Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products and work by reducing stomach acids. Prescription PPIs are meant to treat gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. OTC PPIs treat frequent heartburn. PPIs include AcipHex (rabeprazole sodium), Dexilant (dexlansoprazole), Nexium (esomeprazole magnesium), Omeprazole (omeprazole) OTC, Prevacid (lansoprazole) and OTC Prevacid 24hr, Prilosec (omeprazole) and Prilosec OTC, Protonix (pantoprazole sodium), Vimovo (esomeprazole magnesium and naproxen), and Zegerid (omeprazole and Sodium bicarbonate) and Zegerid OTC.

C. difficile is a bacterium that can cause diarrhea that does not improve. Symptoms include watery stool, abdominal pain, and fever. Patients may develop more serious intestinal conditions and C. diff can be spread in hospitals.

The FDA has notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be linked to an increased risk of C. diff–associated diarrhea (CDAD). A CDAD diagnosis should be considered for patients taking PPIs who develop diarrhea that does not improve.

The FDA said it is working with drug makers to include information on the drug labels about the increased risk of CDAD with use of PPIs. The agency said it is also reviewing CDAD risks in patients who use histamine H2 receptor blockers, prescribed for the treatment of GERD, stomach and small intestine ulcers, and heartburn.

The FDA is advising patients to immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve. Healthcare Professionals should consider a diagnosis of CDAD in for PPI users with diarrhea that does not improve. Also, said the agency, patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

PPIs are known to increase risks for a number of serious medical conditions such as fractures of the hip, spine and wrist; increased risks for serious infections—in addition to C. diff and diarrhea—such as pneumonia; and severe magnesium deficiency, which can lead to life-threatening cardiac arrhythmias. Last year, consumer watchdog, Public Citizen, petitioned the FDA to mandate drug makers list serious adverse reactions associated with PPIs in a prominent black box warning on their labels.

SSRIs such as Celexa, Lexapro, Paxil, Prozac, and Zoloft have been implicated in serious adverse health effects in babies when taken by their mothers during pregnancy.

In this case, the Louisiana couple, Terry and Nelda Rolling, alleged that Zoloft, which Nelda took while pregnant, caused birth defects in their baby, the minor plaintiff, said The Louisiana Record. The Rolling’s are suing Pfizer individually and as parents and natural guardians of their baby—identified as K.R. The lawsuit was filed on January 27 in federal court in New Orleans.

Nelda Rolling claims Zoloft caused her baby, K.R., to be born with congenital birth defects, said The Louisiana Record. The lawsuit accuses Pfizer of not sufficiently warning about Zoloft’s risks; of concealing, suppressing, and failing to disclose Zoloft’s dangers; of violating the Louisiana Products Liability Act; and of allegedly violating the warranty of redhibition.

Zoloft has made news for its links to birth defects before. Just last month, a new study conducted at Sweden’s Karolinska Institute found that expectant mothers taking SSRIs could experience a doubling of the risk of giving birth to a baby born with a serious, life-threatening lung condition known as neonatal pulmonary hypertension (PPHN). The risk was seen in that study as two-fold when SSRIs were taken by the infants’ mothers during pregnancy. Researchers from Sweden, Norway, Iceland, Finland, and Denmark used data collected from birth registries in their countries as part of the study.

Other prior studies have also linked SSRI use during pregnancy to increases in other birth defects, such as skeletal and heart and limb deformities, cleft lip and palate.

The Plaintiffs’ Steering Committee has opposed a January 17 motion by the defense to exclude former FDA commissioner, David Kessler’s, opinions about the current FDA. Kessler, an expert witness for the plaintiffs, noted panel conflicts in an expert opinion in which he stated, after reviewing internal Bayer documents, that Bayer wrongfully withheld safety information from the agency, said Pharmalot.

More than 10,000 lawsuits claiming the birth control pills caused young women to suffer serious blood clots and other serious side effects, are pending in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) in federal court in Illinois. Plaintiffs’ lawyers have cited at least 50 reports of death linked to the drugs from 2004 to 2008.

According to Kessler, it was conflicts of interest that corrupted a meeting with two FDA advisory committees whose findings kept Yaz and Yasmin on the public market, said The Madison Record. On December 8, FDA advisors voted on two issues: If Yaz and Yasmin’s benefits outweighed its risks and if current labeling sufficiently presented the drugs’ risk benefit profile, said The Madison Record.

The FDA advisory committee voted, 15-to-11, that Yaz and Yasmin’s benefits outweigh its risk, said The committee also voted, 21-to-11, that the drugs’ risk benefit profile was not adequately presented. Denton indicated that the agency advised the members and temporary voting members at the start of the meeting that they were subject to federal conflict of interest laws, The Madison Record, said. The decision to allow Yaz and Yasmin to remain on the market, but with some additional information about blood clot risks,.

According to plaintiffs attorneys, Kessler analyzed paperwork on the backgrounds of committee members Paula Hillard, Anne Burke, Melissa Gilliam, and Julia Johnson and opined that, “Due to the complex dynamics that are part of the FDA advisory committee meetings, and in light of the fact that a reasonable person with knowledge of the relevant facts could question the above members’ impartiality, it is my opinion that the FDA advisory committee was not independent of Bayer, and its recommendations and votes need to be viewed as such,” The Madison Record reported.

According to plaintiffs’ attorneys, Kessler cited documents that identified one committee member as a “huge advocate” for Yasmin and a “Bayer trained speaker,” noting that either Bayer hid its connections to these individuals from its experts or that Bayer experts “intentionally omitted” these associations from their reports, The Madison Record said.

The study authors wrote that babies of women who took asthma drugs when pregnant suffered increased risks for isolated esophageal atresia (closed area of the esophagus), isolated anorectal atresia (closed area of the rectum and/or anus), and omphalocele (out-pouching of the intestines), said The Examiner. The risk was specifically seen in pregnant woman who took asthma medications in the month prior to becoming pregnant or in the first three months of being pregnant.

The study, conducted by Shao Lin, PhD and colleagues from the Center for Environmental Health, New York State Department of Health, Troy, utilized National Birth Defects Prevention Study data, said The Examiner. The ongoing, multi-center, population-based, case-controlled study reviewed birth defect causes, The Examiner explained. Interviews with mothers were conducted and DNA from family members was collected and analyzed. Babies with one or more of the involved birth defects—diaphragmatic hernia, esophageal atresia, small intestinal atresia, anorectal atresia, neural tube defects, omphalocele, or limb deficiencies—and babies without these birth defects (control infant), were study, noted The Examiner.

The review involved 2,853 live births, stillbirths, or elective terminations with delivery dates of October 1, 1997 – December 31, 2005 and with at least one of the study-defined birth defects. The control group consisted of 6,726 life births with no birth defects in the same time frame, with babies randomly chosen from birth hospital data or birth certificates, said The Examiner.

The researchers looked at when conception took place—peri-conceptional time—and use of anti-inflammatory drugs, bronchodilators, or both. Asthma medication exposure was defined as use of these drugs at least once in the month before pregnancy and through the third month, said The Examiner. Women who described their asthma drug intake “as needed” and who were unable to provide an exact time frame for medication use were excluded. Among other findings, the study revealed:

• A statistically significant association between isolated esophageal atresia and bronchodilator use.
• A statistically significant increased risk for isolated anorectal atresia with anti-inflammatory use.
• A statistically significant increased risk for isolated omphalocele with both bronchodilators and anti-inflammatory medications.
• Increased risks, not considered statistically significant, for esophageal atresia with anti-inflammatory use alone and with bronchodilators and anti-inflammatory use.

According to the study, from 60 – 67 percent of mothers whose babies were diagnosed with esophageal atresia, anorectal atresia, and omphalocele used bronchodilators during the entire pregnancy term. “With the interview information available for analysis, we were unable to distinguish between the effects of asthma and those of asthma medications; however, we did observe that mothers with possible indicators of uncontrolled asthma or severe asthma episodes (e.g., use of multiple bronchodilators) were at higher risk for delivering a child with one of the defects studied than those who used one bronchodilator.”

The study found that expectant mothers taking widely prescribed antidepressants are at a two-fold increased risk for giving birth to babies diagnosed with a rare, but serious, lung disorder, said WebMD. Specifically, selective serotonin reuptake inhibitor (SSRI) antidepressants such as Celexa, Lexapro, Paxil, Prozac, and Zoloft were linked to persistent pulmonary hypertension in newborns (PPHN) in this study.

According to the U.S. Food and Drug Administration (FDA), SSRIs such as Celexa (citalopram); Lexapro (escitalopram); Luvox and Luvox CR (fluvoxamine); Paxil, Paxil CR, and Pexeva (paroxetine); Prozac, Sarafem, and Symbyax (fluoxetine); Viibryd (vilazodone); and Zoloft (sertraline), are among the most popular drugs prescribed to treat depression during pregnancy. Yet, no sufficient, well-controlled studies of SSRIs in pregnant women exist.

PPHN occurs in about 1-2 newborns per 1,000 births and is a lung disorder in which the arteries are severely restricted. This restriction causes blood pressure in the heart’s pulmonary artery to rise to very high levels, which leaves babies unable to cope with breathing outside the womb, said NewsInferno. Newborns born with PPHN may need intensive care and a mechanical ventilator to increase their oxygen level. Severe, PPHN can lead to multiple organ damage, brain damage, and death.

For this study, the researchers, from Karolinska Institute, Stockholm, Sweden, reviewed birth registry data for all babies born 1996-2007 in Denmark, Finland, Iceland, Norway, and Sweden, which accounted for 1.6 million births. There were 33 cases of PPHN in babies whose mothers took SSRIs late in their pregnancies, which amounted to about three cases per 1,000 births, according to Web MD. This is double the amount that would be expected in the general newborn population for babies.

Babies born to mothers with a history of a prior hospitalization for a psychiatric disorder and who did not take an SSRI when pregnant also had a slightly increased PPHN risk. PPHN risk factors include, said WebMD, maternal obesity, diabetes, and smoking; 5-10 percent of babies with PPHN do not survive.

“This is by far the largest study to examine SSRI use and PPHN, but the fact that women with untreated depression had a higher risk for the disorder raises new doubts about this link,” said Gideon Koren, MD of Toronto’s Hospital for Sick Children. “Many doubts remain, and they should be shared with patients.”

Johnson & Johnson’s McNeil Consumer Healthcare unit wrote in a statement on its website that product testing indicated that some Motrin caplets might not dissolve as soon as they are supposed to when the mediation nears its expiration date, said Bloomberg Businessweek. Customers do not have to return the painkillers; however, there may be what McNeil described as “a delay in relief” after taking Motrin, spokeswoman Bonnie Jacobs told Businessweek.

Earlier this year, McNeil agreed to allow U.S. regulators increased oversight at three of its manufacturing plants, following a McNeil recall of tens of millions of packages of over-the-counter (OTC) medications over quality issues, said Businessweek. This recall involved Motrin distributed in the United States, Puerto Rico, Fiji, Belize, the Bahamas, St. Lucia, and Jamaica, said McNeil.

“Out of an abundance of caution, we are recalling all the listed products since there is a chance they could experience a similar problem as they approach expiration,” McNeil said, wrote Businessweek.

The recall involves lots of Motrin IB 24-count coated caplets, Motrin IB 24-count coated tablets, and Motrin IB 24+6 count coated caplets. According to Jacobs, it does not appear as if other Motrin products are involved and the cause of this problem is being investigated, wrote Businessweek.

NewsInferno recently wrote that drug giant Johnson & Johnson has recalled at least 22 products this year, costing—at last count—over $900 million in sales. The unprecedented series of recalls included at least 20 by McNeil involving hundreds of millions of bottles of adult and children’s formulations of Tylenol, Motrin, and other OTC medications.

Other recalls involved Ortho-McNeil-Janssen Pharmaceuticals’ division of its pre-filled Invega Sustenna syringe, Ethicon division’s surgical drainage products, two of DePuy Orthopaedics unit’s hip replacement implants, Animas unit’s insulin pump cartridges, 1-Day Acuvue TruEye contact lenses, and Simponi injection pens, to name just some, said NewsInferno.

Proscar and Propecia, which are known generically as finasteride belong to a class of drugs called 5-alpha reductase inhibitors, or 5-ARIs. Proscar is used to treat enlarged prostate, while Propecia is used to treat male pattern baldness.

The first lawsuit, filed in New Jersey federal court in February on behalf of a man from Texas and a man from Nevada who took Propecia for male pattern baldness, seeks tort status, said Lawyers USA. A lawyer involved in the case and who has filed scores of lawsuits on the matter, discussed men in their 20s – 40s suffering from depression and anxiety—three committed suicide—over Propecia’s side effects, said Lawyers USA.

Meanwhile, another mass tort petition filed in New Jersey state court on behalf of 46 plaintiffs is expected to ultimately include hundreds of plaintiffs, said Lawyers USA. This month, in New York, a plaintiff filed a motion to centralize cases into a multidistrict litigation, and a lawsuit was filed in Canada in July as a class action against Merck Canada. In that case, lead plaintiff, Michael Miller (22), alleges that after taking Proscar for eight months in 2008 he suffered, and continues to suffer from, erectile dysfunction. The distressing side effect has caused him to drop out of school, temporarily leave employment, and consider suicide, wrote Lawyers USA.

Propecia, and other ARIs, prevent the conversion of the androgen testosterone to dihydrotestosterone (DHT), a hormone critical to male sexual performance, explained NewsInferno. In other words, explained Lawyer USA, the drugs use the blocking enzyme Finasteride, which was approved in 1997 for the treatment of male pattern baldness. Dr. Alan Jacobs, a New York neuroendocrinologist noted that the drug blocks DHT in hair follicles, but can also block the enzyme in the sex organs and the brain, said Lawyer USA.

Merck’s Propecia label does warn about side effects including sexual dysfunction; however, the label indicates that side effects “resolve after discontinued use of the drug, according to a report from Newsnferno.com. The European Propecia label was updated in 2008 to warn of “persistent” sexual side effects; however, that update has not taken place in the United States, said NewsInferno. Lawsuits typically involve men whose symptoms continued even after the drug was stopped.

Dr. Jacobs noted that he has seen more and more men 18 – 30 years of age suffering from hypogonadism—erectile dysfunction, loss of sexual libido and REM sleep-related erections. Some also suffer from brain-related disorders such as anxiety, inability to concentrate, and “brain fog,” he added, said Lawyers USA. Symptoms do not always improve and, in cases in which improvement occurs and patients reinitiate treatment, symptoms return with increased ferocity, “as if the body remembers the drug and has a much more virulent response,” said Dr. Jacobs, wrote Lawyers USA.

A lawsuit filed in Ohio federal court in November, filed by Marc A. Duerk (25) alleged he suffered sexual dysfunction and cognitive impairment that continued after he ceased taking Propecia.

Significantly, sexual dysfunction is not the only side affect linked to 5-ARIs like Propecia. This year, the U.S. Food & Drug Administration (FDA) warned that the drugs were associated with increased risks for high-grade prostate cancer. These drugs may also increase the risks for male breast cancer, said NewsInferno.

Multaq is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.

The new boxed warning stresses study results that revealed that Multaq doubled risks for cardiac complications in patients with permanent AF, said The Associated Press (AP). Permanent AF is a condition in which the heart’s chambers pump out of rhythm. The new label also emphasizes that Multaq is only approved for short-term AF and AFL, a related condition, said the AP.

The FDA announced that it completed a safety review of Multaq that revealed an increased risk of serious cardiovascular events, including death, when used by patients in permanent AF; the FDA’s review was based on data from the PALLAS and ATHENA clinical trials. The revised Sanofi label, which was written collaboratively by the FDA and Sanofi and has been revised with the following changes and recommendations:

• Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
• Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
• Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF).
• Patients prescribed Multaq should receive appropriate antithrombotic therapy.

The FDA initiated its Multaq safety review in January, updating the drug’s label to include “liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Multaq.” In July, the FDA expanding this warning to include heart side effects, following PALLAS study results that revealed that patients taking Multaq for permanent AF were at a two-fold risk of death and increased risks for heart attack and stroke.. PALLAS was ceased over the summer after Multaq patients experienced higher-than-anticipated adverse cardiac events.

Yesterday’s FDA Drug Safety Communication indicated that 25 Multaq patients died during PALLAS, as opposed to 13 in the placebo group. Of those, 14 Multaq patients experienced sudden death or death from arrhythmia, versus 4 in the placebo group. In the Multaq group, 23 patients suffered stroke and 43 were hospitalized with heart failure, versus 10 and 24, respectively, from the placebo group. The FDA also reviewed ATHENA data, which was used to grant Multaq’s approval for temporary AF. The Safety Communication indicated that Multaq patients did not suffer increased cardiovascular death, stroke, or heart failure risks and, because of this, the FDA maintains that Multaq provides a benefit for patients with non-permanent AF.

The FDA’s initial Public Health Advisory issued in July 2006 on this potential risk was based on one published study; however, since, there have been conflicting findings from new studies evaluating the risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN. At this time, the agency is advising health care professionals not to alter their current clinical practice of treating depression during pregnancy. Healthcare professionals and patients should report any adverse events involving SSRIs to the FDA MedWatch Program, the agency said.

The FDA reviewed the additional new study results and said that, given the conflicting results from different studies, a conclusion about a potential link between SSRI use in pregnancy and PPHN would be premature. The FDA plans to update SSRI drug labels to reflect the new data and the conflicting results. SSRIs include Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, and Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); and Viibryd (vilazodone).

SSRIs operate by raising levels of serotonin, which plays a role in the development of the fetus, explained NewsInferno.

PPHN affects between 1 and 2 infants per 1000 live births in the general population; PPHN, although rare, is associated with significant infant morbidity and mortality as well as long term health issues. A 2006 study found a six-fold increase in PPHN among newborns whose mothers were exposed to an SSRI after 20 weeks of pregnancy and a more recent study found a statistically significant association between SSRI use and PPHN, although most SSRI exposure took place during the first trimester of pregnancy.

PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Babies born with PPHN may require intensive care support, including a mechanical ventilator to increase their oxygen level. Severe cases of PPHN can result in multiple organ damage, including brain damage, and even death.

Women who are pregnant or planning to become pregnant are advised to speak with their physicians, if they are depressed or being treated for depression, about appropriate treatment options and the benefits and risks of taking an SSRI during pregnancy. Patients should never stop taking an SSRI without first speaking with their physician as suddenly stopping SSRI treatment can cause a depression relapse and other adverse side effects.

The FDA notes that depression during pregnancy may lead to poor birth outcomes, including low birth weight, preterm delivery, lower Apgar Scores, poor prenatal care, failure to recognize or report signs of labor; an increased risk of fetal abuse; and neonaticide or maternal suicide.

As NewsInferno wrote, the controversy was sparked by research that indicated that medications like Byetta and Januvia might raise risks for pancreatic cancer and pancreatitis. The makers of the drugs continue to maintain the medications are safe.

The medical study, published in the journal Gastroenterology, was based on an analysis of reports made to the U.S. Food & Drug Administration’s (FDA) Adverse Event Reporting (AER) Database between 2004 and 2009. While the study’s findings do not prove that either drug causes cancer, the data raised concerns that they and other GLP-1 therapies, including Victoza, could raise cancer risks, said NewsInferno..

Both Januvia and Byetta lower diabetic blood sugar levels by promoting the action of the hormone glucagon-like peptide 1 (GLP-1) in the gut. This summer’s study revealed that use of either Byetta or Januvia, was linked with a six-fold increased risk for developing pancreatitis, versus other treatments. The study also revealed tat the pancreatic cancer event rate 2.9-fold greater in those patients taking Byetta and 2.7-fold greater in patients taking Januvia versus other treatments.

PharmaLive wrote that, based on the early results from the impact-assessment study, some doctors are questioning their use of Byetta, a glucagon-like peptide-1 mimetic and Januvia, a dipeptidyl peptidase−4 inhibitor sitagliptin (Januvia). About 11-20% of endocrinologists and primary care physicians surveyed indicated that they might decrease their use of the drugs in the future. About 29-30% of the doctors surveyed said that they intend on letting their patients know about the emerging issues concerning Byetta and Januvia, wrote PharmaLive.

This research, said PharmaLive, which tracked endocrinologists and primary care physicians, was conducted November 10-16, 2011, and involved 104 respondents comprised of 52 endocrinologists and 52 primary care physicians.