ADHD Drugs

Concerta, Ritalin and other drugs widely used to treat attention deficit hyperactivity disorder (ADHD) may lead to the possibility of hallucinations and suicidal tendencies in patients taking the drugs.

While such reports of serious psychiatric problems are rare and there is no proof they were caused by the drugs, the FDA has said a fuller discussion of the reports should be on drug labels. Current labeling discusses psychiatric problems that could be associated the drugs, but agency officials said they believe the labels do not clearly spell out the frequency and types of specific psychiatric problems.

The FDA made its decision to rewrite labels after reviewing 135 adverse event reports from Dec. 4, 2003, to Jan. 4, 2005, involving Johnson & Johnson's Concerta, a long-acting form of methylphenidate, the generic name for Ritalin, made by Novartis AG.

The Concerta review was mandated by law in drugs that are studied for use in children. Almost eight million prescriptions were written for Concerta during the same time period covered by the FDA review.

The FDA brought the review of Concerta to its pediatric advisory panel for advice on how best to communicate its concerns to the public. The agency chose not to focus on another category of ADHD drugs that includes Shire Pharmaceuticals PLC's Adderall, which was ordered off the market earlier this year in Canada after reports of 20 sudden deaths in patients, including 12 strokes.

The FDA has also been reviewing ADHD drugs for links to more serious problems like stroke. The drug labels warn of increased blood pressure and suggest the drugs can make any underlying psychiatric disorders worse, but patients may not be fully informed of the risks.

The most concerning serious side effects have been psychiatric events in young people. These have ranged from hallucinations, to suicidal thoughts, and even suicide attempts.

If you or a loved one has taken any ADHD drugs and suffered serious side effects, contact us today to find out if you might have a personal injury claim.

  • Cylert (pemoline) was a drug used for attention deficit hyperactivity disorder for thirty years before it was discontinued.

    In some patients pemoline has been suspected of causing hepatotoxicity (liver toxicity), so the FDA recommended that regular liver tests should be performed on those treated with it.

    Despite attempted efforts to make doctors and patients aware of the risk, the drug has been linked with a number of cases of liver failure, of which 13 resulted in liver replacement or death.

  • Darvocet is a powerful painkiller that combined the opioid drug dextropropoxyphene with acetaminophen. It was removed from the market due to a variety of unforeseen side effects.

    One of the primary risks of Darvocet was the fact that it contained acetaminophen. Overdose of acetaminophen could happen all too easily, leading to potentially fatal liver toxicity.

  • Duragesis pain patches are a delivery method of the painkiller fentanyl that are able to provide up to three days' relief from severe chronic pain, such as that experienced by bone cancer patients. However, the active ingredient, as well as faulty construction of the patches themselves led to serious risks to patients and an FDA ban.

    Dozens of overdoses and deaths were linked to use of Duragesic patches before they were pulled from the market. An overdose of the morphine-like drug can put a patient into a coma and shut down breathing.

  • Eczema, also called atopic dermatitis is painful and troublesome form of skin inflammation. One major type of drug used to treat this condition is the topical immunosuppressant. This category of medication is applied to the skin of patients who do not respond to steroids.

    Two specific drugs, Elidel (pimecrolimus) and Protopic (tacrolimus), approved for treatment of eczema, are not without controversy. They have been closely associated with a possible cancer risk in studies done on animals.

  • Antidepressant drugs such as Effexor (venlafaxine) have been shown to increase the chance of suicidal thoughts and attempts in adults under age 25, while reducing the risk among older adults. Effexor is licensed for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), panic disorder and social phobia.

    The risk of suicidal thinking or attempts is 62 percent higher among the young adults enrolled in clinical trials of antidepressants, compared with patients taking placebos, Food and Drug Administration staff has said. On the other hand, among adults over 25, the risk of suicidal thinking declines by 21 percent.

  • Enteryx is an injection used to treat gastroesophageal reflux disease (GERD). GERD is a chronic digestive disease where stomach acid flows back into the esophagus irritating its lining.

    Enteryx is injected as a liquid that solidifies into a spongy material that cannot be removed. When it is injected properly, it strengthens the lower esophagus, helping prevent stomach acid from entering it and causing pain.

  • Ephedra is an herbal stimulant that was used as a dietary supplement for both weight loss and athletic performance enhancement. However, it was linked to heart attacks, strokes and other health problems, which ultimately led to its ban by the Food and Drug Administration (FDA).

    Products containing ephedra and ephedra extract, also known as ma-huang, were widely promoted for losing weight and enhancing physical performance, with its popularity peaking in the early 2000s.

  • Letrozole is a drug approved for use only in postmenopausal women with breast cancer. But there is evidence some doctors have prescribed it as a fertility treatment because it suppresses estrogen and can promote ovulation. It is marketed under the name Femara.

    The manufacturer of a breast cancer drug, letrozole, has warned fertility doctors that it has been associated with birth defects, a caution prompted by reports that the drug was being used to help a woman become pregnant.

    Swiss drug manufacturer Novartis sent letters to fertility doctors worldwide to reiterate a warning that the drug should not be given to women who may be pregnant.

  • Fenfluramine/Phentermine, commonly called Fen-Phen, is a powerful diet drug that was taken by millions of Americans to combat obesity.

    However, clinical research showed that the fenfluramine portion of the combination can cause heart disease in otherwise healthy patients.

    Studies concluded that this drug could cause potentially fatal pulmonary hypertension and heart valve problems, which led to its eventually being pulled from the market.

    Though efforts were made to ensure that doctors no longer prescribed this harmful substance, many people were put at risk by this powerful drug.

  • Fosamax is an oral biphosphonate prescribed to millions of osteoporosis sufferers over the years. It is supposed to increase bone density by slowing down the body’s process of bone breakdown over time.

    However, researchers have now found that this drug can actually cause bones to weaken and crumble.