Archive for the ‘Online Pharmacies’ Category

Experts See Growing Illegal Market for Buprenorphine

Monday, December 17th, 2007

Buprenorphine (Suboxone) was developed as an alternative to methadone that would be equally effective in treating opiate addiction but less likely to be abused. But Baltimore officials say that a black market for the drug has developed, leading to “bupe” abuse and some deaths, the Baltimore Sun reported Dec. 16.

Unlike methadone, buprenorphine can be prescribed by individual doctors or group practices, not just distributed at treatment clinics. The drug’s formula is designed to minimize its abuse potential — it contains naloxone, which makes users sick if they ingest it — but some users are crushing the pills and snorting or injecting the drug to get high, either filtering out the naloxone or putting up with its ill effects.


New Methadone Restrictions Announced

Thursday, December 13th, 2007

The Drug Enforcement Administration (DEA) announced this week that U.S. pharmaceutical companies have voluntarily agreed to restrict access to larger-dose methadone tablets beginning on Jan. 1, 2008.

The 40-mg methadone hydrochloride tablets will only be distributed to hospitals and authorized opiate addiction and detoxification facilities, the DEA announced. The move was intended to curb the rising number of methadone overdoses and illegal diversion of the drug.

“The 5 mg and 10 mg formulations indicated for the treatment of pain will continue to be available to all authorized registrants, including retail pharmacies,” according to the agency. “The 40 mg strength is not FDA approved for use in the management of pain. Thus, the distribution and availability of the 40 mg formulation will be limited to registrants in only those settings using the 40 mg formulation for the appropriate indication” – namely methadone maintenance for opiate addicts.


Federal Court Filing Asserts That Johnson & Johnson Altered And Withheld Data About Health Risks Of Ortho Evra Birth Control Patch

Thursday, December 13th, 2007

As Of November 2007 J&J Faces 2400 Lawsuits Involving Strokes, Heart Attacks, And Blood Clots Allegedly Caused By Ortho Evra, With Most Cases Pending Before MDL Judge Katz

(Posted by Tom Lamb at

In legal motions filed November 20, 2007 by lawyers representing women claiming to have been injured by their use of the Ortho Evra birth control patch, it is asserted that the drug company Johnson & Johnson (J&J) misled the FDA and doctors in the years leading up to the time that “the Patch” was approved for use by women in the U.S.

According to a November 29, 2007 Bloomberg article, “J&J Altered Birth-Control Patch Data to Hide Risks”, these contentions of misconduct by J&J were presented to U.S. District Judge David Katz, of the U.S. District Court, North District of Ohio, in Toledo, who is the presiding judge for In re Ortho Evra Products Liability Litigation, Multi-district Litigation (MDL) 1742, where currently approximately 1500 federal court lawsuits from around the country have been centralized.


FDA Expected To Comment On Its Safety Evaluation Of Nexium And Prilosec In December 2007

Friday, December 7th, 2007

Agency’s Follow-Up On Its August 2007 “Early Communication” About These Heartburn Drugs Is Late, But Just In Time For Christmas Dinner

(Posted by Tom Lamb at

As reported previously, in early August 2007 the FDA and Men’s health Canada raised concerns about possible serious cardiac events in patients using Nexium and Prilosec, made by AstraZeneca (AZN), which are used for the treatment of gastroesophageal reflux disease (GERD) and esophageal erosions, as well as for maintenance of healing erosions of the esophagus.


State Medicaid Programs Hinder Naltrexone Use

Tuesday, November 20th, 2007

States that allow managed-care programs to limit prescriptions and access to pharmacy networks are hindering the use of naltrexone for treating alcohol addiction, according to research from the Substance Abuse Policy Research Program (SAPRP).

Researchers Carolyn Heinrich of the University of Wisconsin at Madison and Carolyn Hill of Georgetown University found that treatment providers were more likely to prescribe naltrexone in states where use of generic drugs is encouraged in Medicaid programs. In states where managed-care firms dictate prescription rules, however, naltrexone was less likely to be prescribed. Other barriers to naltrexone use were restricting use of Medicaid funds for addiction treatment and the use of restrictive preferred-drug lists for Medicaid patients.


Will New Black Box Warning About Heart Attacks Lead GlaxoSmithKline To Withdraw Avandia From Market?

Friday, November 9th, 2007

One Wonders Whether GSK Might Do A “Soft” Recall Of Its Embattled Diabetes Drug, As Was Done By BMS With Serzone And Tequin In Recent Years

(Posted by Tom Lamb at

Avandia (rosiglitazone) is a prescription drug from GlaxoSmithKline (GSK) approved by the FDA in 1999 to treat Type 2 diabetes.

New Information From FDA On Alleged Problems With Ketek Safety Study 3014

Thursday, November 1st, 2007

October 2007 FDA Letter Says Aventis Did Not Follow Regulations And Statutory Requirements; Company Contends Study Conducted In Good Faith

(Posted by Tom Lamb at

On October 24, 2007 the FDA posted on its web site a copy of an 11-page “Warning Letter” to Sanofi-Aventis (SNY) about problems with Ketek Study 3014.

In her October 25, 2007 Wall Street Journal article, “FDA Says Aventis Failed To Act on Ketek Drug Fears”, Anna Wilde Mathews provided this summary the FDA’s Ketek letter:

In yesterday’s letter, the FDA said visits from an Aventis contractor and the drug maker’s own audits documented “serious protocol violations and regulatory noncompliance by multiple clinical investigators.” The agency said it was “unable to find evidence” that the company either fixed the problems or threw the problematic doctors out of the study and told the FDA. The FDA also faulted Aventis for failing to make sure the study was properly conducted and for allowing unqualified investigators to participate in the trial.


Alcohol Problems Widespread in Workforce

Thursday, October 25th, 2007

A new study shows that alcohol dependency, major depression, and social phobia are widespread in the U.S. workforce, Men’s healthScout News reported July 29.

According to the report, 25 percent of American workers experiences at least one mental or addictive disorder each year.

“The rates are extremely high,” said Robin Hertz, study author and a senior director of population studies at Pfizer Pharmaceuticals Group, which paid for the research. “As a nation, we have to be more attentive to these types of problems. There is a mythology out there that if you are at work you are (more…)

FDA Alerts Doctors About Diabetes Drug Byetta And Acute Pancreatitis Reports

Friday, October 19th, 2007

Package Insert Will Be Changed To Include Stronger Warning About This Potentially Fatal Side Effect

(Posted by Tom Lamb at

On October 16, 2007 the FDA issued an alert to doctors informing them that the agency had reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes.

From this October 2007 FDA document, “Information for Men’s healthcare Professionals - Exenatide (marketed as Byetta)”, we get some breakdown of those 30 adverse reaction reports:


How Should Drug Companies And Their Ad Agencies Respond To Safety Signals?

Monday, October 15th, 2007

Two Perspectives On How Emerging Drug Safety Situations Should Be Handled Going Forward

(Posted by Tom Lamb at

The September 1, 2007 edition of Pharmaceutical Executive starts with the piece “From the Editor: What Do You Say?” which carried this intriguing sub-title: “The first safety signal is detected. Proof or disproof is literally years away. What has to happen so no patient will say, ‘You hid the risk’?”

For a lead-in on this piece, however, we draw from an October 15, 2007 post by Ed Feather “The Vioxx Moment” over at the ART + science: the PARTNERS+simons Blog: