Drugs/Medical Archive

Questions about Antidepressants and Pregnancy

January 14th, 2011. By AbiK

There’s a lot in the news about pregnancy and antidepressants (SSRI’s in particular—and especially Paxil, which has a Category D rating by the FDA). And we get a lot of comments and emails from readers who are either looking for information about SSRI drugs and pregnancy—or who share their stories about negative side effects they’ve experienced while taking antidepressants.

It’s a tough call—particularly when depression and pregnancy are not exactly mutually exclusive of each other. As any mom will tell you—even the ones who “just love being a mom!” and “always wanted to have at least 4 kids!”—you know who I mean—there are moments when you’re exhausted, down, emotionally drained. For many, it’s a circumstantial situation that, given a few hours, some diversions, or a good workout, tends to go away and resolve on its own. But not for everyone. And that’s where depression medication comes into play. Bottom line, it’s no accident that “Peanut Butter, Playdates & Prozac” became a popular read…

We publish a lot of information at LawyersandSettlements to help readers understand what’s going on with antidepressant lawsuits. But we also post background information as well—and for those of you who’ve written in requesting information about antidepressants and pregnancy, I’ve pulled some of our informative posts. Here they are:

Paxil Birth Defects: Baby Beware! A look at Paxil, pregnancy and depression

Antidepressant Guide: the Brands, the Generics & Who Makes Them List of antidepressant brand names and the names of their generic equivalents, and their manufacturers

Antidepressants: Know what they’re Winding you Up With Information about antidepressant drug classifications–the “umbrella” categories that antidepressant drugs fall into: SSRI, SNRI, NDRI, MAOI, and Tricyclics.

Having a Baby? Get to Know the FDA Drug Classifications Information about FDA pregnancy ratings for drugs. (Category A, Category B, Category C, Category D, and Category X—the system in which Paxil has been classified as Category D; and antidepressants like Effexor and Celexa are Category C. For those wondering, the Prozac pregnancy rating and the Zoloft pregnancy rating are both Category C at present as well).

Mom Alert: Would you want a 68% Higher Risk of Miscarriage? Study showing high rate of SSRI miscarriage risk—as well as SNRI and Tricyclic risk. Study looked at citalopram, fluoxetine, fluvoxa-mine, paroxetine, sertraline, ami-triptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramine, venlafaxine, serotonin modulators, monoamine oxidase inhibitors, tetracyclic piperazino-azepines, and dopamine and norepinephrine reuptake inhibitors.

Hope this info helps—but remember, please consult your physician for medical advice about your particular situation—only your doctor(s) can advise and treat you. If you need legal help…that’s another story…

Tags: Antidepressant, paxil, Paxil birth defects, paxil-heart-defects-newborn, Pregnancy, Pregnancy Cateogory, prozac-birth-defects-lung-heart, prozac-heart-birth-defect, SNRI, SSRI, ssri_birth_defects, zoloft-heart-birth-defect, zoloft-lung-heart-birth-defects
Posted in Drugs/Medical, Emerging Issues | 2 Comments »

The Risk of Sleepy Surgeons

January 11th, 2011. By Hunter West

There was a study recently that demonstrated sleepy drivers were just as careless, just as accident-prone and just as dangerous as people who were driving drunk. Sleep deprivation, the researchers found, was just as much an impairment as being high on alcohol. 

So what about doctors? What about surgeons? 

An editorial that came out December 30^th in the New England Journal of Medicine (NEJM) makes that same point for medical professionals. To wit, sleepy doctors are potentially as impaired as drunken doctors. 

It’s something, as patients, we never think about. But think about it—how many times have you been caught yawning on the job? How many times have you nodded off at the computer? How many times have you had to pull over while driving endless miles along a highway, in order to catch a bit of rest because you feel yourself nodding off? 

Should we not assume that surgeons are capable of the same sleepiness? 

The concern is certainly warranted, according to the authors of the NEJM editorial. And one can certainly understand the issue. As an example, a surgeon who has not slept all night following emergency bowel surgery throughout the wee hours is seen scrubbing up for an elective colostomy at nine the following morning. 

Pretty scary thought, huh? 

The editorial authors say that sleepy surgeons should not be allowed to operate without a patient’s Read the rest of this entry »

Tags: medical malpractice, NEJM, Sleep, Surgeon
Posted in Drugs/Medical, Emerging Issues | No Comments »

Levaquin Sales Rep in Need of Auctioneer Training?

January 4th, 2011. By Hunter West

The recent victory by a Levaquin plaintiff in his lawsuit against the manufacturer of the fluroquinolone antibiotic raises an interesting sidebar. 

Earlier this month John Schedin was awarded more than a million dollars by a jury, after he suffered ruptures in both his Achilles tendons three days after starting on Levaquin together with a steroid. The doctor who prescribed the duo to the then-76-year-old indicated that while he was aware of the potential for tendon complications with Levaquin, he was not aware of the increased risk to seniors when Levaquin is taken in concert with a steroid. 

Schedin now has to crawl up the stairs on his hands and knees in order to get to his bed at night. His doctor is mortified at the role he played in his patient’s misfortune. 

The trial featured the usual back-and-forth as to what was known and what wasn’t, what was revealed and what allegedly was not, and so on. The manufacturer (defendant) claims that all the necessary info was made available on the medication guide that came with the product. The plaintiff countered that such information—including the black box warning—was buried deep within the bowels of a document few patients will ever read anyway, let alone their busy doctors. 

The doctor testified that he did not recall the manufacturer’s rep ever referencing tendon problems during her visits to the office. The sales rep, while testifying she did slip an information packet into the basket with all the free samples, did not recall either whether, or not, she had made any verbal reference to the Levaquin tendon issue. 

However, she said, she may not have had time anyway. She testified that in this day and age, with high caseloads, getting to actually talk to the doctor for 30 seconds would leave her feeling ‘lucky…’ 

Thirty seconds? 

Something is wrong here. 

How can a drug company rep effectively disseminate product information to a doctor in that Read the rest of this entry »

Tags: JOhn Schedin, Levaquin, Pharma Sales
Posted in Drugs/Medical | 2 Comments »

Score One for the FDA as Rest of World Finally Yanks Thelin

January 3rd, 2011. By Hunter West

Time to give credit where credit is due. And this time, the US Food and Drug Administration (FDA) got it right. 

Recently it was announced, in a joint statement by Health Canada and Pfizer Canada, that Thelin (sitaxsentan) was being taken off the market in Canada, as well as every country in which it had been sold, due to risk for potentially fatal liver damage. 

Never heard of Thelin? There’s a reason for that. Thelin is not available in the US. Never was. That’s because the FDA refused to approve the drug designed to treat pulmonary hypertension. In the view of the FDA, the benefits did not outweigh the risks. 

In a bid to win FDA approval for marketing Thelin in this country, Pfizer Inc. launched a series of clinical trials. However, those trials have been abandoned following the deaths of three trial participants. 

According to a report in the Globe and Mail, Canada’s national newspaper, liver damage was a known complication of Thelin. However, in announcing that it was abandoning further clinical trials, Pfizer noted that it had discovered a  “new potentially life-threatening idiosyncratic risk” of liver injury among patients that is difficult to predict or guard against. 

Thus, there will be no further clinical trials, and Thelin will be coming off the market in Australia, Europe and Canada where it had been previously approved. Given the known risks associated with Thelin, Canadians are wondering how Thelin ever won Health Canada approval in the first place. 

The FDA has been maligned, chastised, ridiculed and kicked to the curb over the appearance of lax oversight both in the approval, and ongoing supervision of drugs and medical devices. And to be sure, much of that criticism is warranted. 

However, on this occasion the FDA stuck to its guns and has been vindicated. There can be Read the rest of this entry »

Tags: FDA, Pfizer, Thelin
Posted in Drugs/Medical | No Comments »

2010: Annus Horribilis for GlaxoSmithKline?

December 20th, 2010. By Kristine B

Let’s face it, lots of drug companies face a variety of lawsuits and fines from the government. But 2010 might be a year that GlaxoSmithKline would wipe from its memory if it could—a sort of annus horribilis, if you will. Between the reported Paxil settlements, massive fines for illegal activity at its Puerto Rico plant and huge restrictions on its diabetes drug, Avandia, GSK appeared to be facing a TKO as we moved into 4Q’2010. So officials at GlaxoSmithKline could be forgiven if they toast the New Year and hope it’s better than the last 12 months…

Paxil Settlements

Earlier this year, various media outlets reported that GlaxoSmithKline agreed to settle certain lawsuits alleging Paxil caused birth defects. According to Bloomberg, the drug maker agreed to pay more than $1 billion to settle approximately 800 lawsuits.

Meanwhile, a separate lawsuit also alleging Paxil birth defects, saw the family of an infant who died less than two months after birth, settle with GlaxoSmithKline for an undisclosed amount. In yet a different lawsuit, the family of a boy born with heart defects was awarded $2.5 million by a jury, which found that GlaxoSmithKline officials “negligently failed to inform” the mother’s physician about the risk of birth defects.

Fines for the Glaxo Puerto Rico Plant

In October of this year, GlaxoSmithKline agreed to pay $750 million to settle allegations of wrongdoing at the company’s Puerto Rico plant, which is now closed. An investigation into the plant found that improper manufacturing procedures resulted in medications that could split apart or had improper amounts of the active ingredient. Officials alleged that GlaxoSmithKline knowingly manufactured, distributed and sold medications that did not meet FDA standards.

As part of the settlement, a whistleblower in the case received a whopping $96 million. So for her, 2010 might just have been a fantastic year.

Avandia

Also this year, GlaxoSmithKline learned that its diabetes drug, Avandia, would carry severe restrictions on who can take the medication. The decision came after an FDA advisory panel recommended that use of Avandia be restricted in light of serious side effects. Patients who are not currently on Avandia will have to try other diabetes medications before using Avandia and will have to show they have been made aware of Avandia side effects. Although some people consider it a victory that Avandia was not pulled entirely from the market, these restrictions will likely have an impact on Avandia profits.

Based on those three issues alone, 2010 might be a year that GlaxoSmithKline tries—ever so hard—to forget.

Tags: Avandia, avandia-heart-attack, GlaxoSmithKline, GSK, paxil, paxil-heart-defects-newborn
Posted in Drugs/Medical | No Comments »