Intelence, manufactured by Tibotec Therapeutics, is a drug for people with HIV that has now been found to be associated with Steven’s Johnson Syndrome, a rare life threatening blistering and skin death condition, as well as erythema multiforme and toxic epidermal necrolysis (an advanced SJS condition). Tibotec Therapeutics, a subsidiary of Johnson and Johnson, together with the Food and Drug Administration joined forces to alert infectious disease physicians so that they may be able to better educate candidates for Intelence. There will be a text change to the warning label of the Intelence bottle to alert consumers of the latest side effect as well.
Since January of 2008 when Intelence was first introduced to the market, there have been two reports of severe reaction and one death following use. Of the two suffering serious injury, one has seriously suffered from SJS and the other, SJS and liver failure. People using Intelence at this time may not be fully ware of the risks. People who are having any type of skin reaction during the use of Intelence should contact their physician immediately and inquire about changing medications.
Steven’s Johnson Syndrome can be a highly debilitating condition that affects people in varying degrees. In some cases, people experience blistering and skin death that progresses over time. People withsevere SJS are often treated in a burn unit to manage skin death which potentially leads to the person’s death when unresponsive to treatment.
At this time, it is not known how many other people will be affected by SJS, erythema multiforme and toxic epidermal necrolysis. Thus, it is unknown if, when or how many lawsuits against Intelence makers will follow.
Barr Laboratories, Inc., distributor for Dextroamphetamine/Amphetamine 20mg Tablet bottles Lot number 311756, has announced a recall of the company’s Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 20mg Tablets that were distributed beginning June of 2009 for a period of 5 days. It is the potency of the super-therapeutic dose that has caused the alarm. The potency exceeds the approved dosage.
Side Effects from the Overdose Tablets include:
Tardive Dysnkensia
Tachycardia and heart palpitations
High blood pressure
Tremors
Dizziness
Distorted vision
Euphoria
Mania
Anxiety
Nausea
Irregular Bowel Movements
Dry Mouth
Lack of appetite
Consumers, pharmacists and medical providers can identify the tablet by its oval shape, peach color and written text on one side indicating b/973 and 2/0 on the other side. People with these tablets are advised to return them to the pharmacy in which they purchased the prescription.
As Gabriel F. Zambrano, Attorney at Law and partner at Johnson Leiter & Belsky, Ft. Lauderdale, Florida explains, “Many women today may still not be aware of the risks associated with Yaz and Yasmin, the oral contraceptive drugs. This is a cause of great concern for girls as young as 13 years of age and adults using Yaz or Yasmin.” According to IMS Health, Yaz sales were $616 million (17.7% of the U.S. Market) and Yasmin sales were $382 million (11% of market share) in 2008, signifying the need to better inform widespread users. In fact, women using Yaz or Yasmin and doctors may not link medical conditions to Yaz or Yasmin side effects. Berlex Laboratories introduced the drugs in 2001. The company was purchased by Bayer Healthcare in 2006. Still, to date, women’s adverse event reports continue to stack up. As Daniel Gallucci, Attorney at Law, RodaNast, P.C., Lancaster, PA adds, “There are too many drugs today that receive fast track approval by the Food and Drug Administration. To make matters worse, consumers often do not know about warnings issued by the Food and Drug Administration. The consumer’s not knowing of the FDA warnings combined with the risks associated with Fast Track Approval, often can lead to large numbers of people being unnecessarily harmed.
Yaz and Yasmin Side Effects
Serious side effects associated with Yaz and Yasmin may include, but are not limited to:
heart attack
stroke
deep vein thrombosis, blood clots
gall bladder disease
hypertension
liver disorder, signified by jaundice and/or discolored urine
severe allergic reaction
psychological disorders, including mood swings and depression
The issues surrounding Yaz relate to the drug’s ingredients, including: estrogen ethinyl estradiol and drospirenone, a type of progestin. Yaz and Yasmin are comprised of the same ingredients. The tablet strength of ethinyl estradiol is .03 mcg in Yasmin and .03 mcg in Yaz. The ingredient combination may adversely affect the body’s ability to regulate salt and water. This may have an adverse impact on the heart and/or other bodily functions.
The new package insert provided with YAZ and Yasmin advises that women using the contraceptive should undergo potassium testing following one month of use. The reason why potassium testing is important is because the drug may alter the potassium level in women. Women who have unsatisfactory potassium levels may experience muscle cramps, fatigue, nausea, diarrhea, frequent urination, dehydration, low blood pressure, confusion, irritability, paralysis, abnormal heart rhythms, heart arrhythmias and potential heart attacks. Appropriate potassium levels are indicative that salt and water is properly regulating.
Yaz and Yasmin have been prescribed by physicians for use as an oral contraceptive or to treat PMS, PMDD or acne for birth control users. Girls as young as 13 years of age have used Yaz and Yasmin. Some girls as young as 13 years of age have been reported to have suffered from serious side effects because of Yaz/Yasmin. All oral contraceptives have risks, but some of the risks associated with Yaz and Yasmin are elevated when compared with other oral contraceptive drugs.
The Yaz/Yasmin Track Record
In 2003, the Yasmin TV AD denoting “Good Bye Kiss” prompted the first warning letter about the drug’s advertising practices. In 2008, the FDA issued a safety alert about the elevated risks associated with Yaz/Yasmin. This was seven years after the introduction of the drug. In 2008, the FDA ordered Bayer to cease misleading ads that created false impressions for women interested in using the oral contraceptive drug for PMS. In fact, the ads were misleading in numerous ways. As Gabriel F. Zambrano adds, “The ad campaigns overstated the uses and advantages of the drug. The campaigns failed to underscore the risks associated with the use of Yaz.” For example, Yaz has been suspected to be appropriate for women with PMDD, a premenstrual dysphoric disorder which is different than PMS. Yet, the safety and efficacy of Yaz for the treatment of PMDD has only been evaluated for three menstrual periods. In fact, Yaz has not been approved for the treatment of PMS. Moreover people are at an elevated risk for injury if they have Factor V Leiden. However, only a personal and family health history intake is gathered to screen for Factor V Leiden. The current screening process appears inadequate, at best. As Daniel Gallucci adds, “We need to reestablish trust in the review process by the FDA before a drug is placed on the market.”
In February of 2009, the Attorney Generals of 27 states came to settlements totaling $20 million. Bayer also initiated a corrective ad campaign. It is not known if a YAZ RECALL will be considered appropriate by the regulating authorities at this time. The verdict is not out for some Yaz and Yasmin lawsuits involving children as young as 13 years old who have taken the drug.
If you or a loved one has suffered from Yaz or Yasmin, we encourage you to seek out medical attention immediately, secure potassium test results, undergo screening for Factor V Leiden and consult with an attorney that understands the complexities associated with Yaz and Yasmin.
Since 1998, people have been using Singulair to treat asthma. Since 2003, other people with allergy related symptoms were prescribed Singulair by their doctors. In 2008, the FDA began to take a closer look at Singulair following reports of depression and suicide that have been linked to the use of Singulair.Merck, the manufacturer of Singulair, has rewritten the product label to include the risk of tremors, depression, anxiety and suicidal behavior.
The actions of the FDA and Merck signify the need for all consumers that have taken or take Singulair to report depression, anxiety, tremors and suicidal behavior to their doctor immediately. People with depression, anxiety and suicidal tendencies require medical attention to treat symptoms associated with these conditions. Failure to receive treatment for these conditions may lead to deeper depression, anxiety and greater suicide risk. In addition, doctors can provide alternatives to Singulair that may not pose mental condition risks.
Millions of people use Singulair. In fact, Singulair sales rose to $4.3 billion in 2007.Because people with mental conditions often privately see a physiatrist or psychologist about their health issue, the number of people affected by mental conditions as a result of Singulair use may not be accurately documented at this time. Thus, the risks associated with Singulair may be greater than data that has been collected by the FDA and Merck to date. >
People suffering from the adverse side effects of Singulair may seek out the advice of a personal injury attorney that focuses on product liability to learn more about entitlement to a lawsuit against Merck for serious personal injuries that have been sustained because of Singulair use.
Ethex Corporation announced multiple recalls of numerous drugs, including morphine, iron and prenatal vitamins. The string of recalls began to commence last year due to double dose tablets of morphine and other potential concerns. There have been recent reports that the FDA is questioning adequate quality control at the manufacturing facility where the morphine tablets were made. As Richard Schulte, Attorney at Law of Dayton, Ohio explains, “This is a clear case of manufacturer defect. The problem we are faced with now is we do not yet know the extent of defective pills on the market and how great of harm they caused to consumers.”
Signs of Overdose
The long term effects of the prenatal vitamins are unknown. Iron supplement overdose side effects usually occur shortly after intake. Iron poisoning side effects may include, vomiting diarrhea, liver dysfunction, jaundice, internal bleeding, and seizures.-1- The initial signs of overdose in morphine are clear and can be life threatening, but may not be fully apparent to the person using the drug. Opioid overdose includes:
• Rapid Heart Beat
• Hypertension
• Tremors
• Bluish Lips
• Headache
• Insomnia
• Dizziness and Fainting
• Blurred vision
• Upset stomach
• Fainting
• Low Blood Pressure
The List of Ethex Recalls
Isosorbide mononitrate: 30mg and 60mg
Propafenone HCI: 150mg, 225mg, and 300 mg
Dextroamphetamine sulfate tablets: 5mg and 10mg
Morphine sulfate ER: 15mg, 30mg, 60mg, 100mg 200mg
Morphine IR: 15mg and 30mg
Prenatal Vitamin Recalls
Advanced NatalCare® Tablets and Advanced-RF NatalCare® Tablets
Cal-Nate™ Tablets
CareNatal™ DHA Tablets
ComBgen Tablets
ComBiRx™Tablets
NataCaps Capsules
NatalCare Gloss, PIC, PIC Forte, Plus, Rx, Three Tablets
NataTab FA Tablets
NataTab RX Tablets
NutriNate® Chewable Tablets
NutriSpire™ Tablets
Prenatal MR 90 FE and MTR w/Selinium Tablets
Prenatal Rx 1 Tablets
Prenatal Z, Advanced Formula Tablets
Ultra NatalCare Tablets
Iron Supplement Recalls
Anemagen Caplets
Anemagen Forte Caplets
Conison™ Capsules
Fe-Tinic™ 150 Forte Capsules
