Drug Injury Attorney Blog

The U.S. Solicitor General is asking the Supreme Court to refuse to grant an appeal to pharmaceutical companies that want to continue to sell generic versions of Reglan.

This case, which is known as the Mensing Decision, is in response to an appellate court ruling that made the manufacturers of generic Reglan (metoclopramide) liable and accountable for not warning the public properly of the risks of patients developing tardive dyskinesia. Naturally, the makers of generic Reglan want that liability judgment reversed and have filed an appeal of the decision.

Tardive dyskinesia is a rare movement disorder that has been linked to the drug. When the Supreme Court asked the U.S. Solicitor General to give its opinion on the matter of accountability of generic Reglan manufacturers, the Solicitor General expressed its support of the appellate court ruling in an amicus brief filed about two weeks ago.

“The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted,” the Solicitor General says. “A generic manufacturer can (and indeed, must) inform the FDA of new information about the risks that may require a change in the labeling of its drug.”

While it is highly doubtful that the manufacturers will succeed in their appeals, this case brings to mind the many pharmaceutical companies that are suffering from similar judgments against them. Many of these manufacturers of drugs like Reglan are trying to downplay the risks that their drugs pose to patients’ health and safety for the sake of higher sales. While it works for a time before trials and claims start to bring it all down to ashes, the trustworthiness of drug companies is falling ever more into doubt by the public and the FDA. The problem here is that by the time any of these companies is held liable for it, the damage to people's lives has already been done.

A new study performed by researchers from the Institute for Clinical Evaluative Sciences and Sunnybrook Health Sciences Center claims that women that were being treated for breast cancer were more likely to die if they were taking Paxil than those that didn't take the drug.

"These results highlight a drug interaction that is extremely common, widely underappreciated and potentially life-threatening, yet uniformly avoidable," writes researcher David Juurlink.

The research is based on data gathered from 2,430 women ages 65 or older who were treated with the breast cancer drug tamoxifen between 1993 and 2005. Of these women, 30 percent also were taking an antidepressant at the same time.

Those that were taking Paxil with the tamoxifen treatment saw between a 25 and 91 percent higher rate of death — depending on the duration of the drugs’ overlap in treatment. While it isn't completely clear as to why this happened, it is believed that Paxil directly blocks the effects that tamoxifen has on the patients.

If the tamoxifen is going to work, the body has to be able to process it with an enzyme called CYP2D6. However, SSRIs like Paxil can block what the enzyme does for these women that are on the treatment.

"Paxil is a fairly potent inhibitor of that enzyme,” Juurlink says.

While Prozac likely has the same effect on tamoxifen as Paxil does, most of the women studied didn't take that drug. Paxil is the leading SSRI on the market. While this study has shown that women taking Paxil are more likely to die from breast cancer, it still is not recommended for them to stop taking the drug without consulting a doctor because Paxil also is well known to cause severe withdrawal symptoms.

If you currently are taking both of those drugs and want to stop, it is best to consult your doctor first and work out a weaning process. That is the safest way to come off of Paxil and any other antidepressant.

The State of Washington was awarded $6 million in its case against the makers of Paxil, GlaxoSmithKline, after the trial revealed that Glaxo allowed adulterated drugs to be sold.

The charge of adulteration came in 2004; a whistleblower came forward and charged that Glaxo knowingly sold Paxil and other drugs after manufacturing errors brought the drugs’ quality down to almost nil. The $6 million award against Glaxo came from them selling drugs that didn't meet federal standards. While Paxil wasn't the only drug involved in the case (others were Avandamet, Kytril and Bactroban), the current controversy surrounding the popular antidepressant certainly makes Paxil an easy focal point.

The federal government, along with many other states, filed its claim in court when the whistleblower stated that the company made a lot of severe mistakes during the production of the drugs at its plant in Cidra, Puerto Rico. She also stated that because of these mistakes, there were drugs that either had no active ingredient in them, had only the active ingredient in them or lacked the ingredient that made the pills work in controlled release form.

As to what the State of Washington plans to do with its windfall, representatives have stated that officials plan to divide half of the money between the state's Medicaid program and the general fund. With the other half, they will pay back the federal government for the prescription costs of Medicaid.

With all of the complications and controversy surrounding GlaxoSmithKline these days, it is likely that these suits will be just the beginning. However, Glaxo officials seem to have no intentions of admitting full liability and standing behind most of their products — at least not until they are caught in the act. This is something that has been happening to them a lot lately. By the looks of it, cases against Glaxo and Paxil are not over yet.

Last week, I wrote about a prescription painkiller that some defective drug lawyers believe should be pulled from the market because of the risk of overdose. This week, a painkiller is in the national spotlight for even more serious problems -- a risk of fatal health complications from intended use, not overuse. As ABC News reported Nov. 19, the U.S. Food and Drug Administration has asked the maker of Darvon (propoxyphene) and Darvocet (propoxyphene plus acetominophen) to take the drugs off the U.S. market because studies have shown that they can cause serious or fatal heart rhythm abnormalities. Generic drug makers are not obligated to take their own versions off the market, although the FDA has requested this. All versions of the drug have already been withdrawn in the United Kingdom, the European Union and New Zealand, and are strictly regulated in Sweden.

Propoxyphene is a painkiller in the opioid class, which means it’s from the same family of drugs as powerful prescription painkillers as well as opium and heroin. Like many other drugs in its family, it has a high addiction potential and is sometimes illegally used as a recreational drug. However, it is considered weak compared to many other prescription painkillers. Safety groups have cited some of those facts as reasons for withdrawing propoxyphene from the market, but they have also criticized the drug as more likely to cause fatal complications than other, more effective painkillers. An FDA panel voted in January of 2009 to take propoxyphene off the market, but the agency delayed action until a clinical trial in humans showed that the drug disrupts the electrical impulses that keep the human heart beating. A review of safety studies also showed more deaths per 10,000 patients with propoxyphene than with comparable drugs tramadol and hydrocodone.

As a pharmaceutical liability attorney, I’m pleased that the FDA has taken action to protect consumers from the bad effects of this drug. As the agency itself said publicly, the heart arrhythmia problems make it clear that the benefits of the drug do not outweigh its risks. However, I am disappointed that it took the FDA so long to take action after its panel voted to take propoxyphene off the market in January of 2009. It has been nearly two years since then, and Public Citizen estimates that statistically, 1,000 to 2,000 Americans may have died from using the drug during that time. Indeed, even that vote came after some overseas regulators had already banned it. No doubt the makers of Darvon and Darvocet stood to make money during that time as well -- but the FDA is not in the business of helping drug manufacturers make a profit, particularly at the expense of public safety.

Continue reading " FDA Pulls Painkillers From Market After Tests Confirm Fatal Heart Rhythm Problems " »

The relatively popular antidepressant drug Effexor is said to be causing another side effect that most people hadn't banked on. Some doctors are saying that Effexor actually causes anorexia.

It is well known that most antidepressants can come with a slew of negative side effects including severe allergic reactions, nausea, diarrhea, mood swings, insomnia, hallucinations and seizures. They also come with less serious ones, such as drowsiness, dizziness, nervousness, weird dreams, sweating, blurred vision, dry mouth, mild nausea, constipation, lower sex drive, impotence and difficulty having an orgasm.

However, it is not often reported that some people are using drugs like Effexor and Paxil more as appetite suppressants than in combating depression. Since doctors can only go on what their patients tell them about their "symptoms," it is easier and easier for new patients to get their hands on these pills.

Effexor now is being directly associated with anorexia (not to be confused with the eating disorder anorexia nervosa). This form of anorexia is caused by a loss or decrease in appetite and is one of the most common side effects of taking Effexor. While just 8 percent of those taking Effexor for depression experienced anorexia compared to 20 percent in those taking it for social anxiety disorder, the effect is still alarming.

The anorexia side effect has caused some people to refuse taking Effexor. Even though Effexor poses many of the same risks that Paxil does, not all patients deem the anorexia as a bad thing. This can also pave the way for patients taking Effexor to ignore the extreme risks of addiction that Effexor poses, as well as the potential that exist for patients to abuse the drug in an effort to lose weight. One thing that most people don't know until they are on Effexor is that it is the hardest drug to come off of. The withdrawal effects are dastardly, causing many doctors to only prescribe it for patients that are expected to stay on the drug long-term.

In the Philadelphia trial currently taking place over Paxil, a lawyer for the family of an injured teen says that Glaxo did not properly warn the public that Paxil could cause birth defects.

Officials from GlaxoSmithKline had conducted research that dated all the way back to the 1980s. This research showed that Paxil caused death in the babies of animal test subjects and yet attorneys working on behalf of the Blyth family say company officials didn’t warn consumers about it. Kimberly Baden, one of the lawyers working on behalf of Anna Blyth and her family, claims that Paxil caused a narrowing of the aorta that leads from now 14-year-old Anna’s heart.

“We believe the evidence will show Paxil caused Anna’s birth defects,” Baden said during opening statements. “We believe the warnings and instructions put out in 1995 weren’t appropriate and reasonable.”

The Blyth's case is the first case against Paxil that is specifically about birth defects since the company settled a similar case for $2.9 million dollars in 2009. Glaxo currently is denying that the drug Paxil has anything to do with Anna's heart defects; company officials also do not think that the animal testing results play any significant role.

With the large range of cases currently going on against Glaxo over their drug Paxil, company officials likely are hoping this case will let the public know that they will not be settling every single claim brought against them. Glaxo officials probably feel that their agreeing to settle a lot of these cases will only spur on more claimants.

Glaxo's representatives have stated, however, that Glaxo did include references to deaths of animal subjects on their label in 1995. This is the year that Anna's mother Marsha got pregnant. They are also claiming that Marsha read the warning as well. The jury will be hearing more about this case; so far, neither side has the upper hand.

As a dangerous prescription drug attorney, I know the pain medication Fentanyl (fentanil) is an ongoing safety problem for the FDA, with multiple recalls in various forms and under various names. That’s why I wasn’t surprised to see that the FDA has recalled about a million Fentanyl transdermal patches due to concerns about an overdose. Arthritis Today published an article about the recall Oct. 27, and the FDA updated its recall on Nov. 5 to include patients as well as health care providers. The recall is being blamed on a manufacturing error by Corium International, a Michigan company that makes drugs under contract for Fentanyl’s owner, Actavis Inc. The patches are believed to release the drug more quickly than intended, putting patients at risk for an overdose that could slow or stop their breathing, setting them up for brain damage and death. The FDA did not report any injuries or deaths related to the recalled patches.

Fentanyl is an opioid painkiller intended to manage severe pain when less powerful drugs do not help. The patches are supposed to release measured doses into the wearer’s bloodstream to manage pain over a long period. This is frequently used for cancer patients and patients undergoing surgery, as well as for people with certain kinds of arthritis. However, Fentanyl and Duragesic, another brand name for fentanil, have encountered repeated safety problems. Fentanil is derived from opium, making it highly addictive and very powerful. This has led to its use as a street drug and theft and misuse by hospital, clinic, nursing home and other medical employees.

That power is at the root of the safety recalls, most of which are recalls of the drug in patch form. Patches are intended to deliver the drug steadily into the patient’s bloodstream, but slight mistakes during manufacturing can make them deliver too much. Instead of merely killing the pain, an overdose can go further and depress the patient’s respiratory system. Victims can stop breathing or breathe only with difficulty, causing death. In fact, an overdose of fentanil from a legally prescribed Duragesic patch is blamed for the death of Jay Bennett, a former member of the band Wilco, in Illinois. Here in Missouri, inappropriate use of a Fentanyl patch intended for adults is blamed for the death of a six-year-old boy in Willow Springs.

As a pharmaceutical liability lawyer, I am pleased that Actavis is taking this issue seriously enough to recall the patches. But at the same time, I hope the FDA is looking seriously at whether a drug this powerful should be delivered by transdermal patch. This is not the first patch to come under fire; in fact, it’s not even the first fentanil patch to receive FDA action. Duragesic patches were blamed for deaths and other adverse events in 2005 and 2007. Two Fentanyl patch makers recalled products in 2008 because of an overdose risk from manufacturing defects. Another well-known patch safety problem had to do with Ortho Evra, a birth control patch blamed for causing blood clots by releasing too many hormones. Under these circumstances, it’s fair for drug industry observers to wonder whether patch delivery systems are right for drugs that require very careful monitoring of the dosage, which definitely includes Fentanyl.

Continue reading " FDA Recalls Powerful Fentanyl Pain Medication Patches Because of Overdose Risk " »

While Paxil has been used successfully for the most part to treat anxiety, obsessive compulsive disorder, post traumatic stress and depression, one of its off label uses is for the treatment of premature ejaculation.

While Paxil is not approved for the treatment of premature ejaculation, this is a known off-label use of the drug. Currently, it isn't fully understood just how Paxil works for treating premature ejaculation; however, it does list sexual side effects as one of the potential results of using the drug. Premature ejaculation is when a man ejaculates involuntarily during arousal or immediately following sexual penetration.

The most common sexual side effect which occurs when taking Paxil is that it produces delayed ejaculation. While these sexual side effects are usually not the type that most men want, those men that suffer from premature ejaculation will actually prefer the delay. However, it is still seen as an off-label use of the drug.

The term "off-label" is used to describe when a drug is used for treatment of a condition but is not approved by the FDA for that use. While the FDA regulates how a medication can be advertised or promoted by the makers of the drugs (in Paxil's case GlaxoSmithKline), that does not mean that doctors can't prescribe the drugs for those uses that are found to work. However, doctors should use extreme caution when prescribing drugs to treat conditions that are not listed officially because whatever dosage is given can cause severe side effects to the patient. This is particularly true when drugs like Paxil are used for a prolonged period of time.

Since Paxil is an SSRI inhibitor medication, side effect such as heart attacks, strokes, severely modified behavior, suicidal thoughts and even death can occur. Paxil should be taken under the strict guidance of a doctor no matter what you are taking it for.

According to a new study that was published in the Journal of the American Medical Association, most of the antidepressant drugs on the market — including Paxil — that contain paroxetine and imipramine do not provide patients with any benefits that a placebo doesn't when it comes to actually helping patients with mild to moderate or even extreme depression.

According to Robert DeRubeis, who is a psychologist at the University of Pennsylvania and was part of the team that performed the meta-analysis, patients that were taking Paxil would have fared just as well had they not taken antidepressants at all. The meta-analysis was drawn from six studies with more than 800 patients participating.

During the study, the patients each had an initial depression score of 23 or lower and that number dropped an average of 8 points after they were given Paxil. However, the study also showed that there was a 7-point drop in people that were given a placebo. DeRubeis says he hopes that this information encourages doctors and their patients to take a moment to see what else can be done to combat depression before they rush in to prescribe Paxil and other drugs in the same class. He also says that patients can choose things like exercise and psychotherapy instead of taking antidepressants at all.

Paxil, made by GlaxoSmithKline, is one of the most popular SSRI drugs on the market. However, with so many risks involved in taking Paxil, this new information could add to the many woes the company is going through. There have been a lot of claims that Paxil increases suicide risk, heart attacks and strokes — even that it can cause death.

Glaxo has been investigated frequently of late for shady dealings in the making and marketing of other drugs. This report may add even more backlash against the company and even question the validity of Paxil and other drugs. That is something to think about for patients with depression.

While Paxil always has been used to treat depression and anxiety in people, it has come under fire for safety risks recently. Claims that Paxil causes heart attacks, strokes and even death have been around for a while, but one of the less-known side effects of taking Paxil has been setting off quite the buzz: It turns out that some people are trying to get Paxil so that they can lose weight.

Paxil has been associated more commonly with weight gain; however, weight loss is now considered one of the "high sides" of taking the drug. There are several side effects to taking Paxil, including weight loss or weight gain. Studies of the drug have shown that as many as 9% of people taking the drug reported that they lost their appetite. On average, those same people reported to losing a pound or less while taking it.

For some patients, that weight loss potential is good enough to outweigh the more serious risks. However, it is good to note that it is possible for people to lose too much weight while taking Paxil. Weight loss may be a desirable side effect for some and there are numerous message boards with people asking if they should take Paxil just for use as a weight loss drug.

So far it is not really known just why Paxil causes weight loss in some people, but with some of the side effects of the drug being loss of appetite, nausea and diarrhea, it is really not difficult to guess. With so many people inquiring about using the drug as an appetite suppressant, doctors may want to be very careful who they prescribe this drug to. Doctors also should make a larger effort to fully explain the severe side effects that may be fatal to their new patients as well.

The last thing a parent with a teething baby wants is to cause their baby to suffer more pain. Unfortunately, according to a recent recall announced by the U.S. Food and Drug Administration, some parents may have inadvertently done just that. Hyland’s Teething Tablets, a homeopathic product containing belladonna, was recalled after the FDA received reports of serious adverse events in babies who took the product. Belladonna, also known as deadly nightshade, is one of the most well known poisonous plants in the Western hemisphere. As a defective drug lawyer, I applaud the FDA for moving quickly and hope that no more children are harmed.

According to the manufacturer, Hyland's Teething Tablets are meant to provide homeopathic relief for teething babies. The product is sold as an over-the-counter dietary supplement in grocery and drug stores. The recall notice suggests, but does not outright say, that the FDA has already identified manufacturing problems responsible for the adverse event reports it’s received. Those reports suggest that the infants who got sick suffered a toxic overdose of belladonna. The manufacturer has recalled the tablets and parents are advised to stop using them immediately, and to discard any tablets that they still have. The FDA advises consumers to contact a health care professional if their child takes the tablets and then experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation.

As a defective medication lawyer, I think this is a good reminder that patients are not well protected from “dietary supplements” marketed as medical cures. Even though the FDA does not treat homeopathic medications like Hyland's Teething Tablets as drugs, the manufacturer instructs parents to treat it as any other medication, in consultation with a licensed health care practitioner. While the manufacturer says it’s "virtually impossible" to overdose on the product, the FDA’s findings suggest otherwise. The tablets are manufactured to contain a small amount of highly toxic belladonna -- just two to five berries from the plant can kill a child. That means the amount of the belladonna should be carefully controlled -- yet FDA laboratory analysis has shown that the amount of belladonna varies widely from tablet to tablet. In addition, the containers in which the tablets are sold do not have child-proof caps, so children have been able to open the containers and consume more of the tablets than recommended.

Continue reading " Supplement for Teething Infants Recalled Due to Poisonous Herbal Ingredient " »

GlaxoSmithKline, the makers of the controversial drugs Avandia and Paxil, just reported a third quarter profit loss. Company officials are blaming government cost-cutting in Europe after European health authorities banned Avandia from its shelves and the recent FDA restrictions in the U.S. placed on Avandia and Paxil.

According to recent reports, Glaxo is holding falling prices and Obama health care reforms responsible for its poor third quarter, in which the company lost 6 percent in profits.

Andrew Witty, the company’s chief executive, says Glaxo has been forced to cut its drug prices for the European market by about 3.5 percent this year. Usually the company only cuts them 2 percent, but the larger cuts were made because the governments can’t afford to pay more than that for the drugs, according to Witty. In the end, Glaxo was hit the hardest by the European regulators banning Avandia after it was proven to pose a higher risk of patients experiencing heart problems, strokes or death. It didn't help that at the same time, American regulators severely restricted the drug’s availability in the U.S., too.

Glaxo's legal problems over Avandia and Paxil aren't over yet, either. The company confirmed that it also has to answer to a subpoena from the U.S. Department of Justice on the subject of the marketing and development of Avandia as well. Glaxo has also said that they got "civil investigative demands" from more than one states attorneys general office. Under all of this scrutiny regarding the bans and restrictions surrounding drugs like Avandia and Paxil, Glaxo should be less concerned with the forced price cuts and find some satisfaction in the fact that the drugs are still on the market at all.

According to the Associated Press, Mylan, the sellers of generic versions of Paxil CR, claims that the courts will not block the sales of generic versions of the drug Paxil.

This is in response to a temporary order in September that blocked Apotex from selling generic versions of the popular antidepressant that is made by GlaxoSmithKline. Now that the U.S. District Court has denied Mylan's request for a preliminary injunction that permanently blocks other companies from selling the generic versions of Paxil, all Mylan Inc. can do is appeal the decision.

Mylan has had an exclusive agreement with Glaxo since 2008 to sell a generic version of Paxil; its previous lawsuit claimed that Glaxo violated an agreement that guaranteed Mylan primary rights to sell the generic version of the popular antidepressant. Apotex of Canada also was selling the generic version at that time and was Mylan's major competition on the market. In September, Mylan received a temporary restraining order that blocked the two companies from selling their generics until this Monday's hearing.

The appeal process comes directly on the heels of the court's final decision on the original claims made by Mylan against Glaxo. The final decision in the case came down on Oct. 18. Right now Mylan Inc. is the largest U.S.-based generic drug company and the recent decision by the judge will cause a major profit decrease for the company, as generic Paxil was one of Mylan's big sellers. Since May 2008, the company's generic version of Paxil has generated hundreds of millions of dollars in sales in the U.S., and hundreds of thousands worldwide.

Amidst all of the difficulties that currently surround the brand name drug Paxil, GlaxoSmithKline, Apotex and Mylan have much to be upset about. Sales of Paxil may drop due to the recent controversies — and with at least three large companies competing in the same market, that is bound to bring about some harsh financial realities for all of the companies involved.

The iron replacement drug Feraheme (Ferumoxytol) has been associated with "life-threatening" events, including heart problems, and may get a black box warning. The U.S. Food and Drug Administration approved Feraheme last year to treat iron-deficiency anemia in adults with chronic kidney disease. Financial analysts are concerned that reports of fatal events associated with Feraheme will hurt the drug's sales. As a dangerous drug liability attorney, I am more concerned that this drug will hurt patients, and I urge patients taking this drug to educate themselves about its risks.

AMAG Pharmaceuticals, Feraheme's maker, met with the FDA in September to discuss safety concerns about the drug. Fatal and life-threatening problems including hypersensitivity and cardiac events occurred in 146 cases, out of more than 155,000 patient exposures to the drug. Some patients had adverse reactions associated with hypersensitivity, like itching, rash, hives and wheezing. Some also had hypotension, or abnormally low blood pressure, which can cause dizziness, fainting and seizures; and chronic renal failure, the progressive loss of kidney function. The FDA and AMAG are discussing label changes to alert doctors and patients to these dangers, as well as an extension of the 30-minute period for observing patients after the drug has been administered.

Feraheme's sales have declined lately, and AMAG is restructuring its business to improve its profits, cutting 24 percent of its workforce. It may be that AMAG had more employees than it needed, but the firing of trained professionals in its workforce could subject the company, and the patients who use its drugs, to more problems. When employees are spread more thinly, they can lose sight of important quality and safety issues, allowing dangerous drugs to make it through the quality control process, and patients can get hurt. I have seen enough cases in my work as a drug defect lawyer to say that making money is often a higher priority for companies than patient safety. It's good that AMAG is talking with the FDA about how to protect patients, and I hope that losing 24 percent of its workforce will not thwart whatever protections they put in place.

Continue reading " Iron Replacement Drug Feraheme May Get Black Box Warning for Fatal Cardiac Events " »

Since the European Medicines Agency (EMA) decided to remove marketing for the type 2 diabetes drug Avandia last month because of the risk it poses for heart attacks, the research group Datamonitor has conducted a survey in an effort to understand how this decision will affect consumer buying and physicians prescribing the drug.

Of course, the United States’ FDA also has issued severe restrictions on the marketing of Avandia, which is manufactured by GlaxoSmithKline. Datamonitor’s study revealed the following:

• Avandia sales will drop to zero in Europe by 2011 when marketing authorization is suspended. In the USA, Avandia sales will plummet due to safety concerns and FDA restrictions, but Datamonitor predicts a small number of patients will remain on Avandia because they cannot tolerate other therapies.

• There currently is no strategy for most doctors to change patient therapies. This, in turn, will not assist any one anti-diabetic drug to gain market share.

• Even though a lot of patients likely will want to be switched onto the less fearful drug Actos, made by Takeda, it is expected that Takeda will not be able to capitalize for long off of Glaxo's downfall because Takeda will lose its patent protection in 2011.

• More than likely, some other patients will switch to using Merck & Co’s highly-successful drug Januvia (sitagliptin). These drugs don't work as well at lowering blood sugar, but they have proven safer and offer fewer side effects.

• Byetta and Victoza probably will get themselves some patients, and this will definitely help them with their class of drugs — at least, before something else comes along that works better and for a longer time period.

• Some patients will be switched from Avandia to the more common method of just using insulin with needles. This is likely to be the case for those that could benefit from using the once-daily basal insulins like Lantus and Levemir.

• Avandia's sales restrictions will hurt GlaxoSmithKline the most from 2010 to 2012. Datamonitor is predicting the company’s losses to be more than $1.2 billion during that time.

• Regardless of Avandia's losses in 2010 to 2012, the anti-diabetics market will grow by more than $200 million because of the restrictions and patients switching drugs.

Glaxo and the FDA have issued new warnings on Paxil-related birth defects for women who take the drug in their first trimester of pregnancy.

"Healthcare professionals are advised to carefully weigh the potential risks and benefits of using Paxil in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients,” FDA says.

A new study marked the progress of 3,500 women that were taking Paxil during their first trimester. The study revealed that among those women who were on antidepressants and whose babies were born with birth defects, the women that were taking Paxil had twice the amount of defects in their children as the women taking other pills.

While birth defects aren't common in the U.S., it still isn't clear whether Paxil is directly responsible for the defects in children, according to Glaxo. FDA officials have decided to have the labels on Paxil carry warnings to pregnant women.

Most of the birth defects that were detected during the study were heart-related. Of these, the most common heart defects were ventricular septal defects, or holes that are between the heart's two main valves that are used to pump blood through the body. This was a retrospective epidemiological study in that the researchers looked at big groups of people in a hindsight kind of way. There is not information on the children that were born with defect to women that were not taking Paxil while they were pregnant.

So while Glaxo continues to claim that there is no direct evidence linking birth defects in newborns to women that were taking Paxil during their pregnancies, the company and the FDA still decided to issue new warnings on the potential risks of pregnant women taking the drug.