September 2009

I agree wholeheartedly.

The nation's leading group of general internal medicine physicians has taken the U.S. Food and Drug Administration to task over drug safety and urged the agency to adopt a raft of new consumer safeguards for prescription drugs.

The American College of Physicians recommended that the FDA place limits on the advertising of newly approved drugs to the public, and require that prescription drugs that are new to the market bear a symbol alerting consumers to that fact. The internists also urged the agency to improve its system of detecting drug-safety problems once a newly approved drug is in broad circulation, and said the agency must do a better job of monitoring the safety of drugs manufactured abroad.

The first years of a prescription drug's availability can be boom times for manufacturing giants, who generally "roll out" a new FDA-approved drug with a flashy and expensive marketing campaign aimed at doctors they hope will prescribe the drug and patients they hope will ask for it by name. Those efforts often make new drugs "blockbusters" soon after they reach the general patient population.

The problem: The general patient population is generally less healthy, more diverse, less careful about following use instructions and on more other medicines than were the subjects the drug companies used in their preapproval clinical trials. As a result, safety and effectiveness problems are sometimes detected only when a drug goes into wide circulation. The result is that, when drugs are withdrawn from the market over safety concerns, it is typically in the first couple of years they're on the market.

Source: Doctor group calls for warnings on new prescription drugs | Booster Shots | Los Angeles Times

Do you subscribe to FDA warning alerts?  Well, if not, you should.  Because if you did you’d get informative emails like this one:

Audience: Neurological healthcare professionals, patients

[Posted 09/17/2009] FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri.  Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008.  From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.

The risk for developing PML appears to increase with the number of Tysabri infusions received. At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program.

Read the MedWatch safety summary, including a link to the "Information for Healthcare Professionals" page, at:

It came a little late for Diana Levine, but at least it finally came.

TRENTON, N.J. — Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug Administration said Wednesday.

The drug, previously sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan, was at the heart of a U.S. Supreme Court case this spring that ended in a ruling that consumers harmed by a medication approved by the FDA still have the right to sue the manufacturer.

Wyeth had appealed the case up to the Supreme Court after a Vermont woman named Diana Levine, who once played the guitar and piano professionally, sued because she had to have her right arm amputated after being injected with Phenergan. Levine's lawsuit, which claimed she wasn't sufficiently warned of the risks of using Phenergan, won her a $6.7 million jury award.

Source: The Associated Press: FDA requires strong amputation warning on sedative

This is pretty bad for Glaxo:

Sept. 18 (Bloomberg) — Officials of GlaxoSmithKline Plc, the U.K.’s largest drugmaker, said in 2001 that a birth defect in the fetus of a woman taking its Paxil antidepressant likely was linked to the drug, according to court testimony.

After analyzing a 2001 e-mail from a Paxil user who aborted her fetus because it had a heart defect, Glaxo officials noted in company files they were “almost certain” the drug was related to the problem, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury.

Source: Glaxo Linked Birth Defect of Fetus to Paxil, Ex-Executive Says –

If you or someone you know has PPH, and EVER took Fen Phen, Pondimin, Redux, or another weight loss drug, I’d like to talk to you.  There have been cases documented of people developing PPH after using Fen Phen for as little as two months, and there is now evidence that people are developing PPH up to twenty years after taking those diet drugs.  You may want to review some of the documents I have posted at  Or, you can just email me directly at justinian at justinian dot us.  I can put you in touch with attorneys who are helping people who used diet drugs and who many years later developed PPH.  The treatments for PPH are very expensive, so why not hold the Fen Phen makers accountable and force them to pay for the treatments if they caused you to develop PPH?

Watson makes a generic version of the Duragesic fentanyl patch using the reservoir design.  Like Alza, the company that makes Duragesic, Watson has had recalls due to defective patches.

Watson Recalibrates Equipment After Fentanyl Patch Recall

Watson Pharmaceuticals has adjusted calibration for a machine that manufactures its fentanyl transdermal patches after a small number of them that leaked prompted a voluntary recall of one lot of the product.

Source: Watson Recalibrates Equipment After Fentanyl Patch Recall

At my new blog,, I’ve posted a variety of documents from Duragesic lawsuits.  These lawsuits pertain only to the brand name Duragesic patch, or the Sandoz/Actavis generic patch, as it is made in the same factory.

If you have any documents from Duragesic lawsuits, I’d love to post them here or at my other blog.  Or, if you’re looking for a Duragesic lawyer, contact me and I’ll put you in touch with a lawyer who I feel can help you.  I don’t ever get paid for introducing you to my friends, but instead make these introductions because I want to help people hold the fentanyl patch manufacturers accountable for selling a dangerous pain patch.

These documents pertain only to generic fentanyl patch lawsuits, not against the makers of the brand-name Duragesic patch.

In theory, no.  Generic drugs are supposed to be just as safe and effective as brand-name drugs.  However, there is some evidence that they may not be:

“The average citizen would want to know that someone is checking that manufacturers are making the drugs they got approval to make,” says William K. Hubbard of Chapel Hill, N.C., associate commissioner for policy and planning for the FDA from 1991 to 2005 (and no relation to Beth). “That’s not happening, and the risk to consumers is potentially huge. I take generic drugs when they’re prescribed for me, but my confidence in them is lower than it was a year ago—and going down.”

Source: Bad Bargain: The Dangers of Generic Drugs – Page 1 – MSN Health & Fitness – Health Topics

This is particularly interesting to me due to the potential legal ramifications of generic drugs differing from their brand-name counterparts in serious ways.  Generic drugs are approved by the FDA through an abbreviated process.  Rather than having to demonstrate safety and effectiveness of their drugs, they are allowed to rely upon the proof submitted by the manufacturer of the brand-name drug.  Instead, the generic manufacturer merely has to show that their drug has the same active ingredient in the same percentage.  I’m simplifying it a bit, but not by too much.  I wonder if (a) the FDA will be forced to take a harder look at generic drugs, and (b) whether there will be additional liability for generic drug manufacturers.