warning  Jan 13, 2006
A US Food and Drug Administration study last year found Baycol triggered the potential muscle disease 10 times more often than Lipitor, Zocor and Pravachol ... - Toronto Star,

Pfizer says Lipitor shown equally safe at highest dose  Jan 18, 2006
Concerns about the possibility of such muscle side effects have mounted since German drugmaker Bayer AG in 2001 withdrew its Baycol statin after it was linked ... - ABC News

Health Canada Mandates New Warnings on Statins Regarding Risk of ...  Jan 14, 2006
Over the past year, however, the FDA found that Baycol, a statin which was taken off the market in August of 2001, increased the risk of this potential muscle ... - Newsinferno.com,

Review shows Lipitor is safe, Pfizer says  Jan 17, 2006
...condition. Bayer AG withdrew its Baycol statin in 2001, after it was linked 100 patient deaths, but not all statins are alike. The ... - Crain's New York Business,

Federal medicine oversight criticized  Jan 11, 2006
...with a few thousand patients, said Ray, who served as an expert witness in trials for liability cases involving Vioxx and Bayer AG's Baycol cholesterol drug. ... - Arizona Daily Star,

Studies: Statins Don't Cut Risk of Colon, Other Cancers  Jan 9, 2006
The specific statins studied included atorvastatin (Lipitor, Caduet), cerivastatin (Baycol), fluvastatin (Lescol), lovastatin (Advicor, Altoprev, Mevacor ... - ACS News Center,

FDA Needs More Independence, Authority To Protect Consumers, NEJM ...  Jan 12, 2006
Ray, who has served as an expert witness in trials for liability cases for Merck's Vioxx and Bayer's Baycol cholesterol drug, suggests splitting the drug ... - Kaiser network.org,

Bayer expects uplift in pharmaceuticals business  Dec 8, 2005
Nexavar is one of the main hopes for Bayer's pharmaceuticals business, which has suffered from the recall of the big-selling cholesterol drug Baycol in 2001 ... - MSNBC

UPDATE 2-Bayer sets antitrust provision, shares fall  Dec 6, 2005
The legal battle is the latest to hit the German company and comes after it paid more than $1 billion in settlements over its recalled cholesterol drug Baycol. ... - Reuters

Bayer Doubles Nexavar Sales Forecast to EU1 Billion (Update1)  Dec 7, 2005
...to develop a range of new drugs to bolster its pharmaceutical business, which the company reorganized after the 2001 withdrawal of anti-cholesterol drug Baycol ... - Bloomberg

Bayer upbeat on top drugs, starts key trial  Dec 8, 2005
7939 -- are seen as the main hopes for Bayer's healthcare unit, which has been hamstrung by a $1 billion recall of cholesterol drug Baycol, generic competition ... - Reuters

Bayer, Lanxess Set Aside EU336 Million for US Case (Update3)  Dec 6, 2005
...from the biggest shakeup in the company's 142-year history following the 2001 withdrawal of its Lipobay anti-cholesterol drug, also known as Baycol, which was ... - Bloomberg

Bayer recovering from restructuring headache  Nov 13, 2005
Sparked by the forced withdrawal from sale of its cholesterol-reducing drug Baycol in 2001, Bayer underwent a major overhaul, refocusing on its health care ... - Daily Yomiuri Online,

Bayer pays 1.143 bln usd to settle 3,058 cases connected to Baycol  Nov 8, 2005
...end of October it has paid 1.143 bln usd to settle 3,058 cases worldwide related to its former cholesterol-lowering blockbuster drug Baycol (Lipobay), which ... - Forbes

Merck Is Likely to Win First Federal Vioxx Suit, Lawyers Say  Nov 28, 2005
Two years ago, he successfully defended Bayer AG in the first trial over claims that the Baycol cholesterol medication caused a potentially fatal muscle ... - Bloomberg

UPDATE 1-Bayer's Avelox gets FDA nod for abdomen infections  Nov 30, 2005
Wider use of Avelox is key for Bayer's healthcare unit, which has been hamstrung by a $1 billion recall of cholesterol drug Baycol as well as a thin late-stage ... - Reuters

MIDDAY BUSINESS REPORT: OP salt firm ponders UK sale  Nov 9, 2005
Bayer said it has now paid an overall $1.1 billion to settle more than 3,000 cases involving its cholesterol-fighting drug Lipobay, or Baycol in the US Bayer ... - Kansas City Star,

Is it Really Worth It?  Sep 13, 2005
...fear of being in public. The drugs Baycol, Lipobay, and Lipitor are all used to lower cholesterol. Possible side effects, however ... - American Jurist (subscription),

Scientists see wider uses for cholesterol drugs  Sep 26, 2005
...very rare. Bayer's cholesterol drug Baycol was pulled from the market in 2001 after being linked to dozens of deaths. “When we ... - Newsweek

State tort laws will have big impact on lawsuits  Oct 2, 2005
Q: Recent years have seen other national liability cases, such as the anti-cholesterol drug Baycol, the diet drug fen-phen, and defective silicone breast ... - Scranton Times,

Vioxx shows need for civil justice system  Sep 28, 2005
But if the regulatory system could do its job right, the lawsuits over Vioxx, Baycol, Rezulin, PPA and Fen-Phen, just for a few examples, would never have been ... - The State,

Merck to Deny Any Vioxx Link to Heart Attack in Second Trial  Sep 11, 2005
Bayer, which faces suits claiming its Baycol drug caused a muscle-weakening disease, won a key early trial and paid out $1.13 billion to resolve nearly 3,000 ... - Bloomberg

Merck gears up for long Vioxx battle  Sep 11, 2005
Phil Beck, credited with saving German drugmaker Bayer billions of dollars in liability when he led the defence of its withdrawn cholesterol drug Baycol in 2003 ... - Financial Times,

Key Bayer cancer drug gets quick review by US FDA  Sep 14, 2005
Bayer's healthcare unit has been hamstrung by a $1 billion recall of cholesterol drug Baycol, generic competition to antibiotic Cipro and a weak late-stage ... - Reuters

UPDATE 1-Bayer, Onyx file sorafenib in EU for kidney cancer  Sep 11, 2005
...undersized pharmaceuticals business of Bayer, once famous as the developer of Aspirin but now hamstrung by a $1-billion recall of cholesterol drug Baycol in Aug ... - Reuters

Bayer pays 1.138 bln usd to settle 3,017 Baycol cases  Aug 9, 2005
...as of June 30 it has paid 1.138 bln usd to settle 3,017 cases worldwide related to its former cholesterol-lowering blockbuster drug Baycol (Lipobay), which was ... - Forbes

$500 million class action lawsuit launched against Medtronic ...  Sep 7, 2005
Mr. Rochon has taken a leadership role in several well known national class actions, including those involving diet drugs, Baycol, Nortel securities and fire ... - PR Newswire (press release),

Merck weighs up the significance of defeat  Aug 19, 2005
In 2003, Bayer, the German pharmaceuticals group, won two consecutive trials involving Baycol, its cholesterol-reduction treatment, banned in 2001, that was ... - MSN Money

Bayer 2nd-Quarter Profit Held Back by Crop Business (Update4)  Aug 10, 2005
The overhaul, sparked by the August 2001 withdrawal of the cholesterol-reducing drug Baycol, forced the company to reduce the size of its drugs business to ... - Bloomberg

Cardiologist says Vioxx not responsible for man's death  Aug 12, 2005
He said he had testified for both plaintiffs and pharmaceutical companies before, including a case involving cholesterol-lowering Baycol. ... - Newsday,

Merck Loses Round 1 of What May Now Be a Fight for Its Very ...  Aug 19, 2005
...all too familiar in cases involving prescription drugs which have been pulled from the market in the past several years (TYSABRI, BAYCOL, REZULIN, LOTRONEX ... - Newsinferno.com,

Merck shares slip in very heavy trading  Aug 22, 2005
He cited examples including Johnson & Johnson, for heartburn drug Propulsid; Bayer AG, for cholesterol drug Baycol; former drugmaker Warner-Lambert, for ... - BusinessWeek

Bayer 2nd-Quarter Profit Almost Triples on Demand for Plastics  Aug 9, 2005
The overhaul came after the August 2001 withdrawal of the Baycol cholesterol treatment, which was linked to more than 100 deaths. ... - Bloomberg

Bayer 2nd-Quarter Profit Held Back by Crop Business (Update3)  Aug 10, 2005
Wenning's overhaul came after the August 2001 withdrawal of the Baycol cholesterol treatment, which was linked to more than 100 deaths. ... - Bloomberg

A rundown of principals in the nation's first Vioxx trial  Aug 19, 2005
...corporations. She represented Bayer Corp. in the nation's first Baycol trial in Corpus Christi in 2003, where Bayer Corp. was cleared ... - Newsday,

Omega-3 fatty acids better than statins in reducing death  Aug 11, 2005
A seventh statin, cerivastatin (Baycol) was removed from the market in 2001 because of potentially serious side effects and a number of deaths. ... - Health Sentinel

July 25 2005  Jul 25, 2005
Lotronex – 9 months; Duract – 11 months; Posicor – 12 months; Redux – 17 months ; Raplon – 19 months; Raxar – 23 months; Baycol – 27 months ... - Newsinferno.com

Maker of Crestor revises warning label for its controversial ...  Aug 1, 2005
Currently, the risk of Rhabdomyolysis from Crestor is very similar to another cholesterol-lowering medication, Baycol (cerivastatin) which was completely ... - PR Leap (press release)

Bayer Eyes the Kidney Cancer Market  Jul 13, 2005
...could prove crucial for Bayer, which is still looking to recover from the scandal that surrounded the recall of its anti-cholesterol drug Baycol in August 2001 ... - PharmaLive.com (press release)

Trial a matchup of legal powerhouses  Jul 10, 2005
...in a trial in Corpus Christi that cleared the company of ignoring research linking the cholesterol-lowering drug Baycol to dozens of deaths. ... - Houston Chronicle

First Vioxx Suit: Entryway Into a Legal Labyrinth?  Jul 10, 2005
...documents and won a lawsuit in Texas brought by an 82-year-old man who said he had suffered muscle damage after taking its cholesterol-lowering drug Baycol. ... - New York Times

Merck's Vioxx Headache  Jul 19, 2005
Bayer faced a wave of lawsuits after it recalled its cholesterol-lowering drug Baycol, which was linked to deaths from kidney disorders. ... - Smartmoney.com (subscription)

Gavin Law Firm Announces New Website  Jul 22, 2005
...back injury claims, defective product lawsuits, farm machinery accidents, asbestos, mesothelioma, ATV accidents, dangerous drug claims, Baycol side effects ... - PR Leap (press release)

Widow wants Merck to taste a bitter pill  Jul 12, 2005
...successfully defended Bayer in the first of thousands of cases the company faced from plaintiffs who alleged the cholesterol-lowering drug Baycol had harmed ... - Denver Post

First of Merck's many court days  Jul 10, 2005
...to win a lawsuit in Texas brought by an 82-year-old man who claimed that he had suffered muscle damage after taking its cholesterol-lowering drug Baycol. ... - International Herald Tribune

Arianna Huffington: Vioxx Goes to Trial: Will Washington Take Heed ...  Jul 15, 2005
...totaled $2.5 billion. Sadly, the Vioxx case is far from an isolated one. Think Baycol, Rezulin, and Duract. After each of these ... - Yahoo News

UPDATE 1-Bayer, Onyx file for key kidney cancer drug in US  Jul 10, 2005
...euros ($596 million) from the drug, crucial for the German company whose drugs unit has been hit by a $1 billion recall of anti-cholesterol medication Baycol. ... - Reuters

Bayer, Onyx seek cancer drug OK  Jul 12, 2005
...declined after losing patent protection last year while Bayer completes a reorganization forced by the August 2001 withdrawal of the Baycol cholesterol drug. ... - Inside Bay Area

Immunosuppressive Drugs, Fibric Acid Derivatives, Niacin (Nicotinic Acid, Erythromycin, Azole Antifungals:

Skeletal Muscle.

ANTACID (Magnesium-Aluminum Hydroxide): Cerivastatin plasma concentrations were not affected by co-administration of antacid.

CIMETlDINE: Cerivastatin plasma concentrations were not affected by co-administration of cimetidine.

CHOLESTYRAMINE: The influence of the bile-acidsequestering agent cholestyramine on the pharmacokinetits of cerivastatin sodium was evaluated in 12 healthy males in 2 separate randomized crossover studies. In the first study, concomitant administration of 0.2 mg cerivastatin sodium and 12 g cholestyramine resulted in decreases of more than 22% for AUC and 40% for C_max when compared to dosing cerivastatin sodium alone. However, in the second study, administration of 12 g cholestyramine 1 hour before the evening meal and 0.3 mg cerivastatin sodium approximately 4 hours after the same evening meal resulted in a decrease in the cerivastatin AUC of less than 8%, and a decrease in C_max of about 30% when compared to dosing cerivastatin sodium alone. Therefore, it would be expected that a dosing schedule of cerivastatin sodium given at bedtime and cholestyramine given before the evening meal would not result in a significant decrease in the clinical effect of cerivastatin sodium.

DIGOXIN: Plasma digoxin levels and digoxin clearance at steady-state were not affected by co-administration of 0.2 mg cerivastatin sodium. Cerivastatin plasma concentrations were also not affected by co-administration of digoxin.

WARFARIN: Co- administration of warfarin and cerivastatin to healthy volunteers did not result in any changes in prothrombin time or clotting factor VII when compared to co-administration of warfarin and placebo. The AUC and C_max of both the (R) and (S) isomers of warfarin were unaffected by concurrent dosing of 0.3 mg cerivastatin sodium. Co-administration of warfarin and cerivastatin did not alter the pharmacokinetics of cerivastatin sodium.

ERYTHROMYCIN: In hypercholesterolemic patients, steady-state cerivastatin AUC and Cmax increased approximately 50% and 24% respectively after 10 days with co-administration of erythromycin, a known inhibitor of cytochrome P450 3A4.

OTHER CONCOMITANT THERAPY: Although specific interaction studies were not performed, in clinical studies, cerivastatin sodium was used concomitantly with angiotensin- converting enzyme (ACE) inhibitors, betablockers, calcium-channel blockers, diuretics, and nonsteroidal anti-inflammatory drugs (NSAIDs) without evidence of clinically significant adverse interactions.